Medtronic, Inc. (NYSE: MDT) and Kyphon (NASDAQ: KYPH) today announced that the companies have signed a definitive merger agreement under which Medtronic will acquire all of the outstanding shares of Kyphon for $71 per share in cash. The transaction, which was unanimously approved by the boards of directors of both companies, is valued at approximately $3.9 billion. This excludes $320 million in payments associated with the St. Francis Medical Technologies, Inc. and Disc-O-Tech Medical Technologies, Ltd. transactions.
The acquisition price represents a 32% premium over Kyphon’s closing stock price on July 26, 2007 of $53.68 and a 35% premium over Kyphon’s 30-day average trading price of $52.76 per share. The transaction, which is anticipated to close in the first calendar quarter of 2008, is expected to be neutral to Medtronic earnings in the first full fiscal year after closing and accretive thereafter. Medtronic expects the merger to yield significant revenue, cost and tax synergies.
“We expect our combination with Kyphon to help accelerate the growth of Medtronic’s existing spinal business by extending our product offerings into some of the fastest growing product segments and enabling us to provide physicians with a broader range of therapies for use at all stages of the care continuum,” said Art Collins, chairman and chief executive officer of Medtronic. “Importantly, the combination will also enable more patients of all ages to receive the benefits of modern, minimally invasive spinal treatments earlier in their care, with life-style friendly options that are simpler, faster and less invasive than many traditional surgical treatments.
“We have great respect for Rich Mott and his team and look forward to Kyphon’s employees joining Medtronic at the close of the transaction. Kyphon’s world-class, global sales force will play a central role in the continued development of our spinal business,” Collins concluded.
“We are very enthusiastic about the opportunity to deliver outstanding value for our shareholders that fully reflects Kyphon’s innovation and growth potential. This merger also combines two recognized industry leaders in spinal treatments,” said Richard Mott, president and chief executive officer of Kyphon. “By merging our complementary strengths and collective resources into one organization, we will meaningfully increase our ability to ensure we meet the needs of our clinician customers around the world and the patients they serve. This combination also offers our employees the opportunity to become part of an organization with a shared vision and the depth of resources that are increasingly beneficial for sustained success in our industry. We look forward to working with Medtronic to complete the transaction quickly and seamlessly. Our board of directors believes that this acquisition is in the best interests of our shareholders, employees and other stakeholders and has unanimously voted to recommend that Kyphon shareholders vote in favor of it.”
The two companies’ product lines and geographic presence are highly complementary. While both companies have expertise in minimally invasive, highly effective treatments, Medtronic’s spinal surgery focus has been on providing treatment options for younger patients who are suffering from scoliosis and degenerative disc disease in the cervical and lumbar spine. Kyphon’s focus has been on treating older patients suffering from vertebral compression fractures and spinal stenosis. Together, the combined entity will be able to leverage its knowledge of modern fusion, dynamic stabilization, artificial disc replacement, biologics, vertebral augmentation, interspinous process decompression, disc disease diagnosis, navigation and minimally invasive techniques to serve patients with a broader variety of spinal disorders in order to alleviate pain and restore health for more patients.
The combined entity will also have a larger and expanded base of customers than Medtronic serves alone. Medtronic primarily serves orthopaedic and neurological surgeons who specialize in spinal surgery. Kyphon serves these same physicians and also has a significant customer base with interventional radiologists and interventional neuroradiologists.
The transaction will be financed by a combination of cash on the balance sheet and debt.
The transaction is subject to customary closing conditions, including approval by antitrust regulators as well as Kyphon shareholders.
Cleary Gottlieb Steen & Hamilton LLP is acting as legal advisor to Medtronic and Goldman, Sachs & Co. and Piper Jaffray are acting as financial advisors. Latham & Watkins LLP is acting as legal advisor to Kyphon and JPMorgan is acting as financial advisor.
Analyst Conference Call/Webcast
Medtronic and Kyphon will host an investor conference call (612-332-1210) later this morning at 7:30 a.m. central time (5:30 a.m. pacific time) to discuss the Kyphon acquisition. For complete instructions on how to participate in the conference call, or to listen to the live audio webcast or a replay of the webcast, please refer to the Investor Relations sections at http://www.medtronic.com or http://www.kyphon.com.
ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
ABOUT KYPHON INC.
Kyphon develops and markets medical devices designed to restore and preserve spinal function and diagnose the source of low back pain using minimally invasive technologies. The company’s products are used in balloon kyphoplasty for the treatment of spinal compression fractures caused by osteoporosis or cancer, in the Functional Anaesthetic Discography™ (F.A.D.™) procedure for diagnosing the source of low back pain, and in the Interspinous Process Decompression (IPD®) procedure for treating the symptoms of lumbar spinal stenosis. More information about the company and its products can be found at www.kyphon.com and its patient education Web site, www.spinalfracture.com.
Friday, July 27, 2007
GlaxoSmithKline statement in diabetes care study thiazolidinediones and heart failure: a teleo-analysis [1]
This is an analysis of existing data that has been previously published (online in Diabetes Care, 29 May 2007) and provides no new information on the risk of heart failure associated with the thiazolinediones (TZD) class.
“The risk of heart failure in diabetes patients and with use of these medicines is well recognised and is clearly identified in prescribing information to doctors in the UK. Whilst continued patient safety is paramount, we must also remember that Type II diabetes can have devastating consequences including stroke, blindness, amputation and kidney failure. Rosiglitazone therefore has an important role to play as one of the medicines, doctors can use to treat the 2 million patients currently diagnosed with type 2 diabetes in the UK,” said, Dr. Alastair Benbow, European Medical Director, GlaxoSmithKline.
The analysis does not include the results from the ADOPT2 (A Diabetes Outcome Progression Trial) study, and the RECORD3 (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycemia in Diabetes) interim analysis, two recently published long-term prospective studies in which the risk of heart failure is assessed in patients taking rosiglitazone.
The authors correctly point out that diabetic patients are known to be at increased risk of developing congestive heart failure. The authors also report an increased risk of heart failure with TZD therapy. It is well recognized that this class of medicine can cause fluid retention which may exacerbate or lead to heart failure. This is clearly stated in the European prescribing information for rosiglitazone. In addition, in Europe, rosiglitazone is contraindicated for patients with New York Heart Association (NYHA) Class I-IV cardiac failure or those with a history of cardiac failure. These contraindications have been in the SPC since rosiglitazone was approved in Europein June 2000.
Questions about the safety of rosiglitazone are best answered by long-term prospective studies such as ADOPT and RECORD interim analysis. In ADOPT the same number of congestive heart failure (CHF) serious adverse events were reported for rosiglitazone versus metformin in a drug naive diabetic population. However those on glibenclamide experienced a lower rate of serious CHF events compared to both rosiglitazone and metformin.
In the RECORD interim analysis, rosiglitazone was associated with significantly more cases of CHF when compared with patients on control – metformin and sulphonylurea (hazard ratio 2.24). Despite the increase in CHF however, the primary outcome of cardiovascular hospitalizations and death showed no significant difference between the rosiglitazone group and the met/SU group.
It is important for physicians to use rosiglitazone in appropriate patients in line with the European SPC, which states that rosiglitazone should not be used in patients with CHF. GSK is confident in the overall safety profile of rosiglitazone when used appropriately.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
References
1. Singh et. Al. Thiazolidinediones and Heart Failure: A Teleo-Analysis. Diabetes Care. Published online: 29 May, 2007. Print publication: 27 July 2007
2. Kahn S et al. Glycemic durability of rosiglitazone, metformin or glyburide monotherapy. NEJM 2006 355: 23; 2427-2443
3. Home P D, et al. Rosiglitazone Evaluated for Cardiovascular Outcomes – An Interim Analysis. NEJM 2007: 357: 28-38
“The risk of heart failure in diabetes patients and with use of these medicines is well recognised and is clearly identified in prescribing information to doctors in the UK. Whilst continued patient safety is paramount, we must also remember that Type II diabetes can have devastating consequences including stroke, blindness, amputation and kidney failure. Rosiglitazone therefore has an important role to play as one of the medicines, doctors can use to treat the 2 million patients currently diagnosed with type 2 diabetes in the UK,” said, Dr. Alastair Benbow, European Medical Director, GlaxoSmithKline.
The analysis does not include the results from the ADOPT2 (A Diabetes Outcome Progression Trial) study, and the RECORD3 (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycemia in Diabetes) interim analysis, two recently published long-term prospective studies in which the risk of heart failure is assessed in patients taking rosiglitazone.
The authors correctly point out that diabetic patients are known to be at increased risk of developing congestive heart failure. The authors also report an increased risk of heart failure with TZD therapy. It is well recognized that this class of medicine can cause fluid retention which may exacerbate or lead to heart failure. This is clearly stated in the European prescribing information for rosiglitazone. In addition, in Europe, rosiglitazone is contraindicated for patients with New York Heart Association (NYHA) Class I-IV cardiac failure or those with a history of cardiac failure. These contraindications have been in the SPC since rosiglitazone was approved in Europein June 2000.
Questions about the safety of rosiglitazone are best answered by long-term prospective studies such as ADOPT and RECORD interim analysis. In ADOPT the same number of congestive heart failure (CHF) serious adverse events were reported for rosiglitazone versus metformin in a drug naive diabetic population. However those on glibenclamide experienced a lower rate of serious CHF events compared to both rosiglitazone and metformin.
In the RECORD interim analysis, rosiglitazone was associated with significantly more cases of CHF when compared with patients on control – metformin and sulphonylurea (hazard ratio 2.24). Despite the increase in CHF however, the primary outcome of cardiovascular hospitalizations and death showed no significant difference between the rosiglitazone group and the met/SU group.
It is important for physicians to use rosiglitazone in appropriate patients in line with the European SPC, which states that rosiglitazone should not be used in patients with CHF. GSK is confident in the overall safety profile of rosiglitazone when used appropriately.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
References
1. Singh et. Al. Thiazolidinediones and Heart Failure: A Teleo-Analysis. Diabetes Care. Published online: 29 May, 2007. Print publication: 27 July 2007
2. Kahn S et al. Glycemic durability of rosiglitazone, metformin or glyburide monotherapy. NEJM 2006 355: 23; 2427-2443
3. Home P D, et al. Rosiglitazone Evaluated for Cardiovascular Outcomes – An Interim Analysis. NEJM 2007: 357: 28-38
Thursday, July 26, 2007
Medtronic Announces Agreement with Spinal Neuromonitoring Innovator
Medtronic, Inc. (NYSE: MDT) today announced it has entered into a distribution and development agreement with Axon Systems, a privately-held developer of neuromonitoring technology used during spinal surgery. The agreement will allow Medtronic and Axon Systems to bring to market the next generation of surgeon directed and professionally supported spinal neuromonitoring technology and expand the availability of this critical technology.
This agreement will have an immediate impact on Medtronic’s spinal neuromonitoring product line and sets the stage for possible integration across all of Medtronic's core spinal therapy offerings.
The first new products enabled by this strategic alliance will be the NIM-ECLIPSE™ Spinal System of neuromonitoring capital and disposable equipment. NIM-ECLIPSE received 510k clearance in the U.S. in May 2006. This equipment will allow for as many as 32 channels of simultaneous electroencephalography (EEG), evoked potentials (EP) and electromyography (EMG) monitoring. NIM-ECLIPSE™ Spinal System also provides for automatic pedicle screw monitoring with direct nerve and screw stimulation. During spinal surgery, the NIM-Eclipse may allow physicians to monitor critical neural pathways which helps prevent post-operative neurological deficits.
“We are extremely excited about our relationship with Axon Systems and the opportunity to improve the availability of intraoperative spinal neuromonitoring service and technology,” said Pete Wehrly, senior vice president and president of the Spinal and Biologics businesses at Medtronic. “Axon Systems has been a neuromonitoring technology innovator and leader since 1987 and our partnership will enable us to better integrate neuromonitoring technology into Medtronic’s core spinal therapies.”
“Working with Medtronic is a wonderful opportunity for us to improve our abilities of how best to deliver and integrate neuromonitoring technology and techniques into surgical procedures that place the spinal nervous system at risk,” said Howard Bailin, founder and COO of Axon Systems.
About the Spinal and Biologics Business at Medtronic
The Spinal and Biologics business, based in Memphis, Tenn., is the global leader in today’s spine market and is committed to advancing the treatment of spinal conditions. Medtronic collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art therapies for spinal, neurological, orthopaedic and oral maxillofacial conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies. More information about the company and its spinal treatments can be found at http://www.medtronicspinal.com/ and its patient-education Web sites, http://www.back.com/ , http://www.iscoliosis.com/ , http://www.maturespine.com/ and http://www.necksurgery.com/.
About Medtronic
Medtronic, Inc. (http://www.medtronic.com/), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
About Axon Systems
Axon Systems, founded in 1987, is a leading manufacturer of neurological intraoperative (NIOM) and intensive care monitors. Its products are used in operating rooms to monitor critical neural pathways during surgery, aiding surgeons and helping to prevent post-operative neurological deficits. In the intensive care unit Axon products are used for diagnostic long-term monitoring and to provide prognostic information and guiding patient care. More information about the company and its products can be found at http://www.axonsystems.com/
This agreement will have an immediate impact on Medtronic’s spinal neuromonitoring product line and sets the stage for possible integration across all of Medtronic's core spinal therapy offerings.
The first new products enabled by this strategic alliance will be the NIM-ECLIPSE™ Spinal System of neuromonitoring capital and disposable equipment. NIM-ECLIPSE received 510k clearance in the U.S. in May 2006. This equipment will allow for as many as 32 channels of simultaneous electroencephalography (EEG), evoked potentials (EP) and electromyography (EMG) monitoring. NIM-ECLIPSE™ Spinal System also provides for automatic pedicle screw monitoring with direct nerve and screw stimulation. During spinal surgery, the NIM-Eclipse may allow physicians to monitor critical neural pathways which helps prevent post-operative neurological deficits.
“We are extremely excited about our relationship with Axon Systems and the opportunity to improve the availability of intraoperative spinal neuromonitoring service and technology,” said Pete Wehrly, senior vice president and president of the Spinal and Biologics businesses at Medtronic. “Axon Systems has been a neuromonitoring technology innovator and leader since 1987 and our partnership will enable us to better integrate neuromonitoring technology into Medtronic’s core spinal therapies.”
“Working with Medtronic is a wonderful opportunity for us to improve our abilities of how best to deliver and integrate neuromonitoring technology and techniques into surgical procedures that place the spinal nervous system at risk,” said Howard Bailin, founder and COO of Axon Systems.
About the Spinal and Biologics Business at Medtronic
The Spinal and Biologics business, based in Memphis, Tenn., is the global leader in today’s spine market and is committed to advancing the treatment of spinal conditions. Medtronic collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art therapies for spinal, neurological, orthopaedic and oral maxillofacial conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies. More information about the company and its spinal treatments can be found at http://www.medtronicspinal.com/ and its patient-education Web sites, http://www.back.com/ , http://www.iscoliosis.com/ , http://www.maturespine.com/ and http://www.necksurgery.com/.
About Medtronic
Medtronic, Inc. (http://www.medtronic.com/), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
About Axon Systems
Axon Systems, founded in 1987, is a leading manufacturer of neurological intraoperative (NIOM) and intensive care monitors. Its products are used in operating rooms to monitor critical neural pathways during surgery, aiding surgeons and helping to prevent post-operative neurological deficits. In the intensive care unit Axon products are used for diagnostic long-term monitoring and to provide prognostic information and guiding patient care. More information about the company and its products can be found at http://www.axonsystems.com/
Tuesday, July 24, 2007
ISENTRESS (raltegravir), an Investigational Oral HIV Integrase Inhibitor, in Combination Therapy Demonstrated HIV RNA Reduction Comparable to Efaviren
ISENTRESS™ (raltegravir), an Investigational Oral HIV Integrase Inhibitor, in Combination Therapy Demonstrated HIV RNA Reduction Comparable to Efavirenz in Treatment-Naïve HIV-Positive Patients
Results from an ongoing 48 week Phase II study of ISENTRESSTM (raltegravir), an investigational oral HIV integrase inhibitor, under development by Merck & Co., Inc., in combination with tenofovir (Viread®) and lamivudine (Epivir®) demonstrated that ISENTRESS provided reductions in HIV RNA to undetectable levels of less than 50 copies/mL (83 to 88 percent of patients) comparable to efavirenz (Sustiva®) combined with the same agents (87 percent of patients). These results were observed with all four doses of ISENTRESS studied (100 mg, 200 mg, 400 mg or 600 mg twice daily) in treatment-naïve (previously untreated) patients infected with HIV. In addition, ISENTRESS showed minimal impact on total and low-density lipoprotein (LDL) serum cholesterol, serum triglycerides and the ratio of total cholesterol to HDL cholesterol. These results indicate that ISENTRESS provided sustained viral load reduction and minimal lipid effects when compared with the initial 24-week results presented at the 2006 International AIDS Conference in Toronto.
These data were presented this week at the 4th International AIDS Society Conference (IAS) on HIV Pathogenesis, Treatment and Prevention in Sydney, Australia.
"In this study, the viral load reductions were sustained at Week 48 in treatment-naïve patients," said Martin Markowitz, MD, lead study investigator and clinical director of the Aaron Diamond AIDS Research Center in New York. "These findings are consistent with the efficacy and tolerability profiles that were seen with ISENTRESS at 24 weeks."
Study design
These findings are from an ongoing multi-center, dose-ranging double-blind, randomized trial of previously untreated HIV-positive patients. In this study, 198 treatment-naïve HIV-positive patients received either ISENTRESS (100mg, 200mg, 400mg, or 600 mg, each administered orally twice daily) in combination with tenofovir and lamivudine or received 600 mg efavirenz dosed orally once daily in combination with the same agents. The complete 48-week data being presented today compared ISENTRESS to efavirenz both in combination with tenofovir and lamivudine on three measures: sustained reductions in HIV viral RNA; improvements in CD4 cell counts from baseline; and evaluation of safety and tolerability.
Reduction in viral load
At 48 weeks of therapy, 83 to 88 percent of patients receiving the regimen containing ISENTRESS (at all doses studied) maintained reductions in HIV RNA viral load to less than 50 copies/mL. Results were comparable for patients taking the efavirenz combination, with 87 percent of patients maintaining reductions in HIV RNA viral load to less than 50 copies/mL at week 48.
At baseline, HIV RNA for patients on the ISENTRESS arm of the study was 58,206 copies/mL (100 mg; n=39), 64,715 copies/mL (200 mg; n=40), 43,083 copies/mL (400 mg; n=41) and 57,919 copies/mL (600 mg; n=40). Baseline HIV RNA for patients in the efavirenz arm of the study was 67,554 copies/mL (600 mg; n=38).
Increase in CD4 cell counts
Patients on both treatment regimens experienced increases in CD4 cell counts. Mean baseline CD4 cell counts ranged from 271 to 338 cells/uL across all treatment arms. At 48 weeks of treatment, the mean increase from baseline in CD4 cell counts of the groups receiving ISENTRESS ranged from 144 to 221 cells/uL, and mean increase from baseline in CD4 cell counts of the efavirenz group was 170 cells/uL.
Minimal effect on lipid levels
Both treatment regimens were generally well tolerated. ISENTRESS had minimal effect on total and LDL serum cholesterol, serum triglycerides and the ratio of total cholesterol to HDL cholesterol. The mean changes from baseline at Week 48 for ISENTRESS (all doses combined) and efavirenz, respectively, were -2.3 mg/dL and +20.7 mg/dL (p <.001) for total cholesterol; -7.5 mg/dL and +3.0 mg/dL (p=.0016) for LDL cholesterol; -1.0 mg/dL and +49.5 mg/dL (p=.068) for triglycerides and -0.59 mg/dL and -0.47 mg/dL (p=0.52) for the ratio of total cholesterol to HDL cholesterol.
Clinical safety profile
Clinical adverse experiences were generally mild to moderate, with nausea, dizziness and headache reported most frequently. Neuropsychiatric adverse events, such as abnormal dreams, depression, nightmare and suicidal thoughts were less frequent in patients on the ISENTRESS based regimens (all doses combined) compared to those on the efavirenz-based regimen, occurring respectively in 13 versus 29 percent, through week 48.
About ISENTRESS
ISENTRESS, previously referred to as MK-0518, is the first in a new class of investigational antiretroviral agents called integrase inhibitors that inhibit the insertion of HIV viral DNA into human DNA. Inhibiting integrase from performing this essential function blocks the ability of the virus to replicate and infect new cells. There are drugs in use that inhibit two other enzymes critical to the HIV replication process - protease and reverse transcriptase - but there are no approved drugs that inhibit integrase. ISENTRESS is being studied in a twice daily regimen as a single tablet administered without regard to food. ISENTRESS does not require boosting with ritonavir.
The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ISENTRESS for use in treatment-experienced patients and has granted priority review status, a designation for investigational products that address unmet medical needs. Under the priority review designation, the FDA is expected to review and act on the NDA for ISENTRESS within six months of submission. Merck anticipates FDA action by mid-October and as planned is also moving forward with regulatory filings in countries outside of the United States.
ISENTRESS expanded access program
Expanded access programs with ISENTRESS are currently open to HIV/AIDS patients with limited or no treatment options. Expanded access is a mechanism supported by many regulatory agencies for getting investigational treatment to patients who have a life threatening disease and who cannot be satisfactorily treated with an alternative therapy or available drug. Currently, more than 4,000 patients worldwide are participating in the expanded access programs with ISENTRESS. For more information on the program visit www.benchmrk.com
Prevalence of HIV/AIDS
An estimated 40 million people are infected with HIV/AIDS worldwide, and more than 4 million new infections occurred worldwide in 2006i. In 2005, over 1 million Americans were living with HIV and approximately 40,000 new cases of HIV/AIDS were diagnosed.ii AIDS is one of the top causes of infectious disease-related mortality worldwide, responsible for nearly 3 million deaths last year alone.iii
Merck HIV research
Merck is committed to developing innovative therapies that offer advances in the treatment of infectious diseases - including HIV. Merck's efforts to develop investigational treatments and a vaccine against HIV/AIDS have been under way for almost 20 years and continue today. Merck began its HIV integrase inhibitor research in 1993 and was the first to demonstrate inhibition of HIV integrase in vitro and in vivo.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
i UNAIDS, 2006 Report on the Global AIDS Epidemic
ii CDC. Basic Statistics. HIV/AIDS Surveillance Report: HIV Infection and AIDS in the United States and Dependent Areas, 2005.
iii UNAIDS and WHO. AIDS Epidemic Update. December 2006.
Results from an ongoing 48 week Phase II study of ISENTRESSTM (raltegravir), an investigational oral HIV integrase inhibitor, under development by Merck & Co., Inc., in combination with tenofovir (Viread®) and lamivudine (Epivir®) demonstrated that ISENTRESS provided reductions in HIV RNA to undetectable levels of less than 50 copies/mL (83 to 88 percent of patients) comparable to efavirenz (Sustiva®) combined with the same agents (87 percent of patients). These results were observed with all four doses of ISENTRESS studied (100 mg, 200 mg, 400 mg or 600 mg twice daily) in treatment-naïve (previously untreated) patients infected with HIV. In addition, ISENTRESS showed minimal impact on total and low-density lipoprotein (LDL) serum cholesterol, serum triglycerides and the ratio of total cholesterol to HDL cholesterol. These results indicate that ISENTRESS provided sustained viral load reduction and minimal lipid effects when compared with the initial 24-week results presented at the 2006 International AIDS Conference in Toronto.
These data were presented this week at the 4th International AIDS Society Conference (IAS) on HIV Pathogenesis, Treatment and Prevention in Sydney, Australia.
"In this study, the viral load reductions were sustained at Week 48 in treatment-naïve patients," said Martin Markowitz, MD, lead study investigator and clinical director of the Aaron Diamond AIDS Research Center in New York. "These findings are consistent with the efficacy and tolerability profiles that were seen with ISENTRESS at 24 weeks."
Study design
These findings are from an ongoing multi-center, dose-ranging double-blind, randomized trial of previously untreated HIV-positive patients. In this study, 198 treatment-naïve HIV-positive patients received either ISENTRESS (100mg, 200mg, 400mg, or 600 mg, each administered orally twice daily) in combination with tenofovir and lamivudine or received 600 mg efavirenz dosed orally once daily in combination with the same agents. The complete 48-week data being presented today compared ISENTRESS to efavirenz both in combination with tenofovir and lamivudine on three measures: sustained reductions in HIV viral RNA; improvements in CD4 cell counts from baseline; and evaluation of safety and tolerability.
Reduction in viral load
At 48 weeks of therapy, 83 to 88 percent of patients receiving the regimen containing ISENTRESS (at all doses studied) maintained reductions in HIV RNA viral load to less than 50 copies/mL. Results were comparable for patients taking the efavirenz combination, with 87 percent of patients maintaining reductions in HIV RNA viral load to less than 50 copies/mL at week 48.
At baseline, HIV RNA for patients on the ISENTRESS arm of the study was 58,206 copies/mL (100 mg; n=39), 64,715 copies/mL (200 mg; n=40), 43,083 copies/mL (400 mg; n=41) and 57,919 copies/mL (600 mg; n=40). Baseline HIV RNA for patients in the efavirenz arm of the study was 67,554 copies/mL (600 mg; n=38).
Increase in CD4 cell counts
Patients on both treatment regimens experienced increases in CD4 cell counts. Mean baseline CD4 cell counts ranged from 271 to 338 cells/uL across all treatment arms. At 48 weeks of treatment, the mean increase from baseline in CD4 cell counts of the groups receiving ISENTRESS ranged from 144 to 221 cells/uL, and mean increase from baseline in CD4 cell counts of the efavirenz group was 170 cells/uL.
Minimal effect on lipid levels
Both treatment regimens were generally well tolerated. ISENTRESS had minimal effect on total and LDL serum cholesterol, serum triglycerides and the ratio of total cholesterol to HDL cholesterol. The mean changes from baseline at Week 48 for ISENTRESS (all doses combined) and efavirenz, respectively, were -2.3 mg/dL and +20.7 mg/dL (p <.001) for total cholesterol; -7.5 mg/dL and +3.0 mg/dL (p=.0016) for LDL cholesterol; -1.0 mg/dL and +49.5 mg/dL (p=.068) for triglycerides and -0.59 mg/dL and -0.47 mg/dL (p=0.52) for the ratio of total cholesterol to HDL cholesterol.
Clinical safety profile
Clinical adverse experiences were generally mild to moderate, with nausea, dizziness and headache reported most frequently. Neuropsychiatric adverse events, such as abnormal dreams, depression, nightmare and suicidal thoughts were less frequent in patients on the ISENTRESS based regimens (all doses combined) compared to those on the efavirenz-based regimen, occurring respectively in 13 versus 29 percent, through week 48.
About ISENTRESS
ISENTRESS, previously referred to as MK-0518, is the first in a new class of investigational antiretroviral agents called integrase inhibitors that inhibit the insertion of HIV viral DNA into human DNA. Inhibiting integrase from performing this essential function blocks the ability of the virus to replicate and infect new cells. There are drugs in use that inhibit two other enzymes critical to the HIV replication process - protease and reverse transcriptase - but there are no approved drugs that inhibit integrase. ISENTRESS is being studied in a twice daily regimen as a single tablet administered without regard to food. ISENTRESS does not require boosting with ritonavir.
The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ISENTRESS for use in treatment-experienced patients and has granted priority review status, a designation for investigational products that address unmet medical needs. Under the priority review designation, the FDA is expected to review and act on the NDA for ISENTRESS within six months of submission. Merck anticipates FDA action by mid-October and as planned is also moving forward with regulatory filings in countries outside of the United States.
ISENTRESS expanded access program
Expanded access programs with ISENTRESS are currently open to HIV/AIDS patients with limited or no treatment options. Expanded access is a mechanism supported by many regulatory agencies for getting investigational treatment to patients who have a life threatening disease and who cannot be satisfactorily treated with an alternative therapy or available drug. Currently, more than 4,000 patients worldwide are participating in the expanded access programs with ISENTRESS. For more information on the program visit www.benchmrk.com
Prevalence of HIV/AIDS
An estimated 40 million people are infected with HIV/AIDS worldwide, and more than 4 million new infections occurred worldwide in 2006i. In 2005, over 1 million Americans were living with HIV and approximately 40,000 new cases of HIV/AIDS were diagnosed.ii AIDS is one of the top causes of infectious disease-related mortality worldwide, responsible for nearly 3 million deaths last year alone.iii
Merck HIV research
Merck is committed to developing innovative therapies that offer advances in the treatment of infectious diseases - including HIV. Merck's efforts to develop investigational treatments and a vaccine against HIV/AIDS have been under way for almost 20 years and continue today. Merck began its HIV integrase inhibitor research in 1993 and was the first to demonstrate inhibition of HIV integrase in vitro and in vivo.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
i UNAIDS, 2006 Report on the Global AIDS Epidemic
ii CDC. Basic Statistics. HIV/AIDS Surveillance Report: HIV Infection and AIDS in the United States and Dependent Areas, 2005.
iii UNAIDS and WHO. AIDS Epidemic Update. December 2006.
Thursday, July 19, 2007
Genzyme Corporation Announces Phase 3 Trial of Mozobil in non-Hodgkin's Lymphoma Meets Primary Endpoint
Genzyme Corp. (Nasdaq: GENZ) today announced that it has successfully completed its phase 3 trial of MozobilTM (plerixafor) in non-Hodgkin’s lymphoma (NHL), and that the trial has robustly met its primary and secondary endpoints.
The randomized, double-blind, placebo-controlled trial included 298 patients who were undergoing a hematopoietic stem cell transplant (HSCT) for NHL at medical centers in the United States and Canada. It examined the effectiveness of Mozobil in increasing the number of hematopoietic stem cells collected for a transplant. The study compared the hematopoietic stem cell yield from patients treated with Mozobil in combination with G-CSF to patients treated with G-CSF in combination with placebo. G-CSF is the standard of care for stimulating the mobilization of stem cells from the bone marrow; Mozobil is designed to allow for the more rapid and effective release of those stem cells from the marrow into the circulating blood for collection by apheresis.
In the primary efficacy endpoint, 59 percent of patients treated with a combination of Mozobil and G-CSF achieved the target threshold for collection of at least 5 million CD34+cells/kg from the peripheral blood with four or fewer days of apheresis sessions, compared with 20 percent of patients in the G-CSF/placebo group. The three-fold increase was highly statistically significant in favor of the Mozobil-treated patients (p<0.0001). The 40 percent absolute difference between the two treatment groups was nearly double the target that Genzyme prospectively defined in the protocol for the study, which was reviewed by FDA as part of the Special Protocol Assessment process.
In the secondary efficacy endpoint, nearly 87 percent of patients treated with Mozobil and G-CSF achieved the minimum level of stem cells generally associated with a successful transplant (2 million CD34+cells/kg) in four or fewer days of apheresis sessions, compared with approximately 47 percent in the placebo arm. This result was also highly statistically significant in favor of the Mozobil-treated patients (p<0.0001).
The other secondary efficacy endpoints were supportive of these findings, including analysis of the number of days needed to reach target ranges for stem cell mobilization, the success of engraftment, the number of days needed to engraft, and the durability of the engraftment for the first 100 days.
Mozobil was well tolerated in the trial, with the most common adverse events being mild gastrointestinal effects and redness at the site of injection. There were two related serious adverse events seen in the Mozobil plus G-CSF arm, and one in the G-CSF plus placebo arm.
“These are very impressive results with far-reaching clinical importance for patients undergoing a stem cell transplant for lymphoma,” said Principal Investigator John F. DiPersio, M.D., Ph.D., professor, Washington University, St. Louis. “Current literature suggests that increasing the number of stem cells in circulation and the number collected at the time of apheresis may improve the outcomes of patients undergoing a stem cell transplant, reduce the costs associated with stem cell collection and, more importantly, broaden the pool of patients for whom transplantation is an option.”
Based on these results Genzyme expects to file for US and European approval in lymphoma in the first half of 2008. In addition, Genzyme is completing a second phase 3 trial of Mozobil in multiple myeloma, and results are expected in the coming weeks.
About Mozobil
Mozobil, a novel small molecule CXCR4 chemokine antagonist, has been shown in multiple earlier studies to rapidly and effectively increase the number of stem cells in circulation in the blood. Once circulating in the blood, stem cells can be collected for use in a stem cell transplant. Mozobil has been granted special protocol assessment and orphan drug status in the United States and European Union and the pivotal trials have undergone Special Protocol Assessment by the FDA and Protocol Assistance by the EMEA. Genzyme intends to commercialize Mozobil through its existing global transplant business to hematologists and hematopoietic stem cell transplant centers in more than 50 countries throughout the world. Genzyme has been developing Mozobil since its acquisition of AnorMED, Inc. in 2006.
Approximately 55,000 stem cell transplants are performed each year for multiple myeloma, Hodgkin’s and non-Hodgkin’s lymphoma, and other conditions in markets where Genzyme has a commercial infrastructure, including the United States, Europe, Latin America and the Asian Pacific countries.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 9,000 employees in locations spanning the globe and 2006 revenues of $3.2 billion. Genzyme has been selected by FORTUNE as one of the “100 Best Companies to Work for” in the United States.
With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.
The randomized, double-blind, placebo-controlled trial included 298 patients who were undergoing a hematopoietic stem cell transplant (HSCT) for NHL at medical centers in the United States and Canada. It examined the effectiveness of Mozobil in increasing the number of hematopoietic stem cells collected for a transplant. The study compared the hematopoietic stem cell yield from patients treated with Mozobil in combination with G-CSF to patients treated with G-CSF in combination with placebo. G-CSF is the standard of care for stimulating the mobilization of stem cells from the bone marrow; Mozobil is designed to allow for the more rapid and effective release of those stem cells from the marrow into the circulating blood for collection by apheresis.
In the primary efficacy endpoint, 59 percent of patients treated with a combination of Mozobil and G-CSF achieved the target threshold for collection of at least 5 million CD34+cells/kg from the peripheral blood with four or fewer days of apheresis sessions, compared with 20 percent of patients in the G-CSF/placebo group. The three-fold increase was highly statistically significant in favor of the Mozobil-treated patients (p<0.0001). The 40 percent absolute difference between the two treatment groups was nearly double the target that Genzyme prospectively defined in the protocol for the study, which was reviewed by FDA as part of the Special Protocol Assessment process.
In the secondary efficacy endpoint, nearly 87 percent of patients treated with Mozobil and G-CSF achieved the minimum level of stem cells generally associated with a successful transplant (2 million CD34+cells/kg) in four or fewer days of apheresis sessions, compared with approximately 47 percent in the placebo arm. This result was also highly statistically significant in favor of the Mozobil-treated patients (p<0.0001).
The other secondary efficacy endpoints were supportive of these findings, including analysis of the number of days needed to reach target ranges for stem cell mobilization, the success of engraftment, the number of days needed to engraft, and the durability of the engraftment for the first 100 days.
Mozobil was well tolerated in the trial, with the most common adverse events being mild gastrointestinal effects and redness at the site of injection. There were two related serious adverse events seen in the Mozobil plus G-CSF arm, and one in the G-CSF plus placebo arm.
“These are very impressive results with far-reaching clinical importance for patients undergoing a stem cell transplant for lymphoma,” said Principal Investigator John F. DiPersio, M.D., Ph.D., professor, Washington University, St. Louis. “Current literature suggests that increasing the number of stem cells in circulation and the number collected at the time of apheresis may improve the outcomes of patients undergoing a stem cell transplant, reduce the costs associated with stem cell collection and, more importantly, broaden the pool of patients for whom transplantation is an option.”
Based on these results Genzyme expects to file for US and European approval in lymphoma in the first half of 2008. In addition, Genzyme is completing a second phase 3 trial of Mozobil in multiple myeloma, and results are expected in the coming weeks.
About Mozobil
Mozobil, a novel small molecule CXCR4 chemokine antagonist, has been shown in multiple earlier studies to rapidly and effectively increase the number of stem cells in circulation in the blood. Once circulating in the blood, stem cells can be collected for use in a stem cell transplant. Mozobil has been granted special protocol assessment and orphan drug status in the United States and European Union and the pivotal trials have undergone Special Protocol Assessment by the FDA and Protocol Assistance by the EMEA. Genzyme intends to commercialize Mozobil through its existing global transplant business to hematologists and hematopoietic stem cell transplant centers in more than 50 countries throughout the world. Genzyme has been developing Mozobil since its acquisition of AnorMED, Inc. in 2006.
Approximately 55,000 stem cell transplants are performed each year for multiple myeloma, Hodgkin’s and non-Hodgkin’s lymphoma, and other conditions in markets where Genzyme has a commercial infrastructure, including the United States, Europe, Latin America and the Asian Pacific countries.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 9,000 employees in locations spanning the globe and 2006 revenues of $3.2 billion. Genzyme has been selected by FORTUNE as one of the “100 Best Companies to Work for” in the United States.
With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.
Medtronic Completes Implants in SANTE Trial of Deep Brain Stimulation for Epilepsy
Medtronic, Inc. (NYSE: MDT), today announced the completion of implants in its U.S. pivotal clinical study of deep brain stimulation (DBS) for the treatment of medically refractory epilepsy, a form of the neurological condition that does not respond to antiepileptic drugs. With 110 patients now implanted with the Intercept™ Epilepsy Control System, results of the study – the SANTE (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy) Trial – are expected to be available during 2008.
Ongoing at 17 medical centers in the United States, the SANTE Trial is using existing Medtronic DBS technology to determine whether bilateral stimulation of the anterior nucleus of the thalamus – the brain’s central message and relay station – can safely and effectively reduce seizure frequency in people with epilepsy. The same technology is approved for treating motor symptoms of Parkinson’s disease and essential tremor – the two most common movement disorders. It has been used by more than 40,000 people worldwide, however, Medtronic’s DBS therapy has not yet been approved for use in medically refractory epilepsy. Unlike other treatments that involve brain surgery, DBS therapy is non-destructive, adjustable and reversible.
All implanted patients in the SANTE Trial will be monitored for 13 months following implant, with long-term follow-up continuing until the device is approved for treating epilepsy or the study is stopped. Trial participants are adults with partial-onset epilepsy for whom at least three antiepileptic drugs have proven ineffective. (Individuals with partial-onset epilepsy have seizures that originate in a localized area of the brain.) To qualify for enrollment, study patients were required to have had an average of six or more seizures per month. They continue to receive their epilepsy medications while participating in the trial.
“Despite best medical management, a significant proportion of people with epilepsy continue to experience seizures that wreak havoc on their lives,” explained the trial’s principal investigator, Dr. Robert Fisher, professor of neurology and director of Stanford Epilepsy Center at Stanford University in Palo Alto, Calif. “For this underserved patient population, deep brain stimulation may represent a promising new treatment option.”
According to the Epilepsy Foundation, epilepsy and seizures affect more than three million Americans of all ages, at an estimated annual cost of $12.5 billion in direct and indirect costs. Despite trying a range of treatment options, about one-third of people with epilepsy continue to experience debilitating, recurring seizures – brief periods of abnormal electrical activity in the brain. The unpredictability of seizures affects daily activities and disrupts school days, work responsibilities and social functioning.
“The SANTE Trial is one of several major studies that Medtronic is sponsoring or supporting to establish compelling clinical evidence for approved and investigational applications of our neuromodulation technologies, which include implantable neurostimulation systems and site-specific drug-delivery systems,” said Dr. Richard E. Kuntz, M.D., senior vice president of Medtronic, Inc., and president of the Neuromodulation business unit. “With this latest milestone complete, we are one step closer to understanding the effectiveness of DBS therapy for patients with medically refractory epilepsy.”
Medtronic developed and leads the field of neuromodulation, the targeted and regulated delivery of electrical pulses and pharmaceuticals to specific sites in the nervous system. The company’s Neuromodulation business offers innovative therapies for chronic pain, movement disorders, spasticity, overactive bladder and urinary retention, benign prostatic hyperplasia, and gastroparesis.
ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Ongoing at 17 medical centers in the United States, the SANTE Trial is using existing Medtronic DBS technology to determine whether bilateral stimulation of the anterior nucleus of the thalamus – the brain’s central message and relay station – can safely and effectively reduce seizure frequency in people with epilepsy. The same technology is approved for treating motor symptoms of Parkinson’s disease and essential tremor – the two most common movement disorders. It has been used by more than 40,000 people worldwide, however, Medtronic’s DBS therapy has not yet been approved for use in medically refractory epilepsy. Unlike other treatments that involve brain surgery, DBS therapy is non-destructive, adjustable and reversible.
All implanted patients in the SANTE Trial will be monitored for 13 months following implant, with long-term follow-up continuing until the device is approved for treating epilepsy or the study is stopped. Trial participants are adults with partial-onset epilepsy for whom at least three antiepileptic drugs have proven ineffective. (Individuals with partial-onset epilepsy have seizures that originate in a localized area of the brain.) To qualify for enrollment, study patients were required to have had an average of six or more seizures per month. They continue to receive their epilepsy medications while participating in the trial.
“Despite best medical management, a significant proportion of people with epilepsy continue to experience seizures that wreak havoc on their lives,” explained the trial’s principal investigator, Dr. Robert Fisher, professor of neurology and director of Stanford Epilepsy Center at Stanford University in Palo Alto, Calif. “For this underserved patient population, deep brain stimulation may represent a promising new treatment option.”
According to the Epilepsy Foundation, epilepsy and seizures affect more than three million Americans of all ages, at an estimated annual cost of $12.5 billion in direct and indirect costs. Despite trying a range of treatment options, about one-third of people with epilepsy continue to experience debilitating, recurring seizures – brief periods of abnormal electrical activity in the brain. The unpredictability of seizures affects daily activities and disrupts school days, work responsibilities and social functioning.
“The SANTE Trial is one of several major studies that Medtronic is sponsoring or supporting to establish compelling clinical evidence for approved and investigational applications of our neuromodulation technologies, which include implantable neurostimulation systems and site-specific drug-delivery systems,” said Dr. Richard E. Kuntz, M.D., senior vice president of Medtronic, Inc., and president of the Neuromodulation business unit. “With this latest milestone complete, we are one step closer to understanding the effectiveness of DBS therapy for patients with medically refractory epilepsy.”
Medtronic developed and leads the field of neuromodulation, the targeted and regulated delivery of electrical pulses and pharmaceuticals to specific sites in the nervous system. The company’s Neuromodulation business offers innovative therapies for chronic pain, movement disorders, spasticity, overactive bladder and urinary retention, benign prostatic hyperplasia, and gastroparesis.
ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Monday, July 16, 2007
IBM Signs $1.4 Billion Global Strategic Outsourcing Agreement With AstraZeneca
IBM (NYSE: IBM) today announced that they have signed a $1.4 billion, seven-year global strategic outsourcing agreement with AstraZeneca. The agreement renews and expands on the scope of an existing contract and covers the provision of IT infrastructure services to 60 countries. It includes services to additional functions within AstraZeneca, one of the world's largest pharmaceutical companies.
In the terms of the agreement, IBM will provide a single global technical infrastructure, managing IT services for AstraZeneca across its global organisation. This includes server and storage hosting, service desks, PC management, network and communications services, including e-mail, and computer operations support. AstraZeneca will retain control of its overall IT strategy and the development and support of its application systems.
Richard Williams, Chief Information Officer of AstraZeneca, said, "This innovative agreement with IBM will enable AstraZeneca to deliver greater value to the business by providing consistent infrastructure services globally, enabling a faster and more efficient rollout of new technology, with improved levels of service. Leveraging IBM's global delivery capabilities and economies of scale, will allow AstraZeneca to focus its efforts on adding value to its scientific, commercial and supply operations, thereby helping the Company to deliver more medicines that make a meaningful difference to patients. In allowing IBM greater autonomy on methods of delivery, the agreement will result in cost efficiencies when compared with running in-house systems."
"IBM will marshal its global resources to provide a flexible and agile infrastructure enabling AstraZeneca to continue implementing its plans to grow and lead in the pharmaceutical industry," said Doug Elix, Senior Vice President, IBM. "The trust we have built over the past seven years will help IBM and AstraZeneca break new ground in transformational services in the next seven."
The agreement was signed in July 2007.
About IBM
For more information on IBM, visit www.ibm.com.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index.
In the terms of the agreement, IBM will provide a single global technical infrastructure, managing IT services for AstraZeneca across its global organisation. This includes server and storage hosting, service desks, PC management, network and communications services, including e-mail, and computer operations support. AstraZeneca will retain control of its overall IT strategy and the development and support of its application systems.
Richard Williams, Chief Information Officer of AstraZeneca, said, "This innovative agreement with IBM will enable AstraZeneca to deliver greater value to the business by providing consistent infrastructure services globally, enabling a faster and more efficient rollout of new technology, with improved levels of service. Leveraging IBM's global delivery capabilities and economies of scale, will allow AstraZeneca to focus its efforts on adding value to its scientific, commercial and supply operations, thereby helping the Company to deliver more medicines that make a meaningful difference to patients. In allowing IBM greater autonomy on methods of delivery, the agreement will result in cost efficiencies when compared with running in-house systems."
"IBM will marshal its global resources to provide a flexible and agile infrastructure enabling AstraZeneca to continue implementing its plans to grow and lead in the pharmaceutical industry," said Doug Elix, Senior Vice President, IBM. "The trust we have built over the past seven years will help IBM and AstraZeneca break new ground in transformational services in the next seven."
The agreement was signed in July 2007.
About IBM
For more information on IBM, visit www.ibm.com.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index.
NicOx Receives Euro 5 Million Milestone From Merck as Drug Candidate Enters Clinic
NicOx S.A. today announced that Merck & Co., Inc. has initiated the first in a series of planned clinical trials for the first selected drug candidate from the companies' major collaborative agreement to develop new nitric oxide- donating antihypertensive agents using NicOx' proprietary technology. The initiation of this clinical trial follows the review of an exploratory Investigational New Drug (IND) submission for this drug candidate by the US Food and Drug Administration (FDA) and results in a euro 5 million milestone payment from Merck & Co., Inc. to NicOx.
"We believe this candidate has considerable potential as an improved antihypertensive agent, based on its nitric oxide-donating properties," said Jacques Djian MD., NicOx' Cardiometabolic Area Leader. "There is evidence that endothelial nitric oxide plays an important role in the regulation of blood pressure and we believe that this drug candidate could satisfy the clear unmet medical need in the hypertensive market, where more than 40% of treated patients do not achieve blood pressure goals, even with the use of existing therapies. We are delighted that Merck has initiated clinical studies and hope this compound will deliver a major advance in antihypertensive treatment for patients worldwide."
The first trial in the clinical program for this candidate is a phase 1, dose-escalating study in healthy volunteers. The primary objective of this trial is to assess the safety, tolerability and pharmacokinetics of single oral doses, in order to select the dose and dosing regimen for further clinical studies. Merck is responsible for funding and performing the development of this compound going forward. The initiation of this clinical development program follows the announcement in January 2007 of the companies' selection of the first development candidate and that Merck had started the Good Laboratory Practice (GLP) compliant toxicology studies needed to submit an exploratory IND for this compound (see NOTE).
Including the euro 5 million milestone payment announced today, NicOx will have received euro 19.2 million from Merck under their current agreement, of which euro 10 million will have been received since the beginning of 2007. NicOx also stands to receive a potential additional euro 269 million in milestone payments and Merck will pay NicOx industry standard royalties on the sales of products that result from the agreement. Furthermore, NicOx has the option to co-promote products that result from the agreement, on a fee-for- detail basis, to specialist physicians in the United States and certain major European countries.
"NicOx and Merck have been successful in advancing this first compound into the clinic only sixteen months after the signature of our major agreement," said Michele Garufi, Chairman and CEO of NicOx. "We feel confident that the drug candidate resulting from this agreement with Merck, where we have a co-promotion option to specialist physicians in selected markets, together with our lead compound naproxcinod, will represent a solid and attractive basis to transform NicOx into an integrated pharmaceutical company."
NOTE: Submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) is necessary for obtaining approval to conduct clinical trials in humans in the United States. An IND contains information on preclinical toxicology and pharmacology studies in animals (collectively known as IND-enabling studies), in addition to details of the manufacturing of the compound and information prepared for future clinical investigators.
NicOx is a product-driven biopharmaceutical company dedicated to the development of nitric oxide- donating drugs to meet unmet medical needs. NicOx is targeting the therapeutic areas of inflammation and cardio-metabolic disease. Resources are focused on two lead compounds, naproxcinod (formerly HCT 3012); in phase 3 development for the treatment of signs and symptoms of osteoarthritis, and NCX 4016, in phase 2 for type 2 diabetes.
NicOx has strategic partnerships with some of the world's leading pharmaceutical companies, including Pfizer Inc. and Merck and Co., Inc.
NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a public company listed on the Eurolist of Euronext(TM) Paris (segment: Next Economy).
"We believe this candidate has considerable potential as an improved antihypertensive agent, based on its nitric oxide-donating properties," said Jacques Djian MD., NicOx' Cardiometabolic Area Leader. "There is evidence that endothelial nitric oxide plays an important role in the regulation of blood pressure and we believe that this drug candidate could satisfy the clear unmet medical need in the hypertensive market, where more than 40% of treated patients do not achieve blood pressure goals, even with the use of existing therapies. We are delighted that Merck has initiated clinical studies and hope this compound will deliver a major advance in antihypertensive treatment for patients worldwide."
The first trial in the clinical program for this candidate is a phase 1, dose-escalating study in healthy volunteers. The primary objective of this trial is to assess the safety, tolerability and pharmacokinetics of single oral doses, in order to select the dose and dosing regimen for further clinical studies. Merck is responsible for funding and performing the development of this compound going forward. The initiation of this clinical development program follows the announcement in January 2007 of the companies' selection of the first development candidate and that Merck had started the Good Laboratory Practice (GLP) compliant toxicology studies needed to submit an exploratory IND for this compound (see NOTE).
Including the euro 5 million milestone payment announced today, NicOx will have received euro 19.2 million from Merck under their current agreement, of which euro 10 million will have been received since the beginning of 2007. NicOx also stands to receive a potential additional euro 269 million in milestone payments and Merck will pay NicOx industry standard royalties on the sales of products that result from the agreement. Furthermore, NicOx has the option to co-promote products that result from the agreement, on a fee-for- detail basis, to specialist physicians in the United States and certain major European countries.
"NicOx and Merck have been successful in advancing this first compound into the clinic only sixteen months after the signature of our major agreement," said Michele Garufi, Chairman and CEO of NicOx. "We feel confident that the drug candidate resulting from this agreement with Merck, where we have a co-promotion option to specialist physicians in selected markets, together with our lead compound naproxcinod, will represent a solid and attractive basis to transform NicOx into an integrated pharmaceutical company."
NOTE: Submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) is necessary for obtaining approval to conduct clinical trials in humans in the United States. An IND contains information on preclinical toxicology and pharmacology studies in animals (collectively known as IND-enabling studies), in addition to details of the manufacturing of the compound and information prepared for future clinical investigators.
NicOx is a product-driven biopharmaceutical company dedicated to the development of nitric oxide- donating drugs to meet unmet medical needs. NicOx is targeting the therapeutic areas of inflammation and cardio-metabolic disease. Resources are focused on two lead compounds, naproxcinod (formerly HCT 3012); in phase 3 development for the treatment of signs and symptoms of osteoarthritis, and NCX 4016, in phase 2 for type 2 diabetes.
NicOx has strategic partnerships with some of the world's leading pharmaceutical companies, including Pfizer Inc. and Merck and Co., Inc.
NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a public company listed on the Eurolist of Euronext(TM) Paris (segment: Next Economy).
ROTATEQ and GARDASIL Adopted by All Immunization Projects of the Centers for Disease Control and Prevention's(CDC) Vaccines for Children(VFC) Program
Merck & Co., Inc. announced today that both ROTATEQ (rotavirus vaccine, live, oral, pentavalent) and GARDASIL [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] have now been adopted by all 55 U.S.-based immunization projects of the Centers for Disease Control and Prevention's (CDC) Vaccines for Children (VFC) program. The 55 Immunization Projects include the 50 states in addition to city programs in Washington DC, New York City, Philadelphia, Chicago, and San Antonio.
"This milestone is an important step in Merck's ongoing commitment to make our vaccines available to all children who need them, regardless of income," said Mark Feinberg, M.D., Ph.D., vice president of policy, public health and medical affairs, Merck Vaccines. "The adoption of ROTATEQ and GARDASIL by all 55 immunization projects further demonstrates the value these vaccines provide, and we applaud the projects for their prompt action in ensuring timely access to these important vaccines."
Since 1994, the VFC program has provided vaccines to children who are Medicaid-eligible, uninsured, underinsured (when seen at a Federally Qualified Health Center or Rural Health Clinic), or Native American, providing coverage for many who do not have private health insurance.
ROTATEQ is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3 and G4 when administered as a three-dose series to infants between the ages of six to 32 weeks. GARDASIL is indicated for girls and women ages nine to 26, for the prevention of cervical cancer; cervical pre-cancers (CIN 2/3 and AIS), vulvar pre-cancers (VIN 2/3) and vaginal pre-cancers (VaIN 2/3) caused by human papillomavirus (HPV) types 16 and 18 and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18. HPV types 16 and 18 account for approximately 70 percent of cases of cervical cancer, non-invasive cervical cancer (CIN 3, AIS), VIN 2/3 and VaIN 2/3, and account for 50 percent of CIN 2 lesions. HPV 6 and 11 cause approximately 90 percent of genital wart cases.
Merck's commitment to global vaccine access
Merck has submitted applications to seek World Health Organization (WHO) prequalification status for ROTATEQ and GARDASIL as part of the Company's commitment to making its vaccines available in the developing world. Applications for both vaccines have been accepted by WHO and are being reviewed. WHO prequalification verifies that vaccines meet the qualifications of quality, safety and efficacy for procurement by U.N. agencies, including UNICEF and the Pan American Health Organization (PAHO), and is an important step towards providing global access to these vaccines. "Merck is pursuing a systematic, thoughtful approach to the global introduction of ROTATEQ and GARDASIL - partnering with WHO, the GAVI Alliance and other international organizations, conducting global clinical trials and demonstration projects, and committing to making ROTATEQ and GARDASIL available at dramatically lower prices in GAVI-eligible countries," said Margaret G. McGlynn, president, Merck Vaccines.
Merck has made an important stride towards making ROTATEQ available in the developing world through its partnership with the Nicaraguan Ministry of Health (MOH) which was announced in September 2006. Through this joint project, aimed at demonstrating the public health impact of a full rotavirus vaccination program, all infants born in Nicaragua in a three-year period will receive free doses of ROTATEQ. This program represents a significant opportunity to add to the evidence base supporting the efforts of the global public health community to accelerate the introduction of routine rotavirus vaccination in resource-poor countries.
It is estimated that more than 60,000 infants have been vaccinated with ROTATEQ in Nicaragua in the six months since this partnership was initiated. The Nicaragua Rotavirus Vaccine Project marks the first time that a vaccine was introduced in a GAVI-eligible country in the same year it was approved by the U.S. Food and Drug Administration (FDA).
In December 2005, Merck entered into a partnership with PATH, an international non-profit group, to conduct clinical trials of ROTATEQ in Africa and Asia. The first infant was enrolled in a clinical trial in Bangladesh in March 2007. Trials are also under way in Ghana and Mali. Trials in Kenya and Vietnam are expected to begin this year.
Merck will also provide GARDASIL and technical support at no cost to PATH to support demonstration studies in India, Peru and Vietnam. These studies are designed to accelerate the availability of cervical cancer vaccines in the most impoverished nations. In addition, Merck is working with India's Council of Medical Research to study GARDASIL in India.
Merck has also initiated a new U.S. patient assistance program for vaccines for adults. Through this program, currently available in private physicians' offices and private clinics, Merck is making available, free of charge, GARDASIL and other Merck vaccines indicated for use in eligible individuals ages 19 and older who are uninsured and who are unable to afford vaccines.
Both vaccines were approved for use in the U.S. in 2006 and embraced by physicians, parents and public health authorities. The CDC recommends both vaccines as part of their recommended immunization schedule.
Select safety and additional information about ROTATEQ
ROTATEQ should not be administered to infants with a demonstrated history of hypersensitivity to any component of the vaccine.
No safety or efficacy data are available for the administration of ROTATEQ to infants who are potentially immunocompromised, including those who have received blood products within 42 days of vaccination.
More than 71,000 infants were evaluated in three placebo-controlled clinical trials. Serious adverse events occurred in 2.4 percent of recipients of ROTATEQ when compared to 2.6 percent of placebo recipients within the 42-day period of a dose of ROTATEQ. Hematochezia, reported as a serious adverse event for ROTATEQ compared to placebo, was less than 0.1 percent vs. less than 0.1 percent. The most frequently reported serious adverse events for ROTATEQ compared to placebo were bronchiolitis (0.6 percent vs. 0.7 percent), gastroenteritis (0.2 percent vs. 0.3 percent), pneumonia (0.2 percent vs. 0.2 percent), fever (0.1 percent vs. 0.1 percent), and urinary tract infection (0.1 percent vs. 0.1 percent).
In a subset of more than 11,000 infants in these trials, the presence of adverse events was reported for 42 days after each dose. Fever was observed at similar rates in vaccine and placebo recipients (42.6 percent vs. 42.8 percent). Adverse events that occurred at a statistically higher incidence within 42 days of any dose among recipients of ROTATEQ as compared with placebo recipients were diarrhea (24.1 percent vs. 21.3 percent), vomiting (15.2 percent vs. 13.6 percent), otitis media (14.5 percent vs. 13.0 percent), nasopharyngitis (6.9 percent vs. 5.8 percent), and bronchospasm (1.1 percent vs. 0.7 percent).
In post-marketing experience, cases of intussusception have been reported in temporal association with ROTATEQ.
As with any vaccine, vaccination with ROTATEQ may not result in complete protection in all recipients.
The first dose of ROTATEQ should be administered between six and 12 weeks of age, with the subsequent doses administered at four- to 10-week intervals. The third dose should not be given after 32 weeks of age. ROTATEQ was approved by the FDA on February 3, 2006.
Through June 2007, Merck has distributed more than six million doses of ROTATEQ. ROTATEQ has been approved in more than 60 countries around the world.
Select safety and additional information about GARDASIL
GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine.
The health-care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care.
Vaccination with GARDASIL may not result in protection in all vaccine recipients. GARDASIL is not intended to be used for treatment of active genital warts; cervical cancer; CIN, VIN, or VaIN. GARDASIL has not been shown to protect against disease due to other HPV types.
In clinical studies for GARDASIL, vaccine-related adverse experiences that were observed at a frequency of at least 1.0 percent among recipients of GARDASIL and also greater than those observed among recipients of placebo, respectively, were pain (83.9 percent vs. 75.4 percent), swelling (25.4 percent vs. 15.8 percent), erythema (24.6 percent vs. 18.4 percent), fever (10.3 percent vs. 8.6 percent), nausea (4.2 percent vs. 4.1 percent), pruritis (3.1 percent vs. 2.8 percent) and dizziness (2.8 percent vs. 2.6 percent).
GARDASIL is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL should be administered in three separate intramuscular injections in the upper arm or upper thigh over a six-month period. The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose. GARDASIL (sold in some countries as SILGARD®) has been approved in 80 countries, including the United States, the 27 countries of the European Union, Mexico, Australia, Taiwan, Canada, New Zealand and Brazil, and additional applications are currently under review with regulatory agencies in many more countries around the world. Through the first quarter of 2007, Merck distributed five million doses of GARDASIL.
Other Information about GARDASIL
In 1995, Merck entered into a license agreement and research collaboration with CSL Limited of Australia relating to technology used in GARDASIL. GARDASIL also is the subject of other third-party licensing agreements.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com
"This milestone is an important step in Merck's ongoing commitment to make our vaccines available to all children who need them, regardless of income," said Mark Feinberg, M.D., Ph.D., vice president of policy, public health and medical affairs, Merck Vaccines. "The adoption of ROTATEQ and GARDASIL by all 55 immunization projects further demonstrates the value these vaccines provide, and we applaud the projects for their prompt action in ensuring timely access to these important vaccines."
Since 1994, the VFC program has provided vaccines to children who are Medicaid-eligible, uninsured, underinsured (when seen at a Federally Qualified Health Center or Rural Health Clinic), or Native American, providing coverage for many who do not have private health insurance.
ROTATEQ is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3 and G4 when administered as a three-dose series to infants between the ages of six to 32 weeks. GARDASIL is indicated for girls and women ages nine to 26, for the prevention of cervical cancer; cervical pre-cancers (CIN 2/3 and AIS), vulvar pre-cancers (VIN 2/3) and vaginal pre-cancers (VaIN 2/3) caused by human papillomavirus (HPV) types 16 and 18 and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18. HPV types 16 and 18 account for approximately 70 percent of cases of cervical cancer, non-invasive cervical cancer (CIN 3, AIS), VIN 2/3 and VaIN 2/3, and account for 50 percent of CIN 2 lesions. HPV 6 and 11 cause approximately 90 percent of genital wart cases.
Merck's commitment to global vaccine access
Merck has submitted applications to seek World Health Organization (WHO) prequalification status for ROTATEQ and GARDASIL as part of the Company's commitment to making its vaccines available in the developing world. Applications for both vaccines have been accepted by WHO and are being reviewed. WHO prequalification verifies that vaccines meet the qualifications of quality, safety and efficacy for procurement by U.N. agencies, including UNICEF and the Pan American Health Organization (PAHO), and is an important step towards providing global access to these vaccines. "Merck is pursuing a systematic, thoughtful approach to the global introduction of ROTATEQ and GARDASIL - partnering with WHO, the GAVI Alliance and other international organizations, conducting global clinical trials and demonstration projects, and committing to making ROTATEQ and GARDASIL available at dramatically lower prices in GAVI-eligible countries," said Margaret G. McGlynn, president, Merck Vaccines.
Merck has made an important stride towards making ROTATEQ available in the developing world through its partnership with the Nicaraguan Ministry of Health (MOH) which was announced in September 2006. Through this joint project, aimed at demonstrating the public health impact of a full rotavirus vaccination program, all infants born in Nicaragua in a three-year period will receive free doses of ROTATEQ. This program represents a significant opportunity to add to the evidence base supporting the efforts of the global public health community to accelerate the introduction of routine rotavirus vaccination in resource-poor countries.
It is estimated that more than 60,000 infants have been vaccinated with ROTATEQ in Nicaragua in the six months since this partnership was initiated. The Nicaragua Rotavirus Vaccine Project marks the first time that a vaccine was introduced in a GAVI-eligible country in the same year it was approved by the U.S. Food and Drug Administration (FDA).
In December 2005, Merck entered into a partnership with PATH, an international non-profit group, to conduct clinical trials of ROTATEQ in Africa and Asia. The first infant was enrolled in a clinical trial in Bangladesh in March 2007. Trials are also under way in Ghana and Mali. Trials in Kenya and Vietnam are expected to begin this year.
Merck will also provide GARDASIL and technical support at no cost to PATH to support demonstration studies in India, Peru and Vietnam. These studies are designed to accelerate the availability of cervical cancer vaccines in the most impoverished nations. In addition, Merck is working with India's Council of Medical Research to study GARDASIL in India.
Merck has also initiated a new U.S. patient assistance program for vaccines for adults. Through this program, currently available in private physicians' offices and private clinics, Merck is making available, free of charge, GARDASIL and other Merck vaccines indicated for use in eligible individuals ages 19 and older who are uninsured and who are unable to afford vaccines.
Both vaccines were approved for use in the U.S. in 2006 and embraced by physicians, parents and public health authorities. The CDC recommends both vaccines as part of their recommended immunization schedule.
Select safety and additional information about ROTATEQ
ROTATEQ should not be administered to infants with a demonstrated history of hypersensitivity to any component of the vaccine.
No safety or efficacy data are available for the administration of ROTATEQ to infants who are potentially immunocompromised, including those who have received blood products within 42 days of vaccination.
More than 71,000 infants were evaluated in three placebo-controlled clinical trials. Serious adverse events occurred in 2.4 percent of recipients of ROTATEQ when compared to 2.6 percent of placebo recipients within the 42-day period of a dose of ROTATEQ. Hematochezia, reported as a serious adverse event for ROTATEQ compared to placebo, was less than 0.1 percent vs. less than 0.1 percent. The most frequently reported serious adverse events for ROTATEQ compared to placebo were bronchiolitis (0.6 percent vs. 0.7 percent), gastroenteritis (0.2 percent vs. 0.3 percent), pneumonia (0.2 percent vs. 0.2 percent), fever (0.1 percent vs. 0.1 percent), and urinary tract infection (0.1 percent vs. 0.1 percent).
In a subset of more than 11,000 infants in these trials, the presence of adverse events was reported for 42 days after each dose. Fever was observed at similar rates in vaccine and placebo recipients (42.6 percent vs. 42.8 percent). Adverse events that occurred at a statistically higher incidence within 42 days of any dose among recipients of ROTATEQ as compared with placebo recipients were diarrhea (24.1 percent vs. 21.3 percent), vomiting (15.2 percent vs. 13.6 percent), otitis media (14.5 percent vs. 13.0 percent), nasopharyngitis (6.9 percent vs. 5.8 percent), and bronchospasm (1.1 percent vs. 0.7 percent).
In post-marketing experience, cases of intussusception have been reported in temporal association with ROTATEQ.
As with any vaccine, vaccination with ROTATEQ may not result in complete protection in all recipients.
The first dose of ROTATEQ should be administered between six and 12 weeks of age, with the subsequent doses administered at four- to 10-week intervals. The third dose should not be given after 32 weeks of age. ROTATEQ was approved by the FDA on February 3, 2006.
Through June 2007, Merck has distributed more than six million doses of ROTATEQ. ROTATEQ has been approved in more than 60 countries around the world.
Select safety and additional information about GARDASIL
GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine.
The health-care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care.
Vaccination with GARDASIL may not result in protection in all vaccine recipients. GARDASIL is not intended to be used for treatment of active genital warts; cervical cancer; CIN, VIN, or VaIN. GARDASIL has not been shown to protect against disease due to other HPV types.
In clinical studies for GARDASIL, vaccine-related adverse experiences that were observed at a frequency of at least 1.0 percent among recipients of GARDASIL and also greater than those observed among recipients of placebo, respectively, were pain (83.9 percent vs. 75.4 percent), swelling (25.4 percent vs. 15.8 percent), erythema (24.6 percent vs. 18.4 percent), fever (10.3 percent vs. 8.6 percent), nausea (4.2 percent vs. 4.1 percent), pruritis (3.1 percent vs. 2.8 percent) and dizziness (2.8 percent vs. 2.6 percent).
GARDASIL is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL should be administered in three separate intramuscular injections in the upper arm or upper thigh over a six-month period. The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose. GARDASIL (sold in some countries as SILGARD®) has been approved in 80 countries, including the United States, the 27 countries of the European Union, Mexico, Australia, Taiwan, Canada, New Zealand and Brazil, and additional applications are currently under review with regulatory agencies in many more countries around the world. Through the first quarter of 2007, Merck distributed five million doses of GARDASIL.
Other Information about GARDASIL
In 1995, Merck entered into a license agreement and research collaboration with CSL Limited of Australia relating to technology used in GARDASIL. GARDASIL also is the subject of other third-party licensing agreements.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com
GE Healthcare Financial Services Closes $3.3 Million Deal with BioStorage Technologies
GE Healthcare Financial Services has provided a $3.3 million lease line of credit to BioStorage Technologies (BST). The Indianapolis, IN.-based company is a worldwide leader in short-term and long-term biomaterials storage, sample management and cold chain logistics. They will use the loan to support additional BST capital acquisitions.
In the near future, BST plans to purchase additional walk-in and stand-alone freezer units, back-up generators, liquid nitrogen tanks and other equipment to meet growing customer demands. In addition, BST will continue to build out its information technology infrastructure and software development needs.
“Having a strategic partner like GE Healthcare Financial Services has given us the financial flexibility to grow and execute our vision for the future,” said F. John Mills, M.D., Ph.D., BST’s chairman and chief executive officer. “GE HFS’ focus on helping us solve our financing needs allows us to create a broader leadership position in the drug research and development market.”
“GE Healthcare Financial Services is very pleased to have entered into a long-term partnership with BioStorage Technologies and we are focused on providing financial services that help them grow,” said Anthony Storino, senior managing director for GE Healthcare Financial Services’ life science finance group. “Our industry expertise and financial strength enabled us to quickly structure a tailored financing solution that recognized BioStorage Technologies’ current position in the market and will grow with their business.”
About GE Healthcare Financial Services
GE Healthcare Financial Services is a provider of capital, financial solutions, and related services for the global healthcare market. With over $16 billion of capital committed to the healthcare industry, GE Healthcare Financial Services offers a full range of capabilities from equipment financing and real estate financing to working capital lending, vendor programs, and practice acquisition financing. With its knowledge of all aspects of healthcare from hospitals and long-term care facilities to physicians’ practices and life sciences, GE Healthcare Financial Services works with customers to create tailored financial solutions that help them improve their productivity and profitability. For more information, visit http://www.gehealthcarefinance.com
In the near future, BST plans to purchase additional walk-in and stand-alone freezer units, back-up generators, liquid nitrogen tanks and other equipment to meet growing customer demands. In addition, BST will continue to build out its information technology infrastructure and software development needs.
“Having a strategic partner like GE Healthcare Financial Services has given us the financial flexibility to grow and execute our vision for the future,” said F. John Mills, M.D., Ph.D., BST’s chairman and chief executive officer. “GE HFS’ focus on helping us solve our financing needs allows us to create a broader leadership position in the drug research and development market.”
“GE Healthcare Financial Services is very pleased to have entered into a long-term partnership with BioStorage Technologies and we are focused on providing financial services that help them grow,” said Anthony Storino, senior managing director for GE Healthcare Financial Services’ life science finance group. “Our industry expertise and financial strength enabled us to quickly structure a tailored financing solution that recognized BioStorage Technologies’ current position in the market and will grow with their business.”
About GE Healthcare Financial Services
GE Healthcare Financial Services is a provider of capital, financial solutions, and related services for the global healthcare market. With over $16 billion of capital committed to the healthcare industry, GE Healthcare Financial Services offers a full range of capabilities from equipment financing and real estate financing to working capital lending, vendor programs, and practice acquisition financing. With its knowledge of all aspects of healthcare from hospitals and long-term care facilities to physicians’ practices and life sciences, GE Healthcare Financial Services works with customers to create tailored financial solutions that help them improve their productivity and profitability. For more information, visit http://www.gehealthcarefinance.com
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Friday, July 13, 2007
Idenix Pharmaceuticals Halts Hepatitis C Drug Development in U.S.
Idenix Pharmaceuticals today announced that after discussions with the United States Food and Drug Administration (FDA) the development program of valopicitabine (NM283) for the treatment of hepatitis C has been placed on clinical hold in the United States based on the overall risk/benefit profile observed to date in clinical testing.
"We are disappointed with the FDA's perspective on the program and are working with Novartis to evaluate our options for valopicitabine," said Jean- Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix. "We remain committed to building a leading antiviral franchise and will continue to focus on ensuring a successful launch of Tyzeka®/Sebivo® and on advancing our pipeline. We have a novel non-nucleoside reverse transcriptase inhibitor being evaluated in phase I clinical testing for the treatment of HIV. Additionally, we have a comprehensive HCV discovery effort, which includes a second-generation nucleoside polymerase inhibitor that is being evaluated in IND-enabling preclinical testing and novel HCV non-nucleoside polymerase inhibitor and HCV protease inhibitor programs."
As of June 30, 2007, Idenix had approximately $160 million of cash, cash equivalents and marketable securities.
"Over the next few weeks, we will be taking a critical look at our expenses with the goal of investing in programs that we believe will create shareholder value," said Ronald Renaud, chief financial officer of Idenix. "Our balance sheet is strong and we believe that we have enough cash to fund early clinical development of the pipeline."
Conference Call Information
Idenix will hold a conference call today at 8:00 a.m. EDT. To access the call please dial (800) 774-5358 U.S./Canada or (706) 758-9475 International and enter passcode 7177935 or to listen to a live webcast of the call, go to "Calendar of Events" in the Idenix Investor Center at www.idenix.com. Please log in approximately 10 minutes before the call to ensure a timely connection. A replay of the conference call and webcast will be available until July 30, 2007. To access the replay, please dial (800) 642-1687 U.S./Canada or (706) 645-9291 International and enter the passcode 7177935.
About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and HIV. For further information about Idenix, please refer to www.idenix.com.
"We are disappointed with the FDA's perspective on the program and are working with Novartis to evaluate our options for valopicitabine," said Jean- Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix. "We remain committed to building a leading antiviral franchise and will continue to focus on ensuring a successful launch of Tyzeka®/Sebivo® and on advancing our pipeline. We have a novel non-nucleoside reverse transcriptase inhibitor being evaluated in phase I clinical testing for the treatment of HIV. Additionally, we have a comprehensive HCV discovery effort, which includes a second-generation nucleoside polymerase inhibitor that is being evaluated in IND-enabling preclinical testing and novel HCV non-nucleoside polymerase inhibitor and HCV protease inhibitor programs."
As of June 30, 2007, Idenix had approximately $160 million of cash, cash equivalents and marketable securities.
"Over the next few weeks, we will be taking a critical look at our expenses with the goal of investing in programs that we believe will create shareholder value," said Ronald Renaud, chief financial officer of Idenix. "Our balance sheet is strong and we believe that we have enough cash to fund early clinical development of the pipeline."
Conference Call Information
Idenix will hold a conference call today at 8:00 a.m. EDT. To access the call please dial (800) 774-5358 U.S./Canada or (706) 758-9475 International and enter passcode 7177935 or to listen to a live webcast of the call, go to "Calendar of Events" in the Idenix Investor Center at www.idenix.com. Please log in approximately 10 minutes before the call to ensure a timely connection. A replay of the conference call and webcast will be available until July 30, 2007. To access the replay, please dial (800) 642-1687 U.S./Canada or (706) 645-9291 International and enter the passcode 7177935.
About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and HIV. For further information about Idenix, please refer to www.idenix.com.
Sciele Pharma Signs Agreement with Addrenex Pharmaceuticals to Market CLONICEL
Sciele Pharma, Inc. (NASDAQ: SCRX) today announced that it has signed an exclusive agreement with Addrenex Pharmaceuticals, Inc. to market, upon approval by the U.S. Food & Drug Administration (FDA), CLONICEL(R), a patented, sustained-release formulation of clonidine hydrochloride for the treatment of hypertension and attention deficit and hyperactivity disorder in North America. Sciele will also have the right of first refusal for other Addrenex products focused on pediatrics, women's health, and cardiovascular/metabolic diseases. Under the terms of the agreement, Sciele has purchased a $6 million equity stake in Addrenex and will have the right to increase its equity stake in Addrenex by an additional 10%. Sciele will also make regulatory milestone payments of up to $11 million and royalty payments to Addrenex on product sales.
Clonidine hydrochloride is an alpha-2 agonist approved for the treatment of hypertension. During the past year, approximately 11.7 million prescriptions were dispensed for clonidine hydrochloride tablets and approximately 1.8 million prescriptions were dispensed for clonidine patches, according to IMS Health's National Prescription Audit Plus data. CLONICEL(R) is a 12-hour, sustained-release formulation of clonidine hydrochloride, which currently is in pivotal clinical trials for hypertension. A 505(b)(2) NDA filing with the FDA is expected in the second half of 2007. A Phase III clinical trial utilizing CLONICEL(R) for ADHD is expected to begin in the second half of 2007.
Patrick Fourteau, Chief Executive Officer of Sciele Pharma, said, "This agreement with Addrenex provides us with the opportunity to further expand both our cardiovascular and pediatric product lines. We continue to execute on our strategy to diversify our product portfolio and expand our late-stage product pipeline through the licensing and acquisition of products."
Moise Khayrallah, Ph.D., Chief Executive Officer of Addrenex, said, "We are very happy that a successful company such as Sciele sees the potential of our lead compound CLONICEL(R). We look forward to a rewarding partnership that will allow Addrenex to develop and commercialize this product as well as future compounds in our adrenergic regulation portfolio."
About Sciele Pharma, Inc.
Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular/Diabetes, Women's Health and Pediatrics. The Company's Cardiovascular/Diabetes products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes; its Women's Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, coughs and colds, and attention deficit and hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than 900 people. The Company's success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform - an Entrepreneurial Spirit, Innovation, Speed of Execution, Simplicity, and Teamwork.
About Addrenex Pharmaceuticals, Inc.
Addrenex Pharmaceuticals is a focused, specialty pharmaceutical company that develops and commercializes drugs to treat adrenergic dysregulation. Addrenex Pharmaceuticals is based in Morrisville, North Carolina, on the edge of Research Triangle Park. The company was formed in 2006 by a practicing physician and a drug development expert with the mission to explore the impact that neurotransmitter regulation has on a variety of diseases and disorders. Addrenex identified adrenergic regulation as its initial research focus. Adrenergic dysregulation is implicated in medical conditions such as hypertension, ADHD, migraine, and post-menopausal symptoms. Addrenex will use the knowledge and experience gained from developing CLONICEL(R) as the foundation for additional discovery and development in the area of adrenergic regulation.
Clonidine hydrochloride is an alpha-2 agonist approved for the treatment of hypertension. During the past year, approximately 11.7 million prescriptions were dispensed for clonidine hydrochloride tablets and approximately 1.8 million prescriptions were dispensed for clonidine patches, according to IMS Health's National Prescription Audit Plus data. CLONICEL(R) is a 12-hour, sustained-release formulation of clonidine hydrochloride, which currently is in pivotal clinical trials for hypertension. A 505(b)(2) NDA filing with the FDA is expected in the second half of 2007. A Phase III clinical trial utilizing CLONICEL(R) for ADHD is expected to begin in the second half of 2007.
Patrick Fourteau, Chief Executive Officer of Sciele Pharma, said, "This agreement with Addrenex provides us with the opportunity to further expand both our cardiovascular and pediatric product lines. We continue to execute on our strategy to diversify our product portfolio and expand our late-stage product pipeline through the licensing and acquisition of products."
Moise Khayrallah, Ph.D., Chief Executive Officer of Addrenex, said, "We are very happy that a successful company such as Sciele sees the potential of our lead compound CLONICEL(R). We look forward to a rewarding partnership that will allow Addrenex to develop and commercialize this product as well as future compounds in our adrenergic regulation portfolio."
About Sciele Pharma, Inc.
Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular/Diabetes, Women's Health and Pediatrics. The Company's Cardiovascular/Diabetes products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes; its Women's Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, coughs and colds, and attention deficit and hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than 900 people. The Company's success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform - an Entrepreneurial Spirit, Innovation, Speed of Execution, Simplicity, and Teamwork.
About Addrenex Pharmaceuticals, Inc.
Addrenex Pharmaceuticals is a focused, specialty pharmaceutical company that develops and commercializes drugs to treat adrenergic dysregulation. Addrenex Pharmaceuticals is based in Morrisville, North Carolina, on the edge of Research Triangle Park. The company was formed in 2006 by a practicing physician and a drug development expert with the mission to explore the impact that neurotransmitter regulation has on a variety of diseases and disorders. Addrenex identified adrenergic regulation as its initial research focus. Adrenergic dysregulation is implicated in medical conditions such as hypertension, ADHD, migraine, and post-menopausal symptoms. Addrenex will use the knowledge and experience gained from developing CLONICEL(R) as the foundation for additional discovery and development in the area of adrenergic regulation.
Amgen Board Authorizes $5 Billion Increase in Stock Repurchase Program
Amgen today announced that its board of directors has authorized additional repurchases of up to $5 billion in Amgen common stock. The company currently has $1.5 billion remaining under its previous stock repurchase authorization. This new authorization reflects Amgen's confidence in its long-term prospects.
About Amgen
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com
About Amgen
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com
Bayer CropScience’ Nunhems acquires Korean vegetable seed company SeedEx
Bayer CropScience announced today that Nunhems, its vegetable seed business, has completed the acquisition of the assets of the South Korean vegetable seed company SeedEx which specializes in the breeding, production and marketing of Hot pepper and Brassica varieties. Both crops belong to the most important vegetable crops in Asia in terms of acreage and consumption. The Korean authorities had approved the transaction. Financial terms were not disclosed.
The acquisition strengthens Nunhems’ business in the Asia/Pacific region offering access to new Asian markets as well as growth opportunities in other regions of the world. With both crops being strategic crops for Nunhems the germplasm and breeding activities of SeedEx ideally complement Nunhems’ portfolio. Furthermore, the acquisition will bring in specifically skilled and knowledgeable staff.
Mr. Douwe Zijp, Chief Executive Officer of Nunhems comments: “The acquisition of SeedEx is an important step to strengthen our market position in Hot Pepper and Brassica in Asia. The SeedEx team with its well recognized breeding competence and market know-how will be an excellent reinforcement of our global teams.”
Mr. Sang Gil Lee, Managing Director SeedEx comments: “I am proud that my team becomes part of a global specialist company in vegetables seeds. Nunhems will supply additional resources, practical expertise and know-how on biotechnological support for the creation of new varieties.”
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer CropScience AG, a subsidiary of Bayer AG with annual sales of about EUR 5.7 billion (2006), is one of the world’s leading innovative crop science companies in the areas of crop protection, non-agricultural pest control, seeds and plant biotechnology. The company offers an outstanding range of products and extensive service backup for modern, sustainable agriculture and for non-agricultural applications. Bayer CropScience has a global workforce of about 17,900 and is represented in more than 120 countries. This and further news is available at: www.newsroom.bayercropscience.com.
The company’s vegetable seed business operates under the name of Nunhems. Nunhems® is the global specialist in vegetable seeds and sharing smart products, concepts and expertise with the professional horticultural production industry and supply chain. Its portfolio includes leading varieties and brands in crops such as leek, onion, carrot, melon, cucumber, tomato, watermelon, lettuce, pepper and chicory witloof. With annual sales of EUR 190 million in 2006, Nunhems is among the worldZs four leading vegetable seed companies with an extensive rate of 28 species and some 2,500 varieties. With more than 1,200 people Nunhems is present in all major vegetable production areas in the world.
Find more information at www.bayercropscience.com
The acquisition strengthens Nunhems’ business in the Asia/Pacific region offering access to new Asian markets as well as growth opportunities in other regions of the world. With both crops being strategic crops for Nunhems the germplasm and breeding activities of SeedEx ideally complement Nunhems’ portfolio. Furthermore, the acquisition will bring in specifically skilled and knowledgeable staff.
Mr. Douwe Zijp, Chief Executive Officer of Nunhems comments: “The acquisition of SeedEx is an important step to strengthen our market position in Hot Pepper and Brassica in Asia. The SeedEx team with its well recognized breeding competence and market know-how will be an excellent reinforcement of our global teams.”
Mr. Sang Gil Lee, Managing Director SeedEx comments: “I am proud that my team becomes part of a global specialist company in vegetables seeds. Nunhems will supply additional resources, practical expertise and know-how on biotechnological support for the creation of new varieties.”
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer CropScience AG, a subsidiary of Bayer AG with annual sales of about EUR 5.7 billion (2006), is one of the world’s leading innovative crop science companies in the areas of crop protection, non-agricultural pest control, seeds and plant biotechnology. The company offers an outstanding range of products and extensive service backup for modern, sustainable agriculture and for non-agricultural applications. Bayer CropScience has a global workforce of about 17,900 and is represented in more than 120 countries. This and further news is available at: www.newsroom.bayercropscience.com.
The company’s vegetable seed business operates under the name of Nunhems. Nunhems® is the global specialist in vegetable seeds and sharing smart products, concepts and expertise with the professional horticultural production industry and supply chain. Its portfolio includes leading varieties and brands in crops such as leek, onion, carrot, melon, cucumber, tomato, watermelon, lettuce, pepper and chicory witloof. With annual sales of EUR 190 million in 2006, Nunhems is among the worldZs four leading vegetable seed companies with an extensive rate of 28 species and some 2,500 varieties. With more than 1,200 people Nunhems is present in all major vegetable production areas in the world.
Find more information at www.bayercropscience.com
Labopharm and Paladin Labs Ink Tramadol Agreement
Labopharm and Paladin Labs Inc. today announced that they have completed a licensing and distribution agreement under which Labopharm has granted Paladin the exclusive right to market and sell Labopharm's once-daily tramadol product in Canada. Labopharm will retain co-promotion rights.
"With sales and marketing expertise specific to the pain and central nervous system areas and a strong commitment to our product, Paladin is the right marketing partner for our once-daily tramadol in Canada," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "We believe that our once-daily tramadol product will fulfill a need not currently being met within the pain treatment landscape in Canada."
"With considerable sales potential, Labopharm's once-daily tramadol will become the flagship product in our pain portfolio," said Jonathan Ross Goodman, President and Chief Executive Officer of Paladin Labs Inc. "We look forward to launching this unique product into the large and growing Canadian pain treatment market, which in 2006 reached almost 26 million prescriptions representing sales of more than $800 million."
Under the terms of the agreement, Labopharm will receive a transfer price on packaged product supply based on a percentage of the anticipated selling price. Labopharm expects to generate a gross margin on Canadian sales in excess of what the Company is currently experiencing in Europe. Labopharm will also receive up front and milestone payments of up to $1.5 million from Paladin.
The two companies expect the product to be launched in Canada this year.
About Labopharm's Once-Daily Tramadol Product
Labopharm's once-daily tramadol product is based on the Company's proprietary Contramid® technology, which provides a dual matrix delivery system allowing both rapid and sustained drug release that maintains blood levels within the therapeutic range providing a full 24 hours of pain relief. The Company believes that maintaining drug concentrations within the therapeutic range has the advantage of fewer and less severe side effects while maintaining efficacy. Under its global commercialization program, Labopharm's once-daily tramadol product has been approved in 28 countries and a broad European launch is underway.
About Tramadol
Tramadol is a centrally acting analgesic for the treatment of moderate to severe pain. Tramadol has a 30-year history of efficacy and safety and is currently marketed in more than 70 countries worldwide, primarily in formulations that require multiple doses per day. Studies have shown that tramadol provides relief from both acute and chronic pain conditions, including osteoarthritis pain, low back pain, cancer pain, post-operative pain and dental pain. Tramadol avoids the potentially serious side effects such as gastrointestinal bleeding that may be caused by NSAIDs and the potential cardiovascular events recently attributed to COX-2 inhibitors. Compared to stronger opioids, tramadol has, in clinical studies, demonstrated a lower incidence of major side effects, such as respiratory depression.
About Labopharm Inc.
Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets globally. The Company has a robust pipeline of follow-on products in both pre-clinical and clinical development. For more information, please visit www.labopharm.com
About Paladin Labs Inc.
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. With this strategy, a focused national sales team and proven marketing expertise, Paladin has evolved into one of Canada's leading specialty pharmaceutical companies. For more information, please visit the Company's web site at www.paladinlabs.com
"With sales and marketing expertise specific to the pain and central nervous system areas and a strong commitment to our product, Paladin is the right marketing partner for our once-daily tramadol in Canada," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "We believe that our once-daily tramadol product will fulfill a need not currently being met within the pain treatment landscape in Canada."
"With considerable sales potential, Labopharm's once-daily tramadol will become the flagship product in our pain portfolio," said Jonathan Ross Goodman, President and Chief Executive Officer of Paladin Labs Inc. "We look forward to launching this unique product into the large and growing Canadian pain treatment market, which in 2006 reached almost 26 million prescriptions representing sales of more than $800 million."
Under the terms of the agreement, Labopharm will receive a transfer price on packaged product supply based on a percentage of the anticipated selling price. Labopharm expects to generate a gross margin on Canadian sales in excess of what the Company is currently experiencing in Europe. Labopharm will also receive up front and milestone payments of up to $1.5 million from Paladin.
The two companies expect the product to be launched in Canada this year.
About Labopharm's Once-Daily Tramadol Product
Labopharm's once-daily tramadol product is based on the Company's proprietary Contramid® technology, which provides a dual matrix delivery system allowing both rapid and sustained drug release that maintains blood levels within the therapeutic range providing a full 24 hours of pain relief. The Company believes that maintaining drug concentrations within the therapeutic range has the advantage of fewer and less severe side effects while maintaining efficacy. Under its global commercialization program, Labopharm's once-daily tramadol product has been approved in 28 countries and a broad European launch is underway.
About Tramadol
Tramadol is a centrally acting analgesic for the treatment of moderate to severe pain. Tramadol has a 30-year history of efficacy and safety and is currently marketed in more than 70 countries worldwide, primarily in formulations that require multiple doses per day. Studies have shown that tramadol provides relief from both acute and chronic pain conditions, including osteoarthritis pain, low back pain, cancer pain, post-operative pain and dental pain. Tramadol avoids the potentially serious side effects such as gastrointestinal bleeding that may be caused by NSAIDs and the potential cardiovascular events recently attributed to COX-2 inhibitors. Compared to stronger opioids, tramadol has, in clinical studies, demonstrated a lower incidence of major side effects, such as respiratory depression.
About Labopharm Inc.
Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets globally. The Company has a robust pipeline of follow-on products in both pre-clinical and clinical development. For more information, please visit www.labopharm.com
About Paladin Labs Inc.
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. With this strategy, a focused national sales team and proven marketing expertise, Paladin has evolved into one of Canada's leading specialty pharmaceutical companies. For more information, please visit the Company's web site at www.paladinlabs.com
New Brunswick Scientific and Eppendorf AG Enter Into $110 Million Merger Agreement
New Brunswick Scientific Co., Inc. ("NBS") , and Eppendorf Group ("Eppendorf") today announced that they have entered into a merger agreement whereby Eppendorf will acquire the outstanding common stock of NBS for $11.50 per share. Eppendorf has also agreed to settle all the outstanding stock options of NBS for cash. The total value of the transaction, including the settlement of the stock options, is approximately $110 million.
NBS President and Chief Executive Officer James T. Orcutt commented, "The NBS Board has unanimously approved this merger and believes that it is in the best interests of shareholders. Furthermore, the Board recommends that shareholders approve the merger agreement."
The closing of the transaction is subject to customary closing conditions, including receipt of regulatory approvals and the approval of the NBS shareholders. The parties anticipate consummation of the transaction sometime during the third quarter of 2007. Upon completion of the transaction, NBS will become a wholly owned subsidiary of Eppendorf and its common stock will no longer be publicly traded.
Eppendorf has also received commitments from David Freedman, co-founder and chairman of NBS, other Freedman family members and certain members of the executive management and board of directors of NBS representing nearly 26% of the currently outstanding shares to vote their shares in support of the merger. Mr. Freedman stated, "While there is always some sadness in selling the company that we have built, I am pleased that Eppendorf is the buyer. This well-regarded manufacturer offers the opportunity to continue the NBS brand, to support our customers and our products, and to offer the opportunity for our employees to continue with NBS."
Following closing of this acquisition, Eppendorf expects to operate New Brunswick as a Center of Excellence as part of its international activities. In addition to the existing NBS sales force, Eppendorf will enable NBS to benefit from Eppendorf's global distribution network to accelerate the long- term growth of the combined product range.
"Eppendorf is committed to providing our customers products and services that deliver them superior technology, quality, reliability and value. Our customers consider Eppendorf as one of the strongest brands amongst life science tools suppliers. Our growth strategy seeks to build upon these unique competitive advantages, including through acquisitions that seamlessly integrate into our pre-eminent brand position and product range. NBS's strong brand recognition and leadership position in complementary market segments makes this a compelling acquisition opportunity for Eppendorf," said Klaus Fink, chief executive officer of Eppendorf.
Mr. Fink continued, "Like Eppendorf, NBS enjoys a rich history and culture of innovation that seeks to develop solutions that address the unique needs of our customers. This combination offers our customers even greater value, as the combined company can address a broader range of their needs through more comprehensive solutions across equipment, consumables and global service. We are excited to welcome NBS and its employees into the Eppendorf family. Our similar histories and cultures create a solid basis for future successes together."
Deutsche Bank acted as financial advisor to Eppendorf, and Skadden, Arps, Slate, Meagher & Flom LLP acted as legal advisor to Eppendorf. EuroConsult, Inc. acted as financial advisor to NBS, CBIZ Valuation Group, LLC provided a fairness opinion to the Board of Directors of NBS and Morgan, Lewis & Bockius LLP acted as legal advisor to NBS.
About New Brunswick Scientific
New Brunswick Scientific Co., Inc., is a leading global innovator providing a comprehensive line of equipment and instrumentation for the life science industry. NBS's products are used in the creation, maintenance and control of physical and biochemical environments required for the growth, detection and storage of microorganisms for medical, biological and chemical applications, environmental research and commercial products. Established in 1946, NBS is headquartered in Edison, New Jersey, with sales and distribution facilities located in the United States, Europe and Asia.
News releases and other information on NBS are available on the Internet at: http://www.nbsc.com
About Eppendorf
Eppendorf is a global leader in laboratory equipment and associated consumables. Eppendorf products include liquid handling and centrifugation equipment products including related consumables as well as instruments and systems for PCR, cell technology and micro arrays that are used by researchers in life science, drug discovery, clinical, environmental and industrial laboratories. Founded in 1945, Eppendorf, a privately-held company headquartered in Hamburg, Germany, has revenues of more than $400 million, and employs approximately 2,000 people in over 20 countries.
News releases and other information on Eppendorf are available on the Internet at: http://www.eppendorf.com
Important Additional Information Will be Filed with the SEC
NBS plans to file with the SEC a proxy statement in connection with the transaction. NBS shareholders are urged to read the proxy statement and other relevant materials when they become available because they will contain important information about NBS, Eppendorf and the proposed transaction. The final proxy statement will be mailed to shareholders of NBS. In addition to the documents described above, NBS files annual, quarterly and current reports, proxy statements and other information with the SEC. The proxy statement and other relevant materials (when they become available), and any other documents filed with the SEC by NBS, are available without charge at the SEC's website at http://www.sec.gov, or at NBS's website at http://www.nbsc.com.
Participants in Solicitation
Neither NBS nor Eppendorf is currently engaged in a solicitation of proxies from the shareholders of NBS in connection with the proposed transaction. If a proxy solicitation commences, NBS, Eppendorf and their respective directors and officers and other members of management may be deemed to be participants in such solicitation. Information regarding NBS directors and executive officers is available in its Annual Report on Form 10- K for the year ended December 31, 2006, and its proxy statement, dated April 24, 2007, for its 2007 annual meeting of shareholders, which are filed with the SEC. Additional information regarding the interests of such potential participants will be included in the proxy statement and other relevant documents to be filed with the SEC in connection with the proposed transaction.
NBS President and Chief Executive Officer James T. Orcutt commented, "The NBS Board has unanimously approved this merger and believes that it is in the best interests of shareholders. Furthermore, the Board recommends that shareholders approve the merger agreement."
The closing of the transaction is subject to customary closing conditions, including receipt of regulatory approvals and the approval of the NBS shareholders. The parties anticipate consummation of the transaction sometime during the third quarter of 2007. Upon completion of the transaction, NBS will become a wholly owned subsidiary of Eppendorf and its common stock will no longer be publicly traded.
Eppendorf has also received commitments from David Freedman, co-founder and chairman of NBS, other Freedman family members and certain members of the executive management and board of directors of NBS representing nearly 26% of the currently outstanding shares to vote their shares in support of the merger. Mr. Freedman stated, "While there is always some sadness in selling the company that we have built, I am pleased that Eppendorf is the buyer. This well-regarded manufacturer offers the opportunity to continue the NBS brand, to support our customers and our products, and to offer the opportunity for our employees to continue with NBS."
Following closing of this acquisition, Eppendorf expects to operate New Brunswick as a Center of Excellence as part of its international activities. In addition to the existing NBS sales force, Eppendorf will enable NBS to benefit from Eppendorf's global distribution network to accelerate the long- term growth of the combined product range.
"Eppendorf is committed to providing our customers products and services that deliver them superior technology, quality, reliability and value. Our customers consider Eppendorf as one of the strongest brands amongst life science tools suppliers. Our growth strategy seeks to build upon these unique competitive advantages, including through acquisitions that seamlessly integrate into our pre-eminent brand position and product range. NBS's strong brand recognition and leadership position in complementary market segments makes this a compelling acquisition opportunity for Eppendorf," said Klaus Fink, chief executive officer of Eppendorf.
Mr. Fink continued, "Like Eppendorf, NBS enjoys a rich history and culture of innovation that seeks to develop solutions that address the unique needs of our customers. This combination offers our customers even greater value, as the combined company can address a broader range of their needs through more comprehensive solutions across equipment, consumables and global service. We are excited to welcome NBS and its employees into the Eppendorf family. Our similar histories and cultures create a solid basis for future successes together."
Deutsche Bank acted as financial advisor to Eppendorf, and Skadden, Arps, Slate, Meagher & Flom LLP acted as legal advisor to Eppendorf. EuroConsult, Inc. acted as financial advisor to NBS, CBIZ Valuation Group, LLC provided a fairness opinion to the Board of Directors of NBS and Morgan, Lewis & Bockius LLP acted as legal advisor to NBS.
About New Brunswick Scientific
New Brunswick Scientific Co., Inc., is a leading global innovator providing a comprehensive line of equipment and instrumentation for the life science industry. NBS's products are used in the creation, maintenance and control of physical and biochemical environments required for the growth, detection and storage of microorganisms for medical, biological and chemical applications, environmental research and commercial products. Established in 1946, NBS is headquartered in Edison, New Jersey, with sales and distribution facilities located in the United States, Europe and Asia.
News releases and other information on NBS are available on the Internet at: http://www.nbsc.com
About Eppendorf
Eppendorf is a global leader in laboratory equipment and associated consumables. Eppendorf products include liquid handling and centrifugation equipment products including related consumables as well as instruments and systems for PCR, cell technology and micro arrays that are used by researchers in life science, drug discovery, clinical, environmental and industrial laboratories. Founded in 1945, Eppendorf, a privately-held company headquartered in Hamburg, Germany, has revenues of more than $400 million, and employs approximately 2,000 people in over 20 countries.
News releases and other information on Eppendorf are available on the Internet at: http://www.eppendorf.com
Important Additional Information Will be Filed with the SEC
NBS plans to file with the SEC a proxy statement in connection with the transaction. NBS shareholders are urged to read the proxy statement and other relevant materials when they become available because they will contain important information about NBS, Eppendorf and the proposed transaction. The final proxy statement will be mailed to shareholders of NBS. In addition to the documents described above, NBS files annual, quarterly and current reports, proxy statements and other information with the SEC. The proxy statement and other relevant materials (when they become available), and any other documents filed with the SEC by NBS, are available without charge at the SEC's website at http://www.sec.gov, or at NBS's website at http://www.nbsc.com.
Participants in Solicitation
Neither NBS nor Eppendorf is currently engaged in a solicitation of proxies from the shareholders of NBS in connection with the proposed transaction. If a proxy solicitation commences, NBS, Eppendorf and their respective directors and officers and other members of management may be deemed to be participants in such solicitation. Information regarding NBS directors and executive officers is available in its Annual Report on Form 10- K for the year ended December 31, 2006, and its proxy statement, dated April 24, 2007, for its 2007 annual meeting of shareholders, which are filed with the SEC. Additional information regarding the interests of such potential participants will be included in the proxy statement and other relevant documents to be filed with the SEC in connection with the proposed transaction.
YAZ approved in the Netherlands as European Reference Member State
Bayer Schering Pharma AG, Germany, announced today that the Dutch regulatory authorities have granted national approval for their new low dose 24-day oral contraceptive YAZ® (3 mg drospirenone/20 mcg ethinyl estradiol) in the Netherlands. YAZ® will be registered for the indications oral contraception and the treatment of moderate acne in women seeking contraception. The Netherlands will serve as the Reference Member State for the upcoming Mutual Recognition Procedure to gain European-wide marketing approval for the product.
“We are very excited about this first European approval for YAZ®. YAZ® is the first oral contraceptive to combine the unique progestin drospirenone with 20 mcg of ethinyl estradiol in a 24-day active hormone pill regimen. Through its innovative active ingredient drospirenone, YAZ® offers additional benefits, such as the treatment of acne, to women who want reliable birth control,” said Phil Smits, M.D., Head of Women’s Healthcare at Bayer Schering Pharma AG.
YAZ®, which has been available in the U.S. since April 2006, is the fastest-growing oral contraceptive brand in the U.S. YAZ® is also the only oral contraceptive with clinically proven efficacy in the treatment of the emotional and physical symptoms associated with PMDD (Premenstrual Dysphoric Disorder), such as mood swings, irritability, anxiety, changes in appetite and eating habits, breast tenderness, bloating, and headache. YAZ® was granted this indication in the USA in October 2006. Bayer Schering Pharma AG plans to proceed with the application for the registration of the PMDD indication in Europe. With the approval for the treatment of acne in January 2007, YAZ® becomes the first and only oral contraceptive ever approved in the USA for three distinct indications.
About YAZ®
Like Yasmin®, the number one brand birth control pill worldwide, YAZ® contains the innovative progestin drospirenone. Drospirenone exhibits unique antimineralcorticoid and antiandrogenic properties, unlike any other progestin available in oral contraceptives. Due to drospirenone’s antiandrogenic action, YAZ® can be used for the treatment of acne, which is primarily caused by an increased production and/or activity of male sex hormones (androgens).
YAZ® has a new dosing regimen of 24 days of active hormone pills and four days of placebo. This innovative regimen combined with drospirenone’s benefits reduces typical monthly hormonal fluctuations compared to traditional oral contraceptives with intake regimens of 21 days of active pills and seven days of placebo.
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany.The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de
“We are very excited about this first European approval for YAZ®. YAZ® is the first oral contraceptive to combine the unique progestin drospirenone with 20 mcg of ethinyl estradiol in a 24-day active hormone pill regimen. Through its innovative active ingredient drospirenone, YAZ® offers additional benefits, such as the treatment of acne, to women who want reliable birth control,” said Phil Smits, M.D., Head of Women’s Healthcare at Bayer Schering Pharma AG.
YAZ®, which has been available in the U.S. since April 2006, is the fastest-growing oral contraceptive brand in the U.S. YAZ® is also the only oral contraceptive with clinically proven efficacy in the treatment of the emotional and physical symptoms associated with PMDD (Premenstrual Dysphoric Disorder), such as mood swings, irritability, anxiety, changes in appetite and eating habits, breast tenderness, bloating, and headache. YAZ® was granted this indication in the USA in October 2006. Bayer Schering Pharma AG plans to proceed with the application for the registration of the PMDD indication in Europe. With the approval for the treatment of acne in January 2007, YAZ® becomes the first and only oral contraceptive ever approved in the USA for three distinct indications.
About YAZ®
Like Yasmin®, the number one brand birth control pill worldwide, YAZ® contains the innovative progestin drospirenone. Drospirenone exhibits unique antimineralcorticoid and antiandrogenic properties, unlike any other progestin available in oral contraceptives. Due to drospirenone’s antiandrogenic action, YAZ® can be used for the treatment of acne, which is primarily caused by an increased production and/or activity of male sex hormones (androgens).
YAZ® has a new dosing regimen of 24 days of active hormone pills and four days of placebo. This innovative regimen combined with drospirenone’s benefits reduces typical monthly hormonal fluctuations compared to traditional oral contraceptives with intake regimens of 21 days of active pills and seven days of placebo.
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany.The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de
Monday, July 9, 2007
Medtronic Insertable Heart Monitor Gives New Insight Into Heart Rhythm Disorder
Today Medtronic, Inc. (NYSE: MDT) announced the European introduction of Reveal® XT, the first Insertable Cardiac Monitor that offers long-term and continuous monitoring of Atrial Fibrillation (AF). All other current monitoring tools are either for a limited period or on an intermittent basis. Long-term, continuous monitoring means that a clinician no longer needs to rely only on incomplete data to evaluate how AF may be progressing or treatment effectiveness. The device recently received CE (Conformité Européenne) Mark, and the first implant of Reveal XT took place at Asklepios Klinik St. Georg in Hamburg, Germany by Prof. Karl-Heinz Kuck, M.D. The Reveal XT insertable cardiac monitor is not currently available for sale in the United States.
AF is the most common cardiac arrhythmia, experienced by 4.5 million patients in Europe1. Treatment of AF is difficult as episodes often show no symptoms and therefore go unnoticed by patients2. Yet the risks are well known – AF can lead to a two to seven times higher risk of stroke1, an increased risk of heart failure and sudden cardiac death3 due to inefficient pumping in the heart.
“Atrial fibrillation is the most frequent cardiac arrhythmia. It is often accompanied by symptoms that are very unpleasant for the patient,” said Prof. Kuck, Hanseatisches Herzzentrum / Department of Cardiology, Asklepios Klinik St. Georg. “Moreover, atrial fibrillation is linked with increased mortality and an increase in the incidence of stroke, by a factor of two- to seven-fold. However, with the new Reveal XT, atrial fibrillation can now be scrutinized over a period of three years with a subcutaneous monitor. This gives us totally new possibilities for monitoring and adjusting the treatment.”
The Only Way of Precisely Treating AF Is Knowing AF
The Reveal XT Insertable Cardiac Monitor monitors AF patients 24 hours a day, every day for up to three years. There are a variety of ways to treat AF, but up until now physicians had no means of gathering detailed data, over an extended period, on the progression of AF and the effect of treatment. Reveal XT gives new insight into patients’ heart rhythms, which may help physicians to evaluate stroke risk and determine appropriate treatment and therapy options for their patients.
24/7 Monitoring Provides Patient Compliance
As Reveal XT is inserted just under the skin, the patient experiences no restrictions in daily activities. This is not only more comfortable for the patient, but also ensures that cardiac data recorded is not influenced by restrictions in activities. Patients continue to lead their normal life and therefore heart activity recorded shows real-life, relevant information. Once patients leave the clinic, Reveal XT does not require wires or sticky pads to monitor the patients’ heart rhythms.
1 ACC/AHA/ESC Guidelines for the Management of Patients with Atrial Fibrillation
2 T. Fetsch, EHJ. 2004;1385-1394
3 A. Krahn et al. Am J Med. 1995; 98:476-484
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
AF is the most common cardiac arrhythmia, experienced by 4.5 million patients in Europe1. Treatment of AF is difficult as episodes often show no symptoms and therefore go unnoticed by patients2. Yet the risks are well known – AF can lead to a two to seven times higher risk of stroke1, an increased risk of heart failure and sudden cardiac death3 due to inefficient pumping in the heart.
“Atrial fibrillation is the most frequent cardiac arrhythmia. It is often accompanied by symptoms that are very unpleasant for the patient,” said Prof. Kuck, Hanseatisches Herzzentrum / Department of Cardiology, Asklepios Klinik St. Georg. “Moreover, atrial fibrillation is linked with increased mortality and an increase in the incidence of stroke, by a factor of two- to seven-fold. However, with the new Reveal XT, atrial fibrillation can now be scrutinized over a period of three years with a subcutaneous monitor. This gives us totally new possibilities for monitoring and adjusting the treatment.”
The Only Way of Precisely Treating AF Is Knowing AF
The Reveal XT Insertable Cardiac Monitor monitors AF patients 24 hours a day, every day for up to three years. There are a variety of ways to treat AF, but up until now physicians had no means of gathering detailed data, over an extended period, on the progression of AF and the effect of treatment. Reveal XT gives new insight into patients’ heart rhythms, which may help physicians to evaluate stroke risk and determine appropriate treatment and therapy options for their patients.
24/7 Monitoring Provides Patient Compliance
As Reveal XT is inserted just under the skin, the patient experiences no restrictions in daily activities. This is not only more comfortable for the patient, but also ensures that cardiac data recorded is not influenced by restrictions in activities. Patients continue to lead their normal life and therefore heart activity recorded shows real-life, relevant information. Once patients leave the clinic, Reveal XT does not require wires or sticky pads to monitor the patients’ heart rhythms.
1 ACC/AHA/ESC Guidelines for the Management of Patients with Atrial Fibrillation
2 T. Fetsch, EHJ. 2004;1385-1394
3 A. Krahn et al. Am J Med. 1995; 98:476-484
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
New Medtronic Implantable Cardiac Monitor Gives Physicians Valuable Insights Into the Cause of Unexplained Fainting
Medtronic, Inc. (NYSE: MDT) today announced the European introduction of the Reveal® DX, a new Insertable Cardiac Monitor that offers diagnostic and monitoring information related to syncope (fainting) in patients. The device recently received CE (Conformité Européenne) Mark, and the first implant of Reveal DX took place at Ospedali del Tigullio in Lavagna, Italy, by Prof. Michele Brignole, M.D. Placed just under the skin of the chest area using local anesthesia during a simple outpatient procedure, the monitor records important data before, during and after a syncopal event. This data enables the physician to diagnose the patient and determine the right treatment based on long-term cardiac rhythm trend data. The Reveal DX insertable cardiac monitor is not currently available for sale in the United States.
Approximately 1.5 million people worldwide suffer from unexplained syncope. In almost 10 percent of patients, syncope has a cardiac cause; in 50 percent, a non-cardiac cause; and in 40 percent of patients the cause of syncope is unknown¹. It is a leading cause of emergency room visits. Syncope is difficult to diagnose as syncopal episodes are often too infrequent and unpredictable for detection with conventional monitoring techniques.
With the information obtained from the Reveal DX, the physician can understand if the cause of syncope is cardiac related, which may help to appropriately manage the patient’s arrhythmia.
“Syncope can cause a considerable degree of anxiety and activity restrictions for people,” said Prof. Brignole of the Department of Cardiology, Ospedali del Tigullio. “Application of this insertable cardiac monitor helps me to diagnose the underlying cause of syncope so that I can treat my patients appropriately.”
Always on Watch
The Reveal DX continuously monitors the heart’s electrical activity in order to help physicians diagnose whether or not symptoms such as fainting, dizziness and unexplained seizure-like episodes have a cardiovascular cause. Causes of syncope can be heart rhythm disturbances or abnormalities in the structure of the heart. Syncope can lead to serious injury or can be a precursor to sudden cardiac death. Reveal DX is the only insertable cardiac monitor that can record an ECG at the time of a syncopal episode.
¹E.S. Soteriades et al. N Eng J Med. 2002; 347 (12):878-885
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Approximately 1.5 million people worldwide suffer from unexplained syncope. In almost 10 percent of patients, syncope has a cardiac cause; in 50 percent, a non-cardiac cause; and in 40 percent of patients the cause of syncope is unknown¹. It is a leading cause of emergency room visits. Syncope is difficult to diagnose as syncopal episodes are often too infrequent and unpredictable for detection with conventional monitoring techniques.
With the information obtained from the Reveal DX, the physician can understand if the cause of syncope is cardiac related, which may help to appropriately manage the patient’s arrhythmia.
“Syncope can cause a considerable degree of anxiety and activity restrictions for people,” said Prof. Brignole of the Department of Cardiology, Ospedali del Tigullio. “Application of this insertable cardiac monitor helps me to diagnose the underlying cause of syncope so that I can treat my patients appropriately.”
Always on Watch
The Reveal DX continuously monitors the heart’s electrical activity in order to help physicians diagnose whether or not symptoms such as fainting, dizziness and unexplained seizure-like episodes have a cardiovascular cause. Causes of syncope can be heart rhythm disturbances or abnormalities in the structure of the heart. Syncope can lead to serious injury or can be a precursor to sudden cardiac death. Reveal DX is the only insertable cardiac monitor that can record an ECG at the time of a syncopal episode.
¹E.S. Soteriades et al. N Eng J Med. 2002; 347 (12):878-885
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Johnson & Johnson Announces $10 Billion Share Repurchase Program
Johnson & Johnson today announced that its Board of Directors has approved a share repurchase program, authorizing the Company to purchase up to $10 billion of the corporation's shares of common stock.
"This share repurchase program is consistent with our strategy of providing value to our shareholders while maintaining flexibility to continue to invest in future growth opportunities," said William C. Weldon, Chairman and Chief Executive Officer.
Share repurchases will take place on the open market from time to time based on market conditions. The repurchase program has no time limit and may be suspended for periods or discontinued at any time. Any shares acquired will be available for general corporate purposes. The Company had approximately 2,896.6 million shares of common stock outstanding as of April 29, 2007.
The Company intends to finance the share repurchase program through a combination of available cash and debt. The Company expects to retain its triple-A credit rating. Johnson & Johnson will discuss the share repurchase plan on its second-quarter earnings conference call on July 17, 2007.
Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 121,000 men and women in 57 countries and sell products throughout the world.
"This share repurchase program is consistent with our strategy of providing value to our shareholders while maintaining flexibility to continue to invest in future growth opportunities," said William C. Weldon, Chairman and Chief Executive Officer.
Share repurchases will take place on the open market from time to time based on market conditions. The repurchase program has no time limit and may be suspended for periods or discontinued at any time. Any shares acquired will be available for general corporate purposes. The Company had approximately 2,896.6 million shares of common stock outstanding as of April 29, 2007.
The Company intends to finance the share repurchase program through a combination of available cash and debt. The Company expects to retain its triple-A credit rating. Johnson & Johnson will discuss the share repurchase plan on its second-quarter earnings conference call on July 17, 2007.
Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 121,000 men and women in 57 countries and sell products throughout the world.
Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Repla
Late-breaking Phase III clinical trial data presented today at the XXI International Society on Thrombosis and Haemostasis (ISTH) Congress demonstrate that once-daily rivaroxaban achieved superior efficacy in the prevention of venous thromboembolism (VTE) in patients undergoing knee replacement surgery in a head-to-head comparison with enoxaparin, the current standard of care. Patients in the RECORD3 (REgulation of Coagulation in major Orthopaedic surgery reducing the Risk of DVT and PE) study who were treated with rivaroxaban demonstrated a 49 percent relative risk reduction (RRR) (p<0.001) in the composite primary endpoint of deep vein thrombosis (DVT), non-fatal pulmonary embolism (PE) and all-cause mortality compared to those treated with enoxaparin. A 62 percent reduction of risk (p=0.01) for developing major VTE (the composite of proximal DVT, non-fatal PE and VTE-related death) – the secondary endpoint of the trial – was observed in the patients treated with rivaroxaban. Rivaroxaban also demonstrated a similarly low rate of major bleeding compared to enoxaparin (0.6 percent and 0.5 percent, respectively).
Rivaroxaban is an investigational, oral, once-daily direct Factor Xa inhibitor. It is an anticoagulant – a drug designed to prevent and treat blood clots – in advanced clinical development for the prevention and treatment of thrombosis in acute and chronic settings, enabling convenient administration in both the hospital and at home.
Rivaroxaban is being jointly developed by Johnson & Johnson Pharmaceutical Research & Development L.L.C. and Bayer HealthCare AG.
Lead RECORD3 investigator, Michael R. Lassen, MD, of Hoersholm Hospital, University of Copenhagen, Denmark, commented: "The RECORD3 results are exciting, as they indicate that rivaroxaban may better meet the needs of many patients undergoing orthopaedic surgery. It's an important step for this category that a once-daily, oral medication has demonstrated better efficacy in preventing VTE than the current standard of care, while also displaying a promising safety profile. In addition, it is important to note that symptomatic VTE, a secondary endpoint of the study, showed results in favour of rivaroxaban."
Detailed Study Results
RECORD3 is a 2,531-patient, phase III, double-blind trial that assessed the safety and efficacy of 10 mg oral, once-daily rivaroxaban started six-eight hours after surgery versus 40 mg subcutaneous, once-daily enoxaparin started the evening before surgery in elective total knee replacement (TKR) surgery. Both regimens were continued for 10-14 days. The primary efficacy endpoint of the study was the composite of DVT, as diagnosed by mandatory venography, non-fatal PE and all-cause mortality. The primary safety endpoint was major bleeding. Results showed that DVT, non-fatal PE and death occurred in 9.6 percent (79/824) of patients receiving rivaroxaban versus 18.9 percent (166/878) of patients receiving enoxaparin (RRR 49 percent; p < 0.001).
Major VTE (the composite of proximal DVT, non-fatal PE and VTE-related death) – the main secondary efficacy endpoint of the study – occurred in 1.0 percent of the rivaroxaban-treated group and in 2.6 percent of the enoxaparin-treated group. The difference was statistically significant (p=0.01) in favour of rivaroxaban, with an RRR of 62 percent. A reduction was also demonstrated in symptomatic VTE, a pre-specified additional secondary endpoint in the study. Symptomatic VTE occurred in 1.0 percent of patients who received rivaroxaban, compared to 2.7 percent of those in the enoxaparin comparator group, resulting in an RRR of 64 percent.
In the rivaroxaban- and enoxaparin-treated groups, major bleeding rates were 0.6 percent and 0.5 percent, and any bleeding rates were 4.9 percent and 4.8 percent, respectively. The RECORD3 trial demonstrated superior efficacy of rivaroxaban versus enoxaparin, with similarly low bleeding rates, in patients undergoing TKR.
Garry Neil, MD, group president for central nervous system and internal medicine research & development at Johnson & Johnson Pharmaceutical Research and Development commented: "We believe rivaroxaban could alter the landscape of antithrombotic therapy. An effective once-daily oral anticoagulant that can be administered safely and conveniently in the hospital and home settings has the potential to improve upon current therapies and help to treat the significant number of under- and un-treated patients at risk for life-threatening thrombotic events."
The trade name of rivaroxaban is expected to be Xarelto®, pending health authority approval.
Results from other phase III trials in the RECORD program, RECORD1 and RECORD2 are expected to be available by H2 2007.
Unmet Needs in Venous Thromboembolism (VTE)
VTE is a type of thromboembolic disease that affects approximately 6.5 million people worldwide annually. Thromboembolic disease, which is caused by the obstruction of a blood vessel by a blood clot, is a leading cause of global mortality and a concern for many patient populations, including those with atrial fibrillation at risk for stroke; those at risk for myocardial infarction (heart attack); those undergoing orthopaedic surgery at risk for developing DVT and PE; and hospitalized, medically ill patients immobilized by cancer, congestive heart failure, acute respiratory disease, or other illnesses.
About Rivaroxaban (Xarelto®)
Phase IIb data – presented at ISTH in 2005, and published in the Journal of Thrombosis and Haemostasis in 2005 and 2006, and the additional once-daily ODIXa HIP study published in Circulation in 2006 – indicate that rivaroxaban offers predictable anticoagulation, which strongly suggests that routine coagulation monitoring will not be required. In addition, data show that rivaroxaban does not interact with a wide variety of drugs that are commonly given concomitantly with an anticoagulant.
To date, rivaroxaban is the most studied oral direct Factor Xa inhibitor in development.
More than 15,000 patients have been evaluated in the completed phase II programs and enrolled thus far in the phase III programs. More than 40,000 patients are expected to be evaluated in total.
The RECORD3 trial is part of the joint clinical development program led by Johnson & Johnson Pharmaceutical Research and Development and Bayer HealthCare. Upon regulatory approval, rivaroxaban will be commercialized in the United States by Scios Inc. and Ortho-McNeil, Inc. Bayer Schering Pharma will market rivaroxaban throughout the rest of the world.
The companies plan to submit regulatory filings for the prevention of VTE in orthopaedic surgery in late 2007 in Europe and in 2008 in the United States.
About Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., is part of Johnson & Johnson, the world's most broadly based producer of health care products. Johnson & Johnson Pharmaceutical Research and Development is headquartered in Raritan, NJ, and has facilities throughout Europe and the United States. Johnson & Johnson Pharmaceutical Research and Development is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.
Rivaroxaban is an investigational, oral, once-daily direct Factor Xa inhibitor. It is an anticoagulant – a drug designed to prevent and treat blood clots – in advanced clinical development for the prevention and treatment of thrombosis in acute and chronic settings, enabling convenient administration in both the hospital and at home.
Rivaroxaban is being jointly developed by Johnson & Johnson Pharmaceutical Research & Development L.L.C. and Bayer HealthCare AG.
Lead RECORD3 investigator, Michael R. Lassen, MD, of Hoersholm Hospital, University of Copenhagen, Denmark, commented: "The RECORD3 results are exciting, as they indicate that rivaroxaban may better meet the needs of many patients undergoing orthopaedic surgery. It's an important step for this category that a once-daily, oral medication has demonstrated better efficacy in preventing VTE than the current standard of care, while also displaying a promising safety profile. In addition, it is important to note that symptomatic VTE, a secondary endpoint of the study, showed results in favour of rivaroxaban."
Detailed Study Results
RECORD3 is a 2,531-patient, phase III, double-blind trial that assessed the safety and efficacy of 10 mg oral, once-daily rivaroxaban started six-eight hours after surgery versus 40 mg subcutaneous, once-daily enoxaparin started the evening before surgery in elective total knee replacement (TKR) surgery. Both regimens were continued for 10-14 days. The primary efficacy endpoint of the study was the composite of DVT, as diagnosed by mandatory venography, non-fatal PE and all-cause mortality. The primary safety endpoint was major bleeding. Results showed that DVT, non-fatal PE and death occurred in 9.6 percent (79/824) of patients receiving rivaroxaban versus 18.9 percent (166/878) of patients receiving enoxaparin (RRR 49 percent; p < 0.001).
Major VTE (the composite of proximal DVT, non-fatal PE and VTE-related death) – the main secondary efficacy endpoint of the study – occurred in 1.0 percent of the rivaroxaban-treated group and in 2.6 percent of the enoxaparin-treated group. The difference was statistically significant (p=0.01) in favour of rivaroxaban, with an RRR of 62 percent. A reduction was also demonstrated in symptomatic VTE, a pre-specified additional secondary endpoint in the study. Symptomatic VTE occurred in 1.0 percent of patients who received rivaroxaban, compared to 2.7 percent of those in the enoxaparin comparator group, resulting in an RRR of 64 percent.
In the rivaroxaban- and enoxaparin-treated groups, major bleeding rates were 0.6 percent and 0.5 percent, and any bleeding rates were 4.9 percent and 4.8 percent, respectively. The RECORD3 trial demonstrated superior efficacy of rivaroxaban versus enoxaparin, with similarly low bleeding rates, in patients undergoing TKR.
Garry Neil, MD, group president for central nervous system and internal medicine research & development at Johnson & Johnson Pharmaceutical Research and Development commented: "We believe rivaroxaban could alter the landscape of antithrombotic therapy. An effective once-daily oral anticoagulant that can be administered safely and conveniently in the hospital and home settings has the potential to improve upon current therapies and help to treat the significant number of under- and un-treated patients at risk for life-threatening thrombotic events."
The trade name of rivaroxaban is expected to be Xarelto®, pending health authority approval.
Results from other phase III trials in the RECORD program, RECORD1 and RECORD2 are expected to be available by H2 2007.
Unmet Needs in Venous Thromboembolism (VTE)
VTE is a type of thromboembolic disease that affects approximately 6.5 million people worldwide annually. Thromboembolic disease, which is caused by the obstruction of a blood vessel by a blood clot, is a leading cause of global mortality and a concern for many patient populations, including those with atrial fibrillation at risk for stroke; those at risk for myocardial infarction (heart attack); those undergoing orthopaedic surgery at risk for developing DVT and PE; and hospitalized, medically ill patients immobilized by cancer, congestive heart failure, acute respiratory disease, or other illnesses.
About Rivaroxaban (Xarelto®)
Phase IIb data – presented at ISTH in 2005, and published in the Journal of Thrombosis and Haemostasis in 2005 and 2006, and the additional once-daily ODIXa HIP study published in Circulation in 2006 – indicate that rivaroxaban offers predictable anticoagulation, which strongly suggests that routine coagulation monitoring will not be required. In addition, data show that rivaroxaban does not interact with a wide variety of drugs that are commonly given concomitantly with an anticoagulant.
To date, rivaroxaban is the most studied oral direct Factor Xa inhibitor in development.
More than 15,000 patients have been evaluated in the completed phase II programs and enrolled thus far in the phase III programs. More than 40,000 patients are expected to be evaluated in total.
The RECORD3 trial is part of the joint clinical development program led by Johnson & Johnson Pharmaceutical Research and Development and Bayer HealthCare. Upon regulatory approval, rivaroxaban will be commercialized in the United States by Scios Inc. and Ortho-McNeil, Inc. Bayer Schering Pharma will market rivaroxaban throughout the rest of the world.
The companies plan to submit regulatory filings for the prevention of VTE in orthopaedic surgery in late 2007 in Europe and in 2008 in the United States.
About Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., is part of Johnson & Johnson, the world's most broadly based producer of health care products. Johnson & Johnson Pharmaceutical Research and Development is headquartered in Raritan, NJ, and has facilities throughout Europe and the United States. Johnson & Johnson Pharmaceutical Research and Development is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.
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