Confirma And GE Healthcare Expand Strategic Partnership

for MRI, announced today that Confirma and GE Healthcare, the $17 billion global leader in medical imaging and information systems, have expanded their strategic partnership to offer Confirma service to GE Healthcare customers with CADstream. Under the new agreement, Confirma will offer program consultation, experienced applications training, customizable educational courses, and marketing and reimbursement consultation to GE Healthcare customers with CADstream, the standard in CAD for breast MRI.

Since July 2004, Confirma and GE Healthcare have partnered to bring the industry’s leading MRI technologies for breast cancer detection to healthcare providers. Under the agreement, GE Healthcare will continue to distribute CADstream to its MRI customers while Confirma will install, train and support CADstream. The expanded relationship marks significant progress in their mutual goal to advance MRI technology for breast cancer detection. Currently, over 200 CADstream systems have been installed at GE Healthcare customer sites worldwide.

“As physicians begin to offer breast MRI to their patients, there is increasing demand for a truly complete solution. In addition to providing excellent imaging and intervention capabilities, productive workflow and interpretation efficiency are critical to a complete offering. CADstream has been a key component of our solution for the past several years,” said David Handler, General Manager, MR Global Marketing, GE Healthcare. “We look forward to continuing to advance breast MRI together under the new arrangement.”

“This amendment demonstrates our commitment to GE Healthcare and its customers,” said Wayne Wager, President and CEO, Confirma. “We will offer customers expertise and support that continue to improve confidence in breast MRI.”

About Confirma Customer Support

Program Consultation and Experienced Applications

Confirma’s experienced customer service team provides expert consultation for early and advanced breast MRI programs. Additionally, Confirma’s customer support team provides comprehensive training at the customer’s site.

Using remote technology, Confirma’s customer service team can instantly access CADstream systems for service and updates. Confirma expert support is available via telephone 24 hours per day.

Customizable Educational Courses

Confirma supports a variety of CME-accredited breast MRI with CAD educational programs, including didactic and hands-on courses, online case reviews and fellowships led by experienced faculty.

Marketing and Reimbursement Consultation

Confirma offers marketing and reimbursement consultation to customers, including development of direct mail, physician referral brochures and press releases. Reimbursement consultation includes recommendations on program development, coding and appeals.

Advances in Breast MRI

Confirma and CADstream help imaging centers improve confidence in MRI and meet the rapidly-increasing demand for MRI studies. Recently-published clinical studies support breast MRI for improved breast cancer detection and in March 2007, the American Cancer Society started recommending that women with a 20-25 percent or greater lifetime risk of breast cancer undergo an annual MRI in addition to mammography.

It is becoming increasingly important to improve the analysis of these complex, time-consuming studies. CADstream is advancing breast MRI by improving efficiency of study interpretation and reporting. The system automates analysis, reporting and interventional planning of studies and promotes standardization with the incorporation of the American College of Radiology’s Breast Imaging Reporting and Data System (BI-RADS®), which guides the breast cancer diagnosis and decision-making process. Confirma’s next-generation version of CADstream for breast MRI, launched at the RSNA 2007 meeting, includes a customizable BI-RADS®-centric user interface that accommodates a variety of experience levels.

CADstream was first introduced at the RSNA meeting in 2002 and is currently in use by thousands of physicians at hundreds of breast MRI programs around the world.

The July 2007 issue of Radiology published research from the University of Washington and Seattle Cancer Care Alliance indicating that CAD for breast MRI may improve standardization, as well as the analysis of benign and malignant lesions. CADstream was the only CAD system used in this study.

About GE Healthcare

GE Healthcare provides transformational medical technologies that will shape a new age of patient care. GE Healthcare’s expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, disease research, drug discovery and biopharmaceuticals is dedicated to detecting disease earlier and tailoring treatment for individual patients. GE Healthcare offers a broad range of services to improve productivity in healthcare and enable healthcare providers to better diagnose, treat and manage patients with conditions such as cancer, Alzheimer’s and cardiovascular diseases. GE Healthcare is a $17 billion unit of General Electric Company (NYSE:GE) that is headquartered in the United Kingdom. Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit www.gehealthcare.com.

About Confirma, Inc.

Confirma develops and markets application-specific CAD systems and accessories for magnetic resonance imaging studies (MRI). CADstream is the standard in CAD for MRI, with more than 800 installations and 2,500 users worldwide. Confirma’s approach to CAD is unique: CADstream is developed with specific tools for each application in order to streamline workflow and standardize study analysis. CADstream automates the analysis and interventional guidance of MRI studies, providing higher quality imaging studies, lower costs for radiology practices and improved communication tools for physicians and patients. In its initial application, CADstream was developed to assist in the analysis, interventional guidance and reporting of breast MRI studies. CADstream can be integrated into any workflow scenario, and is compatible with all MRI scanners and PACS.

Confirma supports professional development in MRI and CAD technology through its extensive medical education program, including a newly launched continuing medical education (CME) program for breast MRI through the International Center for Postgraduate Medical Education (ICPME).

Confirma has established partnerships with companies including GE Healthcare, Philips Medical Systems, Bayer HealthCare, Medipattern, Vital Images and Carestream Health. Confirma has partnered with hundreds of imaging centers and corporate partners worldwide since 2003, helping develop more standardized, high performance breast MRI programs that deliver premium patient care. Confirma Europe GmbH opened operations in Berlin to further develop the European market. Frost & Sullivan recently recognized Confirma with the 2006 Industry Innovation and Advancement Award for the U.S. CAD market. For more information, visit www.confirma.com or call 877-811-2356.

Medtronic and Weigao Announce Joint Venture in China

Medtronic, Inc. (NYSE:MDT) (“Medtronic”) and Shandong Weigao Group Medical Polymer Company Limited (Hong Kong Stock Exchange: 8199) (“Weigao”) today announced that they have agreed to form a joint venture to market therapies in the spine and orthopedics sector and that Medtronic would acquire a 15% equity interest in Weigao.

The joint venture will market in China Medtronic’s spinal products and Weigao’s orthopedic products which include therapies for the hip, shoulder, spine and trauma. Under the joint venture agreement (“Joint Venture Agreement”), Medtronic will have a 51% interest in the joint venture and Weigao will have a 49% interest.

Medtronic will purchase a 15% equity interest in Weigao for approximately HK$1,726 million (US$221 million) through the purchase of 80,721,081 newly issued H Shares of Weigao that are listed on the Hong Kong stock Exchange at a purchase price of HK$11.138 per share and an equal number of Weigao’s unlisted ordinary shares from Weigao’s existing shareholders at a purchase price of HK$10.247 per share. In connection with the purchase of the shares, Medtronic will have the right to nominate two non executive directors to Weigao’s board of directors as long as Medtronic owns 3.75% of the H Shares.

Closing of the transaction is subject to various conditions, including approval of the Chinese regulators and Weigao’s shareholders.

“China is key to our global strategy as we continue to expand our geographic footprint,” said Bill Hawkins, Medtronic president and CEO. “Weigao has a broad orthopedic and trauma product line that compliments Medtronic’s offerings, but even more importantly, we feel we can generate synergies with their very strong presence and reputation in China. We view Weigao as an ideal strategic partner.”

Mr. Chen Xue Li, chairman of Weigao said, “We take great pride in forming a strategic alliance with Medtronic, the world’s leading medical technology company. The collaboration will further broaden our business and raise our R&D capability, leveraging our extensive customer network and quality production, paving the way for Weigao to be the leading medical device company in Asia. With our localized knowledge, we hope to play an important role in Medtronic’s China strategy bringing Medtronic’s products to benefit millions of patients in China.”

About Medtronic
Medtronic, Inc., (www.medtronic.com) headquartered in Minneapolis, is the world’s leading medical technology company, alleviating pain, restoring health and extending life for people with chronic disease. Its Internet address is.

About Weigao
Weigao (www.weigaogroup.com) based in the Shandong province of the People’s Republic of China, is the leading manufacturer in China of medical devices and single-use consumables including infusion sets, syringes, blood transfusion sets and blood bags as well as orthopedic, cardiovascular stent and blood purification products.

Three Phase III Trials Show Rivaroxaban Outperformed Enoxaparin in Preventing Venous Thromboembolism After Major Orthopedic Surgery

Phase III clinical trial results released today underscore that rivaroxaban, the oral, once-daily, investigational anticoagulant, was significantly more effective than enoxaparin, the standard of care, in preventing venous thromboembolism (VTE) in patients undergoing total hip or knee replacement surgery. Rivaroxaban-treated patients consistently experienced lower rates of VTE events compared to enoxaparin-treated patients across three large studies as well as demonstrating a similar rate of major bleeding events. Rivaroxaban is being jointly developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Bayer HealthCare AG.

Data from the RECORD1 and RECORD2 studies, evaluating rivaroxaban in total hip replacement surgery, were presented at the 49th Annual Meeting of the American Society of Hematology. Additional data from the head-to-head RECORD3 study, which showed similar statistically significant results for rivaroxaban compared with enoxaparin in total knee replacement surgery, also were presented.

Studies presented include:

• RECORD1 (n=4,541), which demonstrated a 70 percent relative risk reduction
  (RRR) (p<0.001) in total VTE when compared with enoxaparin and an 88
  percent RRR (p<0.001) in major VTE


• RECORD2 (n=2,509), which demonstrated a 79 percent RRR (p<0.001) in
  total VTE when compared with enoxaparin, again with an 88 percent RRR
  (p<0.001) in major VTE


• RECORD3 (n=2,531), which demonstrated a 49 percent RRR (p<0.001) in
  total VTE when compared with enoxaparin, and a 62 percent RRR (p=0.016) in
  major VTE


• Major bleeding rates were similar for both drugs (less than or equal to 0.6
  percent) and differences were not statistically significant


• No routine blood monitoring was required in the Phase III RECORD program at
  the 10mg dose, based on the Phase II data and pharmacokinetic profile

"In RECORD1, 2 and 3 we have three Phase III trials showing unprecedented results in major orthopedic surgery for the prevention of VTE, and this is genuinely exciting," said Dr. A.G.G. Turpie, Principal Investigator in the RECORD program, Professor of Medicine, McMaster University, Canada. "In three different trials across large patient populations, we have seen rivaroxaban outperform the current standard of care, enoxaparin, without compromising on safety. This is strong clinical evidence that we are making a major leap forward in oral anticoagulation in orthopedic surgery."

A key secondary endpoint of the study measuring the reduction of symptomatic VTE, also showed clinically meaningful results in favor of rivaroxaban. For this endpoint, the trials showed an RRR of 45 percent (p=0.222) in RECORD1, an 80 percent RRR (p=0.004) in RECORD2 and a 66 percent RRR (p=0.005) in RECORD3, compared to the standard regimen.

"The symptomatic VTE findings in the RECORD trials are extraordinary," added Dr. Turpie. "Previous trials were successful in identifying trends towards reducing symptomatic VTE, but with RECORD2 and 3 we are seeing clinically relevant reductions in symptomatic VTE for the first time in orthopedic surgery. These results are a major milestone in the evolution of anticoagulation therapy."

Rivaroxaban is a novel, oral, once-daily direct Factor Xa inhibitor in advanced clinical development for a range of patients who could benefit from prevention and/or treatment of blood clots. Rivaroxaban works at a pivotal stage in the coagulation process to directly inhibit the enzyme Factor Xa.

Detailed Study Results

Data presented at the ASH meeting are from RECORD (Regulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE), a global program of four pivotal trials involving more than 12,000 patients comparing oral, once-daily rivaroxaban, with subcutaneous enoxaparin in the prevention of VTE after elective, major orthopedic surgery. Following are summary results from RECORD1, RECORD2 and RECORD3:

RECORD1 (Abstract #6)

The RECORD1 trial compared the safety and efficacy of rivaroxaban with enoxaparin in patients undergoing total hip replacement surgery. The duration of thromboprophylaxis in both treatments was five weeks. The study met its primary endpoint, and demonstrated a 70 percent RRR (p<0.001) in total VTE (composite of deep vein thrombosis, non-fatal pulmonary embolism and all-cause mortality), for patients treated with rivaroxaban compared with those treated with enoxaparin (1.1 percent and 3.7 percent, respectively). In addition, against the secondary endpoint, an 88 percent RRR (p<0.001) in major VTE (composite of proximal deep vein thrombosis, non-fatal pulmonary embolism and VTE-related death) was observed in patients treated with rivaroxaban (0.2 percent and 2.0 percent, respectively). Rivaroxaban also demonstrated a similar rate of major bleeding to enoxaparin (0.3 percent and 0.1 percent, respectively, p=0.178).

RECORD2 (Abstract #307)

The RECORD2 study evaluated the safety and efficacy of rivaroxaban compared with enoxaparin and placebo. The duration of thromboprophylaxis in patients undergoing total hip replacement was 35+/- 4 days (extended prophylaxis) for rivaroxaban or 10-14 days for those receiving enoxaparin, followed by placebo. The primary and secondary endpoints were the same as for RECORD1 with a 79 percent RRR (p<0.001) in total VTE and an 88 percent RRR (p<0.001) in major VTE for patients treated with rivaroxaban compared with those treated with enoxaparin. Rivaroxaban demonstrated a similar rate of major bleeding compared to enoxaparin (0.1 percent and 0.1 percent, respectively, p=0.980), despite the greater treatment duration with rivaroxaban in this study.

RECORD3 (Abstract #308)

The RECORD3 trial compared the safety and efficacy of rivaroxaban with enoxaparin in patients undergoing total knee replacement surgery. Enoxaparin was initiated 12 hours before surgery, and rivaroxaban was initiated 6-8 hours after surgery; both treatments were continued for 10-14 days. Primary and secondary endpoints were the same as for RECORD1 and there was a 49 percent RRR (p<0.001) in total VTE and a 62 percent RRR (p=0.016) in major VTE for patients treated with rivaroxaban compared with those treated with enoxaparin. Rivaroxaban demonstrated similar rates of major bleeding to enoxaparin (0.6 percent and 0.5 percent, respectively, p=0.774).

Copies of the abstracts may be viewed online at the ASH website: www.hematology.org/meetings/abstracts.cfm

Unmet Needs in Venous Thromboembolism (VTE)

VTE, a disease process that begins with a blood clot in a vein, includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). Patients undergoing major orthopedic surgery are at risk for VTE because, during the surgery the large veins of the leg that carry blood back to the heart can be damaged, significantly increasing the risk of coagulation and thrombosis.

Each year approximately 700,000 people elect to have hip and knee replacement surgeries in the U.S. and a blood clot is the most common cause of re-hospitalization for this patient group. In fact, VTE is considered the most frequent preventable serious and potentially fatal complication following major orthopedic surgery. But the threat stretches beyond orthopedic surgeries. Blood clots are one of the leading causes of global mortality and a concern for many patient populations, including those with atrial fibrillation at risk for stroke; those at risk for acute myocardial infarction (heart attack); those undergoing major orthopedic surgery; and acutely medically ill patients.

About Rivaroxaban

To date, rivaroxaban is the most studied oral, direct Factor Xa inhibitor in clinical development. More than 20,000 patients have been evaluated in the completed Phase II programs and enrolled thus far in the Phase III programs. Almost 50,000 patients are expected to be evaluated in the total clinical development program.

Bayer HealthCare submitted a regulatory filing to the European Agency for the Evaluation of Medicinal Products (EMEA) at the end of October 2007 for approval to market rivaroxaban in the EU for the prevention of VTE in patients undergoing major orthopedic surgery of the lower limbs. Upon regulatory approval, rivaroxaban will be commercialized in Europe by Bayer Schering Pharma. A filing for rivaroxaban for a similar indication in the U.S. is planned in 2008, where upon approval, it will be will commercialized by Scios Inc. and Ortho-McNeil, Inc., both of which are wholly-owned subsidiaries of Johnson & Johnson.

Johnson & Johnson Pharmaceutical Research and Development

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), is part of Johnson & Johnson, the world's most broadly based producer of health care products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

GSK via its Centre Of Excellence for External Drug Discovery, exercises its options to further develop Exelixis’ anti-cancer C-Met inhibitior XL880

Exelixis, Inc. (Nasdaq: EXEL) today announced that GlaxoSmithKline (GSK) has exercised its option to exclusively license XL880 for further development and commercialisation. XL880 is a small molecule compound currently being evaluated in phase 2 trials in patients with papillary renal cell carcinoma (PRC), gastric cancer and head and neck cancer. Under the terms of the collaboration between Exelixis and GSK initiated in October 2002 and amended in January 2005, GSK’s selection of XL880 entitles Exelixis to a selection milestone of $35 million and additional payments upon the attainment of specific development and commercialisation milestones. The $35 million selection milestone will be applied to repayment of an advance that GSK paid to Exelixis in 2005. Exelixis is also entitled to receive double-digit royalties on product sales if the compound is approved for marketing and commercialised. Exelixis will have certain co-promotion rights to XL880 in North America.


“XL880 is the first MET inhibitor to be evaluated in phase 2 trials, and the clinical data generated to date for this compound has been very compelling,” said George A. Scangos, Ph.D., President and Chief Executive Officer of Exelixis. “We believe that XL880 has substantial potential as a first-in-class therapy, and GSK and Exelixis look forward to the completion of the ongoing XL880 phase 2 trials and evaluation of pivotal trial options. We are pleased that GSK shares our belief in the significant clinical and commercial potential of this compound. Additionally, we believe that GSK’s selection of XL880 validates our strategy of building a franchise in the area of MET inhibition to exploit the potential of this promising target.”


“The exercise of the XL880 option confirms GSK’s growing status as a world leader in the development of new oncology medicines for use in thetreatment, prevention and supportive care of cancer patients,” commented Paolo Paoletti, MD, Senior Vice President of the Oncology Medicines Development Centre at GSK. “It further strengthens our oncology pipeline and demonstrates our commitment to identifying compounds that have the potential to deliver real benefit to patients. The data we have seen from trials conducted by Exelixis have given us confidence in the potential of XL880 for treating diseases for which there is high unmet medical need.”


The collaboration between Exelixis and GSK, which is managed by GSK’s Centre of Excellence for External Drug Discovery (CEEDD), covers seven compounds and their back-up and follow-up compounds currently in the Exelixis development pipeline. Under the terms of the collaboration, Exelixis submits the covered compounds to GSK as they achieve clinical proof-of-concept, which is a pre-determined measure of efficacy, generally based on phase 2 trial data, and GSK has the option to select two compounds, and potentially a third compound, for further clinical development and commercialisation. However, in the case of XL880, GSK requested in August 2007 to review the compound’s data prior to achievement of proof-of-concept. Exelixis agreed to the request and submitted the XL880 data package to GSK in September 2007.


Interim data from an ongoing phase 2 trial of XL880 in patients with PRC were presented in October 2007 at the 2007 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Investigators reported at the conference that 15 of 19 patients (79%) with measurable disease evaluable for tumor response at the time of the data presentation had a decrease in tumour size (4-33%), including one patient with a partial response per RECIST criteria. All 19 evaluable patients with at least one post-baseline tumour assessment were reported to have had stable disease for at least three months, including 12 patients with stable disease for 6 to 15+ months. In 16 patients evaluable for safety at the time of the data presentation, the majority (72%) of adverse events (AEs) related to XL880 were Grade 1, 21% were Grade 2, and 5% were Grade 3 or higher. The Grade 3 AEs were hypertension in three patients. No Grade 4 or 5 AEs related to XL880 treatment were reported by investigators. A total of 15 serious adverse events (SAEs) in seven patients were reported, of which three were considered related to XL880 (two events of vomiting in one patient and hypertension in another patient).


Data from a phase 1 study of XL880 in patients with advanced solid tumours also were presented at the AACR-NCI-EORTC International Conference. Consistent with data previously reported from the phase 1 study, XL880 was reported to be generally well tolerated when given once daily over a 28-day cycle. Ten of 22 patients showed stable disease for at least three months. In a preliminary analysis of plasma samples from 21 patients, statistically significant changes in pharmacodynamic biomarkers were detected in the phase 1 clinical trial consistent with effects reported with other anti-angiogenic agents. This finding is also consistent with the hypertension that has been observed in patients receiving XL880.


Dr. Scangos noted, “We believe the selection of XL880 is a significant event that reflects the maturation of our pipeline and our discovery and development capabilities. XL880 represents one of many potentially significant compounds in our pipeline that we hope will help people with cancer. We believe that GSK’s selection of this novel compound will expedite the development of XL880 and may provide us with additional resources to advance our other compounds into and through clinical development.”


The effectiveness of GSK’s election to develop and commercialise XL880 and the associated technology transfer by Exelixis to GSK are subject to antitrust clearance, which is expected to occur in the first quarter of 2008.


About XL880

XL880 has attractive pharmaceutical properties, with high solubility and oral bioavailability. In preclinical studies, XL880 potently inhibited both MET and VEGFR with nanomolar potency, and retained potent activity against mutationally activated forms of MET found in hereditary papillary renal cell carcinomas. The compound also demonstrated dose-dependent tumor growth inhibition in models of breast cancer, colorectal cancer, non-small cell lung cancer, and glioblastoma, and has been shown to cause substantial tumor regression in all models tested. Significantly, a single dose of XL880 completely inhibited tumor growth for 21 days in a glioblastoma model. Three phase 2 trials of XL880 are ongoing in patients with PRC, gastric cancer and head and neck cancer.


About GlaxoSmithKline

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. For company information, visit GlaxoSmithKline at www.gsk.com.


GSK Oncology is dedicated to producing innovations in cancer that will make profound differences in the lives of patients. Through GSK’s “bench to bedside” approach, we are transforming the way treatments are discovered and developed, resulting in one of the most robust pipelines in the oncology sector. Our worldwide research in oncology includes partnerships with more than 160 cancer centres. GSK is developing a new generation of patient focused cancer treatments in prevention, supportive care, chemotherapy and targeted therapies.


About the GSK CEEDD

GlaxoSmithKline is enhancing the way it discovers and develops drugs by creating a small, dedicated team that will feed the GSK pipeline solely through the efforts of its external alliances. The CEEDD (Centre of Excellence for External Drug Discovery) was formed as further validation of GSK’s strategy to create small, independent and accountable R&D teams (known as Centres of Excellence for Drug Discovery or CEDDs). In essence, the CEEDD is virtualising a portion of the GSK pipeline; namely from target to clinical proof-of-concept, by forming multiple risk-sharing/reward sharing alliances. Capitalising on the speed and efficiency of its collaborators will allow GSK to deliver pharmaceutical products faster to patients. For more information, visit the CEEDD at www.ceedd.com.


About Exelixis

Exelixis, Inc. is a development-stage biotechnology company dedicated to the discovery and development of novel small molecule therapeutics for the treatment of cancer and other serious diseases. The company is leveraging its fully integrated drug discovery platform to fuel the growth of its development pipeline, which is primarily focused on cancer. Currently, Exelixis' broad product pipeline includes investigational compounds in phase 2 and phase 1 clinical development for cancer and renal disease. Exelixis has established strategic corporate alliances with major pharmaceutical and biotechnology companies, including GlaxoSmithKline, Bristol-Myers Squibb Company, Genentech, Wyeth Pharmaceuticals and Daiichi-Sankyo. For more information, please visit the company's web site at http://www.exelixis.com.

FDA Advisory Panel Recommends Against Approval of Merck's NDA for Non-prescription MEVACOR (lovastatin) 20 mg

Merck & Co., Inc. announced today that the U.S. Food and Drug Administration's (FDA) joint panel of the Nonprescription Drugs Advisory Committee (NDAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted against recommending approval at this time of the over-the-counter (OTC) use of MEVACOR® (lovastatin) 20 mg to help lower LDL cholesterol which may prevent a first heart attack.

"We are disappointed in today's outcome. We felt we presented a compelling case to the committee that non-prescription MEVACOR 20 mg would be a valuable option for motivated consumers who know they have moderately elevated cholesterol and certain risk factors, and are already talking with their healthcare provider," said Edwin L. Hemwall, PhD, vice president, Global OTC Regulatory and Scientific Affairs.

The FDA is not bound by the committee's recommendation, but takes its advice into consideration. The anticipated action date by the FDA is Jan. 26, 2008.

About Prescription MEVACOR
MEVACOR is a prescription medicine that is approved in the U.S. for the treatment of elevated cholesterol levels that lifestyle changes alone cannot control and to reduce the risk of a first heart attack, unstable angina and coronary revascularization procedures in healthy men and women with average or moderately elevated cholesterol levels.

Important Safety Information
According to the prescribing information, MEVACOR should not be used by anyone allergic to any of its components, people with liver disease, or by women who are pregnant, breast-feeding, or likely to become pregnant. It is recommended that liver function tests be performed in all patients prior to daily use of MEVACOR 40 mg or more.

Muscle pain or weakness in patients taking prescription MEVACOR should be reported to a doctor because these could be signs of a serious side effect. Patients should tell their doctors about other medications they are taking in order to avoid possible drug interactions.

The most common adverse events reported with MEVACOR 20 mg taken once daily were diarrhea, flatulence, headache and myalgia.

Further information about MEVACOR is available on www.merck.com.

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 http://www.merck.com.

Medtronic Implantable Cardiac Monitors Give Physicians Valuable Insights Into Heart Rhythms

Medtronic, Inc. (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) clearance of the Reveal® DX and Reveal® XT, new Insertable Cardiac Monitors (ICMs) that offer unique diagnostic and monitoring insights to cardiologists managing their patients with syncope (fainting) or abnormal heart rhythms, including ventricular tachyarrhythmias (VT), fast ventricular tachyarrhythmias (FVT), bradyarrhythmias and asystole. The new Reveal devices expand on the cardiac monitoring foundation Medtronic began more than 10 years ago with the Reveal® and Reveal Plus® Insertable Loop Recorders. The Reveal DX will be commercially available in the United States beginning next week; the Reveal XT will follow.

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. 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.

“The Reveal DX showcases Medtronic’s commitment to providing answers to patients with previously unidentified arrhythmias,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business at Medtronic. “These patients often have their lives and activities curtailed because of unexplained fainting episodes. The Reveal monitors provide diagnostics and monitoring that can offer physicians a view into their patients’ conditions even when they’re not present.”

Placed just under the skin of the chest area using local anesthesia during a simple outpatient procedure, the Reveal DX monitor records important cardiac rhythm data, which may help a physician to diagnose the patient so the appropriate treatment can be undertaken. The device weighs just 15 grams and is approximately the size of a memory stick; unlike a pacemaker or implantable cardioverter-defibrillator, there are no leads (tiny wires) that extend from the device into the heart’s chamber(s). To store an electrocardiogram (ECG) at the time of an episode, a patient places a hand-held, pager-sized activator over the device, and presses a button. Later a physician analyzes the stored information and determines if the episode was caused by an abnormal heart rhythm.

¹E.S. Soteriades et al. N Eng J Med. 2002; 347 (12):878-885

About Arrhythmias
Arrhythmias are simply irregular heart rhythms in the heart’s atria (upper chambers) or ventricles (lower chambers). They can be dangerously fast heart rhythms, known as tachycardia or tachyarrhyhmias; dangerously slow rhythms, known as bradycardia or bradyarrhythmias; fibrillation, where the heart quivers instead of pumping blood effectively to the body; or asystole, which is the absence of electromechanical activity within the heart.

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.

Medtronic Receives FDA Marketing Clearance for Complete SE Biliary Stent System

Medtronic, Inc. (NYSE: MDT), announced today that it has received 510(k) marketing clearance from the U.S. Food and Drug Administration for the Complete SE (self-expanding) Biliary Stent System, which is indicated for use in the palliative treatment of malignant neoplasms in the biliary tree – cancerous tumors in the bile duct that can compromise digestion by restricting the flow of digestive fluids.

U.S. commercial sales of the new biliary stent will begin immediately in a wide size range, with diameters of 4 – 10 mm and lengths of 20 – 150 mm.

Bench testing has shown the Complete SE Biliary Stent System to be extremely accurate in terms of stent placement. Accurate stent placement can decrease the likelihood that additional stents are necessary to cover the entire narrowing of the bile duct.

The safety and effectiveness of this device in the vascular system have not been established.

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.

Invitrogen and CytRx Subsidiary RXi Pharmaceuticals Collaborate to Enhance RNAi Technologies for Therapeutic Applications

Invitrogen Corporation (NASDAQ:IVGN), a provider of essential life science technologies for research, production and diagnostics, and CytRx Corporation's (NASDAQ:CYTR) majority-owned subsidiary RXi Pharmaceuticals Corporation (RXi) today announced that they have entered into an agreement whereby RXi will exclusively license second generation RNA interference (RNAi) technology from Invitrogen for designated target genes in all human therapeutic categories.

Invitrogen's patent applications that are part of this agreement cover Stealth™ and other proprietary technologies related to enhanced configurations of chemically modified double-stranded RNA. Terms of the agreement were not disclosed.

“Licensing this broad technology from Invitrogen is part of our strategy to continually enhance our proprietary rxRNA™ compounds for therapeutic applications,” said Dr. Tod Woolf, President and Chief Executive Officer of RXi.

“Currently Invitrogen Stealth™ RNAi synthetic duplexes are widely used for RNAi research across both in vitro and in vivo applications due to their specificity, efficacy and stability,“ said Amy Butler, Invitrogen vice president of gene expression profiling.“We see the use of our Stealth™ RNAi technology in therapeutics as a natural next step in Invitrogen's efforts to be at the cutting edge of in vivo gene regulation.“

About Invitrogen

Invitrogen Corporation provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen's own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, bioinformatics and cell biology -- placing Invitrogen's products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company is celebrating 20 years of accelerating scientific discovery. Invitrogen globally employs approximately 4,700 scientists and other professionals and had revenues of approximately $1.15 billion in 2006. For more information, visit www.invitrogen.com.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics. The Company owns three clinical-stage compounds based on its small molecule "molecular chaperone" co-induction technology. In September 2006, CytRx announced that arimoclomol was shown to be safe and well tolerated at all three doses tested in its Phase IIa clinical trial in patients with ALS. The Company plans to enter a Phase IIb clinical trial with arimoclomol in ALS in 2007, subject to U.S. Food and Drug Administration (FDA) clearance. The FDA has granted Fast Track designation and Orphan Drug status to arimoclomol for the treatment of ALS, which has also been granted orphan medicinal product status for the treatment of ALS by the European Commission. The Company has announced plans to commence a Phase II clinical trial for arimoclomol in stroke recovery in the first half of 2008, subject to FDA clearance. The Company has also announced plans to commence a Phase II clinical trial with its next drug candidate, iroxanadine, for diabetic foot ulcers in the first half of 2008, subject to FDA clearance. CytRx has recently opened a research and development facility in San Diego. For more information on the Company, visit www.cytrx.com.

About RXi Pharmaceuticals Corporation

RXi a discovery-stage biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi) for the treatment of human diseases. RXi's initial focus is on the treatment of neurological diseases, metabolic diseases and cancer. RXi has secured exclusive and non-exclusive licenses under certain issued and pending patents and patent applications covering therapeutic targets, chemistry and configurations of RNAi and delivery of RNAi within the body. The Company was founded by RNAi pioneers Craig Mello, Ph.D., 2006 Nobel Laureate for co-discovering RNAi and co-inventing RNAi therapeutics; Tariq M. Rana, Ph.D., inventor of fundamental technology for stabilizing RNAi and of RNAi nanotransporters; Greg Hannon, Ph.D., discoverer of short hairpin RNAi (shRNA); and Michael Czech, Ph.D., a leader in the application of RNAi to diabetes and obesity. RXi's CEO, Tod Woolf, Ph.D., previously co-invented and commercialized STEALTH™ RNAi, one of the most widely used second-generation RNAi research products. The Company currently operates as a privately held subsidiary of CytRx Corporation (NASDAQ: CYTR) and is located in Worcester, MA.

New Phase III Trial Results for Rivaroxaban to be Presented at the 49th Annual Meeting of the American Society of Hematology

Findings from three phase III clinical trials of rivaroxaban will be presented in the plenary session and during oral presentations at the American Society of Hematology (ASH) Annual Meeting in Atlanta, Georgia, from December 8 to 11, 2007. Rivaroxaban is being jointly developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Bayer HealthCare, AG.

The studies evaluated rivaroxaban in head-to-head comparison with enoxaparin, the current standard of care, for the prevention of venous thromboembolism (VTE) in patients undergoing major orthopaedic surgery. The presentations will highlight results from the recently-completed RECORD1 (Regulation of Coagulation in major Orthopaedic surgery reducing the Risk of DVT and PE) and RECORD2 studies in total hip replacement surgery as well as additional data from the RECORD3 trial, which evaluated rivaroxaban in total knee replacement surgery. Copies of the following abstracts can be viewed online at the ASH website: www.hematology.org/meetings/abstracts.cfm.

Oral Rivaroxaban Compared with Subcutaneous Enoxaparin for Extended Thromboprophylaxis after Total Hip Arthroplasty: The RECORD1 Trial Abstract# 6. Plenary presentation: Sunday, Dec. 9, 3:10 p.m., Hall A1, Georgia World Congress Center
Extended Thromboprophylaxis with Rivaroxaban Compared with Short-Term Thromboprophylaxis with Enoxaparin After Total Hip Arthroplasty: The RECORD2 Trial
Abstract# 307. Oral presentation: Monday, Dec. 10, 11:00 a.m., Rooms B312-B313a

Rivaroxaban – an Oral, Direct Factor Xa Inhibitor – for Thromboprophylaxis After Total Knee Arthroplasty: The RECORD3 Trial
Abstract# 308. Oral presentation: Monday, Dec. 10, 11:15 a.m., Rooms B312-B313a

Four additional abstracts will be presented as poster presentations on Saturday, December 8 and Sunday, December 9, 2007.

Johnson & Johnson Pharmaceutical Research and Development

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), is part of Johnson & Johnson, the world's most broadly based producer of healthcare products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

Nexavar Becomes First and Only Approved Treatment of Hepatocellular Carcinoma in Europe

Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. today announced that the European Commission has granted marketing authorization to Nexavar® (sorafenib) tablets for the treatment of patients with hepatocellular carcinoma (HCC), or liver cancer. Nexavar, an oral anti-cancer drug, is the first and only approved systemic drug therapy for liver cancer and the only drug therapy shown to significantly improve overall survival in patients with the disease. Additional regulatory filings in HCC are under review in countries around the world including the U.S. and, most recently, in Japan. Nexavar is currently approved in more than 60 countries for the treatment of patients with advanced kidney cancer.
“The approval of Nexavar, a novel multi-kinase inhibitor, represents an unprecedented advance for patients with HCC who, until now, had no approved systemic treatment options,” said Arthur J. Higgins, chairman of the Executive Committee of Bayer HealthCare. “This milestone will likely establish Nexavar as the standard of care in HCC and shows the dedication of health authorities to make Nexavar available as quickly as possible. Most importantly, it allows us to offer patients and medical professionals the potential to improve treatment outcomes for this devastating disease.”

“Liver cancer is one of the few cancers in which the number of related deaths continues to increase,” said Hollings C. Renton, chairman, president and chief executive officer of Onyx Pharmaceuticals, Inc. “This second approval for Nexavar – first in advanced kidney cancer and now, less than two years later, in HCC – demonstrates our commitment to expediting the clinical development of this innovative therapy to treat today’s unmet needs in cancer. We will move swiftly to make Nexavar rapidly available to patients.”

The European Commission’s decision to approve Nexavar is based on positive data from the international, Phase 3, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial which demonstrated that Nexavar extended overall survival by 44 percent in patients with HCC (HR=0.69; p=0.0006) versus placebo. The primary objective of the study was to compare overall survival in patients administered Nexavar versus those administered placebo. Median overall survival was 10.7 months in Nexavar-treated patients compared to 7.9 months in those taking placebo. There were no significant differences in serious adverse event rates between the Nexavar and placebo-treated groups with the most commonly observed adverse events in patients receiving Nexavar being diarrhea and hand-foot skin reaction. Based on these data, a supplemental New Drug Application for Nexavar was granted Priority Review status by the U.S. Food and Drug Administration (FDA) in August. Most recently, the regulatory filing in Japan has been submitted.

HCC, the most common form of liver cancer, is responsible for about 90 percent of the primary malignant liver tumors in adults. Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. Over 600,000 cases of liver cancer are diagnosed worldwide each year (about 54,000 in Europe, 19,000 in the U.S. and 390,000 in China, Korea and Japan) and incidence is increasing. Currently, the 5-year survival rate for patients with liver cancer in Europe is less than 8 percent. The 5-year survival rate for liver cancer patients in the United States is 11 percent and less than 10 percent in Asia among patients with non-resectable tumors.

Nexavar’s Differentiated Mechanism
Nexavar targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET. Preclinical models have also demonstrated that Raf/MEK/ERK has a role in HCC. Therefore, blocking signaling through Raf-1 may offer therapeutic benefits in HCC.

Nexavar is currently approved in more than 50 countries, including the United States and the European Union, for the treatment of patients with advanced kidney cancer. In Europe, Nexavar is approved for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Nexavar is also being evaluated by the companies, international study groups, government agencies, and individual investigators as a single agent or combination treatment in a wide range of other cancers, including adjuvant therapy for kidney cancers, metastatic melanoma, breast cancer and non-small cell lung cancer (NSCLC).

About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company developing innovative therapies that target the molecular mechanisms that cause cancer. The company is developing Nexavar, a small molecule drug, with Bayer HealthCare. For more information about Onyx’s pipeline and activities, visit the company’s web site at: www.onyxpharm.com.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of healthcare, 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.

Medtronic Trials Confirm Ability of Interceptor Coronary Filter System and Export® Aspiration Catheter to Reduce Major Cardiac Events

Reflecting its commitment to patient safety and ongoing medical research, Medtronic, Inc. (NYSE: MDT), today announced the findings from two clinical trials highlighting the ability of next-generation technologies to improve patient outcomes following interventional procedures. Results of the AMEthyst and EXPORT trials were presented this week at the 19th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

The AMEthyst trial was an 800-patient, U.S.-based multicenter, randomized trial to evaluate the safety and efficacy of the Interceptor PLUS Coronary Filter System as an adjunct to percutaneous interventions on saphenous vein bypass grafts (SVGs). The findings demonstrate that when compared to commercially available control devices (Medtronic’s Guardwire® Temporary Occlusion Balloon and Boston Scientific’s Filterwire EZ™), Medtronic’s new Interceptor PLUS Coronary Filter System works equally well in reducing major adverse cardiac events (MACE).

Medtronic also announced new findings from the EXPORT trial, a study assessing the safety and efficacy of the Export Aspiration Catheter, a device designed to remove thrombus and embolic material that is present in many blood vessel lesions and may become dislodged during interventional procedures. The study, a randomized, controlled trial of 250 patients at 24 sites in Europe and India comparing the use of Export prior to stent implantation with conventional stenting in patients with acute myocardial infarction (AMI), demonstrated the effectiveness of the Export Aspiration Catheter in improving blood flow in AMI patients.

Interceptor PLUS
A significant number of U.S. patients undergo coronary artery bypass grafting (CABG) procedures each year. The improved blood flow gives patients a new lease on life but, unfortunately, approximately half of these grafts can also become blocked or diseased over time. Moreover, they can become blocked by fragile, brittle and “friable” atheromous material as they age. When this occurs, cardiologists perform stent angioplasty to keep blood flowing through the vein grafts – a process that can also release showers of embolic debris. Embolic debris, if not contained, can flow downstream to result in blockages of tiny tributary vessels and trigger “microinfarcts,” or tiny heart attacks that destroy areas of heart muscle.

The Medtronic Interceptor PLUS Coronary Filter addresses this problem through its unique design. A braided nitinol filter mounted on a 0.014” hypotube, Interceptor PLUS is delivered in a closed state into the artery, moved past the blockage and opened before performing conventional stent angioplasty. The Interceptor PLUS Coronary Filter maintains blood flow in saphenous vein grafts while trapping the embolic debris.

Data from the AMEthyst trial showed that Interceptor PLUS met the primary study endpoint to demonstrate safety, MACE at 30 days, indicating non-inferiority of Interceptor PLUS compared to control devices. Interceptor PLUS also demonstrated efficacy with device success over 90 percent and a low incidence of clinical failure when compared to commercially available control devices. Medtronic’s successful completion of this study enables the company to pursue 510(k) clearance with the FDA to market the device in the U.S.

Export XT
Cleared for use in the U.S. in 2006, the Export XT Aspiration Catheter design allows for superior deliverability in even the most demanding cases. The full-wall variable braiding design helps eliminate segment joints and weak points in the catheter to improve kink resistance, and allows enhanced deliverability due to seamless transition of shaft stiffness from one end of the catheter to the other. The device features a soft tip material with a short, beveled design for minimal vessel trauma and improved debris capture, plus a hydrophilic coating for greater lubricity. Since its introduction in 2001, the Export Aspiration Catheter product line has been used to remove embolic debris in more than 200,000 patients worldwide.

Data from the EXPORT trial found Export met its primary endpoint. In patients presenting with an AMI, primary aspiration using the Export Aspiration Catheter is associated with a higher percentage of patients with ST segment resolution of greater than 50 percent at 60 minutes post procedure and/or a myocardial blush grade III immediately post-procedure than in patients with conventional stenting. In addition, primary aspiration using the Export catheter is associated with a lower rate of no-flow, higher corrected TIMI frame count post procedure, and a lower requirement for bail-out techniques.

“These trials demonstrate the Medtronic commitment to innovate new technologies that are specifically designed to reduce the risks associated with interventional procedures,” said Sean Salmon, vice president and general manager of the Coronary and Peripheral business at Medtronic. “The performance of these new devices is well characterized and represents a significant advance in interventional cardiology.”

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.

New Long-Term Data Suggest Clinical Differences in Safety and Efficacy Between CYPHER Sirolimus-Eluting Coronary Stent and Taxus Stent

An analysis of fifteen-month data from the Western Denmark Heart Registry found that patients who received the CYPHER® Sirolimus-eluting Coronary Stent had a lower risk of blood clots (stent thrombosis) and were less likely to need another procedure at the same lesion site (target lesion revascularization) than patients who received a Taxus Stent. The study is being shown at the Transcatheter Cardiovascular Therapeutics 2007 meeting (TCT 2007).

The differences between the CYPHER® Stent and the Taxus Stent in terms of definite stent thrombosis, definite/probable/possible stent thrombosis and target lesion revascularization were statistically significant and favorable for the CYPHER® Stent. Patients who received the Taxus Stent were 55 percent more likely to develop definite stent thrombosis than patients who received the CYPHER® Stent [confidence interval (CI) 0.21-0.94]. Taxus Stent patients were also 49 percent more likely to develop definite/probable/possible stent thrombosis than patients who received a CYPHER® Stent (CI 0.30-0.87). In addition, the CYPHER® Stent performed considerably better than the Taxus Stent in terms of target lesion revascularization, as Taxus Stent patients were 32 percent more likely to need a repeat procedure compared with patients who received the CYPHER® Stent (CI 0.52-0.90).

"The study data show that the clinical outcomes following drug-eluting stent implantation may depend on the type of stent used to treat a patient with coronary artery disease," said Professor Leif Thuesen, MD, DMSci, from Aarhus University Hospital in Denmark.

"The CYPHER® Stent continues to demonstrate excellent outcomes in clinical trials and in real-world settings," said David E. Kandzari, M.D., F.A.C.C., F.S.C.A.I., Chief Medical Officer, Cordis Corporation. "These findings are consistent with the results of other studies recently published in peer-reviewed medical journals [i.e. Stettler et al. Lancet 2007;370:937-48, Schömig et al. J Am Coll Cardiol 2007;50:1373-80, and Daemen et al. Lancet 2007;369:667-78] and build on the growing body of evidence indicating that the CYPHER® Stent and the Taxus Stent should be evaluated separately."

The Western Denmark Heart Registry is a multi-center, prospective, observational registry of all patients in western Denmark who receive coronary angiograms or coronary interventions, including percutaneous interventions and bypass surgery. This analysis evaluated patients from the registry who received a drug-eluting stent – either the CYPHER® Stent or Taxus Stent – from January 2002 through June 2005. Patients who received a combination of drug-eluting and bare metal stents (BMS) were excluded. All patients were followed for 15 months.

The primary endpoints of the study were stent thrombosis, myocardial infarction and death. No significant differences were found in the clinical outcomes of myocardial infarction or death.

Stent thrombosis was defined according to the Academic Research Consortium (ARC) definitions for thrombosis: definite, which required confirmation of a clot by angiogram at follow-up; probable, which included a heart attack in the treated vessel in patients who did not have an angiographic confirmation of a thrombosis; and possible, which included sudden unexplained death.

About the CYPHER®Stent

The CYPHER® Stent is the most studied drug-eluting stent in history and has been chosen by cardiologists worldwide to treat more than three million patients with coronary artery disease. The safety and efficacy of the device is supported by a robust clinical trial program that includes more than 70 studies that examine the performance of the CYPHER® Stent in a broad range of patients.

The CYPHER® Stent is currently available in more than 80 countries and has the broadest clinical experience and longest-term clinical follow-up of any drug-eluting stent. The next version of a sirolimus-eluting stent, the CYPHER® SELECT™ Sirolimus-eluting Coronary Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. The CYPHER® SELECT™ Plus Stent, the third version of a sirolimus-eluting coronary stent, received CE Mark in 2006 and is currently available in many markets outside the United States.

For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at www.cypherstent.com.

About Cordis Corporation

Cordis, a Johnson & Johnson company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease.

Vanda Pharmaceuticals Hires Chief Commercial Officer Al Gianchetti

Vanda Pharmaceuticals Inc. (Nasdaq: VNDA), a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders, today announced that Al Gianchetti will join the Company as Senior Vice President and Chief Commercial Officer effective October 25, 2007. Mr. Gianchetti joins Vanda with more than 18 years of experience in commercial roles at GlaxoSmithKline. Most recently, he held the position of Vice President, Global Commercial Strategy, where he was responsible for the global launches of Levitra(R) and Avodart(R). Prior to this role he was a Regional Vice President in the largest U.S. sales region within GSK. Before this, he launched Avandia(R), and Augmentin ES(R), two blockbuster products.

"We are very pleased to have Al join the Vanda Team," said Mihales Polymeropoulos, M.D., President and CEO of Vanda. "His depth of industry experience and proven track record across a wide spectrum of therapeutic areas are pivotal to the commercial success of Vanda's late stage pipeline."

About Vanda Pharmaceuticals Inc.

Vanda Pharmaceuticals Inc. is a biopharmaceutical company with a particular focus on the development and commercialization of clinical-stage product candidates for central nervous system disorders. The company has three product candidates in clinical development. In addition to iloperidone, Vanda is developing VEC-162, a compound for the treatment of sleep and mood disorders which is currently in Phase III for sleep disorders. Vanda's third product candidate in clinical development, VSF-173, is currently in a Phase II trial for the treatment of excessive sleepiness. For more on Vanda Pharmaceuticals Inc., please visit http://www.vandapharma.com/.

Invitrogen and HUPO Announce New Standard for Mass Spectrometry

Invitrogen Corporation (NASDAQ:IVGN), a provider of essential life science technologies for research, production and diagnostics, in collaboration with the Human Proteome Organization (HUPO), an international scientific organization that promotes proteomics, announced the launch of the HUPO Gold Mass Spectrometry (MS) Protein Standard sampling program. This will become the first commercially available all-recombinant human protein standard for mass spectrometry.

The HUPO Gold MS Protein Standard, which is a defined mixture of known human proteins designed to allow scientists to benchmark the quality of their experimental data and compare results from experiment to experiment, is expected to become an essential tool in data validation for all mass spectrometry-related analysis. This standard should allow scientists to validate and cross-reference their data, independent of sample types processed, mass spectrometry workflows performed, or actual mass spectrometers used.

"With a variety of published mass spectrometry workflows, as well as the large number of instruments and data-analysis software packages available for use, researchers today face major challenges validating and comparing their published data," said John Bergeron, Chair of HUPO Scientific Initiatives. "The HUPO Gold MS Protein Standard together with HUPO directed training should lead to field-generated data of greater run-to-run accuracy and reproducibility."

"Currently available standards for mass spectrometry are isolated directly from human samples, so they potentially contain naturally occurring contaminants, as well as proteins subject to natural genetic variations leading to slight changes in protein mass which can contribute to reduced reliability and reproducibility of a standard," said Paul Predki, Invitrogen Vice President of Research and Development. "By developing this new standard using recombinant methods, we have designed a valuable resource that will aid scientists in making their substrate identification more definitive and will allow them to reference their efforts on a global research scale."

Samples of the HUPO Gold MS Protein Standard are immediately available to members of HUPO. The entire HUPO Gold MS Protein Standard will be commercially available in the first quarter of 2008.

For more information please visit www.invitrogen.com/hupogold.

About Invitrogen

Invitrogen Corporation (NASDAQ:IVGN) provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen's own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, bioinformatics and cell biology -- placing Invitrogen's products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company is celebrating 20 years of accelerating scientific discovery. Invitrogen globally employs approximately 4,300 scientists and other professionals and had revenues of more than $1.15 billion in 2006. For more information, visit www.invitrogen.com.

About HUPO

HUPO (www.hupo.org) was launched on February 9, 2001. On that date, a global advisory council was officially formed that included leading international experts in the field of proteomics from the academic, government and commercial sectors. HUPO's council currently has 48 members from 19 countries, all of whom are renowned proteomics researchers from the academic and industrial sectors. HUPO's headquarters have been located at the McGill University and Genome Quebec Innovation Centre in Montreal, since January 2005. HUPO now has 2000 founding members from 69 countries.

HUPO promotes the development and awareness of proteomics research and advocates on behalf of proteomics researchers throughout the world. It has benefited from substantial contributions of time and energy from members of HUPO's council, research institutions and pharmaceutical companies around the globe.

Genetic Immunity Closes $2 Million Dollar Bridge Financing

Genetic Immunity LLC, a clinical stage biopharmaceutical company and a leader in the development of DNA based nanoparticle immunotherapies, announced today the completion of a $2 million dollar bridge financing.

Genetic Immunity's lead product is DermaVir Patch developed for the treatment of HIV/AIDS. The Company believes that this biopharmaceutical product will reconstitute HIV-specific immunity and reduce the viral load set-point in HIV-infected individuals enabling them to manage the disease safely prior to the initiation of the currently approved drug regimes. DermaVir Patch applies the Company's patented platform technology to efficiently deliver the nanoparticle medicine topically (needle free) to dendritic cells for transport to the draining lymph nodes where T cells are educated to kill the virus. The product has been demonstrated as safe and effective in reducing viral loads in monkey studies. A Phase I clinical trial has demonstrated safety and immunogenicity of DermaVir Patch in HIV-infected individuals. NIH and Karolinska Institute sponsored Phase II trials are ongoing in the U.S. and Sweden.

The Company also announced the engagement of the New York based investment firm of Rodman & Renshaw, LLC as its financial advisor.

"We are pleased to have secured the bridge financing which will enable the Company to launch an additional Phase II trial to demonstrate the proof of concept of DermaVir Patch in reducing the viral load in HIV positive individuals," said Dr. Julianna Lisziewicz, President and CEO of Genetic Immunity. "We are also very excited to be working with such a well regarded and respected firm as Rodman & Renshaw to assist the Company to develop the financial strategies for completing our clinical trials and bringing DermaVir Patch to the market."

About Genetic Immunity

Genetic Immunity is a U.S. - Hungarian clinical stage biopharmaceutical company focusing on the development and commercialization of its patented immunotherapeutic platform technology which addresses unmet medical needs for chronic diseases such as HIV/AIDS and allergies. Since its founding in 1998, the Company has pursued its goal of being the first company to bring an in vivo immunotherapeutic product to the market to treat one of the world's deadliest disease - HIV/AIDS. The Company intends to be the leader in developing immunotherapies for the burgeoning industry of molecular medicine.

About Rodman & Renshaw

Rodman & Renshaw is a full service investment bank dedicated to providing investment banking services to companies that have significant recurring capital needs due to their growth and development strategies, along with research and sales and trading services to institutional investor clients that focus on such companies. Through its AcumenBioFin(TM) division, Rodman is a leading investment banking firm to the biotechnology sector, a capital intensive market segment, as well as a leader in the PIPE (private investment in public equity) and RD (registered direct placements) transaction markets.

Invitrogen and Natural Selection Team to Bring New MicroRNA Sequences to Researchers

Invitrogen Corporation (NASDAQ:IVGN), a provider of essential life science technologies for research, production and diagnostics, announced today it has entered into a licensing agreement with Natural Selection, Inc. to make new microRNA sequences available to researchers. This agreement enables Invitrogen to provide the most comprehensive human and mouse microRNA arrays on the market.

The microRNA sequences have been verified experimentally using deep sequencing, array profiling, and qRT-PCR methods. Invitrogen is the first company to commercialize microRNA content discovered using these new deep sequencing technologies. The agreement will lead to a significant increase in human and mouse microRNA content on the market and available to researchers. The microRNA sequences will be submitted to the on-line database of The Sanger Institute, a leading biomedical research charity. Its on-line database, recently updated to 10.0 version, is the world repository for microRNA sequences.

"For the first time, scientists will be able to investigate the role of many novel and previously unknown microRNAs using Invitrogen's microRNA arrays with Natural Selection content," said Amy Butler, Invitrogen Vice President of Gene Expression Profiling. "By combining these new sequences with the latest Sanger 10.0 content, we are greatly expanding the potential for discovery of novel microRNA biomarkers for disease and development."

Also as part of the agreement, Invitrogen will make available a larger set of computationally-predicted microRNA sequences over the next few years for human and mouse resulting from a proprietary design algorithm developed by Natural Selection, Inc. under funding from the National Science Foundation.

"These new tools will significantly enhance the research community's understanding of the role of small RNAs in biological processes," said Dr. Gary Fogel, Vice President of Natural Selection. "This advance is particularly important in the areas of cancer and stem cell research, where microRNAs have been found to play a critical role. We are very pleased to team with Invitrogen to make these sequences available to the research community."

For more information on Invitrogen products for microRNA profiling, visit www.invitrogen.com/ncode. The Sanger microRNA database is located at http://microrna.sanger.ac.uk/sequences/.

About Invitrogen

Invitrogen Corporation (Nasdaq:IVGN) provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen's own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, bioinformatics and cell biology -- placing Invitrogen's products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company is celebrating 20 years of accelerating scientific discovery. Invitrogen globally employs approximately 4,300 scientists and other professionals and had revenues of more than $1.15 billion in 2006. For more information, visit www.invitrogen.com.

About Natural Selection, Inc.

Natural Selection, Inc. (NSI) is a private firm specializing in the application of computational intelligence methods for problem solving in medicine and biochemistry, such as image analysis, pharmaceutical design, structure prediction, sequence analysis, and personalized medicine. NSI also supports a variety of defense and industry applications. Founded in 1993 by Dr. Lawrence J. Fogel, a pioneer of evolutionary computation, NSI is headquartered in San Diego, California. For more information, visit www.natural-selection.com

GSK applies for licence to market OTC weight loss product In Europe

GlaxoSmithKline (GSK) today announced its marketing application for non-prescription orlistat 60mg for weight loss has been accepted for review by the European Agency for the Evaluation of Medicinal Products (EMEA).

Orlistat 60 mg was approved for non-prescription sale in the US by the FDA in February 2007 for use by overweight adults in conjunction with a reduced-calorie, low-fat dietand went on sale there in June 2007 under the brand name alli™. Alli is the only FDA-approved weight-loss product available to consumers without a prescription, and it is the first clinically-proven over-the-counter product to be combined with a comprehensive support programme.

John Clarke, President GSK Consumer Healthcare said: “This is a significant milestone and an important opportunity for GSK. Obesity is a rapidly increasing problem and a significant burden for healthcare systems in Europeand elsewhere. Leveraging our considerable expertise in OTC switches, we hope to offer consumers a new, clinically-proven option which can help to tackle this problem.

“So far, alli is performing well in the US and, if our application is successful, we will commit to rolling out a similar responsible marketing campaign with the same level of support for consumers in Europeas we have done in the US. We want to see people achieving gradual, sustained weight loss by using alli in tandem with a healthy eating, low-fat diet and increased exercise. We’ve said all along that this is no magic pill. If people are looking for a quick fix, this is not it but it is a powerful motivator, helping people lose up to 50% more weight than with diet alone*.”


If the regulatory process is successful, GSK would be granted a licence to market non-prescription orlistat 60mg in all 27 EU member countries, although initial launch markets have not been confirmed.



*- Anderson JW, Schwartz SM, Hauptman J et al. Low-dose orlistat effects on body weight of mildly to moderately overweight individuals: a 16 week, double-blind, placebo-controlled trial. Ann Pharmacother 2006; 40: 1717-23

- Study BM14149 and study NM14161. GSK data on file.


About Orlistat

§ Orlistat is the most comprehensively studied weight loss medication to date. Its safety and efficacy are well documented and have been established through data from more than 100 clinical studies involving more than 30,000 patients.

One of these studies – for Xenical®** - was the four-year landmark XENDOS trial conducted by Roche, its inventor and manufacturer. In this study alone, over 3,000 people were followed for four years while taking Orlistat, and it isthe longest completed study conducted to date for a weight-loss medicine. In all, since the launch of the 120 mg dose of orlistat as the prescription drug Xenical™ in 1999, there have been more than 28 million patient treatments with orlistat in more that 145 countries worldwide.


§ GlaxoSmithKline completed an agreement with Roche in February 2007 that enables the company to seek regulatory approval for the first non-prescription weight loss medicine in countries outside of the US excluding Japan.


The overweight and obese population in Europe


§ The prevalence of obesity has risen by between 10-50% in the majority of European countries in the last 10 years (International Obesity Taskforce (http://www.iotf.org )


§ Currently almost 400 million adults in Europe are estimated to be overweight and about 130 million to be obese. (WHO 2006; Fact sheet; The challenge of obesity in the WHO European Region http://www.euro.who.int/document/mediacentre/fs1305e.pdf )


§ The average BMI in Europe is nearly 26.5 and overweight affects 25-75% of the adults in Europe. A BMI of 25 and above is overweight and 30 and above is obese. (WHO 2006; Fact sheet; The challenge of obesity in the WHO European Region http://www.euro.who.int/document/mediacentre/fs1305e.pdf


• Obesity and overweight increase the risk of type 2 diabetes, cardiovascular disease, certain cancers, and gallbladder disease, resulting in a decreased quality of life and an increased risk of premature death (WHO 2003; Fact sheet: Obesity and overweight www.who.int/hpr/NPH/docs/gs_obesity.pdf






**Xenical® is a registered trademark of the Roche Group



About GSK

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. For company information, please visit www.gsk.com/media

GE and Lilly Announce Research Collaboration to Co-Develop Molecular In Vitro Diagnostics for Cancer Treatments

GE Global Research, the General Electric Company’s (NYSE:GE) centralized research and development organization, and GE Healthcare today announced a three-year collaborative research agreement with Eli Lilly and Company (NYSE:LLY) to discover and develop advanced in vitro diagnostic assays that may predict cancer treatment response to targeted therapies.

In addition to Lilly’s existing chemotherapy agents, Lilly is developing targeted cancer therapeutics, which are now in both early and late stage clinical development. GE is developing advanced multiplexed tissue-based assays and image analysis tools that can measure multiple biological pathways. The goal of this collaboration is to discover key protein and gene signatures that will predict the likelihood that a medication will be effective in treating certain cancers. Once identified the signatures can then be used to pre-select patients who are good candidates for the targeted therapy.

“The co-development of diagnostics and therapeutics is a major strategy of GE Healthcare’s “Early Health” vision, and our collaboration with Lilly and our expansion into in vitro diagnostics is right in line with this strategy,“ said, Dr. Michael Montalto, head of Molecular Imaging and Diagnostics Advanced Technologies for Global Research. “The combination of diagnostics and therapeutics is opening new doors in the fight against cancer and other life-threatening diseases. Through the application of molecular and cell biology to understanding disease, we can provide pharmaceutical companies with more advanced tools to develop more optimal drug therapies for cancer patients.”

“Our collaboration with GE complements Lilly’s research and development strategy of tailored therapeutics, or in other words, finding the right dose of the right medication at the right time for patients. Through our collaboration with GE Healthcare and GE Global Research, we hope to identify biomarkers for two of our targeted cancer therapeutic agents by examining patient tissues in order to determine which patients are most likely to respond to the medications and just as importantly which are not,” said Dr. Richard Gaynor, M.D., vice president, cancer research and global oncology platform for Eli Lilly and Company.

As the world becomes more educated and advanced in molecular medicine, the healthcare industry is experiencing a growing convergence of therapeutics and diagnostics. Through the use of molecular diagnostic tools that can discover key protein or gene signatures, pharmaceutical companies can begin to use that information to determine which patients are most likely to respond to a particular medication based on their particular genetic makeup.

The agreement between GE and Lilly will provide GE with access to clinical tissue samples from unidentified patients enrolled in Lilly’s clinical trials. In turn, Lilly will have access to GE’s advanced technologies in automated tissue-based image analysis and molecular reagents. These tools can be used during drug development to aid Lilly in evaluating the effectiveness of their drug candidates and potentially select patients for future trials.

In addition to helping Lilly identify patients for future trials, the diagnostic tools GE is providing also have the potential to greatly reduce the time and cost of cancer drug development.

The collaboration with Lilly is consistent with GE Healthcare’s Early Health Vision, which is about transforming healthcare delivery from a focus on treating late disease to a focus on adopting an Early Health model of care – where prevention, pre-disease detection, and early diagnosis are the key drivers. GE Healthcare has a strong portfolio of in vivo diagnostic imaging technologies and molecular contrast agents to assist with the detection and diagnosis of cancer, and expanding this strength toward in vitro diagnostics is a natural extension of this strategy.

About GE Global Research

GE Global Research is one of the world's most diversified industrial research organizations, providing innovative technology for all of GE’s businesses. Global Research has been the cornerstone of GE technology for more than 100 years, and is now focused on developing breakthrough innovations in areas such as molecular medicine, alternative energy, nanotechnology, advanced propulsion, and security technologies. GE Global Research is headquartered in Niskayuna, N.Y. and has facilities in Bangalore, India; Shanghai, China; and Munich, Germany. Visit Global Research at www.ge.com/research.

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.

GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

Headquartered in the United Kingdom, GE Healthcare is a US$17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

Medtronic and Kyphon Announce Clearance from German Federal Cartel Office for the Merger of Medtronic and Kyphon

Medtronic, Inc. (NYSE: MDT) and Kyphon Inc. (Nasdaq: KYPH) announced today that the German Federal Cartel Office has given its clearance in connection with the previously announced merger agreement between Kyphon and Medtronic, Inc. Completion of the transaction, which is expected later this year or in the first quarter of 2008, remains subject to obtaining approvals of antitrust authorities in several other jurisdictions, the approval of Kyphon’s stockholders and other customary closing conditions. A special meeting of Kyphon’s stockholders to vote on the proposed merger has been called for October 16, 2007. If further antitrust clearances are obtained prior to the Kyphon stockholders' meeting, the companies will provide an update at the time of the meeting.


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.


Medtronic is a registered trademark of Medtronic, Inc.


ABOUT KYPHON
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 http://www.kyphon.com/ and its balloon kyphoplasty patient education Web site, http://www.spinalfracture.com/.


Kyphon and IPD are registered trademarks, and Functional Anaesthetic Discography and F.A.D. are trademarks, of Kyphon Inc.