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.