Healthcare Industry News: hepatitis B virus
News Release - December 13, 2006
Schering-Plough Licenses Worldwide Rights to Pradefovir, Oral Hepatitis B Treatment In Development With Valeant Pharmaceuticals and Metabasis TherapeuticsKENILWORTH, N.J., Dec. 13 (HSMN NewsFeed) -- Schering-Plough Corporation (NYSE: SGP ) today announced the signing of definitive licensing agreements with Valeant Pharmaceuticals International (NYSE: VRX ) and Metabasis Therapeutics, Inc. (Nasdaq: MBRX ) for exclusive worldwide development and commercial rights to pradefovir, an investigational oral antiviral compound currently in Phase II clinical development for the treatment of chronic hepatitis B.
Valeant licensed pradefovir from Metabasis in 2000 and has been conducting clinical trials to evaluate the safety and efficacy of pradefovir for compensated chronic hepatitis B. Pradefovir is a pro-drug of PMEA that uses Metabasis' HepDirect® technology to enable higher concentrations of the drug in the liver, the primary site of replication for the hepatitis B virus, and lower concentrations elsewhere in the body.
"Pradefovir has the potential to offer improved treatment options for patients with chronic hepatitis B, a serious blood-borne infection affecting some 400 million people worldwide," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "Schering-Plough is continuing its leadership in hepatitis through internal research programs and strategic collaborations, with a focus on developing targeted oral antiviral agents," he said.
Hepatitis B is a potentially fatal disease that can lead to complications such as cirrhosis and primary liver cancer. Approximately 2 billion people worldwide are estimated to have hepatitis B, with 350-400 million people estimated to be chronically infected.
The transaction is expected to close in the first quarter of 2007 subject to expiration or early termination of the waiting period under the Hart-Scott- Rodino Antitrust Improvements Act of 1976 and the satisfaction of other customary closing conditions.
Under the terms of the agreements, Schering-Plough will make upfront payments to Valeant and Metabasis and will pay additional fees to Valeant and Metabasis upon the achievement of certain development and regulatory milestones. Schering-Plough will also pay royalties to Valeant and Metabasis in the event pradefovir is commercialized. Schering-Plough will be responsible for all forward research and development activities, including clinical studies and regulatory filings.
Valeant Pharmaceuticals is a global specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, infectious disease and dermatology. More information about Valeant can be found at http://www.valeant.com.
Metabasis Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of novel drugs to address some of the world's most widespread and costly chronic diseases. The company has established a pipeline that includes clinical stage and preclinical product candidates targeting major diseases with significant unmet medical needs. Targeted diseases include metabolic diseases such as diabetes, hyperlipidemia and obesity as well as liver diseases such as hepatitis and primary liver cancer. Metabasis has developed several proprietary technologies for use in discovering and optimizing drugs, including the NuMimetic(TM) and HepDirect® technologies. Metabasis is continuing to identify and develop new product candidates using its proprietary technologies and expertise.
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company's strategy and the potential development of and market for pradefovir for treating chronic hepatitis B. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A. Risk Factors in the Company's second quarter 2006 10-Q.
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