Valeant Pharmaceuticals and Metabasis Therapeutics License Rights to Hepatitis B Compound Pradefovir to Schering-Plough Corporation.COSTA MESA, Calif. & SAN DIEGO -- Valeant Pharmaceuticals International Valeant Pharmaceuticals International is a pharmaceutical company with activities spanning the drug discovery pipeline from target identification through clinical trials and commercialization. (NYSE NYSE See: New York Stock Exchange :VRX VRX Virtual Resources Executive VRX Voice Receive Mode ) and Metabasis Therapeutics, Inc. (Nasdaq:MBRX) today announced the signing of definitive agreements for the assignment and license of development and commercial rights to pradefovir to Schering-Plough Corporation (NYSE:SGP SGP Singapore (ISO Country code) SGP Schering-Plough (stock symbol) SGP Stability and Growth Pact SGP Southern Great Plains SGP Staatkundig Gereformeerde Partij SGP Speedway Grand Prix ). 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 The Hart-Scott-Rodino Antitrust Improvements Act of 1976 (Public Law 94-435, known commonly as the HSR Act) is a set of amendments to the antitrust laws of the United States, principally the Clayton Antitrust Act. The HSR Act was signed into law by President Gerald R. of 1976 and the satisfaction of other customary closing conditions. Valeant licensed pradefovir from Metabasis in 2000 and has been conducting clinical trials to evaluate the safety and efficacy of pradefovir for the treatment of compensated chronic hepatitis Chronic hepatitis Long lasting inflammation of the liver due to viruses or other causes. Mentioned in: Tube Compression of the Esophagus and Stomach chronic hepatitis B. Pradefovir is a pro-drug of PMEA PMEA Pennsylvania Music Educators Association PMEA Powder Metallurgy Equipment Association PMEA Physician Meeting & Event Audit PMEA Programa Municipal de Educação Ambiental PMEA Phosphonyl Methoxy Ethyl Adenine , an antiviral compound that uses Metabasis' HepDirect[R] technology to enable higher concentrations of the drug in the liver, the primary site of replication for the hepatitis B Hepatitis B Definition Hepatitis B is a potentially serious form of liver inflammation due to infection by the hepatitis B virus (HBV). It occurs in both rapidly developing (acute) and long-lasting (chronic) forms, and is one of the most common chronic virus (HBV HBV hepatitis B virus. HBV abbr. hepatitis B virus ) and lower concentrations elsewhere. Under the terms of the agreements, Schering-Plough will make an upfront payment of $19.2 million to Valeant and $1.8 million to Metabasis and will pay up to an additional $90 million in aggregate fees upon the achievement of certain development and regulatory milestones to Valeant and Metabasis. Approximately $65 million of the additional fees would be paid to Valeant and $25 million to Metabasis. The amount to be paid to Metabasis includes the remaining $16 million in milestone payments that could have been realized under the previous agreement between Metabasis and Valeant. Schering-Plough will also pay royalties to Valeant and Metabasis in the event pradefovir is commercialized. Timothy C. Tyson, Valeant's president and chief executive officer, said, "We are very pleased to license pradefovir to Schering-Plough, a partner with a global reach and commitment to developing medicines for treating life-threatening diseases like hepatitis B. Our development program for pradefovir has produced encouraging results. The compound's Phase 2 results showed significant reductions in viral load viral load n. The concentration of a virus, such as HIV, in the blood. viral load, n a measure of the number of virus particles present in the bloodstream, expressed as copies per milliliter. , which if confirmed in Phase 3 trials, could demonstrate a potential advantage over current therapies." Dr. Paul Laikind, Metabasis' president and chief executive officer, said, "Based on the clinical results to date, we believe pradefovir's profile could make it best-in-class should it be approved. The agreements announced today with Schering-Plough, a company with a strong commitment to providing innovative treatments for hepatitis, further validate this product candidate's potential. Like our colleagues at Valeant, we are very pleased with the fact that pradefovir is moving to a team that can complete development and maximize the commercial potential of the product." About Hepatitis B Hepatitis B is a potentially fatal disease that can lead to complications such as cirrhosis and primary liver cancer Liver Cancer Definition Liver cancer is a relatively rare form of cancer but has a high mortality rate. Liver cancers can be classified into two types. . Approximately 2 billion people worldwide are estimated to have hepatitis B, with 350-400 million people estimated to be chronically infected. According to a recent study, the HBV market currently represents more than $1 billion in annual sales, and is expected to grow to over $2.8 billion by 2012. Pradefovir is an investigational compound that has not been found by the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) or any other regulatory agency regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. to be safe or effective in the diagnosis, mitigation, treatment or cure of any disease or illness. It may not be sold or promoted in the United States unless and until the FDA has approved its New Drug Application. Similar restrictions apply in other countries. About Valeant Valeant Pharmaceuticals International (NYSE:VRX) 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 Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. and dermatology. More information about Valeant can be found at www.valeant.com. About Metabasis (www.mbasis.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 hyperlipidemia /hy·per·lip·id·emia/ (-lip?i-de´me-ah) elevated concentrations of any or all of the lipids in the plasma, including hypertriglyceridemia, hypercholesterolemia, etc. 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(R) technologies. Metabasis is continuing to identify and develop new product candidates using its proprietary technologies and expertise. Forward-looking Statement forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. This press release contains forward-looking statements, including, but not limited to, statements regarding the expected closing of the assignment and license to Schering-Plough as well and the anticipated benefits and potentially successful development of pradefovir. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the assignment and license will not close as currently anticipated, as well as risks and uncertainties relating to the future development of pradefovir, dependence on Schering-Plough relating to the development and regulatory approval of pradefovir, approval of pradefovir by the FDA and other similar governmental authorities outside the United States, and the receipt of milestone and other payments under the pradefovir license agreement, and other cautionary statements discussed in the companies' filings with the U.S. Securities and Exchange Commission. Valeant and Metabasis wish to caution the reader that these factors are among the factors that could cause actual results to differ materially from the expectations described in the forward-looking statements. Valeant and Metabasis also caution the reader that undue reliance should not be placed on any of the forward-looking statements, which speak only as of the date of this release. The companies undertake no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this release or to reflect actual outcomes. |
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