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It is estimated that up to 3% of the world population have been infected with HCV, according to NHANES III (Third National Health and Nutrition Examination Survey), which means there are over 170 million chronic carriers at risk of developing liver cirrhosis and/or liver cancer. Nearly 4 million Americans are infected with HCV and about 2.7 million Americans (70%) of those are chronically infected with HCV. In 2002 the NIH issued a report which conservatively estimated that HCV is responsible for 10,000 to 12,000 yearly deaths in the United States, and the number of people diagnosed with chronic HCV is expected to increase fourfold from 1990 to 2015. Merck has paid an execution fee to Metabasis and will fund Metabasis' efforts to synthesize suitable HepDirect™ prodrugs of the Merck HCV compounds. The agreement provides Merck with the exclusive responsibility for further development and commercialization of HepDirect™ HCV drugs that result from the collaboration. Should a collaboration drug be successfully developed, Metabasis will receive milestone payments, and will share in the commercial success of any resulting product through a royalty on worldwide sales. At the end of the first year of the collaboration, Merck will also have the option to extend their exclusive use of the HepDirect™ technology for HCV. In this case, an additional fee will be paid and milestone payments and royalties will be increased. Should Merck elect to license a HCV product discovered solely by Metabasis, additional fees, milestone payments and royalties will be required. According to Metabasis, the proprietary HepDirect™ technology is a prodrug technology that specifically targets production of the biologically active form of certain drugs to the liver and preclinical studies have shown that use of the HepDirect technology may result in higher active drug concentrations in the liver and decreased exposure to non-liver tissue. Accordingly, HepDirect™ prodrugs may have the potential to improve efficacy, reduce toxicity and thus improve the treatment of liver and liver-related diseases. "By combining Merck drug candidates with our proprietary HepDirect™ liver targeting technology, we have an opportunity to rapidly develop effective new treatments for this devastating and widespread disease", said Dr. Paul Laikind, Chairman, President and CEO of Metabasis. "We believe Merck's leadership in drug development, marketing, and sales will best position us to take advantage of this opportunity. We are very pleased to have Merck as a partner." Dr. Mark Erion, Metabasis' Executive Vice President of Research and Development, added "Metabasis has gained a great deal of experience using the HepDirect technology over the past few years. We now intend to apply the knowledge obtained from our two non-HCV clinical stage HepDirectTM prodrugs towards Merck's compounds as well, and leverage this technology to discover drugs to treat HCV." Dr. Mervyn Turner, Merck's Senior Vice President of Worldwide Licensing and External Research commented that "Merck is delighted to have the opportunity to partner with Metabasis in an attempt to bring forward new treatments for HCV patients. Partnering with the best of biotech remains a core goal of Merck, and our collaboration with Metabasis fits well with this strategy. " About Metabasis Metabasis Therapeutics, Inc. (www.mbasis.com) is a privately held, biopharmaceutical company that develops proprietary products principally for the treatment of liver and liver-related metabolic diseases. Metabasis has expertise in the fields of nucleoside/nucleotide chemistry and metabolism, liver biology and liver-specific drug delivery. Metabasis has discovered and developed a new class of drug candidates for treating diabetes that act to lower liver glucose production in diabetic patients. The first drug candidate from this program, CS-917, is being developed in collaboration with Sankyo Co., Ltd. and is currently undergoing clinical testing. Metabasis has also developed its HepDirect technology that allows liver-specific delivery of new and existing drugs. Two novel drug candidates derived from the HepDirect technology are in clinical testing: a drug for hepatitis B called Hepavir B, developed in collaboration with Valeant Pharmaceuticals International Inc. and a drug for primary liver cancer called MB7133, to which Metabasis retains exclusive rights.
Merck & Co., Inc. is a global, research-driven pharmaceutical products company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through joint ventures.
This press release contains "forward-looking statements"
as that term is defined in the Private Securities Litigation Reform
Act of 1995. These statements involve risks and uncertainties, which
may cause results to differ materially from those set forth in the
statements. The forward-looking statements include statements regarding
product development. No forward-looking statement can be guaranteed,
and actual results may differ materially from those projected. Merck
undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events,
or otherwise. Forward-looking statements in this press release should
be evaluated together with the many uncertainties that affect Merck's
businesses, particularly those mentioned in the cautionary statements
in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2002,
and in the company's periodic reports on Form 10-Q and Form 8-K
(if any) which are incorporated herein by reference.
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