To: scaram(o)uche who wrote (4211 ) 3/29/2006 1:20:46 AM From: zeta1961 Read Replies (1) | Respond to of 12215 MRK licenses IDIX's NM283..wonder how WS will like this given the recent disclosure of GI effects no position..watching from sidelines.. Idenix Announces Licensing of Valopicitabine (NM283) by Novartis ~ Potential License Fees and Regulatory Milestone Payments Total Up to $525 Million ~ CAMBRIDGE, Mass., March 29 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases, announced today that Novartis has exercised its option to license valopicitabine (NM283). Valopicitabine, an oral antiviral, is Idenix's lead compound in development for the treatment of hepatitis C, a condition estimated to affect more than 170 million people worldwide and a major cause of liver disease. "This is a very significant event for Idenix given the development program planned for valopicitabine," said Jean-Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix Pharmaceuticals, Inc. "Our collaboration with Novartis contributes additional clinical, regulatory and marketing expertise to these efforts, as well as funding for this development program." Under the terms of the agreement, Idenix may receive up to $70 million in license fees, of which $25 million is payable to Idenix in conjunction with the option exercise. The remaining $45 million in license fees is payable to Idenix by Novartis upon the advancement of valopicitabine into phase III clinical trials in treatment-naive and treatment-refractory patients in the United States. In addition, Idenix may receive up to $455 million in milestone payments upon achievement of regulatory filings and marketing authorization approvals of valopicitabine in the United States, Europe and Japan. Expenses associated with the development of valopicitabine incurred by Idenix subsequent to the date of license will be reimbursed by Novartis. If successfully developed, Idenix and Novartis will co-promote valopicitabine in the United States and each of the five major European markets (United Kingdom, Spain, France, Italy and Germany). Novartis will have exclusive rights to market and promote valopicitabine in the rest of the world. More About Valopicitabine Valopicitabine is an investigational compound for the treatment of hepatitis C that is being evaluated in ongoing clinical trials. Valopicitabine blocks hepatitis C virus (HCV) replication by specifically inhibiting the HCV RNA polymerase. In initial clinical trials, valopicitabine, administered orally once a day, was shown to reduce HCV viremia in patients infected with the genotype 1 strain of HCV. The ongoing phase IIb clinical trials are evaluating the combination of valopicitabine and pegylated interferon in hepatitis C patients who previously failed to respond to antiviral treatment, as well as in patients who have not yet been treated for hepatitis C. Valopicitabine has dose-related gastrointestinal (GI) side effects, which are more common at higher dosing levels (e.g., 800 mg/day). The GI side effects are typically mild-to-moderate, are transient in most patients, and are less common at lower dosing levels (200 to 400 mg/day). As a result of this observation, Idenix has recently modified its phase IIb clinical trials to reduce valopicitabine dosing levels from 800 mg/day to 200 mg/day or 400 mg/day. About Hepatitis C