Hepatitis :: Roche and InterMune’s ITMN-191 HCV protease inhibitor for hepatitis c

Roche and InterMune Inc. announced that the companies have entered into an exclusive worldwide collaboration agreement to develop and commercialize products from InterMune?s Hepatitis C (HCV) protease inhibitor program. The agreement includes InterMune?s lead candidate compound ITMN-191, expected to enter clinical trials before the end of the year. The companies will also collaborate on a research program to identify, develop and commercialize novel second-generation HCV protease inhibitors.

?This agreement with InterMune is part of our ongoing commitment to advancing therapies for hepatitis C patients,? said Peter Hug, Global Head of Pharma Partnering for Roche. ?We believe that protease inhibitors may become an important new component of HCV treatments and we look forward to working with InterMune in the development of ITMN-191 and other potential compounds that may emerge from our collaboration.?

Dan Welch, President and Chief Executive Officer of InterMune commented: ?We are very pleased to be partnering with Roche. We believe this partnership will help accelerate the development of ITMN-191 and future second-generation protease inhibitors, while allowing InterMune to share in the substantial value creation opportunity of this important program.?

Terms of the Agreement
Roche will exclusively license ITMN-191 and will have the right to exclusively license further HCV protease inhibitor development candidates resulting from the research collaboration. For ITMN-191, InterMune will conduct Phase I studies, and thereafter Roche will lead clinical development and commercialization. Upon closing, InterMune will receive from Roche an upfront payment of $60 million. In addition, assuming the successful development and commercialization of ITMN-191 in the U.S. and other countries, InterMune could potentially receive up to $470 million in milestones, including $35 million within the next 12 months. For ITMN-191, Roche will fund 67% of the global development costs and the companies will co-commercialize the product in the U.S. and share profits on a 50-50 basis. InterMune will receive royalties outside the U.S. InterMune may opt-out of either co-development or co-commercialization for ITMN-191 in which case InterMune would receive higher royalties on ex-US sales, and royalties instead of profit sharing in the U.S.

The economic terms for ITMN-191 could also apply to additional compounds that InterMune and Roche develop and commercialize. The transaction will close following the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvement Act of 1976, as amended.

About ITMN-191
InterMune has successfully completed preclinical toxicology and pharmacokinetic studies in multiple species in support of initiating Phase I clinical studies of ITMN-191 for the treatment of chronic HCV. The European Clinical Trial Authorization (CTA), which was submitted on September 26th, 2006, includes results of 28-day preclinical toxicology studies utilizing doses many-fold higher than those expected to be given to humans. These studies demonstrate that ITMN-191 has a favorable safety and toxicology profile, allowing the compound to be studied in clinical trials over a range of doses predicted to have antiviral efficacy. ITMN-191 has also demonstrated high in vitro potency and specificity in biochemical assays and in assays utilizing the HCV replicon system. Moreover, ITMN-191 displays a favorable cross-resistance profile, including significant potency against variants of the NS3/4A protease that are resistant to other HCV protease inhibitors currently in development. The preclinical pharmacokinetic results support the exploration of twice-daily oral dosing in HCV patients.

About HCV and HCV Protease Inhibitors
According to the Centers for Disease Control and Prevention (CDC), an estimated 3.9 million Americans (1.8%) have been infected with HCV, of whom 2.7 million are chronically infected. It is estimated that there are 170 million people worldwide afflicted with this disease. Currently available therapies are insufficient, creating a need for the development of novel therapeutic approaches. The HCV NS3/4 protease is an attractive drug target because of its potential involvement in viral replication and suppressive effects on host response to viral infection. Inhibitors of the HCV protease, such as ITMN-191, represent a promising new class of drugs for HCV and are likely candidates for use in combination with Pegasys and other HCV compounds in the Roche portfolio.

About Roche as a Partner
Roche is a valued partner to more than 60 companies worldwide. During the past two years, Roche has led the pharmaceutical industry in the number of clinical compound deals signed. In 2006 to date, Roche has entered into eight partnerships to jointly develop products for optimal patient benefit and value. Recent collaborations have complemented the company?s autoimmune disease franchise and oncology research pipeline, the latter being in line with a diagnostics collaboration strengthening Roche?s position in personalized medicines. This deal with InterMune adds to Roche?s hepatitis C portfolio and has the potential to bring important new treatment options to HCV patients.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world?s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people?s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, while the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).

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