Roche and InterMune collaborate on hepatitis C protease inhibitors

Roche is to develop and commercialise products from InterMune's Hepatitis C (HCV) protease inhibitor programme.

InterMune is a US-based biopharmaceutical company focused on developing therapies in hepatology and pulmonology. This latest deal covers its lead candidate compound ITMN-191, expected to enter clinical trials before the end of the year. The two companies will also collaborate on a research programme to develop novel second-generation HCV protease inhibitors.

Peter Hug, global head of Pharma Partnering for Roche, said: "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."

Roche will exclusively license ITMN-191 and will have the right to license further HCV protease inhibitor development candidates resulting from the research collaboration. InterMune will conduct Phase I studies for ITMN-191, and thereafter Roche will lead clinical development and commercialisation.

After closing, InterMune will receive from Roche an upfront payment of $60 million. In addition, if the drug is successful, InterMune could potentially receive up to $470 million in milestones, including $35 million within the next 12 months.

Roche will fund 67% of the global development costs and the companies will co-commercialise the product in the US and share profits on a 50-50 basis. InterMune will receive royalties outside the US, but may opt-out of either co-development or co-commercialisation for ITMN-191, in which case it would receive higher royalties on ex-US sales, and royalties instead of profit sharing in the US.

The Centers for Disease Control and Prevention estimates 3.9 million Americans (1.8%) have been infected with HCV, of whom 2.7m are chronically infected. It is estimated that there are 170m people worldwide afflicted with this disease.

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.