Romark and Chugai sign licensing agreement

Romark Laboratories, a privately held biopharmaceutical company, and Chugai Pharmaceutical, a member of the Roche Group, have entered into an exclusive licensing agreement for the development and commercialisation of nitazoxanide as a treatment of chronic hepatitis C in Japan.

Under the terms of the agreement, Chugai has paid an upfront payment to Romark, and will make additional payments based on the achievement of certain clinical and regulatory milestones. Romark will participate in profits from product sales in Japan through a supply agreement and royalties.

Nitazoxanide, the first of a new class of broad spectrum antiviral drugs known as the thiazolides, is undergoing worldwide development as a treatment of chronic hepatitis C. Phase II clinical trials are ongoing in the U.S. in patients with hepatitis C virus genotype 1.

Jean-Francois Rossignol, chairman and chief science officer of Romark, said: Chugai is an excellent partner for us in Japan. They bring substantial expertise in the development and marketing of treatments for chronic hepatitis C exemplified by their experience with Pegasys and Copegus. This agreement is an important step in accelerating the worldwide development and commercialisation of nitazoxanide for treating this disease.