Roche, ICN Pharmaceuticals and Ribapharm have agreed on a settlement regarding the pending patent disputes over ribavirin.The companies will stop all legal actions regarding ribavirin, including the lawsuits filed in the US.Roche will continue to register and commercialize its own version of ribavirin, Copegus, globally. The financial terms of this settlement agreement, which includes a license by Ribapharm of ribavirin to Roche, were not disclosed.
"This settlement is in the interest of all parties and we can now fully concentrate on the marketing of our respective products," said William Burns, Head of Pharmaceutical Division at Roche.Roche, ICN and Ribapharm, ICN's 80 per cent owned subsidiary, co-operate on several other projects, including Roche's exclusive license to Ribapharm's Levovirin, an antiviral currently in clinical development for patients infected with HCV.
Robert W. O'Leary, Chairman and Chief Executive Officer of ICN, commented, "We are pleased to have played a significant role in resolving the legal issues surrounding ribavirin."Dr. Johnson Y.N. Lau M.D., Chairman, Chief Executive Officer and President of Ribapharm, stated, "We are very pleased that this agreement will add to Ribapharm's revenues and further our ongoing business relationship with Roche."
Copegus was approved in the European Union in September 2002.Copegus is indicated for the treatment of adult patients with chronic hepatitis C who have not previously been treated, including patients with fibrosis or compensated cirrhosis.It is also indicated for the treatment of adult patients who have responded to interferon alpha monotherapy, but have since relapsed.Copegus is prescribed as a combination regimen with Pegasys (peginterferon alfa-2a [40 KD]).
In the United States, Copegus was approved in combination with Roche's Pegasys, on December 3, 2002.Copegus is supplied as a light pink, oval shaped, film-coated tablet containing 200 mg of ribavirin.