Maxygen Eyeing 2006 for Hepatitis Treatment INDs

Maxygen and Roche are completing late-stage preclinical studies and manufacturing on their collaborative effort to develop improved interferon alpha protein therapeutics to treat hepatitis C virus (HCV) and hepatitis B virus (HBV) infections, and they expect to file an investigational new drug application toward Phase I clinical trials next year, Maxygen said.

The companies forged a $230 million strategic alliance in May 2003 in which Roche licensed worldwide commercialization rights to Maxygen for specific novel interferon product candidates, Maxygen said. Under the agreement, Maxygen will receive development funding, milestone payments and royalties on sales of any resulting products.

Before beginning Phase III clinical trials, Maxygen has the option to co-develop in the U.S. any products for which Roche acquires a license in exchange for an increased royalty rate or profit sharing, said Maxygen, which is based in Redwood City, Calif.