AMGEN SIGNS LICENSING DEAL.

Byline: Deborah Adamson Daily News Staff Writer

Amgen Inc. in Thousand Oaks said Thursday it signed a licensing agreement with Japan's third-largest pharmaceutical company for the right to market a new anti-viral drug worldwide, except for the U.S. and Canada.

The biotechnology firm made a deal with Yamanouchi Pharmaceutical Co. Ltd. of Tokyo to market Consensus Interferon, which fights the hepatitis C virus.

``We want to concentrate our resources in this country and work with Yamanouchi, who has experience in the interferon market,'' said Amgen spokesman David Kaye.

He said the drug, which will be marketed as Infergen in domestic markets, likely will be Amgen's third product, following Epogen and Neupogen.

Epogen treats anemia related to kidney disease and Neupogen is a stimulator of the immune system. Interferon is a class of drugs under which Infergen is classified.

``This agreement does give Amgen a major partner in the largest market for interferon,'' said Alex To, biotechnology analyst at Donaldson, Lufkin & Jenrette in New York. ``(But) most of the analysts have written off Infergen as not a significant contributor to Amgen's business. The drug faces very significant competition and will be entering a mature market.''

Yamanouchi has paid Amgen $15 million and will make additional payments if certain milestones are achieved, the company said. The Japanese company also will pay royalties on sales. Amgen declined to discuss details.

Yamanouchi also granted Amgen's Japanese and Hong Kong subsidiaries the right to co-develop and co-market the new drug in Japan, China, Hong Kong and Taiwan.

The drug, whose approval from the U.S. Food and Drug Administration is pending, will have to go through clinical trials and regulatory approval in Japan.

Amgen expects to get FDA approval by late 1997 and clear regulatory hurdles in Japan in two to three years.

Kaye said that by that time, Yamanouchi's rights to market another interferon drug, known as Intron in the U.S., will have expired.

The U.S. interferon market is estimated at close to half a billion dollars, while worldwide sales are at least $1 billion. Japan represents at least 70 percent of the world market.

The hepatitis C virus infection is one of the most common causes of chronic hepatitis, cirrhosis and hepatocellular carcinoma.

Amgen said its new drug is ``safe and effective'' in treating chronic hepatitis C virus and is ``more effective'' in reducing the virus in patients with HCV genotype 1 when compared with another interferon treatment.