Amgen Gets OK to Sell Its First New Drug Since 1991
Amgen Inc. said Tuesday that it won U.S. Food and Drug Administration approval to sell its third biotechnology drug--and its first new drug since 1991--to treat the potentially fatal liver virus hepatitis C. But analysts cautioned that sales will be modest, because Amgen’s new drug is similar to established ones already on the market.
Amgen’s entry, called Infergen, is a bioengineered laboratory protein designed to combat hepatitis C, which can lead to cirrhosis or liver cancer. There are at least 400,000 diagnosed cases.
Rivals Schering-Plough and Hoffmann-La Roche Ltd. already sell hepatitis C drugs in what analysts said is a $1-billion-plus market worldwide.
“Amgen has an excellent marketing organization, so they’ll take some market share. But when you’re late into the market without a significant advantage, it’s a tough sale,” said Jim McCamant, editor of the Medical Technology Stock Letter in Berkeley. He estimates that Infergen’s annual sales in the U.S. will peak at “under $100 million. Maybe as low as $50 million.”
Amgen’s shares rose $1.75 to close at $49.44 on Nasdaq.
“The expectations for Infergen are fairly low,” conceded Amgen spokesman David Kaye. “But we believe it could be a very nice franchise for us.”
Amgen hopes to win market share in conventional hepatitis C treatments and to grab new shares, Kaye said, because human tests showed that Infergen can help some patients who didn’t respond well to existing drugs.
Amgen has licensed most foreign sales of Infergen to Japan’s Yamanouchi Pharmaceutical Co., although the drug is still in human trials overseas.
Analyst David Crossen, with NationsBank Montgomery Securities, said that by 2000 Infergen sales may hit $200 million worldwide. “It will help. But this third drug is not remotely as important as Amgen’s first two,” he said.
Amgen’s first drug, called Epogen, was approved by the FDA in 1989. Neupogen came to market two years later. Each was a scientific breakthrough and became wonder drugs, with the pair producing $2.2 billion in sales last year. Epogen treats chronic anemia in kidney-disease patients, and Neupogen is versatile in fighting off infection in cancer and AIDS patients.
In recent years, though, investors have become anxious waiting for the Thousand Oaks company to bring new drugs to market. In January, Amgen announced that a drug it was developing to treat deadly Lou Gehrig’s disease failed to work in a large human clinical trial.
Amgen has 11 new drugs in development for treating conditions such as obesity, stopping internal bleeding in cancer patients and combating toxic chemotherapy doses in breast cancer patients.
