Amgen Inc. said Friday Phase III trial results of itsversion of alpha interferon for hepatitis C are goodenough to apply for FDA approval, but not so exciting asto give the company a sales edge over two pharmaceuticalfirms already marketing the antiviral protein for the samedisease.

"The Phase III trials are complete," said David Kaye,spokesman for the Thousand Oaks, Calif.-basedcompany. "Could we submit [the drug] to the FDA? Yes.And would the FDA approve it? It's hard to say what theFDA would do," he noted, adding that if the agencycleared the drug for marketing Amgen would be lockedinto a label based on the existing trial findings.

Kaye said Amgen is conducting "several extensions to thetrials that generate data on a monthly basis to help us puttogether a competitive picture of the drug."

He said Amgen will evaluate the additional results beforedeciding whether to submit the product, which is calledInfergen, to the FDA for approval.

Among the data the company hopes to derive from theextended trials are results demonstrating Infergen'sadvantages over its competitors.

The Phase III studies showed Infergen was "safe andeffective in treating chronic hepatitis C," Kaye said, butno details were disclosed.

"What we haven't found for competitive reasons, we'renot going to announce now," he said.

Infergen is a consensus alpha interferon and is differentfrom the natural protein. It was expected to perform betterthan current alpha interferon products on the basis ofefficacy or safety. Another advantage targeted wasdurability of response. Because alpha interferon is toxic,patients periodically must stop taking the drug and oftenthey experience a relapse of the disease. Delaying theonset of a relapse was among the goals for Infergen.

"Apparently what [Amgen] has at this point is a `me-too'product," said Robert Faulkner, an analyst with S.G.Warburg & Co. in New York. "It's questionable whetherit would be worth launching in the U.S. They need aproduct that's a lot better or a lot less toxic."

Schering-Plough Corp., of Madison, N.J., is the onlycompany with alpha interferon on the market in the U.S.for hepatitis C. Schering-Plough and Switzerland-basedRoche Holdings Ltd. sell alpha interferon outside the U.S.for the disease.

Barbara Hoffman, an independent analyst with Hoffman& Co. in Denver, noted the market in the U.S. for alphainterferon as a hepatitis treatment is small, about $100million a year. The vast majority of the drug's worldwidesales for hepatitis are outside the U.S., particularly inJapan, where Amgen only is in Phase I testing.

Based on the crowded competitive situation and the smallmarket in the U.S., Hoffman described as "no big deal"Amgen's delay in deciding whether to seek FDAapproval of Infergen.

Amgen's product pipeline has other promising drugcandidates, she said, especially the potential expansion ofNeupogen's label to include infectious diseases.

Neupogen, recombinant human granulocyte colonystimulating factor, now is sold for restoring white bloodcells in cancer patients undergoing chemotherapy. Thedrug, one of two Amgen products on the market, is inPhase III trials for community-acquired pneumonia.Amgen's other drug is Epogen, recombinant humanerythropoietin, which is a red blood cell booster sold totreat anemia in kidney disease.

Combined sales of Neupogen and Epogen for 1994topped $1.5 billion and for the first six months of thisyear revenues were more than $870,000.

Faulkner said Infergen's success is important because it isthe only potential "bridge" product to enhancesignificantly Amgen's growth between now and 1998when the company's other drug candidates may emergefrom the pipeline.

On Friday, Faulkner said he downgraded Amgen's stock(NASDAQ:AMGN) to "hold" from "buy" based onInfergen and the prospect of a reduced growth rate overthe next year and a half.

Amgen's decision to continue evaluating Infergen wasdisclosed late Thursday in its earnings report for thesecond quarter, ending June 30. The company's stockclosed Friday at $80, up $1.50.

-- Charles Craig

(c) 1997 American Health Consultants. All rights reserved.