A WHOLE NEW BALLGAME; AFTER HOME RUNS WITH ITS FIRST TWO DRUGS, AMGEN TRIES TO PUT ITS HEPATITIS C PRODUCT IN PLAY.

Byline: Ben Sullivan Daily News Staff Writer

One year after drug maker Amgen Inc. won government approval for a drug to treat hepatitis C, the biotechnology company has found the product's value so far lies not so much in its sales, but in the knowledge gained on how to market a niche medicine.

Hepatitis C is a nasty virus that if left untreated can destroy the human liver and eventually kill its host. Like HIV, the virus that causes AIDS, hepatitis C is contracted through the exchange of bodily fluids. But with more than 4 million carriers in the United States alone, it is far more common than HIV, and as such represents an enormous potential market for drug makers.

When Amgen got approval from the U.S. Food and Drug Administration last year to sell Infergen, an artificially derived form of the human protein interferon, it hoped to tap into that would-be gold mine. But after nearly a year of marketing, Infergen now accounts for just 8 percent of prescriptions written in the United States to treat the disease.

Analysts say that's not a terrible performance, considering Amgen faced entrenched competitors in Schering-Plough Corp. and Roche Holding AG. Indeed, given the growing but still limited market for the drug - fewer than 300,000 Americans have been treated for hepatitis C - no one expected Infergen to match the blockbuster status of Amgen's two other products, Epogen and Neupogen, which each generate $1 billion-plus a year in sales.

Still, with Infergen earning smaller profits per prescription than competitors' more costly interferon products, it will be years, if ever, before the company can recoup the hundreds of millions it spent bringing the drug to market.

At less than $15 million in projected 1998 sales, ``it's another line to add to our (estimates) model, but not much of one,'' said analyst Charles Engelberg at AmeriCal Securities in San Francisco.

Instead, company officials say Infergen's true legacy could lie in the lessons the product is offering Amgen on how to market a niche drug, knowledge that will be essential for the company to successfully shift from a business model based on two ``home run'' drugs to one driven by a number of ``singles'' and ``doubles.''

``Some people say what Amgen needs is another Epogen,'' said company spokesman David Kaye. ``But Epogens are few and far between. We have to have the capability of marketing a lot of smaller products.''

So far, the main lesson derived from the Infergen effort is that in the absence of overwhelming evidence that one product outshines another - or in the case of Epogen and Neupogen, products that are the only games in town - winning the hearts and minds of opinion leaders is essential.

With Infergen, Amgen officials said they did a fine job of managing clinical trials that led up to FDA approval, but dropped the ball after getting clearance.

``There's a small number of hepatologists out there, and what they like to do is treat patients in a clinical trial setting,'' said Tom Nusbickel, director of marketing for Infergen.

By failing to adequately involve these specialists in post-approval trials, Amgen missed an opportunity to bring them on board and build their comfort with, if not loyalty to, the drug.

The company has subsequently begun several such trials. If, as expected, Amgen wins FDA approval next year for Stemgen, a drug that promotes the growth of blood platelets, it will be sure to have such tests ready at the start.

Another key lesson of the Infergen effort is that to grow a niche field into one with larger revenue potential, a drug maker must take a lead role in promoting public awareness.

In the case of Infergen, Amgen donated an undisclosed sum to the nonprofit American Liver Foundation to encourage people through billboards, commercials and literature to be tested for the hepatitis C virus. If just 10 percent of those thought to be infected were tested, and 10 percent of those received Infergen, if would more than quadruple the company's 1998 sales.

If applied to future product launches, such lessons could in themselves justify the millions spent on developing Infergen.

``We knew we were launching into a competitive marketplace,'' Nusbickel said. ``But now we're becoming capable of operating in that intense environment ourselves.''

CAPTION(S):

Drawing, Box

Drawing: (Color) Hepatitis C virus

Box: AT A GLANCE

HEPATITIS C

SOURCE: Centers for Disease Control

Dionisio Munoz/Daily News