Thursday, December 05, 2002
BY ED SILVERMAN
Star-Ledger Staff
Hoffmann-La Roche Inc. is about to begin one of its most important marketing battles -- thanks to regulatory approval received late Tuesday for a hepatitis C treatment.
The product includes two components -- an injectable medicine called Pegasys that was recently approved for use on its own and Copegus, a pill also known as ribavirin. However, this combination therapy, as doctors refer to it, is widely believed to be more effective.
The approval is a big boost for Roche, which has been struggling in recent years thanks to product recalls, disappointing sales of key medicines and controversies over the Accutane acne and Lariam anti-malaria pills, both of which have been blamed for suicides.
By the same token, the regulatory approval poses a challenge for Schering-Plough Corp., which has dominated the market for hepatitis C treatments for the past few years with its own combination therapy.
That is because hepatitis C is one of the next battlegrounds in the pharmaceutical industry, where drug makers are increasingly willing to slug it out over any and every ailment. Already, Roche is betting its combination therapy will one day generate $1 billion in sales.
About 4 million Americans are infected and another 40,000 more are diagnosed each year with hepatitis C, which is a viral infection of the liver that is spread mainly by exposure to infected blood. The illness is also the primary reason for liver transplants.
Roche hopes to woo doctors with data showing patients can be effectively treated by using its therapy less frequently than those taking Schering-Plough's treatment, which is known as Peg-Intron.
A recent study found the Roche combination therapy effectively controlled the virus in 46 percent of patients who are hardest to treat. The product label on Schering- Plough's medicine claims 41 percent effectiveness.
Schering-Plough said this week its product is used by more than 150,000 patients and that it is conducting a comprehensive study.
At the same time, Roche hopes to attract patients with convenience -- Pegasys is a once-a-week, long-acting therapy. However, some patient advocates are upset that Roche last month priced Pegasys at higher-than-expected levels and are skeptical of the company's intentions.
"I was told the Copegus tablets won't be released until January, so they are not saying what the pricing will be now. This is a cutesie way to deflect attention from the price and just concentrate on the approval," said Brian Klein of Hepatitis C Action & Advocacy Coalition.
Ed Silverman can be reached at esilverman@starledger.com or (973) 392-1542.
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