Schering-Plough Corp. said Tuesday it is seeking U.S. regulatory approval to sell its combination hepatitis C therapy to a wider group of patients, including those who haven't been treated already with standard hepatitis-fighting drugs.
The news follows an announcement last month that the combination of drugs developed by Schering-Plough and Costa Mesa-based ICN Pharmaceuticals Inc. offers significant benefits to previously untreated patients. Currently, the combination is only approved for patients who have suffered a relapse after therapy.
"There are many more patients who would be treated," said Robert Consalvo, a spokesman for the Madison, N.J.-based drug maker. Only about 1.5% of patients eligible for therapy are receiving it because current drugs often don't benefit patients, he noted.
Combination therapy, which has been shown to work better than single-drug therapy, may encourage more patients to seek treatment, he said.
Schering-Plough shares rose $1.63 to $88.50, while ICN's stock rose 88 cents a share to $43.88. Both trade on the New York Stock Exchange.
The company asked the Food and Drug Administration to give the application a "priority review," which generally means completing the review within six months. A decision from the FDA on that issue should come within two months, Consalvo said.
Schering-Plough sells the combination, made up of its Intron-A and ICN's Rebetol, under the brand name Rebetron.
If approved for patients who haven't yet been treated, Rebetron would compete in a larger market dominated by Schering-Plough's own Intron-A as a stand-alone treatment and drugs sold by Roche Holding AG and Amgen Inc. Intron-A, also approved for a variety of antiviral and anti-cancer uses, had sales of $164 million in the first quarter.
Hepatitis C has generated much attention in recent years as scientists have learned more about the condition, first identified in 1989. Experts estimate that almost 4 million Americans are infected with hepatitis C, a virus most often transmitted through contaminated needles or a tainted blood transfusion before screening tests were available. The disease sometimes appears in patients with no risk factors.
Hepatitis C can cause severe liver problems, including cirrhosis, in about 20% of those infected. Others may lead a full life with few problems.
To date, there's no cure for the condition and many patients get no long-term benefit from available treatments.