Firm hopes FDA will make therapy, revenue possible

Saturday, January 4, 2003Pittsburgh Tribune-ReviewBy Michael Yeomans

This is the year a start-up generic drug firm from Cranberry could produce its first revenue, if it can battle its way out of the courts and win Food and Drug Administration approval for its inaugural product.

Three Rivers Pharmaceuticals LLC has been trying for three years to get approval to make a generic version of Rebetol, a treatment for liver disease hepatitis C that is taken as part of a drug cocktail to contain the disease.

The drug currently has nearly $800 million in annual sales for its distributor, Schering-Plough. Patient groups are clamoring for approval of generic medications that typically cost far less than those of the branded drug manufacturers.

Paul Fagan, attorney for Three Rivers, says the delay in obtaining FDA approval stems from problems with the drug’s informational labeling for doctors, which would give detailed instructions for use and possible side effects. The proposed label refers to another Shering-Plough drug, which is taken in combination with Rebetol for treating hepatitis C.

“The labeling needs to be finished. The FDA tells you what the labeling will be like,” Fagan said. “Our position is, ‘tell us what you want, and we’ll put it in.'”

Fagan said the company is prepared to begin distributing the drug once FDA approval is received and outstanding lawsuits with Schering-Plough are resolved over patent issues. Three Rivers countersued Schering-Plough in August 2001, claiming that its method of manufacture would not infringe on Schering-Plough’s patent.

Shering-Plough filed the initial lawsuit, alleging patent infringement, a common practice by branded drug manufacturers aimed at obtaining a 30-month stay from the courts during which time generics are barred from the market.

Three Rivers Pharmaceuticals has outsourced the raw materials and production of the drug. It has also licensed the retail distribution rights to Par Pharmaceutical Inc. of Spring Valley, N.Y. Three Rivers will distribute the drug on its own to institutional customers like hospitals and prisons, where hepatitis is a growing problem.

Fagan anticipates the first sales could come as early as the second quarter of this year. So far, the company has funded its operations with investments from its management and through so-called angel investors high net worth individuals with an appetite for high risk for potentially higher rewards.

Fagan declined to comment on whether Three Rivers is preparing to pursue generic versions of other drugs coming off patent.

Michael Yeomans can be reached at or (412) 320-7908.

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