New Use for Genentech Drug Approved : Pharmaceuticals: Activase can now be sold as a treatment to dissolve blood clots. Its price has been controversial.
The Food and Drug Administration has given Genentech approval to market its genetically engineered drug Activase for use as a treatment to dissolve blood clots in lungs, the company said Wednesday.
The approval comes at a propitious time for Genentech, which has traveled a rocky road with Activase, its brand name for tissue plasminogen activator (t-PA). The company has been selling the drug since November, 1987, for use in treating heart attack patients, amid controversy over its high cost and effectiveness. Last year, Activase accounted for about half of Genentech’s $400 million in revenue.
Denise Gilbert, an analyst who follows Genentech for Montgomery Securities in San Francisco, said this new market could bring in another $25 million in annual revenue.
The FDA action gives Genentech more good news to take to shareholders at its annual meeting Friday. Although the primary agenda item for the meeting is the $2.1-billion merger of the South San Francisco-based company with Swiss pharmaceuticals giant Roche Holdings, concerns about Activase are also likely to be addressed.
Genentech has admitted some nervousness over possible long-term effects on Activase sales of a recent study of heart attack cases, in which Activase performed no better than a drug costing one-tenth as much. Activase costs $2,200 a dose.
That study and others mean that Genentech is likely to face stiffer competition in the heart attack treatment arena. In the market for treatment of pulmonary embolisms (obstructions of arteries to the lung), Activase will go up against a product by Abbott Laboratories that has been the medical standard for 20 years.
But G. Kirk Raab, Genentech’s chief executive, expressed optimism. “We believe that the effectiveness of Activase has the potential to make it as important in the treatment of pulmonary embolism as it has become in the treatment of heart attacks,” Raab said in a statement.
In recent weeks, a flurry of positive announcements have come from Genentech. Analysts say the heavy news flow is likely to continue throughout the year because of the high number of projects and products the biotechnology company has in the works.
