First Launch Of Reteplase Follows EU/US Approvals

Boehringer Mannheim launched its genetically-engineered thrombolytic Rapilysin (reteplase), a recombinant plasminogen activator, onto the German market on October 1, shortly after receiving marketing approval from the European Medicines Evaluation Agency. This is the first world launch for the product, which is indicated for use in patients with acute myocardial infarction.

Just after the launch announcement, the news came through that reteplase had been approved by the US Food and Drug Administration as well. The next introduction will be in Austria on December 1, with a US launch taking place in January. In the USA, the product will be marketed as Retevase.

Pricing Takes On Alteplase In Germany, reteplase is priced in direct competition with Genentech's Actilyse (alteplase), its major competitor, which is produced and sold under license in the country by CH Boehringer Sohn, Ingelheim. Reteplase costs between 2,000 and 2,600 Deutschemarks ($1,324-$1,720) per course, and is given as a double bolus of 2 x 10 units spaced 30 minutes apart. Other thrombolytics need to be given by continuous infusion, which involves catheterizing the patient.