Related Coverage. See more stories. At the same time, other big pharmaceutical makers could consider a CVR in future deals now it has become a cornerstone of a large acquisition like Genzyme, helping to mitigate risk as they seek new revenue sources.
He will resign as chairman and CEO of Genzyme when the transaction is completed. Genzyme was the first company to show that money could be made by making drugs for diseases with small patient populations.
The FDA finally approved Lemtrada in November , over seven months past the approval deadline specified in the rights agreement. However, Lemtrada was not approved fully — it was approved only as a third-line therapy to be used after other treatments had been tried and failed. In the complaint, the trustee takes issue with how long it took Lemtrada to gain FDA approval. Among the ten MS drugs with the highest sales in , the FDA approval process took an average of thirteen months, less than half the twenty-nine months it took for Lemtrada to be approved.
With the delay in Lemtrada approval, the price of the Genzyme contingent value rights fell significantly. Further complicating the situation, Lemtrada is expected to lose patent protection in September , further limiting its prospects.
Once the patent protection runs out, Sanofi will not have to pay any of the promised milestones, according to the trustee. The FDA in approved Aubagio in just over a year and Sanofi created a sales force to market Aubagio almost immediately. The complaint also alleged that Sanofi has conducted more consumer marketing events for Aubagio than for Lemtrada. Thomas Sullivan is Editor of Policy and Medicine, President of Rockpointe Corporation, founded in to provide continuing medical education to healthcare professionals around the world.
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