Alemtuzumab regulatory update

Sanofi's Genzyme Corp. subsidiary withdrew cancer drug MabCampath alemtuzumab from the European market to prepare for commercialization of the anti- CD52 mAb under a different name and dosing regimen for multiple sclerosis. The U.S. version of the cancer drug, known as Campath, will also no longer be commercially available, effective Sept. 4. MabCampath/Campath was marketed for B cell chronic lymphocytic leukemia (CLL). In June, Genzyme submitted regulatory applications to EMA and FDA for alemtuzumab under the name Lemtrada for MS (see BioCentury, June 18).

In July, Sanofi said the availability of MabCampath/Campath could affect its ability to successfully launch Lemtrada and achieve the sales milestones tied to the Genzyme contingent value right. Last year, Sanofi acquired Genzyme for about $20.1 billion, plus the $14 CVR, $13 of which is devoted to milestones for Lemtrada in MS. Worldwide sales of MabCampath/Campath were $76 million in 2011, and the pharma said revenue has been flat to declining over the last several years. About 4,000 patients annually are treated with the product. Sanofi said it is working with healthcare authorities to establish patient access programs for Campath/MabCampath CVR (see BioCentury, Feb. 21, 2011 & April 11, 2011). ...