Lemtrada alemtuzumab regulatory update

Sanofi’s Genzyme Corp. unit said Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) approved Lemtrada alemtuzumab to treat adults with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features. The humanized mAb against CD52 is also approved in the EU, Australia, Canada, Mexico, Brazil and Guatemala. In May, Genzyme said FDA accepted for review a resubmitted sBLA for Lemtrada to treat relapsing MS. Genzyme said it expects a decision in 4Q14; the specific PDUFA date is not disclosed. The product has Fast Track designation in the U.S.

Bayer AG (Xetra:BAYN, Leverkusen, Germany) has an option to co-promote alemtuzumab for MS and full rights in solid organ transplant indications. The product is partnered with BTG, which owns the IP and is eligible for undisclosed royalties in all approved indications (see BioCentury, April 6, 2009 & June 8, 2009). ...