The Food and Drug Administration (FDA) yesterday allowed German drug maker Sandoz and Momenta Pharmaceuticals Inc. of Cambridge, Mass., to make the first generic version Lovenox, which is widely used as a blood thinner. The approval means that Momenta and Sandoz can now develop a cheaper but an affective alternative to Lovenox, which recorded sales worth $4.5 billion last year. Lovenox is the 15th-bestselling drug in the world.
The FDA also rejected an argument by Sanofi-Aventis, which makes Lovenox that the drug is made from sugar molecules found in heparin and the makers of the generic versions of the drugs would find it very difficult to copy it in a perfect manner. Heparin is derived from pig intestines. The Sandoz-Momenta team had been fighting with Amphastar Pharmaceuticals Inc. of Rancho Cucamonga for the last five year to get the approval of the FDA. They will make the drug under the generic name enoxaparin.
Amphastar last year accused the FDA's top drug official Janet Woodcock of a conflict of interest claiming that she was involved with Momenta scientists in the past. Amphastar complaint was however, dismissed by the Department of Health and Human Services inspector general. "The approval of M-Enoxaparin marks a key milestone for Momenta and we are extremely pleased," Momenta Chief Executive Craig Wheeler said in a statement.
Momenta's shares jumped to $21.70, up $9.77 after the news of approval broke out, while shares of Sandoz's parent, Swiss pharmaceutical giant Novartis, went down 35 cents to end day's trading at $49.21. The shares of Sanofi-Aventis lost $1.29, closing at $29.35.
