FDA approves second generic of thrice-weekly Copaxone

The Sandoz Ltd. unit of Novartis AG (NYSE:NVS; SIX:NOVN) and partner Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) said FDA approved an ANDA for thrice-weekly 40 mg/mL Glatopa glatiramer acetate injection as a generic version of multiple sclerosis drug Copaxone from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA).

Novartis and Momenta confirmed Sandoz has launched 40 mg/mL Glatopa, but Novartis spokesperson Eric Althoff declined to disclose its whole acquisition cost (WAC).

Glatopa, which is indicated to treat relapsing forms of MS, has been on the market as a 20 mg/mL formulation since 2015 when FDA approved it as the first once-daily Copaxone generic. Last October, FDA approved once-daily 20 mg/mL and thrice-weekly 40 mg/mL generic competitors from Mylan N.V (NASDAQ:MYL) (see BioCentury Extra, Oct. 4).

Teva has been in legal dispute with generic competitors, including Sandoz and Momenta, over patents covering Copaxone. Last year, the U.S. District Court for the District of Delaware invalidated all claims for four U.S. patents covering Copaxone. Teva appealed the decision, which is pending oral argument. Teva has five U.S. patents and one European patent covering Copaxone, all of which expire in 2030.

Teva posted $821 million in 4Q17 worldwide sales of Copaxone, down 19% from 4Q16. It reported a 25% decline in U.S. revenues of the drug over the same period, which it attributed to generic competition.

Sandoz and Momenta partnered on developing Glatopa, which is a selective major histocompatibility complex class II (MHCII) modulator, under a 2006 deal.

Momenta was slid $0.30 to $16 on Tuesday, while Teva lost $0.75 to $18.52 in New York and NIS0.35 to NIS66.10 in Tel Aviv. Mylan fell $0.19 to $40.41 in New York.