FDA warning letter to contracted Glatopa fill/finish manufacturer

US drugmaker Momenta Pharmaceuticals (Nasdaq: MNTA), whose shares were halted at $19 after hours on Friday, following its announcement that Sandoz’s contracted fill/finish manufacturing partner, US pharma giant Pfizer (NYSE: PFE), has received a US Food and Drug Administration warning letter.

The Pfizer facility is a key part of the supply chain for the company’s Glatopa products. Pfizer has indicated that the warning letter does not restrict the production or shipment of the Glatopa 20mg (glatiramer acetate injection) product that is currently marketed by Sandoz, the generics and biosimilars subsidiary of Swiss pharma giant Novartis (NOVN: VX) in the USA. The companies launched their 20mg generic version of Teva Pharmaceutical Industries’ (NYSE: TEVA) blockbuster multiple sclerosis drug Copaxone (glatiramer acetate) in the USA in June 2015.

The Glatopa 40mg Abbreviated New Drug Application (ANDA) remains under regulatory review. Momenta believes the application review could be completed at any time. However, under FDA policy, an approval of the application is dependent on the satisfactory resolution of the compliance observations at the Pfizer facility used to make the final product, and Momenta expects that an approval in the first quarter of 2017 is now unlikely. Momenta is working with its collaboration partner Sandoz to resolve this matter in order to allow for an ANDA approval as soon as possible.