Alchemia Ltd has become aware of a potential competitor for its fondaparinux sodium, a generic version of GlaxoSmithKline’s Arixtra synthetic anticoagulant used for the prevention of deep vein thrombosis.

Apicore LLC has filed a drug master file (DMF) for the fondaparinux sodium active pharmaceutical ingredient (API) with the US Food and Drug Administration (FDA). The company has partnered with a major generic pharmaceutical company to develop the API and prefilled syringes with the goal of obtaining approval for an Abbreviated New Drug Application (ANDA) to distribute a generic product equivalent to the brand name product Arixtra.

Alchemia’s manufacturing partner Dr Reddy’s Ltd filed its DMF for fondaparinux in November 2008, followed by the ANDA filing in March 2009 by Alchemia’s North American marketing partner Dr Reddy’s Inc.

The ANDA application for Alchemia’s fondaparinux is receiving priority review as it was the first filing of a generic version.

Alchemia CEO Dr Peter Smith says the company had hitherto been unaware of Apicore’s activity in developing a process for the manufacture of fondaparinux sodium.

Source: News Bites