US launch of lead drug candidate naproxcinod expected to be significantly delayed
French company NicOx SA has decided to close the US headquarters of NicOx Inc with effect from 31 August 2010. The decision follows a review of the Group’s structure and requirements after the US FDA said it could not approve its lead drug candidate naproxcinod, which is expected to at least significantly delay any potential US launch.
NicOx plans to discuss possible next steps as early as possible with the FDA and to continue to pursue the European regulatory process for naproxcinod. The company will also actively seek to enter into partnerships for naproxcinod in Europe and the rest of the world as well as for other products in its pipeline whilst also pursuing appropriate in-licensing and M&A opportunities.
‘We very much regret having to close our operations in the US,’ said Michele Garufi, ceo of NicOx. ‘As we seek to work out possible next steps for naproxcinod in the US and to pursue the approval process in Europe, it is essential that we manage our resources in the most effective manner.’