Pozen Receives Positive News on MT 100 in the UK

Pozen has received a letter from the Committee on Safety of Medicines (CSM), the Advisory Group to the UK's Medicines and Healthcare products Regulatory Agency (MHRA), agreeing to advise MHRA that a marketing authorization be granted for MT 100 in the UK, provided that Pozen supplies additional information and meets certain conditions outlined in the letter.

If UK approval is granted unconditionally by MHRA, Pozen will seek approval in Denmark, Sweden, Norway and Finland through the European Union Mutual Recognition Procedure (MRP), in order to enable its licensing partner Nycomed to commercialize MT 100 in those countries. Pozen will also be seeking a partner to market MT 100 in other key European countries to be included in the MRP.