LAINATE (May 31, 2011) Cosmo Pharmaceuticals S.p.A. (SIX: COPN) today announced that, based on the successfully concluded clinical trials in the US and EU, it had filed the documentation required for the Marketing Authorization Application (MAA) of Budesonide MMX® for induction of remission in patients with mild to moderate active ulcerative colitis. This MAA was filed with 15 EU countries with Dutch Regulatory Agency acting as reference member state.
Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals, and Santarus Inc. (NASDAQ: SNTS), are collaborating on the entire Budesonide MMX® phase III clinical program. In late September 2010, Cosmo Pharmaceuticals and Santarus announced positive top-line results from the phase III pivotal clinical study of Budesonide MMX® in North America and in India and in November 2010 Cosmo Pharmaceuticals and Santarus announced positive top-line results from the phase III pivotal clinical study of Budesonide MMX® in Europe and the rest of the world.
Mauro Ajani, Chief Executive Officer of Cosmo Pharmaceuticals, said: “I am very pleased that we have completed the documentation and were able to file the MAA within the planned time frame. The European regulatory environment calls for certain drugs to be filed centrally at EMA and others such as drugs for Ulcerative Colitis to be filed with national agencies. We are following the decentralized procedure in 15 countries with the Dutch Agency as the reference member state for the other European countries; the remaining European countries will follow later on through the mutual recognition procedure. We now look forward for our US licensee, Santarus, to integrate the data compiled in the recently completed extension study so that they can proceed with the filing of the NDA with the FDA in the USA. Around 900’000 people in Europe suffer from Ulcerative Colitis. I am pleased that we have moved a step closer in providing these with a better treatment option.”