Morepen Labs has got an approval of International Patent of new Crystalline form (VI) of Atrovastatin, cholesterol lowering drug. Atorvastatin is the largest selling drug in the World, with a market size over USD10 billion. The same has been published by World Intellectual Property Organization (WIPO) under the Patent Cooperation Treaty (PCT). This is a second international patent for Atorvastatin; Morepen got the World patent for amorphous form of Atorvastatin last year.

Statins are growing at a phenomenal rate globally with market size close to USD 20 billion today, Morepen has kept in pace with these developments. The company had developed for the first time, a novel Crystalline form of Fluvastatin. An international patent application has also been filed recently with WIPO under the PCT for this highly stable and pure novel crystalline form of cholesterol lowering drug Fluvastatin sodium. Fluvastatin patent has already expired in Canada & Europe, hence ensuring an early and easy entry for Morepen in these markets vis-à-vis Atorvastatin the patent of which expires in 2011. The DMF for Fluvastatin has already been submitted to the Europe and Canada authorities recently and US DMF will be filled very soon. The market size of Fluvastatin (Lescol) is USD 376mn growing steadily at 25%.

Morepen is also filling an ANDA's for both these molecules and expects them to fetch a business of approximately USD 250mn in next 10 years. Morepen would continue to focus on the manufacture of life style disease drugs. The new crystalline form of Atorvastatin is highly pure and stable polymorphic form of cholesterol lowering drug Atorvastatin Calcium (Brand name-Lipitor), The gaining of Intellectual Property Rights (IPR) of the new polymorphic of this high value high volume drug gives an exclusive opportunity to Morepen for entry in the highly regulated market in US, Canada and Europe after it becomes generic internationally. The preliminary bio-equivalence studies performed with the new formulation of Morepen indicate it to be comparable to the innovator's drug -- Lipitor

The company is in active discussions with several international Pharma majors who are interested in a long-term strategic alliance for contract sourcing and co-marketing of this product in regulated markets. Morepen is also in the advanced stage of submission of Drug Master Files (DMFs) to the US, Canadian and European authorities.

The above patent filings are in line with Morepen's objectives of being a leading supplier of APIs in global regulated markets as also its priority of being the preferred outsourcing hub for finished dosages in regulated and other markets for leading global generics players.