Morepen Labs has received international patent for a new crystalline form (VI) of Atrovastatin, cholesterol lowering drug. This is expected to help Morepen gain entry into regulated markets once the drug gets off patent.

The new crystalline form of Atorvastatin is highly pure and stable polymorphic form of cholesterol lowering drug Atorvastatin Calcium (Brand name-Lipitor), The preliminary bio-equivalence studies performed with the new formulation of Morepen indicate it to be comparable to the innovator's drug - Lipitor, claimed a company press release.

Atorvastatin is the largest selling drug in the world, with a market size over USD10 billion. This is a second international patent for Atorvastatin; Morepen got the world patent for amorphous form of Atorvastatin last year.

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.

Statins are growing at a phenomenal rate globally with current market size of close to USD 20 billion. 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 drug master file (DMF) for Fluvastatin has already been submitted to the Europe and Canada authorities recently and US DMF will be filed very soon. The market size of Fluvastatin (Lescol) is USD 376mn growing steadily at 25 per cent.

Morepen is also filling abbreviated new drug applications (ANDAs) 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 release said.