Glenmark Gets US Regulator's Nod for Cholesterol-Lowering Drug Ezetimibe

Leading new molecules maker of India, Glenmark Pharmaceuticals, has received approval from the US Food and Drug Administration (US FDA) for its cholesterol-lowering drug Ezetimibe. It is the generic version of Merck-Schering Plough's cholesterol-lowering drug with the product name Zetia.

Glenmark has sole exclusivity on the drug for 180 days. However, the company cannot launch it in the US immediately owing to an out of court settlement entered into with Merck. Glenmark had settled the patent litigation case with Merck for Ezetimibe in May 2010, by which Glenmark can launch the drug in December 2016 for 134 days sole exclusivity, ahead of the April 25, 2017, expiry of Merck's patent exclusivity for Zetia.

Last month, Glenmark received a final approval from the US FDA for its generic version of desmopressin acetate tablets, used in treating diabetes and bed-wetting. Its current portfolio consists of 97 products authorized for distribution in the US and 68 abbreviated new drug approvals with the US FDA.

Earlier this month, Glenmark signed an agreement with Russia's biggest innovation fund, the Skolkovo Foundation, which envisages a two-way cooperation whereby the Mumbai-based company can move R&D operations to Russia to leverage Skolkovo's infrastructure, and Russian expertise, as well as financing from Skolkovo.

From the generics business earlier, Glenmark has now become a major player in the new molecules pharmaceuticals business, with seven of them in various stages of development. Under the chairmanship of Glenn Saldanha, the company set up a 3,000 square meters laboratory in Switzerland in 2006 to become the first Indian life science enterprise to establish an R&D facility outside the country. It employs 60 scientists, all Swiss nationals.

The Indian company, along with its US subsidiary, has 13 manufacturing facilities in four countries, as well as five R&D centers.

Source: IANS