Business
Glenmark gets US regulator nod for cholesterol drug
New Delhi, June 30
India's leading new
molecules maker Glenmark Pharmaceuticals has received approval from the
US Food and Drug Administration (USFDA) for its cholesterol-lowering
drug Ezetimibe.
Ezetimibe 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 but 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 the
Mumbai-based company 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 final
approval from the USFDA for its generic version of desmopressin acetate
tablets, used in treating diabetes and bed-wetting.
Its current
portfolio consists of 97 products authorised for distribution in the US
and 68 abbreviated new drug approvals with the USFDA.
Earlier
this month, Glenmark signed an agreement with Russia's biggest
innovation fund, the Skolkovo Foundation, which envisages a two-way
cooperation whereby the Indian 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 become a major player in the new molecules
pharmaceuticals business, with seven of them in various stages of
development.
Under chairman Glenn Saldanha, the company set up a
3,000 square metres 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 company, along with its US subsidiary, has 13 manufacturing facilities in four countries, as well as five R&D centres.