Mumbai: Glenmark Generics, USA, the subsidiary of Glenmark Generics, has received the United States Food and Drug Administration (USFDA)'s approval for a skin ointment, Hydrocortisone Butyrate Cream, in an abbreviated new drug approval (ANDA) format. The cream is a generic version of Locoid Lipocream.
Glenmark Generics is a subsidiary of the Mumbai-headquartered Glenmark Pharmaceuticals. In April 2011, Glenmark had entered into a royalty-bearing license agreement with Triax Pharmaceuticals, Astellas Pharma Europe BV and Astellas Pharma International BV to settle a patent infringement suit against the commercialisation of the generic version of Locoid Lipocream.
The Indian company had agreed to launch the cream near the end of 2013. Glenmark is entitled to 180 days of exclusivity with respect to its cream as it is the first generic company to file an ANDA for the product.
The cream is indicated for the relief of skin infections. According to IMS Health, sales data for the 12-month period ending June 2013, Hydrocortisone Butyrate Cream garnered annual sales of approximately $34 million.
Moreover, on September 27, 2013, Glenmark Pharmaceuticals received a small research fee payment from Forest Laboratories towards a collaboration for the development of a molecule to treat chronic inflammatory conditions. The milestone payment would support the next phase of work.
Glenmark is expecting an additional payment to support the advancement of the programme. Forest has an exclusive option to obtain license rights to the programme upon the completion of pre-clinical trials. Under the terms of the agreement signed in FY 2012-13, Forest had made a $6-million upfront payment to Glenmark and also made an additional $3 million to support the next phase of work for the development of the drug.
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