Glenmark Pharma has been sued by the US headquartered Astella Pharma and Triax Pharma in the US for allegedly infringing upon the latter?s patent coverage by attempting to manufacture the generic version of Locoid Lipocream (Hydrocortisone Butyrate). Hydrocortisone Butyrate is used to treat skin conditions such as severe eczema, psoriasis and dermatitis. The Mumbai-based drugmaker believes that it is the first to file an Abbreviated New drug Application (Anda) with the US Food and Drug Administration for the generic version of this drug which implies it would be entitled to a 180 days of exclusive marketing in US, should its product get a final valid approval. The drug clocks revenue worth $38 million per annum in the US market.
Glenmark also said on Monday that it has completed the critical phase-III trials for its novel, first in class anti-diarrhoea drug, Crofelemer, pushing its shares up 3.56 % to close at Rs 377on Monday. The drug, used in the treatment of HIV-associated diarrhoea, will be launched in 140 countries, the company said. Glenmark has developed Crofelemer in partnership with US drugfirms, Napo Pharmaceuticals and Salix Pharmaceuticals. The Mumbai-based drugmaker has exclusive marketing and distribution rights to this compound across 140 countries and is also the sole global supplier of active pharmaceutical ingredients except in China, the drugmaker added. Glenmark would invest significant resources to fast-track its development plan to ensure early regulatory approvals for Crofelemer and launch it in most of the markets, Glenn Saldanha, chief executive and managing director, Glenmark, said in a statement.
The company expects the approval for the drug in India in 2012, it said. ?The results from these pivotal phase III studies for Crofelemer in the treatment of HIV-associated diarrhoea are very encouraging for Glenmark as this will accelerate our goal to provide patients access to this drug across multiple diarrheal conditions. We are encouraged by these results as we could now prepare for the launch of Crofelemer and this will be our first novel product,? Saldanha said. He added, ?Besides HIV-related diarrhoea, most of the markets where Glenmark has exclusive rights have significant incidence of acute diarrhoea, especially in young children. Crofelemer has previously shown benefit in patients with mild to severe acute watery diarrhoea?.