Glenmark Pharmaceuticals Ltd and Napo Pharmaceuticals Inc have entered into collaboration agreement for Napo's proprietary anti-diarrheal compound Crofelemer. The agreement grants the Company the exclusive license to develop and commercialize Crofelemer for India and several other markets to treat paediatric diarrhoea, acute infectious diarrhoea, and chronic diarrhoea in people living with HIV/AIDS (AIDS-related diarrhoea).
Crofelemer targets several gastrointestinal indications and is in advanced clinical development to treat AIDS-related diarrhoea and diarrhoea-predominant Irritable Bowel Syndrome (D-IBS) in the US.
According to the company release, the company will have the exclusive right commercialize crofelemer in over 140 countries, almost all markets outside North America, Japan, China and Europe. Additionally, the company will exclusively supply Napo's global API requirements for development and commercial sales under cGMP manufacturing according to US FDA requirements. The Company expects to launch the product in India and several other territories starting in 2007. Napo will receive royalties ranging from high single digits to early teens on net sales of the product in different geographies. As part of the collaboration, the Company will also participate in Napo's latest round of financing with a contribution of USD 1.0 million to its preferred stock.
"This collaboration is the beginning of our plan to complement our-generic development efforts for India and less regulated markets with proprietary products. It also illustrates the benefit of being an integrated company; executing our responsibilities will call upon our API, formulation development and clinical development skills." Glenn Saldanha, managing director and CEO of the Company commented. He added, "Collaborations with companies such as Napo will complement our business approach and provide access to a larger basket of patented drugs that can be marketed through the Company's global marketing infrastructure. In addition, apart from global marketing reach, Glenmark can offer partners a range of capabilities that include process chemistry, formulation development, clinical development, regulatory know-how and US FDA compliant and approved manufacturing facilities."