- Potential First-in-Class Anti-Secretory Anti-Diarrheal Agent for Multiple Indications Including HIV-Associated Diarrhea
- Glenmark has Crofelemer Rights for diarrhea Indications in 140 Countries; Molecule Currently in Phase 3 trials. ROW Sales Market Opportunity of US $ 80 Million for HIV-Associated Diarrhea
- Crofelemer has Been Granted Fast Track Designation by US-FDA
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MUMBAI, December 22MUMBAI, December 22 /PRNewswire/ -- Glenmark Pharmaceuticals Limited today announced new developments that should accelerate the launch of Crofelemer, a novel drug in development for multiple indications including HIV-Associated Diarrhea by a consortium of partners including Glenmark. Following the recent collaboration between Napo Pharmaceuticals and Salix Pharmaceuticals, it is expected that by the first half of 2010, the NDA (New Drug Application) for HIV-associated diarrhea would be filed in the USA. By that time, Glenmark plans to make regulatory submissions in ROW markets (excluding North America, Europe, China and Japan) and obtain approvals starting in 2010. Glenmark expects peak sales opportunity of US $ 80 mn in ROW markets alone in HIV-related diarrhea indication in addition to potential sales in adult acute infectious diarrhea in 140 countries around the world. Glenmark and Salix have also entered into a commercial supply agreement for the Crofelemer API. In addition to customary margins on global supplies, Glenmark would be entitled to receive royalty on sales in the western markets from Napo.
Mr. Glenn Saldanha, MD & CEO, Glenmark Pharmaceuticals Limited mentioned, "This is an exciting development for Glenmark. We are optimistic about the opportunity that Crofelemer presents. The recent collaboration agreement for the US market, the fast track status for the molecule granted by the US-FDA and the burgeoning issue of HIV-associated diarrhea provides a huge opportunity for our organization."
Crofelemer, is currently being investigated in a Phase 3 study in the US, as an anti-secretory anti-diarrheal agent for the treatment of chronic diarrhea in people living with HIV/AIDS, or HIV-associated diarrhea. The 350-patient Phase 3 trial (ADVENT) is being conducted in a two stage adaptive design. The protocol for this study has been reviewed and approved by the U.S. Food and Drug Administration (FDA) as a Special Protocol Assessment (SPA). Additionally, the FDA has granted Crofelemer fast track designation.
Approximately 40% of the 25 million people in ROW countries living with HIV/AIDS are affected by chronic diarrhea. HIV-associated diarrhea is a serious unmet medical condition that contributes to increased mortality and morbidity by reducing treatment compliance and efficacy as well as the quality of life in patients. If Crofelemer is approved, Glenmark should be well-positioned to leverage its specialty sales force in many of these countries to deliver this much needed solution to patients. If Crofelemer proves successful in the clinic, additional indications for Crofelemer may be investigated to address the broader diarrhea market.
For further information, please contact: Jason D'Souza / Medha Satam, Glenmark Pharmaceuticals Limited, Tel: +91-22-40189919 / 40189993, Email : media@glenmarkpharma.com .
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