- Potential First-in-Class Anti-Secretory Anti-Diarrheal Agent forMultiple Indications Including HIV-Associated Diarrhea
Advertisement
- Glenmark has Crofelemer Rights for diarrhea Indications in 140Countries; Molecule Currently in Phase 3 trials. ROW Sales Market Opportunityof US $ 80 Million for HIV-Associated Diarrhea
Advertisement
- Crofelemer has Been Granted Fast Track Designation by US-FDA
Glenmark Pharmaceuticals Limited today announced new developments thatshould accelerate the launch of Crofelemer, a novel drug in development formultiple indications including HIV-Associated Diarrhea by a consortium ofpartners including Glenmark. Following the recent collaboration between NapoPharmaceuticals and Salix Pharmaceuticals, it is expected that by the firsthalf of 2010, the NDA (New Drug Application) for HIV-associated diarrheawould be filed in the USA. By that time, Glenmark plans to make regulatorysubmissions in ROW markets (excluding North America, Europe, China and Japan)and obtain approvals starting in 2010. Glenmark expects peak salesopportunity of US $ 80 mn in ROW markets alone in HIV-related diarrheaindication in addition to potential sales in adult acute infectious diarrheain 140 countries around the world. Glenmark and Salix have also entered intoa commercial supply agreement for the Crofelemer API. In addition tocustomary margins on global supplies, Glenmark would be entitled to receiveroyalty 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 theopportunity that Crofelemer presents. The recent collaboration agreement forthe US market, the fast track status for the molecule granted by the US-FDAand the burgeoning issue of HIV-associated diarrhea provides a hugeopportunity 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 chronicdiarrhea in people living with HIV/AIDS, or HIV-associated diarrhea. The350-patient Phase 3 trial (ADVENT) is being conducted in a two stage adaptivedesign. The protocol for this study has been reviewed and approved by theU.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 withHIV/AIDS are affected by chronic diarrhea. HIV-associated diarrhea is aserious unmet medical condition that contributes to increased mortality andmorbidity by reducing treatment compliance and efficacy as well as thequality of life in patients. If Crofelemer is approved, Glenmark should bewell-positioned to leverage its specialty sales force in many of thesecountries to deliver this much needed solution to patients. If Crofelemerproves successful in the clinic, additional indications for Crofelemer may beinvestigated 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 : [email protected] .
SOURCE Glenmark Pharmaceuticals Ltd.
