Glenmark Pharmaceuticals Limited announced new developments that should accelerate the launch of Crofelemer, a novel drug in development for multiple indications including HIV-associated diarrhoea 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 diarrhoea 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 million in ROW markets alone in HIV-related diarrhoea indication in addition to potential sales in adult acute infectious diarrhoea 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.

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-diarrhoeal agent for the treatment of chronic diarrhoea in people living with HIV/AIDS, or HIV-associated diarrhoea. The 350-patient phase-3 trial (ADVENT) is being conducted in a two stage adaptive design.

In Stage 1 the first 200 patients will receive either one of the three doses of Crofelemer or Placebo. Results from Stage 1 will be utilized to determine the dose selected for Stage 2. The final 150 patients will be randomized on a 1:1 ratio to receive either the selected dose of Crofelemer or placebo. Both stages of the study involve a 10-day screening period, a 31-day treatment phase and a 5-month extension phase. The primary objective of the study treatment phase is to determine the proportion of HIV-positive patients experiencing relief of diarrhea with Crofelemer compared to placebo. The protocol for this study has been reviewed and approved by the US Food and Drug Administration (FDA) as a Special Protocol Assessment (SPA). Additionally, the FDA has granted Crofelemer fast track designation.

Approximately 40 per cent of the 25 million people in ROW countries living with HIV/AIDS are affected by chronic diarrhoea. HIV-associated diarrhoea 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 diarrhoea market.

Earlier this year, positive results of a successfully completed Phase 2 trial for CRO-ID (Crofelemer for the treatment of acute adult infectious Diarrhea) conducted by Glenmark were announced. The primary endpoints of the trial were stool weight, duration of Diarrhoea, stool frequency and stool consistency; additional endpoints followed include degree of patient dehydration and reduction in gastrointestinal index score. The conclusions from the study were that treatment with Crofelemer was well tolerated and resulted in statistically significant improvements in all the primary endpoints and statistically significant reduction in the additional endpoints as well. Overall clinical success was achieved in 79.1 per cent of the evaluable patients receiving Crofelemer compared to 28.2 per cent of the evaluable patients receiving placebo.