Glenmark Pharmaceuticals Initiates Phase 2 Trial for Crofelemer for Acute Infectious Diarrhea
SOUTH SAN FRANCISCO, Calif., Dec. 6 /PRNewswire-FirstCall/ -- Napo Pharmaceuticals, Inc., , which focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace in collaboration with local partners, is pleased to announce that its licensee, Glenmark Pharmaceuticals Limited, has initiated a Phase 2 clinical trial for crofelemer for the indication of acute infectious diarrhea at two sites in India. This placebo-controlled crofelemer trial is expected to conclude in six months.
Glenmark licensed crofelemer for the indications of acute infectious diarrhea, chronic diarrhea in persons living with HIV/AIDS and pediatric diarrhea in over 140 emerging economies and developing countries. Once these indications are approved in Glenmark's territories, Glenmark will pay ascending royalties to Napo on sales of crofelemer for these indications.
Glenmark is the manufacturer of crofelemer API (active pharmaceutical ingredient) for Napo's current Phase 3 trial for crofelemer for chronic diarrhea in persons living with HIV/AIDS, which is being conducted at sites in the United States under a special protocol assessment agreement with the FDA.
"We are delighted that Glenmark has moved forward with this trial," said Lisa A. Conte, CEO of Napo. "Including Glenmark's current trial, we are expecting clinical results from four trials of crofelemer around the end of Q1 2008, including the interim results from the Phase 3 CRO-HIV trial and look forward to filing a NDA for this fast tracked indication in Q3 2008."
About Napo Pharmaceuticals, Inc.
Napo Pharmaceuticals, Inc. focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace in collaboration with local partners. Napo was founded in November 2001, and is based in California, USA with a subsidiary in Mumbai, India. Napo's late-stage proprietary gastro-intestinal compound, crofelemer, is in various stages of clinical development for four distinct product indications, including a late-stage Phase 3 program:
The FDA has granted fast-track status to CRO-IBS and CRO-HIV.
Crofelemer, a proprietary patented agent, is extracted from Croton lechleri, a medicinal plant which can be sustainably harvested from several countries in South America. Napo also plans to develop an early clinical stage product, NP-500, for the treatment of insulin resistant diseases of Type II diabetes and metabolic syndrome (Syndrome X; pre-diabetic syndrome). Napo also has a plant library of approximately 2,300 medicinal plants from tropical regions, and Napo has entered two screening relationships associated with this collection. Currently, products are based on the chemical and biological diversity derived from plants with medicinal properties, but future products may be in-licensed from other sources.
Napo has partnerships with Trine Pharmaceuticals, Inc. of the United States; Glenmark Pharmaceuticals Limited of India; and AsiaPharm Group Ltd. of China. For more information please visit www.napopharma.com.
Glenmark Pharmaceuticals Limited is a research-led, global, fully integrated pharmaceutical company headquartered in Mumbai, India. The Company is a leader in India in the discovery of new molecules. Glenmark has 11 lead molecules at various stages of development in NCE & NBE research. Three of the leads are in Phase 2 whereas eight other leads are into the pre-clinical and discovery stages in the broad areas of inflammation and metabolic disorders.
The Company has generic formulation and API business interests in over 80 countries across the world including the highly regulated markets of USA and Europe. The formulation business spans several product segments such as Dermatology, Internal Medicine, Pediatrics, Gynecology, ENT, Cardiology, Diabetes and Oncology.
Glenmark's first Asthma/COPD molecule, Oglemilast [GRC 3886], was licensed out to Forest Laboratories and Teijin Pharma Limited for the North American and Japanese markets, respectively, in two landmark deals. The Company's second lead GRC 8200, a DPP-IV inhibitor for Type II Diabetes was out-licensed to Merck KGaA, Germany for the North American, European and Japanese markets. A third molecule targeting pain, GRC 6211, undergoing Phase 2 clinical trials in Europe, has recently been out-licensed to Eli Lilly & company.
Crofelemer, a proprietary patented agent, is extracted from Croton lechleri, a medicinal plant which can be sustainably harvested from several countries in South America. Crofelemer is in various stages of clinical development for four distinct product indications, one in Phase 3, two in Phase 2 and one in Phase 1.
Crofelemer has been tested in trials involving approximately 1500 patients in double-blind placebo-controlled, mostly published trials of AIDS diarrhea, diarrhea-predominant IBS, and acute infectious diarrhea. It is generally well tolerated and has shown significant anti-diarrheal activities and improvement in gastrointestinal symptoms. Crofelemer produces several effects when administered orally providing for activity in several disease indications. Crofelemer's anti-secretory mechanism reduces excess fluid secreted into the gastro-intestinal tract, while its anti-inflammatory and analgesic activity may provide the rationale for its significant benefit in abdominal pain. Crofelemer acts locally in the intestines, with limited systemic exposure.
CONTACT: Lisa Conte, Chief Executive Officer, +1-650-616-1902, or Charles
Thompson, Chief Financial Officer, +1-650-616-1903, both of Napo
Pharmaceuticals, Inc.; or Tim Anderson, or Mary-Jane Johnson,
+44-020-7466-5000, both of Buchanan Communications; or Ms. Vasudha Jha,
General Manager, Corporate Communications, Glenmark Pharmaceuticals Ltd.,
+91-22-40189919, Fax, +91-22-40189986, email@example.com
Web site: http://www.napopharma.com/