SOUTH SAN FRANCISCO, Calif., Aug. 3 /PRNewswire-FirstCall/ -- Napo Pharmaceuticals, Inc., , which focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace in collaboration with local partners, today announced that it has received approval from the Drug Controller General of India (DCGI), to start a Phase II trial with crofelemer, Napo’s proprietary gastro-intestinal compound for the treatment of acute infectious diarrhea. The trial will be initiated by Glenmark Pharmaceuticals Limited (Glenmark), a research-led global pharmaceutical company headquartered in India. Glenmark is Napo’s product development and commercialization partner for crofelemer in India and more than 110 emerging and developing country economies for the indications of AIDS related diarrhea, infectious diarrhea and pediatric diarrhea. Upon marketing Glenmark will pay up to 14% royalties to Napo.
The trial is expected to commence in calendar 2006 and will involve sixty adult patients suffering from acute diarrhea in a prospective, randomized, parallel group using a controlled double-blind placebo method. The trial will be concluded within three months from the start of dosing. Glenmark is also working on a development plan for the other indications of AIDS related diarrhea and pediatric diarrhea.
“We are delighted that the DCGI has approved initiation of this Phase II clinical trial, which will evaluate crofelemer for treating acute infectious diarrhea (CRO-ID),” said Ms. Lisa Conte, Chief Executive Officer of Napo Pharmaceuticals Inc. “We are advancing our pipeline according to schedule and look forward to furthering the development of this important compound. The impact that CRO-ID will have against various causes of infectious diarrhea, many of which are demonstrating resistance to antibiotic therapy in emerging and developing markets, where there is vast unmet need across the globe, is potentially huge.”
About Crofelemer
Crofelemer is an oligomeric proanthocyanidin and has a well-documented, novel anti-secretory mechanism of action which blocks chloride ion secretion via the CFTR channel, normalizes water flow in the gut, treating diarrhea and thereby preventing dehydration from occurring, thus targeting and providing substantial relief for several gastrointestinal indications. The mechanism of action provides a unique approach for managing diarrhea without the resistance risk of antibiotics.
Crofelemer has shown significant anti-diarrheal activities in multiple clinical trials with approximately 1500 patients. Because crofelemer is not absorbed and works locally, it has an important safety advantage over alternative treatments, particularly for chronic administration.
Crofelemer is extracted from a medicinal rainforest plant. The drug has now completed Phase II clinical testing for traveller’s diarrhea in an US FDA approved trial and is currently in Phase II clinical testing, sponsored by Napo, for cholera infected patients in Bangladesh at the International Centre for Diarrheal Disease Research. Napo recently received a grant for approximately $600,000 USD from the National Institutes of Health (NIH) in support of this product. There are an estimated 4 billion cases of acute infectious diarrhea globally each year, often creating the potential for fatal dehydration.
About Napo Pharmaceuticals, Inc.
Napo Pharmaceuticals, Inc. is focused on developing and commercializing proprietary pharmaceuticals for the global marketplace, in collaboration with local partners, in order to address major global unmet medical needs in developed and developing countries. Napo is currently developing crofelemer, which is in various stages of clinical development for four distinct product indications, including one product in Phase III, two in Phase II and one in Phase I clinical trials. Napo’s four indications include AIDS diarrhea, Irritable Bowel Syndrome (IBS), acute infectious diarrhea (traveler’s diarrhea and cholera) and pediatric diarrhea. The Company has been granted FDA fast-track status for the AIDS and IBS products and has generated extensive safety data on more than 1500 patients across all indications. Napo’s partners include Trine Pharmaceuticals Inc., Glenmark Pharmaceuticals of Mumbai, India, and the AsiaPharm Group Ltd., headquartered in Singapore and Shanghai. Napo also has a medicinal product library of over 2,300 plants, which is the subject of pre-clinical discovery collaboration. More information can be found at www.napopharma.com.
About Glenmark Pharmaceuticals Ltd.
Glenmark Pharmaceuticals Ltd. is a research-led, global, fully integrated pharmaceutical company headquartered in Mumbai, India. 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 and Diabetes.
The Company in also engaged in cutting-edge research in discovering new molecules and runs discovery projects in the areas of inflammation (Asthma/COPD, etc) and metabolic disorders (Diabetes, Obesity, etc). Its 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. This compound subsequently completed Phase I clinical trials successfully and has recently entered Phase II clinical trials in the US. The Company’s second lead GRC 8200, a DPP-IV inhibitor for Type II Diabetes, is in Phase II clinical trials in South Africa. Glenmark’s third lead is a compound named GRC 10389, a CB-I receptor antagonist for the treatment of Obesity. This compound is completing pre-clinical studies and is expected to be filed for a Phase I trial in H1 FY07. The Company has three other programs across inflammation and pain management at the pre-clinical stages. More information can be found at www.glenmarkpharma.com.
For more information please contact: Napo Pharmaceuticals, Inc. Lisa A. Conte, CEO 650 616 1902 Noonan Russo, a division of Euro RSCG Life PR David Schull, Managing Director 858 546 4810
Disclaimer The Shares referenced in this announcement are not for distribution, directly or indirectly, in or into the United States or to any US person as defined in Regulation S under the US Securities Act of 1933, as amended (“Regulation S”). This announcement is not an offer of securities for sale into the United States or elsewhere. The Shares described above have not been registered under the US Securities Act of 1933, as amended (the “Securities Act”) and may not be offered or sold in the United States or to, or for the account or benefit of, US persons (as such term is defined in Regulation S) unless they are registered under the Securities Act or they are exempt from registration under the Securities Act. No offer or sale of Regulation S securities has been made or will be made in the United States. Hedging transactions involving these securities may not be conducted unless in compliance with the Securities Act.
Napo Pharmaceuticals, Inc.
CONTACT: Lisa A. Conte, CEO of Napo Pharmaceuticals, Inc.,+1-650-616-1902; or David Schull, Managing Director of Noonan Russo, adivision of Euro RSCG Life PR, +1-858-546-4810
