SOUTH SAN FRANCISCO, Calif., Nov. 17 /PRNewswire-FirstCall/ -- Napo Pharmaceuticals, Inc., , which focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace in collaboration with local partners, announces the successful production of crofelemer Active Pharmaceutical Ingredient (“API”) for use in a final pivotal phase 3 trial for chronic diarrhea in people living with HIV/AIDS. Napo is targeting approval of crofelemer for HIV/ AIDS (“CRO-HIV”) in 2008. The crofelemer API is manufactured by Glenmark Pharmaceuticals Ltd. at a dedicated unit at its FDA approved facility in Ankleshwar, India.
Glenmark is also the licensee of crofelemer from Napo for the indications of adult acute infectious diarrhea (“CRO-ID”), pediatric diarrhea (“CRO-PED”) and HIV/AIDS related diarrhea in approximately 140 countries outside the western world. More than 2 million children die of diarrhea each year in these territories, with rates as high as 30% when children take nourishment from sources other than the mother. Diarrhea is one of the primary killers of children under 2 years old in resource-constrained areas. Glenmark has received approval from the DCGI (Drug Controller General of India; the drug regulatory authority in India) to initiate a Phase 2 trial for CRO-ID, based on access to Napo’s existing safety and regulatory package. Napo will receive royalties from Glenmark on sales of crofelemer in Glenmark’s licensed territories.
“We are very excited about the completion of successful technology transfer to Glenmark and the subsequent production of API. Not only does this allow Napo to commence its final Phase 3 trial to support approval of CRO-HIV, but it gives us great confidence that we have a strategic partner and supplier of crofelemer for commercialization for CRO-HIV and other indications. Napo’s global approach benefits shareholders as it allows the Company to bring down cost of goods and to work towards its goal of improving access of affordable products in emerging and developing economies,” said Lisa A. Conte, CEO of Napo.
“We see this as an important product to treat diarrhea for India and Glenmark’s licensed territories,” said Glenn Saldanha, Managing Director & CEO of Glenmark Pharmaceuticals Ltd. “Many diarrhea diseases are resistant to antibiotics; crofelemer’s mechanism of action treats the symptom of dehydration regardless of cause. Furthermore, strong safety database including approximately 1500 patients to date will help us target successful registration and launch of crofelemer for diarrhea by 2008/2009.”
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 new approach for managing diarrhea without the resistance risk of antibiotics.
Crofelemer has shown significant anti-diarrhoeal activities in multiple clinical trials involving 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 traveler’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 Diarrhoeal 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. Crofelemer is also in Phase 2b testing for diarrhea-predominant irritable bowel syndrome by Napo’s licensee for that indication, Trine Pharmaceuticals, Inc.
For more information please contact: Napo Pharmaceuticals, Inc. Lisa Conte, Chief Executive Officer +1-650 616 1902 Charles Thompson, Chief Financial Officer +1-650 616 1903 Buchanan Communications +44(0)20 7466 5000 Tim Anderson, Mary-Jane Johnson Nomura Code Securities Limited +44(0)20 7776 1204 Juliet Thompson 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.
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 70 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, Paediatrics, Gynaecology, ENT, Diabetes and Oncology.
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 and India, and was recently out-licensed to Merck KGaA, Germany for the North American, European and Japanese markets. Glenmark has four other programs across obesity, inflammation and pain management at the pre-clinical stages; three of which will enter the clinics in FY 2007. More information can be found at http://www.glenmarkpharma.com.
Napo Pharmaceuticals, Inc.
CONTACT: Lisa Conte, Chief Executive Officer, +1-650-616-1902, or CharlesThompson, Chief Financial Officer, +1-650-616-1903, both of NapoPharmaceuticals, Inc.; or Tim Anderson or Mary-Jane Johnson, both ofBuchanan Communications, +44(0)20-7466-5000; or Juliet Thompson of NomuraCode Securities Limited, +44(0)20-7776-1204
Web site: http://www.glenmarkpharma.com/
