Healthcare Industry News: Crofelemer
News Release - November 8, 2006
Napo Pharmaceuticals, Inc. ("Napo" or "the Company") Appointment of VP Clinical Affairs and Chief Medical OfficerSOUTH SAN FRANCISCO, Calif., Nov. 8 (HSMN NewsFeed) -- Napo Pharmaceuticals, Inc., (LSE: NAPL ), which focuses on the development and commercialisation of proprietary pharmaceuticals for the global marketplace in collaboration with local partners, is pleased to announce today that M. Scott Harris, MD., has joined the Company as its Vice President, Clinical Affairs and Chief Medical Officer. Dr. Harris, a gastroenterologist who has published in the areas of intestinal secretion and irritable bowel syndrome, has worked as a consultant to Napo since July 2006. He will be responsible for the upcoming pivotal Phase 3 trial for AIDS-related diarrhoea (CRO-HIV). Dr. Harris will also oversee Napo's ongoing clinical development activity including the design of pre-clinical and clinical trials.
Since 2005, Dr. Harris, age 53, has been a principal of Middleburg Consultants, Inc., a pharmaceutical and healthcare consulting firm, and, more recently, Professor of Clinical Medicine and Director of the Center for Inflammatory Bowel Disease, Georgetown University Hospital. In 2002, Dr. Harris joined Otsuka America as project leader for the global clinical development of tetomilast (OPC-6535), a small molecule for treatment of ulcerative colitis, in North America, Australia, and Europe. Prior thereto, he served as medical director at Abbott Laboratories. In 1999, Dr. Harris joined the pharmaceutical industry as US Director of Medical Affairs at Schwarz Pharma where he supported the development of generic omeprazole and was actively involved in the launch of NuLev®.
"We are very excited that we can attract someone of Scott's background and training to the global development of Crofelemer," said Lisa A. Conte, CEO of Napo. "Scott's experience in the design of gastrointestinal-related clinical trials as well as his participation as an investigator provides Napo with a real asset to the team developing Crofelemer. Napo expects to initially gain approval for Crofelemer in the US market by mid-2008 for AIDS-related diarrhoea, which has been fast-tracked by the FDA, and is also working with its US-based and international partners to progress clinical trials to develop a treatment for irritable bowel syndrome as well as life threatening dehydration from diarrhoea in emerging and developing economies."
Commenting on this announcement, Dr Scott Harris added: "I am very happy to be joining Napo at this stage of the Company's development. Based on my experience as a gastroenterologist, as well as my pharmaceutical experience with GI-related drugs, I believe Crofelemer's anti-secretory mechanism of action has an excellent opportunity to treat multiple indications. Drug development for the treatment of diarrhoea has been lagging, so new approaches are sorely needed. I look forward to the successful development of Crofelemer across the spectrum of its indications and to working on new indications."
For more information please contact:
Napo Pharmaceuticals, Inc
Lisa Conte, Chief Executive Officer 001 + 650 616 1902
Charles Thompson, Chief Financial Officer 001 + 650 616 1903
Buchanan Communications + 44 (0)20 7466 5000
Tim Anderson, Mary-Jane Johnson
Noonan Russo001 + 858 546 4810
Nomura Code Securities Limited +44 (0)20 7776 1204
Napo Pharmaceuticals Inc., focuses on the development and commercialisation 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:
-- CRO-HIV for AIDS diarrhoea, Phase 3
-- CRO-IBS for diarrhoea irritable bowel syndrome ("D-IBS"), Phase 2
-- CRO-ID for acute infectious diarrhoea (including cholera), Phase 2
-- CRO-PED for paediatric diarrhoea, Phase 1
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 its first screening relationship 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 of America; Glenmark Pharmaceuticals Limited of India; and AsiaPharm Group Ltd. of China. For more information please visit http://www.napopharma.com
Dr Scott Harris
Dr. Harris has held faculty positions at the Medical College of Wisconsin, where he conducted basic research in the mechanisms of diarrhoea and intestinal secretion, and the University of Wisconsin in Milwaukee, where he served as Clinical Professor and Head of the Division of Gastroenterology. Dr. Harris is a magna cum laude graduate of Harvard College and Harvard Medical School. He undertook his post-graduate medical training at Johns Hopkins Hospital and Yale University School of Medicine, where he completed an NIH research fellowship. He holds an M.S. in population health and administrative medicine from the University of Wisconsin Schools of Medicine. He is also a Fellow of the American College of Physicians and board certified in internal medicine and gastroenterology.
Dr. Harris has been an investigator in numerous industry-sponsored studies. He has been a member of the International Advisory Panel of the International Foundation for Functional Gastrointestinal Disorders, the leading organisation for irritable bowel syndrome advocacy, research and education, and an organiser of the 1st International Symposium for Functional Gastrointestinal Disorders; President of the Crohn's & Colitis Foundation of America (CCFA) in Wisconsin; and recipient of the CCFA Premier Physician Award.
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.
These products have been tested in trials involving approximately 1500 patients in double-blind placebo-controlled, mostly published trials of AIDS diarrhoea, diarrhoea-predominant IBS, and acute infectious diarrhoea. The products are generally well tolerated and have shown significant anti- diarrhoeal 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.
Source: Napo Pharmaceuticals
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