Napo Pharmaceuticals
Crofelemer
A proprietary gastro-intestinal compound in clinical development for four distinct product indications
news
Appointment of VP Regulatory Affairs and Quality Assurance
South San Francisco, California, July 30, 2007 -
South San Francisco, California, 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 the appointment of Dr. Merfyn H. Williams as Vice President Regulatory Affairs and Quality Assurance effective 20 August 2007.
Dr. Williams, aged 72, has 20 years of pharmaceutical experience, including eight years with the US Food and Drug Administration ("FDA") as well as experience in the pharmaceutical industry with companies including Bayer Corporation and Glaxo Smithkline. In addition to his pharmaceutical experience, Dr. Williams has been a Professor of Immunology and Microbiology at universities in the United Kingdom, the United States and the Middle East.
Prior to joining Napo, Dr. Williams was a consultant for several companies on regulatory affairs. From 2004 to 2006, he was Senior Director of Regulatory Affairs for Intarcia Therapeutics, Inc. From 2000 to 2004, he was Senior Director of Regulatory Affairs, Biotechnology Products for Bayer Corporation and was with Sequella Foundation and CL McIntosh & Associates prior thereto. While at the FDA, Dr. Williams was in the Center for Biologics Evaluation and Research and had responsibility for collaborations between the FDA and the Ministry of Health in India and the Ministry of Health in Egypt. Dr. Williams has worked on both New Drug Applications and Biologic License Applications many of which have successfully passed through the regulatory approval process.
Dr. Williams has an Honors B.Sc.in Bacteriology from the University of Birmingham (UK) and a Ph.D. in Clinical Immunology from the Welsh National School of Medicine.
Lisa A. Conte, CEO of Napo Pharmaceuticals, Inc. commented: "We are delighted to have someone with Merfyn's vast international experience joining us to head our regulatory affairs group. Merfyn's background is a big plus for us as we progress our lead product, CRO-HIV, to completion of its final Phase 3 trial under an SPA with the FDA, targeting our first NDA drug approval in mid-2008."
Commenting on this announcement, Dr. Williams, said: "I am pleased to be part of Napo's team and the development of crofelemer for HIV/ AIDS and its other intended indications. I feel the future of drug development will depend on international collaborations and global business models such as those which Napo has implemented with its partnerships."
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
020 7466 5000
Tim Anderson, Mary-Jane Johnson
Nomura Code Securities Limited
020 7776 1205
Clare Terlouw
About Napo Pharmaceuticals, Inc.
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 diarrhea, Phase 3
- CRO-IBS for diarrhea irritable bowel syndrome ("D-IBS"), Phase 2
- CRO-ID for acute infectious diarrhea (including cholera), Phase 2
- CRO-PED for paediatric diarrhea, Phase 1
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 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 www.napopharma.com.
About Crofelemer
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, 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.