Healthcare Industry News: Crofelemer
News Release - November 2, 2006
Appointment of VP Program Planning and ManagementSOUTH SAN FRANCISCO, Nov. 2 (HSMN NewsFeed) -- Napo Pharmaceuticals, Inc., (LSE: NAPL ), which focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace in collaboration with local partners, is pleased to announce today that Mark Longer, Ph.D., has joined the Company as its Vice President, Program Planning and Management. Dr. Longer, who joins Napo having provided consultancy to Napo for approximately six months and who was most recently Senior Director, Pharmaceutical Sciences at Pfizer Global R&D, will be responsible for planning, management, and integration of Napo's ongoing chemistry, manufacturing and controls (CMC) and clinical development programs focusing on Napo's lead product, Crofelemer.
Dr. Longer, aged 49, has more than fifteen years of broad pharmaceutical development experience, having worked in the areas of CMC, formulation development and manufacturing, clinical supplies management, and product enhancement/lifecycle management. Prior to working at Pfizer, where he was Senior Director, Pharmaceutical Sciences at Pfizer Global R&D in La Jolla, he held positions of increasing responsibility at Agouron Pharmaceuticals in the areas of formulation development and Regulatory CMC, and was an assistant professor in the College of Pharmacy at the University of Florida. He has been actively involved in the development and registration of three products in his career, including both formulation and regulatory CMC work on Viracept® while at Agouron. He has prepared numerous IND submissions for programs in all phases of development, in therapeutic areas of oncology, virology, ophthalmology and diabetes/obesity. In addition, he has prepared over a dozen post-approval submissions, and has participated in FDA meetings and Pre-Approval Inspections (PAIs). Dr. Longer received a BA in Chemistry from The College of Wooster (Ohio) and a Ph.D. in Pharmaceutics from the University of Wisconsin.
"We are extremely pleased that Mark Longer has joined our organisation," said Lisa A. Conte, CEO of Napo. "Mark brings a wealth of experience from both big pharma and specialty pharma and has the know-how that we need to take our programs, and in particular Crofelemer, through regulatory approval. Mark has worked with the team at Napo over these past few months and we are confident that he will contribute to the effort to bring Crofelemer to market by mid-2008."
Commenting on this announcement, Dr Mark Longer added: "I am really excited to be a part of Napo at this important time in its growth. Napo's portfolio of both late- and early-stage development compounds is attractive, and they have an extremely dedicated and talented group of people on board. Our opportunity here is very significant, given the significant amount of historical clinical testing and Phase 3 development status of Crofelemer. Moreover, the Company's mission to address the huge market potential and need for Crofelemer globally is a model for worldwide proprietary drug development programs which the company will follow of compounds in its diabetes program. I'm eager to contribute to Napo's success in realising our goals."
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
Tim Anderson, Mary-Jane Johnson+ 44 (0)20 7466 5000
David Schull 001 + 858 546 4810
Nomura Code Securities Limited
Juliet Thompson +44 (0)20 7776 1204
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:
* 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
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. CRO-IBS has shown improvement in diarrhoea and significant improvement in abdominal pain in female D-IBS patients. 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.
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.
Source: Napo Pharmaceuticals
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