Napo Pharmaceuticals

news

Napo Licenses CFTR Patents and Technology

South San Francisco, California, 16 August, 2007 - South San Francisco, California, 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 that it has reached agreement for the in-licensing of certain patents and technology relating to CFTR (cystic fibrosis transmembrane conductance regulator) inhibitors. The CFTR inhibitors have a mechanism of action similar to that of crofelemer which Napo and its partners are developing for indications including diarrhea predominant irritable bowel syndrome, diarrhea associated with HIV/AIDS, infectious diarrhea and pediatric diarrhea.

Napo intends to use the CFTR technology to build upon its significant experience in the gastro-intestinal and secretory diarrhea fields to develop potential second generation antisecretory diarrhea products that could be follow on products for the indications above as well as expand the indications.

The CFTR research will be conducted in collaboration with Dr. Alan Verkman, PhD, professor of medicine and physiology at The University of California San Francisco (UCSF). Dr. Verkman is one of the foremost authorities on CFTR mechanisms and the UCSF research has led the discovery of novel inhibitors of CFTR that have provided preclinical proof of activity in a rodent model of cholera toxin-mediated secretory diarrhea.

The agreement will provide Napo with a commercially exclusive (subject to certain rights of UCSF and the US government) royalty-bearing worldwide licence with sublicense rights. The Company will pay a conventional signing fee together with a licence maintenance fee. In addition, it will pay various milestone and royalty payments upon commercialization. The agreement provides for a minimum royalty payment.

Lisa A. Conte, CEO of Napo Pharmaceuticals, Inc. commented: "We are thrilled to be working with a leader in CFTR channel blocker mechanisms, Dr. Alan Verkman. The mechanism of this naturally occurring compound is an important tool in symptom management of multiple gastro-intestinal diseases. Dr. Verkman's work allows us to prepare for potential second generation products by the same mechanism of action as our lead molecule, crofelemer, which is expected to be on the market in approximately 1 year for the initial fast-tracked indication of chronic diarrhea in people living with HIV/AIDS."

Dr. Steven King, Napo's VP of Sustainable Supply and Ethnobotanical Research, added: "We are pleased to have this opportunity to work with UCSF and expand upon Dr. Verkman's development of small molecule CFTR inhibitors. With our focus on the global marketplace we hope to further develop this technology for all patient populations that can benefit, in both western and developing countries."

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) + 020 7466 5000
Tim Anderson, Mary-Jane Johnson

About Napo Pharmaceuticals, Inc.

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 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

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 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, 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.

Crofelemer has been tested in trials involving approximately 1500 patients in double-blind placebo-controlled, mostly published trials of AIDS diarrhea, diarrhea-predominant IBS, and acute infectious diarrhea. It is generally well tolerated and have 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.

About CFTR

The cystic fibrosis transmembrane conductance regulator (CFTR) is a cAMP-activated Cl- channel expressed in various epithelial cells, and is a pharmacological target for activators and inhibitors. Activators are useful for the pharmacotherapy of cystic fibrosis, specifically for those mutations that affect CFTR protein by reducing its ability to stay in the open state. Conversely, inhibitors are potentially useful to treat secretory diarrhea caused by enterotoxins, as the CFTR is the main route for Cl- flux in the intestine. Recently, a variety of potent modulators of the CFTR Cl- channel activity have been identified by high-throughput screening of a large collections of small molecules. The identification of CFTR activators and inhibitors with novel chemical scaffolds might help with the rational design of compounds with improved pharmacological properties.

References

Galietta, Luis and Moran, Oscar, Identification of CFTR Activators and Inhibitors: Chance or Design? Current Opinion in Pharmacology, Volume 4, Issue 5, October 2004 pages 497-503