Napo Pharmaceuticals

news

Positive Progress with Cholera Clinical Trial for Treatment of Secretory Diarrhea Associated with Cholera Infection

South San Francisco, California, February 15, 2007 - South San Francisco, California, 15 February, 2007 Napo Pharmaceuticals, Inc., (LSE: NAPL), which focuses on the development and commercialisation of proprietary pharmaceuticals for the global marketplace in collaboration with local partners, announces today that it has received the interim safety results following a clinical study which used Napo's lead drug, crofelemer, for the treatment of Diarrhea associated with cholera infection. Napo initiated the study in Bangladesh at the International Centre for Diarrheal Disease Research (ICDDR,B) in the first quarter of 2006. The ICDDR,B Centre treats approximately 100,000 patients suffering from Diarrhea each year in its Dhaka hospital. As of June 30, 2006, there were 61 patients enrolled in the study. The initial study design was for one treatment arm compared to placebo. The interim analysis confirmed the safety profile of crofelemer in this patient population which gave a basis for continuation of the study.

Based on the results of this interim analysis and prior clinical trials, and subject to approval by the ICDDR,B, the study will now test different formulation(s) and lower doses of crofelemer. These formulations are expected to provide benefit across all of crofelemer's intended indications. Napo will fund the development of the new formulations through an approximately $600,000 grant received from the National Institute of Allergy and Infectious Diseases.

Dr. Pradip Bardhan, Head of the Special Care Unit of ICDDR,B commented: "I have high hopes for the anti-secretory mechanism of action of crofelemer benefiting the immediate severity of dehydration in the cholera patients we see. This is the first agent with a specific targeted mechanism we've seen tested in this patient population."

Lisa Conte, Napo's CEO, stated: "Once again, we are finding crofelemer continues to be well-tolerated. Based on recent pre-clinical and clinical data, the product warrants efficacy testing at lower doses for all indications, which is commercially beneficial."

About Cholera

Cholera is an acute, diarrheal illness caused by infection of the intestine with the bacterium Vibrio cholerae. The infection can be severe and life-threatening, characterized by profuse watery diarrhea, vomiting, and leg cramps. In such individuals, rapid loss of body fluids leads to dehydration and shock. Without treatment, death can occur within hours.. The primary current treatment is replacement of fluid which is complicated by the continued production of high volume watery Diarrhea. The disease continues to occur endemically and epidemically in South-East Asia, South Asia, Africa and South America but also sporadically occurs in the South Eastern United States. In 2005, WHO reported the incidence of cholera resistance was 100 percent for certain antibiotics in certain outbreaks. Diarrhea is the result of stimulation of active chloride secretion across the CFTR (cystic fibrosis transport regulator) channel by cholera toxin.

References

*Scott Gottlieb, MD, 2006 Conference on Adaptive Trial Design, July 10, 2006, http://www.fda.gov/oc/speeches/2006/trialdesign0710.html.

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. 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's clinical stage product for diabetes and metabolic syndrome, NP-500 is a candidate for Phase 2 clinical development. Napo also has a medicinal product library of over 2,300 plants, which is the subject of pre-clinical discovery collaboration.