Print   



For immediate release

10 July 2008

Napo Pharmaceuticals Inc.

('Napo' or 'the Company')

Review of Existing Phase 2 Trial Data Indicates Positive Effect on Pain-Discomfort-Free Days in Patients with Diarrhea Predominant Irritable Bowel Syndrome Treated with Crofelemer

South San Francisco, California, 10 July 2008 Napo Pharmaceuticals, Inc., (LSE: NAPL and NAPU) announces results from a recently completed intent-to-treat analysis of the existing data from the two Phase 2 trials conducted by Napo's former licensee, Trine Pharmaceuticals, Inc (previously referred to as Phase 2a and Phase 2b) evaluating the effects of crofelemer in the treatment of diarrhoea predominant irritable bowel syndrome ('D-IBS').

The analysis of the data of the dose-ranging Phase 2 study in D-IBS patients indicates that crofelemer at a dose of 500 mg twice daily, produced statistically and clinically meaningful improvement in pain-discomfort free days in female D-IBS patients. This improvement represents an important observation with respect to a key regulatory endpoint for D-IBS. Crofelemer did not affect any other bowel function parameters. This statistical analysis of the data was conducted by an independent third party and has not been previously disclosed.  

As previously announced, Trine Pharmaceuticals, Inc. had conducted a single-dose evaluation of crofelemer in a Phase 2 study in female D-IBS patients following a dose-ranging Phase 2 study in male and female D-IBS patients. The results from an outlier analysis of the dose-ranging Phase 2 study were presented at Digestive Disease Week in May 2007. In the later single dose Phase 2 study with crofelemer, Trine evaluated a 125 mg twice daily dose of a different formulation of crofelemer from the one used in the dose-ranging Phase 2 study. There were no serious drug related adverse events associated with crofelemer in either of the Phase 2 studies in D-IBS patients. 

Napo received the full datasets of the Phase 2 studies in March, 2008, shortly after the termination of the license agreement with Trine Pharmaceuticals. Napo announced its intention to conduct a full analysis in its announcement of 11 February 2008. The results announced today as part of Napo's analysis of the full dataset have not been previously disclosed or noted publicly in Trine's announced results.

Lisa A. Conte, CEO of Napo Pharmaceuticals, Inc. commented: 'Napo's evaluation of the full data set spanning two Phase 2 studies indicates a positive signal in pain free days. Because of the positive signal in pain free days, the target population could include not only diarrhea-predominant IBS patients, yet perhaps alternating as well.'  

For more information please contact: 

Napo Pharmaceuticals, Inc. 
Lisa Conte, Chief Executive Officer 
+001 (650) 616-1902 

Charles Thompson, Chief Financial Officer
+001 (650) 616-1902 

Buchanan Communications
+ 44 (0)20 7466 5000
Tim Anderson, Mary-Jane Johnson, Catherine Breen 

About Napo Pharmaceuticals, Inc. 

Napo Pharmaceuticals, Inc. focuses on the development and commericalization 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 pediatric diarrhea, Phase 1 

The FDA has granted fast-track status to CRO-IBS and CRO-HIV. 

Crofelemer, a proprietary patented first in class agent, is extracted from Croton lechleri, a medicinal plant which can be sustainably harvested from several countries in South America. Napo has exclusive worldwide rights to synthetic compounds in pre-clinical development which act by the same mechanism of action. 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) and has 4 issued patents for anti-cancer agents in pre-clinical development. Napo has a plant library of approximately 2,300 medicinal plants from tropical regions and Napo has entered two screening relationships 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 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 1700 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. 

ENDMSCFKKKDPBKDNOD