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Napo Pharmaceuticals Completes Dose Selection Phase of ADVENT Trial

Final Stage to Begin in Adaptive Study of Treatment for Chronic Diarrhea in People living with HIV/AIDS

SOUTH SAN FRANCISCO, California, Aug. 4, 2009 - Napo Pharmaceuticals, Inc. is pleased to announce the completion of the dose selection stage (Stage I) of the ADVENT trial of crofelemer for the treatment of chronic diarrhea in people living with HIV/AIDS on antiretroviral therapies. Up to 30 percent of the one million people living with HIV in the United States are managing diarrhea chronically. Crofelemer is a first-in-class anti-secretory agent that acts locally in the gastrointestinal tract. Napo focuses on the development and commercialization of proprietary pharmaceuticals in the global marketplace in collaboration with local partners.

The ADVENT trial is a randomized, double-blind, parallel-group, placebo-controlled, two-stage, adaptive design study. Stage I consisted of 28 days of treatment for three dose groups (125 mg, 250 mg, and 500 mg orally twice daily), and a placebo group, totaling approximately 200 patients, with about 50 patients in each group. To select a dose for Stage II, an independent review board conducted an interim analysis of the safety and efficacy of each dose per preset protocol guidelines. This was not a futility analysis, and did not provide the opportunity for the trial to be halted based on efficacy parameters.

The trial will now progress with the addition of 150 patients, 75 of whom will be randomized to the Stage II dose of crofelemer, and the other 75 to placebo. These 150 Stage II patients will be combined, respectively, with the 50 subjects from Stage I who were on the dose selected for Stage II and the 50 who were on the placebo, for a final Stage II patient population of 250 (125 in each group). All patients in the trial will be treated in a five-month extension phase after their 28 day treatment.

"This is an important achievement in the development of crofelemer," said Napo CEO Lisa Conte. "With the initiation of Stage II of the ADVENT trial, our partners, Glenmark and Salix, will be rapidly advancing toward manufacturing scale-up of crofelemer and planning for its anticipated commercial launch."

Napo's licensee Salix Pharmaceuticals, Inc. has licensed the rights to crofelemer for all indications in North America, Europe (excluding certain smaller countries), and Japan, and, for certain other indications including irritable bowel syndrome, worldwide. Salix estimates that the HIV-associated diarrhea market opportunity alone may be $300 million. The ADVENT trial is being conducted under fast track status and Special Protocol Assessment agreement with the FDA.

Crofelemer has also been licensed to Glenmark Pharmaceuticals, Ltd. in India plus 140 emerging countries for indications related to HIV (CRO-HIV), use in acute adult infectious diarrhea (CRO-ID), and use in pediatric diarrhea (CRO-PED). Glenmark anticipates approval of crofelemer in India in 2010. Glenmark and Salix have entered into a commercial supply agreement for crofelemer active pharmaceutical ingredient (API).

AsiaPharm Group, Ltd. has licensed rights to crofelemer in China (including Hong Kong and Macau).

CROFELEMER PEDIATRIC APPLICATIONS (CRO-PED)
Napo is organizing a program to accelerate the development of crofelemer in pediatric infectious diarrheal diseases, targeting FDA approval in 2011-2012 (pending additional funding). The company has established a global advisory board to ensure that the development guidelines for a pediatric product incorporate World Health Organization (WHO) Essential Medicines guidelines for oral rehydration solution (ORS), zinc, etc., and to generate a formulation that is practical and safe for resource-constrained regions with limited health personnel. Napo has formed alliances with Direct Relief International and others to make crofelemer accessible to every childhood population in need.

Napo is also in the planning stages for clinical development of crofelemer for severe cholera in pediatric populations at the International Centre for Diarrheal Disease Research (ICDDR,B) in Bangladesh.

About Crofelemer
Napo's proprietary patented gastrointestinal compound, crofelemer, is a first-in-class anti-secretory agent extracted from Croton lechleri, a medicinal plant sustainably harvested from several countries in South America. Crofelemer is in various stages of clinical development for four distinct programs, including a late-stage Phase 3 program:

- CRO-HIV for HIV-related diarrhea, Phase 3 (under Special Protocol Assessment)
- 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 crofelemer development for IBS and HIV related indications (CRO-IBS and CRO-HIV).

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. The company seeks partners in both traditional high-value markets and in the higher volume business models of emerging and developing economies. Napo was founded in November 2001 and is based in South San Francisco, Calif., with a subsidiary in Mumbai, India.

Napo holds the exclusive worldwide rights to novel small-molecule potential second-generation anti-secretory agents, which have been licensed to Napo from the Regents of the University of California, and are the subject of NIAID funding. Napo is developing an early clinical stage/ready for Phase 2 product, NP-500, for the treatment of insulin-resistant diseases of Type II diabetes and metabolic syndrome (Syndrome X; pre-diabetic syndrome). Napo has a library of approximately 2,300 medicinal plants.

For more information please contact:
Lisa Conte, CEO, Napo Pharmaceuticals, Inc.
1 650 616 1902
www.napopharma.com

Please note: The materials provide herein contain projections and other forward-looking statements regarding future events. Such statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the cost and unpredictability of the duration and results of clinical trials and FDA approval; the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; market acceptance for approve products; ability to secure the product; and generic and other competition and the need to acquire new products.