Napo Gathers International Panel on Global Health

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Wed Oct 7, 2009 11:02am EDT

Experts Illuminate Impact of Enteric Disease and Lack of Access to Clean Water
on Global Health, the Environment, and Human Rights
SOUTH SAN FRANCISCO, Calif.--(Business Wire)--
Napo Pharmaceuticals, Inc. (Napo) recently hosted an educational panel to
address the impact of the lack of access to clean water and enteric disease on
global health, the environment, and human rights. Robert F. Kennedy, Jr., Napo`s
Environmental Advisor, discussed the negative consequences of non-sustainable
development on indigenous peoples and the environment. 

Other speakers included E. Benjamin Skinner, who has written about the
connection between the war on diarrhea and modern-day slavery in his book, A
Crime So Monstrous; and James Workman, whose book, Heart of Dryness, details the
current and future struggles surrounding the scarcity of clean water, as told
through the experiences and traditional wisdom of bushmen in southern Africa`s
Kalahari region. Dr. Pradip Bardhan of the International Centre for Diarrhoeal
Disease Research in Bangladesh (ICDDR,B), a state-of-the-art cholera hospital,
shared his experiences with enteric disease, not only at the ICDDR,B, but also
with respect to cholera crises around the world, such as the recent outbreak in
Zimbabwe. 

"This event was an important gathering of world experts to address the various
factors affecting the health of global populations," said Napo CEO Lisa Conte.
"The development of crofelemer, Napo`s investigational drug for secretory
pediatric infectious diarrhea, is part of an effort by many partners to address
the devastating dehydration in pediatric populations, regardless of their
geography of social or economic status." 

Napo invites you to view highlights of the discussion at
http://vimeo.com/6819224. You may view the entire hour-long event at
http://vimeo.com/6819500. 

The panel event followed a recent discussion among international experts on
Napo`s global advisory board about the development of crofelemer for use in
pediatric population. In addition, on Oct. 2, Ms. Conte addressed the MIT
Legatum Center`s second annual Progress Through Innovation conference, which
highlights the development and empowerment of people in developing regions of
the world. Ms. Conte`s remarks focused on Napo`s global business plan to bring
its first-in-class anti-diarrheal agent, crofelemer, to all populations in all
countries through a sustainable business model by working with local partners.
She also commented on the human-rights impacts and environmental repercussions
of unmet global health needs, and the common traits shared by innovators and
entrepreneurs around the globe. 

Crofelemer for Pediatric Populations (CRO-PED)

Napo is organizing a program to accelerate the development of crofelemer for
pediatric infectious diarrheal diseases, targeting regulatory approval in
2011-2012 (pending additional funding). The company has established a global
advisory board to ensure that the development of a pediatric product
incorporates 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 ICDDR,B. 

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 in several South American countries. Crofelemer is
in various stages of clinical development for four distinct programs, including
a late-stage Phase 3 program. The FDA has granted fast-track status to
crofelemer development for IBS and HIV-related indications (CRO-IBS and
CRO-HIV):

* 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

Napo`s licensee, Salix Pharmaceuticals, Inc. has exclusive rights to crofelemer
for all indications in North America, Europe (excluding Iceland, Liechtenstein,
Norway, and Switzerland), 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 of crofelemer as a treatment for chronic diarrhea in patients on
antiretroviral therapies for HIV or AIDS 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 and
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 and Salix have entered into a commercial supply agreement for
crofelemer active pharmaceutical ingredient (API). AsiaPharm Group, Ltd. has
rights to crofelemer in China (including Hong Kong and Macau). 

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. 

About the Legatum Center

The Legatum Center for Development and Entrepreneurship was founded on the
belief that economic progress and good governance in low-income countries emerge
from entrepreneurship and innovations that empower ordinary citizens. The Center
was founded at the Massachusetts Institute of Technology in 2007 through a
structured gift of $50 million from Legatum, a global investment firm. The
Center administers programs and convenes events that promote and shape discourse
on bottom-up development. Led by Iqbal Z. Quadir, founder of GrameenPhone and
Emergence BioEnergy, the Center runs a highly competitive fellowship program for
MIT graduate students who intend to launch enterprises in low-income countries.
In addition, the Center convenes an annual conference, hosts lectures, and
supports teams of enterprising men and women at MIT who are passionate about
starting viable businesses in the developing world. 

Please note that the materials provided 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 approved products; ability to secure the
product; and generic and other competition and the need to acquire new
products.

Napo Pharmaceuticals, Inc.
Lisa Conte, 1-650-616-1902 (CEO)
www.napopharma.com

Copyright Business Wire 2009

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