Napo Participation in Call to Action to Prevent Deaths From Diarrheal Diseases in Children Under Five Years of Age

SOUTH SAN FRANCISCO, Calif.--(Business Wire)--
Napo Pharmaceuticals, Inc. ("Napo") is proud to announce that the Company is
part of the Call to Action led by PATH, UNICEF, and WHO to raise the visibility
of diarrheal disease and solutions to address it. The Call to Action includes
the invitation to "invest in the research and development of new effective,
appropriate and affordable prevention and treatment options for diarrheal
disease."

Napo's drug development efforts should come as welcome news for all those
supporters of such a call to action and to those who suffer from the immense
mortality and morbidity imposed on children from diarrheal diseases. Recent
clinical trial results show that Napo's lead drug candidate, crofelemer, is
effective in limiting the life threatening dehydration associated with severe
cholera and severe watery diarrhea of multiple causes. Crofelemer has a novel
anti-secretory mechanism of action, which, because it targets a "downstream"
mechanism of normalizing ion flow and water flow into the intestines without
affecting normal gut motility, can be used effectively and safely: (i)
regardless of the cause of the secretory diarrhea; (ii) without the risk of
emerging antibiotic resistance; (iii) in conjunction with other therapies (in
fact, without drug-drug interactions); and, (iv) in both acute and chronic
situations. While the World Health Organization ("WHO") advocates against the
use of currently available anti-diarrheals in children due to lack of safety,
crofelemer has so far safely been tested in ~1800 patients, including children
as young as 3 months of age, without any drug-related adverse events. Crofelemer
acts locally in the gut with no or minimal systemic exposure to the patient.

Crofelemer is in Phase 3 testing for chronic diarrhea in people living with
HIV-AIDS (US) and adult acute infectious diarrhea, including cholera (India,
Bangladesh, Jamaica, and Mexico). The first product approval in adults is
expected in mid-2010. Napo is organizing a program to accelerate the development
and approval of a pediatric formulation of crofelemer targeting approval in
2011-2012 (pending additional funding), including the establishment of a global
advisory board to ensure that the development program for an FDA approved
pediatric product incorporates the current WHO guidelines for oral rehydration
solution ("ORS"), zinc, and other guidelines for Essential Medicine treatment of
diarrheal disease and to generate a formulation that is practical and safe for
resource-constrained regions with limited healthcare-trained personnel.

Diarrheal disease is the most common cause of illness and the second leading
cause of child death in the world, ~2 million each year. The UN Millennium Goal
4 ("MG4") to reduce by 2015 the number of deaths in children <5 by 2/3 is
seriously off-track. Addressing needs in unsafe water and poor sanitation could
prevent diarrheal disease. Continued education and usage of ORS could provide
further gains in child survivability, though ORS does not decrease the length or
severity of diarrhea. Until now, the prospect of relatively near-term
introduction of a novel anti-secretory therapeutic agent developed specifically
for pediatric populations in need has not been part of the global health
community awareness.

Dr. Pradip Bardhan, Scientist and Head of Special Care Unit at the International
Centre for Diarrheal Disease Research, Bangladesh ("ICDDR,B"), who also led the
team of experts addressing the recent cholera outbreak in Zimbabwe, commented,
"The mechanism of action of crofelemer promises synergy with existing public
health programs to treat pediatric diarrhea. With efficient efforts to further
prove safety and efficacy in children, crofelemer could help reach and surpass
the Millennium Development Goals on reduction in childhood mortality."Dr.
Bardhan was the principal investigator on the recently conducted successful
trial with crofelemer in the treatment of adult patients with severely
dehydrating cholera.

Napo has supplemented its global commercial collaborations for crofelemer which
cover every country in the world, with alliances with relief organizations, such
as Direct Relief International and others, to ensure crofelemer will be
accessible to every childhood population in need.

For more information please contact:

Napo Pharmaceuticals, Inc.
Lisa Conte, Chief Executive Officer
1 + 650 616 1902

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 HIV-related diarrhea, Phase 3 (under a 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 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. Crofelemer is a first-in-class anti-secretory agent. Napo holds
the exclusive worldwide rights to novel small molecule potential second
generation anti-secretory agents, which have been licensed by Napo from the
University of California regents.

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 also has a plant
library of approximately 2,300 medicinal plants from tropical regions, and the
company has entered two screening relationship associated with this collection.

For more information please visit www.napopharma.com.

Napo Pharmaceuticals, Inc.
Lisa Conte, 415-516-2732
lconte@napopharma.com

Copyright Business Wire 2009