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Napo Pharma Inc (NAPL)

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Thursday 16 August, 2007

Napo Pharma Inc

New CFTR Licenses

Napo Pharmaceuticals Inc
16 August 2007

For immediate release                                           16 August 2007

                           Napo Pharmaceuticals, Inc
                           ('Napo' or 'the Company')

                   Napo Licenses CFTR Patents and Technology

South San Francisco, California,   16 August, 2007 - South San Francisco,
California, Napo Pharmaceuticals, Inc., (LSE: NAPL), which focuses on the
development and commercialisation of proprietary pharmaceuticals for the global
marketplace in collaboration with local partners, is pleased to announce that it
has reached agreement for the in-licensing of certain patents and technology
relating to CFTR (cystic fibrosis transmembrane conductance regulator (or
chloride channel - CFTR is not a 'receptor')) inhibitors.  The CFTR inhibitors
have a mechanism of action similar to that of crofelemer which Napo and its
partners are developing for indications including diarrhoea predominant
irritable bowel syndrome, diarrhoea associated with HIV/AIDS, infectious
diarrhoea and pediatric diarrhoea.

Napo intends to use the CFTR technology to build upon its significant experience
in the gastro-intestinal and secretory diarrhoea fields to develop potential
second generation antisecretory diarrhoea products that could be follow on
products for the indications above as well as expand the indications.

The CFTR research will be conducted in collaboration with Dr. Alan Verkman, PhD,
professor of medicine and physiology at The University of California San
Francisco (UCSF).  Dr. Verkman is one of the foremost authorities on CFTR
mechanisms and the UCSF research has led  the discovery of novel inhibitors of
CFTR that have provided preclinical proof of activity in a rodent model of
cholera toxin-mediated secretory diarrhoea.

The agreement will provide  Napo with a commercially exclusive (subject to
certain rights of UCSF and the US government) royalty-bearing worldwide licence
with sublicense rights.  The Company will pay a conventional signing fee
together with a licence maintenance fee.  In addition, it will pay various
milestone and royalty payments upon commercialisation.  The agreement provides
for a minimum royalty payment.

Lisa A. Conte, CEO of Napo Pharmaceuticals, Inc. commented: 'We are thrilled to
be working with a leader in CFTR channel blocker mechanisms, Dr. Alan Verkman.
The mechanism of this naturally occurring compound is an important tool in
symptom management of multiple gastro-intestinal diseases. Dr. Verkman's work
allows us to prepare for potential second generation products by the same
mechanism of action as our lead molecule, crofelemer, which is expected to be on
the market in approximately 1 year for the initial fast-tracked indication of
chronic diarrhea in people living with HIV/AIDS.'

Dr. Steven King, Napo's VP of Sustainable Supply and Ethnobotanical Research,
added: 'We are pleased to have this opportunity to work with UCSF and expand
upon Dr. Verkman's development of small molecule CFTR inhibitors.  With our
focus on the global marketplace we hope to further develop this technology for
all patient populations that can benefit, in both western and developing

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
(44) + 020 7466 5000
Tim Anderson, Mary-Jane Johnson

About Napo Pharmaceuticals, Inc.

Napo Pharmaceuticals, Inc. focuses on the development and commercialisation 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 diarrhoea, Phase 3
  • CRO-IBS for diarrhoea irritable bowel syndrome ('D-IBS'), Phase 2
  • CRO-ID for acute infectious diarrhoea (including cholera), Phase 2
  • CRO-PED for paediatric diarrhoea, 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. 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). Napo also has a plant
library of approximately 2,300 medicinal plants from tropical regions, and Napo
has entered two screening relationship 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 Trine Pharmaceuticals, Inc. of the United States of
America; Glenmark Pharmaceuticals Limited of India; and AsiaPharm Group Ltd. of
China. For more information please visit

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 1500 patients in
double-blind placebo-controlled, mostly published trials of AIDS diarrhoea,
diarrhoea-predominant IBS, and acute infectious diarrhoea. It is generally well
tolerated and have shown significant anti-diarrhoeal 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.

About CFTR

The cystic fibrosis transmembrane conductance regulator (CFTR) is a
cAMP-activated Cl-  channel expressed in various epithelial cells, and is a
pharmacological target for activators and inhibitors. Activators are useful for
the pharmacotherapy of cystic fibrosis, specifically for those mutations that
affect CFTR protein by reducing its ability to stay in the open state.
Conversely, inhibitors are potentially useful to treat secretory diarrhoea
caused by enterotoxins, as the CFTR is the main route for Cl-  flux in
the intestine. Recently, a variety of potent modulators of the CFTR Cl-
channel activity have been identified by high-throughput screening of a large
collections of small molecules. The identification of CFTR activators and
inhibitors with novel chemical scaffolds might help with the rational design of
compounds with improved pharmacological properties.(1)


(1)Galietta, Luis and Moran, Oscar,  Identification of CFTR Activators and
Inhibitors:  Chance or Design?   Current Opinion in Pharmacology, Volume 4,
Issue 5, October 2004 pages 497-503.


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