NAPU Napo Pharm Di

RNS Number:0575S
Napo Pharmaceuticals Inc.
10 April 2008

For immediate release                                      10 April 2008



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


  Napo Announces Successful Clinical results in Phase 2 Study of Crofelemer in
                        Acute Adult Infectious Diarrhoea


South San Francisco, California, 10 April 2008 - Napo Pharmaceuticals, Inc.,
(LSE: NAPL and NAPU) is pleased to announce the positive results of a
successfully completed Phase 2 trial for CRO-ID (crofelemer for the treatment of
acute adult infectious diarrhoea) conducted by its partner, Glenmark
Pharmaceuticals Limited (BSE: Glenmark).  The primary endpoints of the trial
were stool weight, duration of diarrhoea, stool frequency and stool consistency;
additional endpoints followed include degree of patient dehydration and
reduction in gastrointestinal index score.


The conclusions from the study were that treatment with crofelemer was well
tolerated and resulted in statistically significant improvements in all the
primary endpoints and statistically significant reduction in the additional
endpoints as well.  Overall clinical success was achieved in 79.1% of the
evaluable patients receiving crofelemer compared to 28.2% of the evaluable
patients receiving placebo.


There were no drug related adverse events associated with crofelemer.


The Phase 2 study was a randomized, parallel group, double-blind,
placebo-controlled which enrolled 98 Indian adult male and female patients aged
between 18 to 65 years with acute diarrhoea defined as the occurrence of three
or more unformed stools (soft or watery consistency) within the 24 hour period
preceding entry into the study.   Patients suffering from acute infectious
diarrhoea were dosed 250mg of crofelemer, QID (4 times per day) until recovery
or for a maximum of three days.   Details regarding the stool weight, stool
frequency, stool consistency, duration of diarrhoea, and other gastrointestinal
symptoms were recorded by the investigators at baseline, and days 1, 2 and 3 of
treatment. All patients had a scheduled follow-up visit 30 days after the end of
the last dose.


In conclusion, adult Indian patients with infectious diarrhoea treated with
crofelemer showed a faster recovery with the first dose itself as observed by
the reduction in stool weight, stool frequency and passage of formed stools.
Crofelemer was well tolerated and most adverse events were mild to moderate in
severity and not different from the placebo group.  Furthermore, the adverse
events disappeared with continued therapy and causality was not attributed to
the treatment.


Glenmark is Napo's exclusive licensee for crofelemer in over 140 countries for
the indications of CRO-HIV, CRO-ID and CRO-PED.  Glenmark anticipates it will
begin another dose-ranging trial for CRO-ID in 2008, investigating the
opportunity to treat with lower doses and lower frequency of dosing.


In combination with previous success in treating infectious diarrhoea in
travellers in Mexico and Jamaica with crofelemer, Napo is investigating the
regulatory pathway to file an NDA for acute infectious diarrhoea treatment with
crofelemer coincident with its on-going Phase 3 program in chronic diarrhoea in
people living with HIV/AIDS (CRO-HIV).  Napo is targeting an NDA filing for
CRO-HIV around the end of the year.  Napo has exclusive worldwide rights to
crofelemer in all western territories.


Lisa A. Conte, CEO of Napo Pharmaceuticals, Inc. commented:  "Napo is extremely
pleased to see the achievement of statistical significance in this trial and
that once again, crofelemer's safety profile has been confirmed.  The success of
this study is a very important step for Glenmark in its goal to develop
crofelemer for CRO-ID in its territories.  For Napo, it represents a significant
step toward the realization of royalties from sales of crofelemer by Glenmark in
over 140 countries, and may address the devastating morbidity and mortality
issues associated with the billions of episodes of diarrhoea in developing
countries with a novel anti-secretory mechanism of action."


Pravin Chaturvedi, PhD, President and Chief Scientific Officer of Napo
commented:  "The effects of crofelemer in this study of secretory diarrhoea
caused by infectious pathogens provides additional support and confidence to the
mechanistic rationale for treating diarrhoea in patients with different causes.
In conjunction with the on-going Phase 3 trial that Napo is conducting in
chronic diarrhoea in people living with HIV/AIDS, this Glenmark trial will
provide a new pathway to a therapy for both acute and chronic secretory
diarrhoea. Glenmark expects to file for approval of crofelemer for the CRO-ID
indication in India in 2009, and, in combination with Napo's NDA programs for
crofelemer, the various approvals may allow for subsequent approvals in the
multiple countries where Glenmark is a licensee."


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 Glenmark Pharmaceuticals Limited of India and
AsiaPharm Group Ltd. of China. For more information please visit
www.napopharma.com.

About Glenmark Pharmaceuticals Limited

Glenmark is a leader in India in the discovery of new molecules and is focused
in the areas of inflammation (Asthma/COPD, etc.) and metabolic disorders
(Diabetes, Obesity, etc.). The Company is in the process of creating marketing
front-ends for the launch of its proprietary products in the future. Glenmark's
speciality business alone is guided to generate US$ 306 Mn in Net Sales in FY 08
and US$ 352 Mn in FY 09. Glenmark's first Asthma/COPD molecule, Oglemilast (GRC
3886), was licensed out to Forest Laboratories and Teijin Pharma Limited for the
North American and Japanese markets, respectively, in two landmark deals.
Oglemilast is presently undergoing Phase II clinical trials in the US. GRC 6211,
undergoing Phase II clinical trials in Europe, has been outlicensed to Eli Lilly
& company. Visit www.glenmarkpharma.com for further details

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.




                      This information is provided by RNS
            The company news service from the London Stock Exchange

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