Napo Announces Successful Clinical Results in Phase 2 Study of Crofelemer in Acute...

Napo Announces Successful Clinical Results in Phase 2 Study of Crofelemer in
Acute Adult Infectious Diarrhea

SOUTH SAN FRANCISCO, Calif., April 10 /PRNewswire/ -- 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 diarrhea) conducted by
its partner, Glenmark Pharmaceuticals Limited (BSE: Glenmark). The primary
endpoints of the trial were stool weight, duration of diarrhea, 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 diarrhea 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 diarrhea 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 diarrhea, 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 diarrhea 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 diarrhea in
travelers in Mexico and Jamaica with crofelemer, Napo is investigating the
regulatory pathway to file an NDA for acute infectious diarrhea treatment with
crofelemer coincident with its on-going Phase 3 program in chronic diarrhea 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, said, "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 diarrhea in
developing countries with a novel anti-secretory mechanism of action."
Pravin Chaturvedi, PhD, President and Chief Scientific Officer of Napo
added, "The effects of crofelemer in this study of secretory diarrhea caused
by infectious pathogens provides additional support and confidence to the
mechanistic rationale for treating diarrhea in patients with different causes.
In conjunction with the on-going Phase 3 trial that Napo is conducting in
chronic diarrhea in people living with HIV/AIDS, this Glenmark trial will
provide a new pathway to a therapy for both acute and chronic secretory
diarrhea. 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
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 AIDS
diarrhea, Phase 3
-- 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. 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 $306 million (US)
in Net Sales in fiscal year 2008 and $352 million (US) in fiscal year 2009.
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 2
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 diarrhea,
diarrhea-predominant IBS, and acute infectious diarrhea. It is generally well
tolerated and has shown significant anti-diarrheal 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.
SOURCE Napo Pharmaceuticals, Inc.

Lisa Conte, Chief Executive Officer, +1-650-616-1902, Charles Thompson, Chief
Financial Officer, +1-650-616-1903, both of Napo Pharmaceuticals, Inc.; Tim
Anderson, or, Mary-Jane Johnson, both of Buchanan Communications, (44) + 020
7466 5000