NAPL Napo Pharm.Regs

RNS Number:3814N
Napo Pharmaceuticals Inc
06 February 2008



For immediate release                                           6 February 2008


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

Napo Receives Enteric Coated Formulation of Crofelemer Patent from United States
                                 Patent Office

South San Francisco, California, 6 February 2008 - 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 today that it has obtained U.S. Patent
No. 7,323,195 for "enteric formulations of proanthocyanidin polymer
antidiarrheal compositions" from the United States Patent Office.

The patent relates to enteric coated formulations of crofelemer used to treat
secretory diarrhoea. The enteric coating allows crofelemer to pass through the
stomach into the intestine where it dissolves and acts locally on the cystic
fibrosis transmembrane conductance regulator. The patent life extends until
2017. This patent has also issued in India, Taiwan, Australia, New Zealand and
South Korea.

Napo also has patents issued on the composition of matter and pending on dosing,
manufacture, and additional indications of crofelemer.

Commenting on this announcement, Lisa Conte, Chief Executive Officer of Napo
Pharmaceuticals, said: "We have been eagerly anticipating the issuance of this
patent. Napo expects the opportunity to receive an extension of the patent term
under the Hatch-Waxman Act extending our IP coverage beyond 2017. The IP
complements other barriers to entry of potential competitors, including the
programs Napo has in place in S. America for sustainable supply and benefit
sharing for the raw plant material from which crofelemer is isolated."

Dr. Steven King, Vice President of Sustainable Supply and Ethnobotanical
Research further noted that: "The programs in place for sustainable supply and
benefit sharing have been developed over the past 18 years with trusted and
dedicated local business partners."

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
020 7466 5000
Mary-Jane Johnson, Tim Anderson

Nomura Code Securities Limited
020 7776 1205
Clare Terlouw

About Enteric Formulations of Proanthocyanidin Polymer Antidiarrheal
Compositions

The invention relates to pharmaceutical formulations of a proanthocyanidin
polymeric composition, which has been isolated from a Croton spp. or Calophyllum
spp., which formulations are effective for the treatment of secretory diarrhea,
particularly for the reduction of the fluid loss and resulting dehydration
associated with secretory diarrheas. A preferred embodiment of the invention
relates to pharmaceutical formulations of proanthocyanidin polymeric
compositions which protect the compositions from the acid environment of the
stomach after oral administration, particularly those formulations which are
enteric coated, and formulations of directly compressible proanthocyanidin
polymer compositions.

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 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 paediatric 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 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 www.napopharma.com.

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, 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.




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

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