SAN FRANCISCO - Napo Pharmaceuticals, Inc. (Napo)
is pleased to announce the positive results of a successfully
completed Phase 2 study of crofelemer for the treatment of
hospitalized adult patients with mild to moderate acute watery
diarrhea conducted by its partner Glenmark Pharmaceuticals Ltd.
(Glenmark - BSE: 532296 NSE: GLENMARK).
In the randomized, placebo-controlled, multi-center study,
resolution of diarrhea was significantly higher in patients
treated with crofelemer than in those given placebo. Crofelemer
continues to be found safe, with no apparent differences in
adverse events in patents treated with crofelemer as compared to
In November 2010, Napo released the highly statistically
significant results of a Phase 3 study of crofelemer for
treatment of chronic diarrhea in people living with HIV/AIDS on
anti-retroviral therapy (HIV-related diarrhea). A new drug
application for crofelemer for this indication will be filed
mid-year and has been given fast track designation by the FDA.
Based on these successful results, Lady Neelam Sekhri Feachem,
recently joined Napo as leader of its global access program and
alliance management. "I am pleased to be working with the Napo
team because of its unique commitment to ensuring access to its
first-in-class anti-diarrheal drug in every part of the world,"
she said. "I look forward to working with Napo's commercial
partners, international NGOs, donors, and others in the global
health community to ensure rapid and affordable access to
crofelemer and Napo's future products. Napo's program to
accelerate the development of a pediatric product for acute and
HIV-related diarrhea is especially exciting. I am delighted that
Napo's partners are committed to the development of this
lifesaving drug for children."
"Napo is committed to global access to crofelemer--each and every
country and patient in need," said Napo CEO Lisa Conte. "Napo
prospectively negotiated rights in agreements with its licensees
to ensure availability of this important medicine to emerging
markets and the developing world, at the same time as in Western
markets. Emerging markets for pharmaceutical sales are expected
to grow at 17% over the next year, more than double the rate of
the global market for pharmaceuticals. Napo welcomes Glenmark's
commitment to bring crofelemer, its first NCE (new chemical
entity), to emerging and developing markets. Napo is committed to
that goal and is currently accelerating development of crofelemer
for pediatric populations around the world, including those most
vulnerable to severe disease and death from diarrhea
Pediatric Applications for Crofelemer
Diarrhea is the second largest killer of children globally.
Dehydration from watery diarrhea causes death in approximately
two million children under age 5 each year, and measurable
morbidity in hundreds of millions more. Napo estimates that
pediatric diarrhea is the largest market opportunity and need in
developing and emerging markets. Napo has established a global
advisory board of key opinion leaders to work with Napo in its
development of the pediatric indication of crofelemer. In
addition to its focus on the growing private sector of emerging
markets, Napo has formed alliances with Direct Relief
International and others to make crofelemer accessible to every
child in need. This program is recognized as a Clinton Global
Napo's proprietary patented gastrointestinal compound,
crofelemer, is a first-in-class anti-secretory agent extracted
from Croton lechleri, a medicinal plant sustainably harvested
under fair trade working conditions from several countries in
South America. Crofelemer is in various stages of clinical
development for four distinct indications:
1. Crofelemer for HIV-related diarrhea (CRO-HIV), Phase 3 (under
Special Protocol Assessment); highly significant data recently
released, NDA filing targeted for mid-2011.
2. Crofelemer for diarrhea predominant irritable bowel syndrome
3. Crofelemer for acute infectious/watery diarrhea (including
cholera), Phase (CRO-ID)
4. Crofelemer for pediatric diarrhea (CRO-PED), Phase 1
The FDA has granted fast track status to crofelemer development
for IBS- and HIV-related indications.
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. The company
seeks partners in both traditional high-value markets as well as
in the higher volume business models of emerging and developing
economies. Napo was founded in November 2001 and is based in San
Francisco, Calif., with a subsidiary in Mumbai, India.
In addition to crofelemer, Napo holds exclusive worldwide rights
to novel small-molecule potential second-generation
anti-secretory agents, which have been licensed to the company by
the Regents of the University of California, and are the subject
of NIAID funding. 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. Napo has a library of approximately 2,300 medicinal
Napo's discovery process leverages the knowledge of traditional
healers, or shamans, working in rain forest areas. The company
provides benefit sharing to the cultures with which it works
through a non-profit it established called the Healing Forest
Conservancy, devoted to recognizing the intellectual
contributions of indigenous knowledge, the conservation of
biological diversity, indigenous cultures, and the basic human
rights of those communities.
Please note: The materials provided herein contain projections
and other forward-looking statements regarding future events.
Such statements are just predictions and are subject to risks and
uncertainties that could cause the actual events or results to
differ materially. These risks and uncertainties include, among
others: the cost and unpredictability of the duration and results
of clinical trials and FDA approval; the possible impairment of,
or inability to obtain, intellectual property rights and the
costs of obtaining such rights from third parties; market
acceptance for approved products; ability to secure the product;
and generic and other competition and the need to acquire new
Napo Pharmaceuticals, Inc.
Lisa Conte, CEO, +1 415-516-2732