NEW TREATMENT PRESENTED FOR CHRONIC DIARRHEA IN HIV/AIDS PATIENTS
SAN FRANCISCO, CA, March 8, 2012 - A poster describing the results of the final Phase 3 clinical trial for crofelemer, a drug being developed for the
indication of chronic diarrhea in people living with HIV/AIDS on anti-retroviral therapy (CRO-HIV), was presented in Seattle this afternoon. The presentation
took place as part of a session titled, “ADVENT Trial: Crofelemer for the Treatment of Secretory Diarrhea in HIV+ Individuals” during the Conference
on Retroviruses and Opportunistic Infections (CROI). Crofelemer is a product of San Francisco-based Napo Pharmaceuticals, Inc.
Approximately 40% of those living with HIV experience diarrhea severe
enough to interfere with life in the post-HAART ('highly active anti-retroviral
therapy') era, including over 338,000 people in the U.S. alone. As anti-retro viral
therapy ("ART") is extended to global HIV positive populations, including
prophylaxis to mitigate the onset of AIDS symptomatology, the management of
side-effects of therapy is even more important to facilitate adherence to drug
therapy. Resistant HIV viral strains have emerged in HIV positive populations on
ART with unmanaged diarrhea.
Globally, the mortality and morbidity of watery diarrhea is devastating, with
the latest estimates from the NIAID putting diarrhea as the second leading cause of global
deaths from infectious disease. Approximately 2.5 million people die
each year from diarrhea, many of them children. It is expected crofelemer will be
effective in reducing these deaths.
Crofelemer is an intraluminal, locally active, first in class antidiarrheal
agent that has demonstrated therapeutic benefit in clinical studies by reducing
fluid and CI-secretion through the inhibition of both the cystic fibrosis
transmembrane conductance regulator (CFTR) and calcium activated CIchannels
(CaCC) in the intestinal epithelium. Results have been published for
>2500 patients for both chronic and acute watery diarrhea indications, with no
serious drug related adverse events reported.
A New Drug Application (NDA) for CRO-HIV was accepted for filing by the
U.S. Food and Drug Administration ("FDA") with a Priority Review designation.
The FDA has set June 5, 2012 as the action date for the NDA under the
Prescription Drug User Free Act ("PDUFA").
It should be noted the NDA filing for CRO-HIV was made by Salix
Pharmaceuticals, Inc. However, on November 4, 2011, Napo terminated its
Collaboration Agreement with Salix to commercially develop crofelemer. The
termination was based on Salix's breaches of the Collaboration Agreement,
including Napo's claims that Salix did not honor its obligations to use
commercially reasonable efforts to develop and commercialize this FDA designated
Fast Track product for the benefit of people living with HIV/AIDS and
others. Despite positive Phase 3 results announced on November 4, 2010, Salix
did not file its NDA with the FDA until after it was notified of the termination by
Napo has already invested tens of millions of dollars in the development of
crofelemer and is encouraged by its receiving a Priority Review designation. On
the March 5th Burill Report podcast, Lisa Conte, CEO of Napo Pharmaceuticals,
spoke about the history of crofelemer and its potential benefits. To listen, visit
Napo’s proprietary patented gastrointestinal compound, crofelemer, is a
first-in-class anti-secretory agent extracted and purified from Croton lechleri, a
medicinal plant from South America. Napo maintains the sustainable harvest of
Croton lechleri under fair trade working conditions. Crofelemer is in various
stages of clinical development for four distinct indications, and has potential for
other indications as well, such as chemotherapy induced diarrhea:
1. Crofelemer for HIV-related diarrhea (CRO-HIV), SPA agreements with
FDA, NDA filed-Priority Review - PDUFA date June 5, 2012
2. Crofelemer for diarrhea predominant irritable bowel syndrome (CRO-IBS),
3. Crofelemer for acute infectious/watery diarrhea (including cholera), (CROID),
4. Crofelemer for pediatric diarrhea (CRO-PED), Phase 1
The FDA has granted fast track status to crofelemer development for IBSrelated
and HIV-related indications.
Napo Pharmaceuticals, Inc.
Napo focuses on the development and commercialization of proprietary
pharmaceuticals for the global marketplace. The company's business model
merges traditional high-value markets in the West with the higher volume
business models of emerging and developing economies. Napo's discovery
process is based on the knowledge of traditional healers, or shamans, working in
rain forest areas and provides benefit sharing to the communities with which it
works. Visit Napo at www.napopharma.com.
R.C. Auletta and Company