New Treatment Presented for Chronic Diarrhea in HIV/AIDS Patients
SAN FRANCISCO--(BUSINESS WIRE)--Mar 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-retro viral 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 CI-channels (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.
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 www.burrillreport.com.
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), Phase 2
3. Crofelemer for acute infectious/watery diarrhea (including cholera), (CRO-ID), Phase 3
4. Crofelemer for pediatric diarrhea (CRO-PED), Phase 1
The FDA has granted fast track status to crofelemer development for IBS-related 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.
Contact: R.C. Auletta and Company
Jason Solomon, 212-355-0400
Posted: March 2012