NAPO pushes Crofelemer for Pediatric Populations
Excerpt From Napo press release:
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Napo Pharmaceuticals, Inc. (Napo) recently hosted an educational panel to address the impact of the lack of access to clean water and enteric disease on global health, the environment, and human rights. Robert F. Kennedy, Jr., Napo’s Environmental Advisor, discussed the negative consequences of non-sustainable development on indigenous peoples and the environment.
Other speakers included E. Benjamin Skinner, who has written about the connection between the war on diarrhea and modern-day slavery in his book, A Crime So Monstrous; and James Workman, whose book, Heart of Dryness, details the current and future struggles surrounding the scarcity of clean water, as told through the experiences and traditional wisdom of bushmen in southern Africa’s Kalahari region. Dr. Pradip Bardhan of the International Centre for Diarrhoeal Disease Research in Bangladesh (ICDDR,B), a state-of-the-art cholera hospital, shared his experiences with enteric disease, not only at the ICDDR,B, but also with respect to cholera crises around the world, such as the recent outbreak in Zimbabwe.
“This event was an important gathering of world experts to address the various factors affecting the health of global populations,” said Napo CEO Lisa Conte. “The development of crofelemer, Napo’s investigational drug for secretory pediatric infectious diarrhea, is part of an effort by many partners to address the devastating dehydration in pediatric populations, regardless of their geography of social or economic status.”
The panel event followed a recent discussion among international experts on Napo’s global advisory board about the development of crofelemer for use in pediatric population. In addition, on Oct. 2, Ms. Conte addressed the MIT Legatum Center’s second annual Progress Through Innovation conference, which highlights the development and empowerment of people in developing regions of the world. Ms. Conte’s remarks focused on Napo’s global business plan to bring its first-in-class anti-diarrheal agent, crofelemer, to all populations in all countries through a sustainable business model by working with local partners. She also commented on the human-rights impacts and environmental repercussions of unmet global health needs, and the common traits shared by innovators and entrepreneurs around the globe.
Crofelemer for Pediatric Populations (CRO-PED)
Napo is organizing a program to accelerate the development of crofelemer for pediatric infectious diarrheal diseases, targeting regulatory approval in 2011-2012 (pending additional funding). The company has established a global advisory board to ensure that the development of a pediatric product incorporates World Health Organization (WHO) Essential Medicines guidelines for oral rehydration solution (ORS), zinc, etc., and to generate a formulation that is practical and safe for resource-constrained regions with limited health personnel. Napo has formed alliances with Direct Relief International and others to make crofelemer accessible to every childhood population in need. Napo is also in the planning stages for clinical development of crofelemer for severe cholera in pediatric populations at the ICDDR,B.
Napo’s proprietary patented gastrointestinal compound, crofelemer, is a first-in-class anti-secretory agent extracted from Croton lechleri, a medicinal plant sustainably harvested in several South American countries. Crofelemer is in various stages of clinical development for four distinct programs, including a late-stage Phase 3 program. The FDA has granted fast-track status to crofelemer development for IBS and HIV-related indications (CRO-IBS and CRO-HIV):
- CRO-HIV for HIV-related diarrhea, Phase 3 (under Special Protocol Assessment)
- 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
Napo’s licensee, Salix Pharmaceuticals, Inc. has exclusive rights to crofelemer for all indications in North America, Europe (excluding Iceland, Liechtenstein, Norway, and Switzerland), and Japan, and, for certain other indications including irritable bowel syndrome, worldwide. Salix estimates that the HIV-associated diarrhea market opportunity alone may be $300 million. The ADVENT trial of crofelemer as a treatment for chronic diarrhea in patients on antiretroviral therapies for HIV or AIDS is being conducted under fast-track status and Special Protocol Assessment agreement with the FDA.
Crofelemer has also been licensed to Glenmark Pharmaceuticals, Ltd. in India and 140 emerging countries for indications related to HIV (CRO-HIV), use in acute adult infectious diarrhea (CRO-ID), and use in pediatric diarrhea (CRO-PED). Glenmark and Salix have entered into a commercial supply agreement for crofelemer active pharmaceutical ingredient (API). AsiaPharm Group, Ltd. has rights to crofelemer in China (including Hong Kong and Macau).
see Journal of Pediatric Gastroenterology and Nutrition: for more information on Infectious Diarrhea in Children
see google journal search results for studies with Crofelemer