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Napo Pharmaceuticals Announces License of Crofelemer to Salix Pharmaceuticals

SAN FRANCISCO, Dec. 10 /PRNewswire/ -- Napo Pharmaceuticals, Inc. ("Napo") is pleased to announce a collaboration with Salix Pharmaceuticals, Inc. ("Salix") for the license of crofelemer for all indications in North America, Europe (excluding certain smaller countries), and Japan, and certain indications worldwide. Crofelemer is Napo's novel anti-secretory, gastrointestinal agent currently in a final Phase 3 trial for the treatment of chronic diarrhea in people living with HIV/AIDS (the "ADVENT" program) under fast-track status and Special Protocol Assessment agreement with the FDA. This is the first indication targeted for approval and commercialization, with a market opportunity in the US of approximately $300 million.

The terms of the deal include an up-front license fee for the crofelemer intellectual property of $4.5 mm and an equity investment of $500,000 for the purchase of 250,000 shares of Napo common stock; as well as regulatory and sales milestone(s) payments tailored to the significance of the indication and performance of the product; and tiered royalty rates ascending to a $400 million annual sales threshold. The terms provide for full funding by Salix of the on-going ADVENT program, some of which costs will be off-set against future milestone payments to Napo.

Salix, a leading U.S. specialty pharmaceutical company focusing on products to treat gastro-intestinal disorders, will have the commercialization rights to an agent with potential application -- to a broad range of indications. Crofelemer is currently in clinical development for three additional indications: adult acute infectious diarrhea, including cholera -- in Phase 2; irritable bowel syndrome (IBS) -- in Phase 2; and pediatric diarrhea -- in Phase 1.

The FDA has granted fast-track status to crofelemer for the indications of chronic diarrhea in people living with HIV/AIDS and IBS. Positive clinical data in the treatment of severe cholera, and in increasing pain-discomfort-free days in diarrhea-predominant IBS patients, were released earlier this year. Crofelemer has demonstrated an excellent safety profile across all indications, both with chronic and acute administration. Crofelemer is sustainably harvested from the Amazonian tree, Croton lechleri, in several countries in South America.

Crofelemer product labeling by Salix (or its affiliates, sub-licensees or distributors as defined in the Collaboration Agreement) will include a reference to Napo as the licensor and will include Napo's logo and refer to the sustainable supply of crofelemer, to the extent legally allowed.

This collaboration allows Napo to proceed with its mission to provide global access to novel, branded pharmaceuticals. Diarrheal diseases are a major cause of child mortality and morbidity. Each year, 4 billion cases of diarrhea occur worldwide, causing 2-3 million deaths among children under five years.

Crofelemer is also licensed to Glenmark Pharmaceuticals, Ltd. of Mumbai, India in 140 emerging and developing countries for diarrhea indications; and to AsiaPharm, Ltd. in greater China for diarrhea indications. In conjunction with this license to Salix, Glenmark and Salix have entered into a commercial supply agreement for crofelemer API (active pharmaceutical ingredient).

Lisa Conte, Napo founder and CEO, commented, "Salix is an important force in providing solutions and expertise in the gastro-intestinal field. We are thrilled to have their leadership, skill, and committed resources to bring crofelemer first to the HIV community in the US. Ultimately, this license and Salix's international network in the gastro-intestinal field can provide global access of crofelemer to all populations for all indications."

Earlier this year, Napo announced, as part of the Crofelemer Access Program, an alliance with Direct Relief International to provide crofelemer for pediatric populations in disaster situations in resource-constrained geographies, pending receipt of a new drug approval for crofelemer from the FDA.


Despite the advent of anti-retroviral (ARV) therapy, chronic diarrhea continues to be a hallmark of HIV/AIDS. More than 1 million people with HIV are currently in the United States, and 15-30% are managing diarrhea chronically.

There are many reasons to treat diarrhea in people with HIV/AIDS, and the documented medical importance for doing so enhances the financial opportunities in such market. These reasons include:

    -- intolerability of chosen course of therapy, resulting in the need to
       switch therapy;
    -- decreased absorption of drugs, and poor adherence to drug regimen due
       to side-effect of diarrhea, indirectly increasing risk of emergence of
       resistant HIV strains;
    -- higher cost of managing HIV/AIDS in those suffering with chronic
    -- difficulty in maintaining nutritional status of patient; and
    -- quality of life issues.

Compared to the limited therapeutic options available for the management of chronic diarrhea, crofelemer has no motility related side-effects, is hardly absorbed systemically (acts locally in the gut), and has an excellent safety profile.


Diarrheal diseases are a major cause of child mortality and morbidity. Each year, 4 billion cases of diarrhea occur worldwide, causing 2-3 million deaths among children under five years. Cholera, the most severe of diarrheal diseases, is an ongoing pandemic and the number of affected countries continues to increase, especially in Africa.

The morbidity caused by diarrheal diseases is increasing. Children under 5 in developing countries suffer on average 3.2 episodes of diarrhea annually. These children risk not only death but also long-term sequelae: impairment of growth, fitness, school performance, and cognitive function.

There are no anti-diarrheal drugs safe for children for adjunct use with oral rehydration therapy (ORT). It is believed that novel drugs that reverse the devastating fluid loss of diarrheal diseases will help reduce the burden of diarrheal diseases worldwide.

Vibrio cholerae is an intestinal infection which results in the abrupt loss of large volumes of electrolyte rich watery stools, leading to severe and rapidly progressing dehydration and shock. Cholera, identified and detailed from the beginning of recorded history, was initially endemic to the Indian sub-continent. The disease began spreading almost 200 years ago, and is now pandemic and persists primarily in the developing world. The bacteria spreads through contaminated water and food. Because outbreaks can become massive epidemics, it is a reportable disease and is listed as a category B bioterrorism agent/disease by the Department of Health and Human Services - Centers for Disease Control.


Napo Pharmaceuticals, Inc. focuses on the development and commercialization 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 and offices in Boston, South San Francisco, and southern California.

Other than crofelemer, Napo's pipeline has an early clinical stage drug candidate, NP-500, for the treatment of Type II diabetes mellitus and metabolic syndrome and novel and proprietary anti-cancer agents in pre-clinical development. Napo also has a plant library of approximately 2,300 medicinal plants from tropical regions. Napo has entered into two screening relationships associated with this collection.

Napo has established a B corporation subsidiary which prioritizes sustainable harvesting, fair-trade work practices, and benefit sharing to recognize the intellectual contribution of indigenous knowledge.


Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Salix's strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete any required development and regulatory submission of these products, and market them through the company's gastroenterology specialty sales and marketing team.

SOURCE Napo Pharmaceuticals, Inc.
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