Napo Pharmaceuticals, Inc. (“Napo”) announced today that the New Drug Application (“NDA”) submitted on December 5, 2011 for crofelemer for the indication of chronic diarrhea in people living with HIV/AIDS on anti-retro viral therapy (“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 Fee Act (“PDUFA”).

The FDA grants a NDA a Priority Review designation when a drug offers major advances in treatment or provides a treatment where no adequate therapy exists. The NDA filing for CRO-HIV was made by Salix Pharmaceuticals, Inc. (“Salix”) after Napo terminated its Collaboration Agreement with Salix to commercially develop crofelemer.

The termination, on November 4, 2011, was based on Salix’s breaches of the Collaboration Agreement, which had been signed in December 2008. Despite positive Phase 3 results announced on November 4, 2010, Salix did not file its NDA with the FDA until after it was terminated by Napo from the Collaboration Agreement.

Crofelemer is a treatment for diarrhea, a life-threatening ailment that impacts millions of people across the world. Napo has already invested tens of millions of dollars in the development of crofelemer and is encouraged by today’s announcement of crofelemer receiving a Priority Review designation. Napo is particularly interested in progressing the pediatric indication of crofelemer. Worldwide, each year it is estimated that approximately 1.5 to 2 million children die of dehydration from diarrhea (roughly one every fifteen seconds).

“After the highly statistically significant Phase 3 trial results for CRO-HIV, this outcome was not unexpected,” says Lisa A. Conte, CEO of Napo. “We are encouraged by the FDA’s recognition of crofelemer’smedical importance and anxious to finally bring this important therapy to the HIV Community.”

Ms. Conte continued, “It is estimated that 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, a prevalence in the U.S. that exceeds 338,000 individuals. Globally, we envision an even broader impact. The mortality and morbidity of 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.”

On December 5, 2011, Salix filed the NDA for CRO-HIV, approximately 13 months after the highly statistically significant ADVENT Phase III clinical trial results for CRO-HIV were announced. The FDA previously granted CRO-HIV fast-track designation.

About Crofelemer

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), 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 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

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