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Napo Pharmaceuticals, Inc. Terminates Glenmark Pharmaceuticals for Failure to Commercially Develop Crofelemer


12/12/2011 11:15:03 AM

SAN FRANCISCO--(BUSINESS WIRE)--Napo Pharmaceuticals, Inc. (“Napo”) announced today that it has terminated its Collaboration Agreement with Glenmark Pharmaceuticals Ltd. (“Glenmark”), dated July 2, 2005. Pursuant to the Collaboration Agreement, Glenmark was to develop and commercialize the drug crofelemer in over 140 countries. The compound is a treatment for both acute and chronic watery diarrhea, life-threatening ailments that impact millions of people across the world.

Effective December 8, 2011, the termination was based on Glenmark’s alleged breaches of the Collaboration Agreement between the two parties. Based in India, Glenmark has yet to file a single application for regulatory approval with the Drugs Controller General India or any other regulatory agency.

Glenmark has failed to develop, commercialize, file for or gain regulatory approval for crofelemer for use in people living with HIV/AIDS – for which successful phase 3 clinical trial results were announced in 2010 – or adult acute watery diarrhea, for which there have been several successful clinical trial results. It has also failed to develop the drug for the treatment of pediatric diarrhea. According to the World Health Organization, 1.5 million children die annually from dehydration due to acute diarrhea, with millions more suffering long-term harm. Child mortality and illness due to diarrheal diseases is especially severe in India.

“Napo believes Glenmark has materially breached the Collaboration Agreement by failing to fulfill its basic responsibilities to develop and commercialize this important drug,” says William A. Brewer III, partner at Bickel & Brewer and counsel for Napo. “Most notably, Glenmark has not filed a single application to register this drug in any country in the world, despite having had the license for more than six years.”

On September 9, 2011, Napo sent Glenmark a notice of default, which gave Glenmark 60 days to remedy its defaults alleged therein. Napo terminated the agreement based on Glenmark’s failure to cure these defaults.

“Our company is committed to the distribution of crofelemer given the many ways in which it can benefit millions of people around the world,” says Lisa A. Conte, CEO of Napo. “We are disappointed that Glenmark did not move forward to make this first-in-class drug available in any one of the 140 countries in which it was licensed to do so. We will bring this life-saving drug to the global market as quickly as possible.”

The Glenmark termination follows a November 10, 2011, announcement by Napo that it terminated its Collaboration Agreement with Salix Pharmaceuticals, Inc. to commercially develop crofelemer in the U.S., Canada, Mexico, Europe and Japan. The termination of the Glenmark and Salix Collaboration Agreements paves the way for Napo to enter into new licensing agreements and press forward with registration and commercialization worldwide, in countries such as India, Russia, Romania, Brazil, Australia, Switzerland, and South Africa. Napo has already invested tens of millions of dollars in the development of the compound.

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.

About Bickel & Brewer:

Founded in 1984, Bickel & Brewer has earned a reputation as one of the most successful law firms in the United States practicing exclusively in the field of complex commercial litigation and dispute resolution. With offices in New York and Dallas, Bickel & Brewer represents a wide spectrum of industry leaders – from entrepreneurs to Fortune 500 corporations – facing the most challenging of legal issues. Visit Bickel & Brewer at www.bickelbrewer.com.

Contacts

on behalf of Napo and Bickel & Brewer
Travis J. Carter, 214-653-4856
tcarter@bickelbrewer.com

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