Napo Pharmaceuticals Signs Development, Commercialization Alliance With AsiaPharm of China - Press Releases

Napo Pharmaceuticals Signs Development, Commercialization Alliance With AsiaPharm of China
June 15, 2005
Napo Receives Equity Investment and Royalties, Licenses Crofelemer for CHINESE Market Place
SOUTH SAN FRANCISCO, Calif., June 15 /PRNewswire/ -- Napo Pharmaceuticals Inc. announced today that it has granted AsiaPharm Group Ltd. an exclusive license to develop and commercialize for China (including Hong Kong and Macau) products derived from crofelemer to treat chronic diarrhea in people living with HIV/AIDS (AIDS-related diarrhea), acute infectious diarrhea and pediatric diarrhea. Crofelemer targets several gastrointestinal indications and is in advanced clinical development to treat AIDS-related diarrhea and diarrhea- predominant Irritable Bowel Syndrome (D-IBS) in the U.S.

AsiaPharm will contribute process development, manufacturing and pediatric formulation expertise; and has made an equity investment in Napo. Napo will also receive royalty payments from AsiaPharm from sales of crofelemer-derived products in China. Napo will provide consulting and expertise to AsiaPharm to enable it to become an FDA-approved cGMP manufacturer of crofelemer. Napo will be the exclusive supplier of sustainably harvested raw plant material to AsiaPharm for the extraction of crofelemer.
"This collaboration will allow Napo to bring a novel therapy for these debilitating and sometimes deadly diseases to both traditional Western markets and resource constrained areas of the world," said Napo CEO Lisa Conte. "AsiaPharm understands the potential of crofelemer as a major global medicine with enormous market potential targeting billions of episodes a year. AsiaPharm is expert at working with plant-derived therapeutics, and they have the know-how to successfully deliver drugs to very large populations, which should ultimately provide for beneficial economies of scale," she added.
"This transaction, the first of this kind, was completed in just four months, demonstrating the opportunity both partners see for this drug both in the marketplace and to help those in need," commented Charles Thompson, VP of Finance and CFO of Napo.
"We are particularly excited about the novel mechanism of action, which provides a unique approach for managing diarrhea," said Liu Dianbo, Executive Chairman of AsiaPharm. "Through our alliance with Napo, we have gained access to an exciting gastrointestinal product with significant clinical experience for a huge unmet medical need in China."
Napo Pharmaceuticals' Lisa Conte, CEO, and Dr. Steven King, VP of Ethnobotany, will participate in panel sessions on global health and bioprospecting at BIO 2005 in Philadelphia, Penn. on June 20 at 4 p.m. and June 22 at 11 a.m. respectively. A media briefing to discuss the business objectives and progress of Napo is scheduled for June 20, 2005 at 5:30 p.m. EDT after Ms. Conte's presentation in Philadelphia.
About Crofelemer
Crofelemer (CAS 148465-45-6) is an oligomeric proanthocyanidin derived from the latex of Croton lecheri. Crofelemer has a well-documented, novel anti-secretory mechanism of action which blocks chloride ion secretion via the CFTR channel, normalizes water flow in the gut, treating diarrhea and thereby preventing dehydration from occurring. Crofelemer has shown significant anti-diarrheal activities in multiple clinical trials with more than 1,000 patients. Because crofelemer is not absorbed and works locally, it has a unique safety advantage over alternative treatments. Napo plans to initiate a final pivotal Phase III trial in the spring of 2006 for the indication of AIDS-related diarrhea and has received fast track status from the US FDA. Napo's partner for D-IBS, Trine Pharmaceuticals Inc. is currently conducting a Phase II clinical trial. Additional indications include acute infectious diarrhea (Traveler's diarrhea) and pediatric diarrhea. Napo holds supply rights for sustainably harvested raw materials and intellectual property rights for the composition of matter of the compound and its derivatives and licenses those rights to pharmaceutical partners in western, emerging, and developing markets.
About Diarrhea
Diarrhea is characterized by loose stool and abdominal cramps resulting in a significant loss of quality of life and severe potential dehydration; severe diarrhea can lead to death. Diarrhea is one of the most prevalent conditions with billions of episodes annually worldwide, including chronic diarrhea in people living with HIV/AIDS, pediatric diarrhea and acute infectious diarrhea or Traveler's diarrhea.
Approximately 15 to 30 percent of the HIV/AIDS infected population (estimated 1.1 million in the U.S. in 2003) manages diarrhea chronically, and 50 percent of those are completely refractory to currently available therapies. Diarrhea in children under five leads to severe dehydration, which caused 5 million deaths in developing countries in 2003, and approximately 35 million episodes annually in the U.S. Acute infectious diarrhea or Traveler's diarrhea annually affects between 20 percent and 50 percent of international travelers. High-risk destinations for Traveler's diarrhea include the low-income countries in Latin America, Africa, the Middle East and Asia and to a lesser degree Southern Europe and some Caribbean countries.
In addition, because of its unique mechanism of action, crofelemer is being developed for D-IBS. IBS accounts for 3 million physician visits annually in the U.S. and afflicts up to 20 percent of the population chronically in the U.S., of which 45 percent manage D-IBS, with another 30 percent cycling between D-IBS and constipation-predominant IBS.
About AsiaPharm Group Ltd.
AsiaPharm is one of China's leading specialty pharmaceutical groups focused on the research, development, production and sale of natural drugs and chemical drugs using new formulations in the fields of orthopedics, neurology, gastroenterology and hepatology. The Group has received GMP certification from the Chinese SFDA for all its production lines, including the production lines for lyophilized powders, tablets, capsules, granules and gels as well as sodium aescinate. AsiaPharm has in-house pharmaceutical research capabilities from pre-clinical evaluation to pharmacology research, drug safety evaluation and clinical trials. The Group provides contract research services to other pharmaceutical manufacturers and sells its R&D results and/or patents of new drugs to other pharmaceutical manufacturers. Its R&D center currently employs more than 100 researchers and professionals. With an extensive distribution network of 35 sales support offices covering 30 provinces, municipals and autonomous regions, the Group's products are sold directly and through its distributors to approximately 2,000 hospitals throughout the PRC. More information can be found at www.asiapharm.biz.
About Napo Pharmaceuticals Inc.
Napo Pharmaceuticals Inc. is a privately-held biopharmaceutical company focused on licensing, developing and commercializing proprietary specialty pharmaceuticals, in collaboration with partners in more resource efficient economies, in order to address major global unmet medical needs in developed and developing countries. Napo has a medicinal product library of over 2,300 plants, of which 344 have been used to treat viral diseases. Napo is currently developing crofelemer-derived products for gastrointestinal indications such as chronic diarrhea in people living with HIV/AIDS, pediatric diarrhea and acute infectious diarrhea. Napo's partner Trine Pharmaceuticals Inc. is developing crofelemer to treat diarrhea-predominant irritable bowel syndrome (D-IBS) worldwide. AsiaPharm is developing crofelemer for the Chinese market to treat chronic diarrhea in people living with HIV/AIDS, acute infectious diarrhea and pediatric diarrhea. More information can be found at www.napopharma.com.