Napo Pharmaceuticals
Crofelemer
A proprietary gastro-intestinal compound in clinical development for four distinct product indications
news
Napo Pharmaceuticals, Inc. Appoints New Vice-President of Business Development
South San Francisco, California, May 19, 2009 - Napo Pharmaceuticals, Inc., (Napo) which focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace in collaboration with local partners, is pleased to announce the appointment of Deebie Symmes, as Vice President - Business Development. Ms. Symmes will be responsible for maximizing the value of Napo's pipeline through partnering arrangements. Ms. Symmes has almost 20 years of business development experience with pharmaceutical companies including Chiron Corporation, IntraBiotics Pharmaceuticals, Tularik Inc. and ARYx Therapeutics originating and closing transactions across the pharmaceutical spectrum.
Lisa A. Conte, CEO of Napo Pharmaceuticals, Inc. commented: "We are delighted to have someone with Deebie's broad experience joining us to head our business development effort. Deebie's background in pharmaceutical collaborations will be a big plus for us as we prioritize our partnering efforts for our second generation CFTR inhibitors which are small molecule drug candidates that the same mechanism of action as crofelemer, Napo's first-in-class Phase 3 compound for diarrhea and other gastrointestinal diseases."
Additionally, Napo is seeking a partner for its diabetes compound, NP 500, which has a novel mechanism of action and is ready to enter Phase 2 clinical studies. Napo has a broad early stage screening program for novel agents derived from medicinal plants used traditionally in tropical areas for the indications of diabetes and infectious diseases.
Commenting on this announcement, Deebie Symmes, said: "I am pleased to be part of Napo's team and in particular the partnering of the CFTR technology. Napo's expertise in chloride channel technology has a benefit in gastrointestinal diseases, where crofelemer has generated important clinical data in AIDS-related diarrhea, cholera, and IBS. This novel mechanism may also have application in polycystic kidney disease, a leading cause of renal failure. In addition, Napo's NP-500 program may potentially provide a new avenue for early treatment in type 2 diabetes via a novel mechanism."
For more information please contact:
Napo Pharmaceuticals, Inc.
Lisa Conte, Chief Executive Officer
(001) + 650 616 1902
About Napo Pharmaceuticals, Inc.
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.
Napo's late-stage proprietary gastro-intestinal compound, crofelemer, is in various stages of clinical development for four distinct product indications, including a late-stage Phase 3 program:
- CRO-HIV for AIDS diarrhea, Phase 3 (under a 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
The FDA has granted fast-track status to CRO-IBS and CRO-HIV.
Napo has licensed crofelemer to Salix Pharmaceuticals, Inc. for all indications in North America, Europe (excluding certain smaller countries), and Japan including chronic diarrhea in people living with HIV/AIDS which is currently in Phase 3, and certain indications worldwide. Crofelemer is also licensed to Glenmark Pharmaceuticals, Ltd. of Mumbai, India in 140 emerging and developing countries for CRO-HIV, CRO-ID and CRO-PED indications; and to AsiaPharm, Ltd. in greater China for the same indications.
Crofelemer, a proprietary patented agent, is extracted from Croton lechleri, a medicinal plant which can be sustainably harvested from several countries in South America. Napo also plans to develop an early clinical stage product, NP-500, for the treatment of insulin resistant diseases of Type II diabetes and metabolic syndrome (Syndrome X; pre-diabetic syndrome). Napo also has a plant library of approximately 2,300 medicinal plants from tropical regions, and Napo has entered two screening relationship associated with this collection.
For more information please visit www.napopharma.com.
About Crofelemer
Crofelemer, a proprietary patented agent, is extracted from Croton lechleri, a medicinal plant which can be sustainably harvested from several countries in South America. Crofelemer is in various stages of clinical development for four distinct product indications, one in Phase 3, two in Phase 2 and one in Phase 1.
Crofelemer has been tested in trials involving approximately 1700 patients in double-blind placebo-controlled, mostly published trials of AIDS diarrhea, diarrhea-predominant IBS, and acute infectious diarrhea. It is generally well tolerated and has shown significant anti-diarrheal activities and improvement in gastrointestinal symptoms. Crofelemer produces several effects when administered orally providing for activity in several disease indications. Crofelemer's anti-secretory mechanism reduces excess fluid secreted into the gastro-intestinal tract, while its anti-inflammatory and analgesic activity may provide the rationale for its significant benefit in abdominal pain. Crofelemer acts locally in the intestines, with limited systemic exposure.