Company Overview of Napo Pharmaceuticals, Inc.
Napo Pharmaceuticals, Inc. develops and commercializes proprietary pharmaceuticals for international markets. It offers Crofelemer for gastrointestinal indications, including chronic diarrhea in persons living with HIV/AIDS; and NP-500, a product for insulin-resistant diseases. The company also provides CRO-IBS for diarrhea-predominant IBS; CRO-HIV for AIDS-related diarrhea; CRO-ID for acute infectious diarrhea; and CRO-PED for pediatric diarrhea. It offers its products for D-IBS, HIV, acute-cholera, and pediatric markets. The company was founded in 2001 and is based in San Francisco, California. It has a subsidiary location in Mumbai, India.
185 Berry Street
San Francisco, CA 94107
Founded in 2001
Key Executives for Napo Pharmaceuticals, Inc.
President and Chief Scientific Officer
President of Napo India Private Limited
Compensation as of Fiscal Year 2012.
Napo Pharmaceuticals, Inc. Key Developments
Napo Pharmaceuticals, Inc. Files for MUMS Designation for Crofelemer for Chemotherapy Induced Diarrhea in Dogs
Sep 12 12
Napo Pharmaceuticals, Inc. announced it had applied for a Minor Use in a Major Species (MUMS) designation for crofelemer, for use in chemotherapy induced diarrhea in dogs -- (CID). Crofelemer is also the subject of a pending New Drug Application for use in humans for the indication of chronic diarrhea in people living with HIV/AIDS. A MUMS designation in dogs is limited to a population of 70,000. Based upon existing literature, Napo estimates that there is a patient population of approximately 50,000 dogs in the US. Napo has strong pre-clinical and clinical data to support the mechanistic rationale for the use of crofelemer for CID in dogs based upon previous human studies of over 2,000 patients. Crofelemer is a first-in-class new chemical entity (NCE) that treats watery/secretory diarrhea irrespective of the etiology. The drug normalizes chloride and water flow and transit time of fluids within the lumen of the gut. Crofelemer is a locally acting agent, demonstrating no to minimal systemic adsorption.
Napo Pharmaceuticals, Inc. Learns FDA to Continue Review of Crofelemer New Drug Application
Sep 6 12
Napo Pharmaceuticals, Inc. was informed that the Food and Drug Administration is continuing its review of the new drug application seeking approval of crofelemer for the treatment of chronic diarrhea in people living with HIV/AIDS on anti-retroviral therapy. Salix Pharmaceuticals, Inc. never informed Napo that Salix had filed the NDA for approval of crofelemer as a botanical drug. According to the FDA website, botanical drug products are complex mixtures with a lack of a distinct active ingredient and substantial prior human use as a complex mixture. Fermentation products and highly purified or chemically modified botanical substances are not considered botanical drug products. The FDA has never previously approved an orally acting botanical drug. Crofelemer is a natural product isolated and purified from a tree found in the Amazon Basin, Croton lechleri.
ICDR Rules in Favor of Glenmark Pharmaceuticals Ltd on the Arbitration Claim it Filed against Napo Pharmaceuticals
Aug 23 12
The International Centre for Dispute Resolution ruled in favor of Glenmark Pharmaceuticals Limited on the arbitration claim it filed on August 8, 2011 against Napo Pharmaceuticals, Inc. seeking, among other things, a ruling that Glenmark's exclusive rights to develop, commercialise and distribute Crofelemer in 140 countries for treatment of diarrheal diseases includes the exclusive rights to distribute through relief agencies in these countries and an injunction prohibiting Napo from sharing confidential information concerning the manufacture of Crofelemer. The ICDR ruled that Glenmark's exclusive rights to commercialise and distribute Crofelemer include the exclusive right to distribute Crofelemer through relief agencies into the 140 countries that comprise the Glenmark territory. The ICDR also ruled that Glenmark has two years from the time Crofelemer is approved in India (on an indication by indication basis) to file for regulatory approval in the 140 countries in its territory. Finally, the ICDR found that Napo breached the Collaboration Agreement by disclosing confidential information concerning the manufacture of Crofelemer to Aptuit Laurus and enjoined Napo from disclosing such confidential information to third parties and from purchasing or obtaining Crofelemer from Aptuit. Napo also had filed a claim in the same proceeding seeking a ruling that Glenmark had materially breached the Collaboration Agreement between the parties by failing to, among other things, commercialise Crofelemer in all 140 countries in its territory and to manufacture a pediatric formulation for Crofelemer. In its ruling today, the ICDR rejected Napo's material breach claim, finding that Glenmark has complied with all of its obligations under the Collaboration Agreement.
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