Napo Pharmaceuticals, Inc. Receives Enteric Coated Formulation of Crofelemer Patent from United States Patent Office
The patent relates to enteric coated formulations of crofelemer used to treat secretory diarrhoea. The enteric coating allows crofelemer to pass through the stomach into the intestine where it dissolves and acts locally on the cystic fibrosis transmembrane conductance regulator. The patent life extends until 2017. This patent has also issued in India, Taiwan, Australia, New Zealand and South Korea.
Napo also has patents issued on the composition of matter and pending on dosing, manufacture, and additional indications of crofelemer.
Commenting on this announcement, Lisa Conte, Chief Executive Officer of Napo Pharmaceuticals, said: "We have been eagerly anticipating the issuance of this patent. Napo expects the opportunity to receive an extension of the patent term under the Hatch-Waxman Act extending our IP coverage beyond 2017. The IP complements other barriers to entry of potential competitors, including the programs Napo has in place in S. America for sustainable supply and benefit sharing for the raw plant material from which crofelemer is isolated.“
Dr. Steven King, Vice President of Sustainable Supply and Ethnobotanical Research further noted that: “The programs in place for sustainable supply and benefit sharing have been developed over the past 18 years with trusted and dedicated local business partners.”
For more information please contact: Napo Pharmaceuticals, Inc. Lisa Conte, Chief Executive Officer (001) + 650 616 1902 Charles Thompson, Chief Financial Officer (001) + 650 616 1903
Buchanan Communications 020 7466 5000 Mary-Jane Johnson, Tim Anderson Nomura Code Securities Limited 020 7776 1205 Clare Terlouw
About Enteric Formulations of Proanthocyanidin Polymer Antidiarrheal Compositions The invention relates to pharmaceutical formulations of a proanthocyanidin polymeric composition, which has been isolated from a Croton spp. or Calophyllum spp., which formulations are effective for the treatment of secretory diarrhea, particularly for the reduction of the fluid loss and resulting dehydration associated with secretory diarrheas. A preferred embodiment of the invention relates to pharmaceutical formulations of proanthocyanidin polymeric compositions which protect the compositions from the acid environment of the stomach after oral administration, particularly those formulations which are enteric coated, and formulations of directly compressible proanthocyanidin polymer compositions.
About Napo Pharmaceuticals, Inc.
Napo Pharmaceuticals, Inc. focuses on the development and commercialisation 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 • CRO-IBS for diarrhea irritable bowel syndrome ("D-IBS"), Phase 2 • CRO-ID for acute infectious diarrhea (including cholera), Phase 2 • CRO-PED for paediatric diarrhea, Phase 1 The FDA has granted fast-track status to CRO-IBS and CRO-HIV. 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. Currently, products are based on the chemical and biological diversity derived from plants with medicinal properties, but future products may be in-licensed from other sources. Napo has partnerships with Trine Pharmaceuticals, Inc. of the United States of America; Glenmark Pharmaceuticals Limited of India; and AsiaPharm Group Ltd. of China. 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 1500 patients in double-blind placebo-controlled, 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.