Jaguar Health Subsidiary Receives Notice of Allowance from Canadian Intellectual Property Office for Patent Application

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[{"type":"text","content":"SAN FRANCISCO, CA / ACCESSWIRE / September 30, 2019 / Jaguar Health, Inc. (NASDAQ:JAGX) (\"Jaguar\" or the \"Company\"), today announced that the Company's wholly-owned, human-health focused subsidiary, Napo Pharmaceuticals, Inc. (\"Napo\"), has received a Notice of Allowance from the Canadian Intellectual Property Office for Canadian Patent Application No. 2,816,416, titled Methods and Compositions for Treating HIV-Associated Diarrhea.\"We are very pleased to receive this Notice of Allowance from the Canadian Intellectual Property Office for this patent,\" Steven King, PhD, Jaguar's executive vice president of sustainable supply, ethnobotanical research and intellectual property, commented. \"Jaguar, through Napo, holds extensive global rights for crofelemer, comprising a valuable and significant barrier to entry. At the present time we hold approximately 141 issued worldwide patents, with coverage in many cases that extends until 2031. These issued patents cover multiple indications including HIV-AIDS diarrhea, IBS, IBD, manufacturing, enteric protection from gastric juices, among others. We also have approximately 24 pending patent applications worldwide in the human health areas that are being prosecuted.\"Additionally, Mytesi is the first oral drug approved by the U.S. Food and Drug Administration (FDA) under botanical guidance, which provides another barrier to entry from potential generic competition. The FDA requires that the manufacturer of crofelemer use a validated proprietary bioassay to release the drug substance and drug product of Mytesi. While most generic products are fashioned to meet chemical release specifications that are in the public domain, the specifics of this assay are not publicly available. There is no pathway by which a generic product can be developed for a drug approved under botanical guidance. In addition, Mytesi is not systemically absorbed, so the classic approach of creating a generic drug by matching pharmacokinetic blood levels is not possible. A generic player would have to conduct costly and risky clinical trials.The patent covers methods for treating diarrhea by administering to a patient in need thereof, an inhibitor of chloride-ion transport in an amount sufficient to treat diarrhea. Treatment of diarrhea includes the treatment of the diarrhea as well as the pain, abdominal discomfort ...

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