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RedHill Biopharma Gains Orphan Drug Status for Pancreatic Drug

By Barry Teater, NCBiotech Writer

RedHill Biopharma, an Israeli company with U.S. headquarters in Raleigh, has received orphan drug designation for its pancreatic drug candidate from the U.S. Food and Drug Administration.

The designation will give RedHill various incentives to develop the drug including tax credits for qualified clinical testing, waiver of a prescription drug user fee upon submission of a potential marketing application and a seven-year marketing exclusivity period if the drug is approved.

The drug, Mesupron (upamostat), is a proprietary, first-in-class, orally administered protease inhibitor for the adjuvant treatment of pancreatic cancer. It has several potential mechanisms of action to inhibit tumor invasion and metastasis and represents a new, non-cytotoxic approach to cancer therapy, RedHill said in a news release.

The drug has undergone several Phase 1 studies and two Phase 2 proof-of-concept studies.

RedHill recently announced the receipt of a Notice of Allowance from the U.S. Patent and Trademark Office for a new patent covering the use of Mesupron and RedHill’s Phase 2-stage investigational compound, Yeliva, in combination with a known antibiotic, for hard-to-treat cancers.

RedHill said it is also evaluating the use of Mesupron in several inflammatory gastrointestinal indications following the identification of two high-affinity molecular targets, human trypsin-2 and human trypsin-3. The company has an ongoing research collaboration agreement with the Department of Molecular Biology and Genetics of Aarhus University in Denmark for the evaluation of Mesupron.

RedHill acquired the exclusive worldwide rights to Mesupron, excluding China, Hong Kong, Taiwan and Macao, from Germany’s Wilex AG for all indications.

Pancreatic cancer is the third leading cause of cancer mortality in the United States. Worldwide sales of pancreatic cancer therapies are estimated to reach about $1.6 billion in 2017.

RedHill, established in 2009 in Tel-Aviv, is a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of orally administered, small-molecule drugs for gastrointestinal and inflammatory diseases and cancer. The company’s shares are publicly traded on the NASDAQ stock market and the Tel-Aviv Stock Exchange.

RedHill’s 40-person sales team, based in Raleigh, promotes three gastrointestinal products in U.S. markets: Donnatal, an oral drug to treat irritable bowel syndrome and acute enterocolitis; EnteraGam, a medical food intended for the dietary management of chronic diarrhea and loose stools; and esomeprazole strontium, a proton pump inhibitor for treating gastroesophageal reflux disease and other gastrointestinal conditions.

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