RedHill Biopharma Ltd (RDHL)

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RedHill’s Aemcolo® Granted FDA QIDP 5-Year Exclusivity Extension

https://finance.yahoo.com/portfolio/p_4/view/view_17

RedHill Biopharma (Nasdaq: RDHL) today announced that the U.S. Food and Drug Administration’s (FDA) Exclusivity Board has granted Aemcolo® five years’ exclusivity under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, in addition to the five years’ data exclusivity granted as a new chemical entity (NCE) for the treatment of travelers’ diarrhea (TD) caused by non-invasive strains of Escherichia coli (E. coli) in adults.

· Aemcolo granted five years’ exclusivity under the FDA’s Qualified Infectious Disease Product (QIDP) designation in addition to the five years NCE data exclusivity, extending regulatory exclusivity through to 2028

· Aemcolo (rifamycin) is a non-systemic antibiotic whose delivery is targeted to the site of non-invasive Escherichia coli (E. coli) infection in the distal small bowel and colon, approved by the FDA for the treatment of Travelers’ Diarrhea caused by non-invasive strains of E. coli in adults

· Aemcolo is listed as an acute diarrhea antibiotic treatment recommendation in the Centers for Disease Control and Prevention (CDC) Yellow Book

Patricia Anderson, RedHill's Senior Vice President of Regulatory Affairs said: “Given the great concerns around maintaining effective therapeutic options for infectious diseases in the face of growing microbial resistance, Aemcolo represents an important innovation to meet significant unmet need. This FDA grant of five additional years’ exclusivity for Aemcolo under the FDA’s Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, in addition to the five years awarded to Aemcolo based on new chemical entity exclusivity, will protect that innovation through to 2028.”

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