April 13, 2017
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RedHill Biopharma acquires exclusive US rights to GI product EnteraGam

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RedHill Biopharma Ltd. has signed an exclusive license agreement with Entera Health Inc. granting them the U.S. rights to EnteraGam, a commercially-available medical food intended to manage chronic diarrhea and loose stools, according to a press release.

“This is another important step in implementing our strategic plan of becoming a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company in the U.S.,” Adi Frish, senior VP of business development and licensing at RedHill, said in the release. “We continue to pursue additional commercial product opportunities in the specialty [gastrointestinal] area to further expand our commercial operations.”

EnteraGam, a serum-derived bovine immunoglobulin/protein isolate (SBI) with a unique mechanism of action intended to restore balance in the gut, has been studied for inflammatory bowel disease, diarrhea-predominant irritable bowel syndrome and HIV-associated enteropathy. Prior research supports the use of SBI in the dietary management of chronic diarrhea and loose stools, showing that it can reduce loose stools and improve stool consistency, abdominal pain, bloating and urgency in patients.

Since its introduction in 2013, roughly 3 million doses of EnteraGam have been administered to patients in the U.S., with an overall adverse events rate of less than 0.2%. Net sales of EnteraGam in 2016 were over $5 million in the U.S.

“We look forward to initiating the promotion of ... EnteraGam in mid-2017,” Guy Goldberg, JD, chief business officer at RedHill, said in the release. “We are currently in advanced stages of building RedHill’s commercial operations in the U.S. and are excited to complement our product portfolio with a second commercial product geared towards gastroenterologists.”

Disclosures: Frish and Goldberg are employees of RedHill Biopharma Ltd.