RedHill Biopharma signs exclusive US license from Entera health for commercial GI product EnteraGam

RedHill expects to initiate US promotion of its two commercially-available gastrointestinal specialty products, Donnatal and EnteraGam, in mid-2017.

EnteraGam is a commercially available medical food intended for the dietary management of chronic diarrhea and loose stools which must be administered under medical supervision. 2016 net sales of EnteraGam in the US were over $5 million. EnteraGam - a serum-derived bovine immunoglobulin/protein isolate (SBI) with a unique mechanism of action intended to restore gut balance - has been studied for various uses, such as diarrhea-predominant irritable bowel syndrome (IBS-D), inflammatory bowel disease (IBD) and human immunodeficiency virus (HIV)-associated enteropathy.

Guy Goldberg, RedHill’s Chief Business Officer, said: “We look forward to initiating the promotion of Donnatal and EnteraGam in mid-2017. We are currently in advanced stages of building RedHill’s commercial operations in the US and are excited to complement our product portfolio with a second commercial product geared towards gastroenterologists. We would like to thank our new partners at Entera Health and look forward to a successful long-term partnership.”

Adi Frish, RedHill’s Senior VP, Business Development and Licensing, said: “This is another important step in implementing our strategic plan of becoming a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company in the US. We continue to pursue additional commercial product opportunities in the specialty GI area to further expand our commercial operations. In parallel, we continue to advance the development of our three Phase III GI products, which, if approved by the FDA, we intend to commercialize in the US.”

Aage Lauridsen, Entera Health’s CEO, said: “We are very pleased to partner with RedHill to secure the continued marketing of EnteraGam in the US and are confident that RedHill’s sales team will continue to grow the value of this unique product.”

Under the terms of the agreement, RedHill licensed the exclusive US rights to EnteraGam for all indications for human use. RedHill will pay Entera Health tiered royalties on net sales generated from the sale of EnteraGam by RedHill, and is not required to make any upfront or milestone payments. Under the terms of the agreement, Entera Health will also grant RedHill certain US rights to its FDA-approved dicyclomine hydrochloride oral solution USP (10 mg/5 mL), an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome.

In January 2017, RedHill announced an exclusive co-promotion agreement with a subsidiary of Concordia International, granting RedHill certain promotional rights in the US for Donnatal, a prescription oral drug used with other drugs in the treatment of IBS (irritable colon, spastic colon, mucous colitis) and acute enterocolitis (inflammation of the small bowel).