- RedHill expects to initiate U.S. promotion of its two commercially-available gastrointestinal specialty products, Donnatal®(1) and EnteraGam®(2), in mid-2017
- Under the terms of the agreement, RedHill will pay Entera Health royalties on net sales generated from the sale of EnteraGam® by RedHill
RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal (GI) and inflammatory diseases and cancer, today announced the signing of an exclusive license agreement with Entera Health Inc. ("Entera Health"), a privately held U.S. company focused on the research, manufacturing, and commercialization of value-added proteins and protein co-products, granting RedHill the exclusive U.S. rights to EnteraGam®(2).
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 U.S. were over $5 million. EnteraGam® is a serum-derived bovine immunoglobulin/protein isolate (SBI) with a unique mechanism of action intended to restore gut balance. EnteraGam® 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(3).
Guy Goldberg, RedHill’s Chief Business Officer, said: "We look forward to initiating the promotion of Donnatal®(4) and EnteraGam® in mid-2017. 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. 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 U.S. 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 U.S."
Aage Lauridsen, Entera Health’s CEO, said: "We are very pleased to partner with RedHill to secure the continued marketing of EnteraGam® in the U.S. 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 U.S. 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 U.S. rights to its FDA-approved dicyclomine hydrochloride(5) oral solution USP (10 mg/5 ml), an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome.
Numerous publications of clinical studies and retrospective chart reviews support the use of SBI in the dietary management of chronic diarrhea and loose stools(4). The combined effect of SBI is intended to fulfill a distinctive nutritional requirement associated with various gastrointestinal conditions, where chronic diarrhea or loose stools are present and normal dietary proteins alone are insufficient. SBI has been shown in clinical studies to reduce loose stools and improve stool consistency as well as other symptoms, such as abdominal pain, bloating and urgency, in patients with chronic diarrhea and loose stools(4). Several studies in patients suffering from inflammatory bowel diseases, such as ulcerative colitis and Crohn’s disease, suggest that SBI improves clinical symptomatic management of patients who are not fully managed on traditional therapies(4). SBI has also been studied in patients wi...
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