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Monday, 11/06/2017 9:29:44 AM

Monday, November 06, 2017 9:29:44 AM

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RedHill Biopharma Announces EnteraGam® Poster Presentation at the ISPOR 20th Annual European Congress

https://finance.yahoo.com/news/redhill-biopharma-announces-enteragam-poster-120000081.html

TEL-AVIV, Israel and RALEIGH, N.C., Nov. 06, 2017 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary drugs for gastrointestinal and inflammatory diseases and cancer, today announced a planned poster presentation relating to EnteraGam® (serum-derived bovine immunoglobulin/protein isolate, SBI)1, one of RedHill’s commercial products, at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 20th Annual European Congress, on Tuesday, November 7, 2017, from 09:45 AM – 1:30 PM (GMT), at the Scottish Event Campus in Glasgow, Scotland.

EnteraGam® is a medical food intended for the dietary management of chronic diarrhea and loose stools, which must be administered under medical supervision. EnteraGam® is one of three gastrointestinal products promoted by RedHill’s sales force in the U.S., together with Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide)2 and Esomeprazole Strontium Delayed-Release (DR) Capsules 49.3 mg3. RedHill licensed the exclusive U.S. rights to EnteraGam® from Entera Health Inc. (“Entera Health”).

The poster4, entitled “Economic and Clinical Impact of Serum-Derived Bovine Immunoglobulin / Protein Isolate (SBI) in the Management of Chronic Diarrhea in Inflammatory Bowel Disease (IBD)”, presents data from a pharmacoeconomic study conducted by Entera Health. The aim of the study was to evaluate the real-world economic and clinical impact of EnteraGam® (SBI) use in patients suffering from IBD. The authors conclude that inclusion of EnteraGam® for the management of chronic diarrhea in IBD can offer clinical benefits of overall disease management, while also lowering the overall cost to the healthcare system and patients, resulting in net savings primarily due to a reduction in utilization of high-cost prescription medications.

Numerous publications of clinical studies and retrospective chart reviews support the use of SBI in the dietary management of chronic diarrhea and loose stools5. 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 stools6. Several studies in patients suffering from IBD, such as ulcerative colitis and Crohn’s disease, where SBI was given due to uncontrolled chronic diarrhea and loose stools, suggest that SBI improves management of chronic diarrhea and loose stools in patients who are refractory or partially responding to traditional therapies7. SBI has also been studied in patients with fecal incontinence with chronic diarrhea, in patients with celiac and non-celiac gluten sensitivity with chronic diarrhea and in additional gastrointestinal conditions8.

About EnteraGam®:
EnteraGam® (serum-derived bovine immunoglobulin/protein isolate, SBI) is a medical food product intended for the dietary management of chronic diarrhea and loose stools. EnteraGam® must be administered under medical supervision. EnteraGam® binds microbial components9, such as toxic substances released by bacteria that upset the intestinal environment. This helps prevent them from penetrating the lining of the intestine, which may contribute to chronic diarrhea and loose stools in people who have specific intestinal disorders10.

Safety Information about EnteraGam®:
EnteraGam® contains beef protein; therefore, patients who have an allergy to beef or any other component of EnteraGam® should not take this product. EnteraGam® has not been studied in pregnant women, in women during labor and delivery, or in nursing mothers. The choice to administer EnteraGam® during pregnancy, labor and delivery, or to nursing mothers is at the clinical discretion of the prescribing physician.

EnteraGam® does not contain any milk-derived ingredients such as lactose, casein or whey. EnteraGam® is gluten-free, dye-free and soy-free.
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