RedHill Biopharma Initiates Promotion Of Donnatal And Enteragam In The U.S.
Tel-Aviv, Israel, Raleigh, NC, USA, June 13, 2017 / B3C newswire / -- 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 and inflammatory diseases and cancer, today announced the initiation of the promotion of two gastrointestinal specialty products, Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide)(1) and EnteraGam® (a serum-derived bovine immunoglobulin/protein isolate, SBI)(2) in the U.S.
RedHill’s U.S. commercial operations, headquartered in Raleigh, NC, include a gastrointestinal-focused sales force of more than 30 sales representatives promoting Donnatal® and EnteraGam® in select U.S. territories.
Guy Goldberg, RedHill’s Chief Business Officer, said: “We are excited to initiate promotion of Donnatal® and EnteraGam® in the U.S. This strategic step marks the transition of RedHill into a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company in the U.S. RedHill has assembled an experienced sales force and an accomplished commercial home office team with a proven track-record in the GI field. We are eager to serve the needs of patients and target the greater market potential of Donnatal® and EnteraGam®. Our U.S. commercial operations are an integral part of RedHill’s strategic plan to commercialize our proprietary late-stage GI products, BEKINDA® (RHB-102)(3) for gastroenteritis and IBS-D, RHB-105 for H. pylori infection and RHB-104 for Crohn’s disease in the U.S., if approved by the FDA.”
Donnatal® is a prescription oral drug used with other drugs for the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis (inflammation of the small bowel). RedHill has an exclusive co-promotion agreement with Concordia Pharmaceuticals Inc., a subsidiary of Concordia International Corp. (NASDAQ: CXRX) (TSX: CXR) (“Concordia”), granting RedHill certain U.S. promotion rights for Donnatal®. Under the terms of the agreement, RedHill and Concordia will share the revenues generated from the promotion of Donnatal® by RedHill, based on an agreed upon split.
EnteraGam® is a medical food intended for the dietary management of chronic diarrhea and loose stools which must be administered under medical supervision. RedHill has a license agreement with Entera Health Inc. (“Entera Health”), granting RedHill the exclusive U.S. rights to EnteraGam®. Under the terms of the agreement, RedHill will pay Entera Health royalties based on net sales generated from the sale of EnteraGam® by RedHill.
About Donnatal®
Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide), a prescription drug, is classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Donnatal® slows the natural movements of the gut by relaxing the muscles in the stomach and intestines. Donnatal® comes in two formulations: immediate release Donnatal® Tablets and immediate release Donnatal® Elixir, a fast-acting liquid.
Important Safety Information about Donnatal®
Donnatal® is contraindicated in patients who have glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract, paralytic ileus, unstable cardiovascular status, severe ulcerative colitis, myasthenia gravis, hiatal hernia with reflux esophagitis, or known hypersensitivity to any of the ingredients. Patients who are pregnant or breast-feeding or who have autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia or hypertension should notify their doctor before taking Donnatal®. Side effects may include: dryness of the mouth, urinary retention, blurred vision, dilation of pupils, rapid heartbeat, loss of sense of taste, headache, nervousness, drowsiness, weakness, dizziness, insomnia, nausea, vomiting and allergic reactions which may be severe.
Further information, including prescribing information, can be found on www.donnatal.com.
Please see the following website for complete important safety information about Donnatal®:
http://www.donnatal.com/professionals/important-safety-information/
To report suspected adverse reactions, contact Concordia Pharmaceuticals Inc. at
1-877-370-1142