RedHill Biopharma Announces U.S. Commercialization Agreement for FDA-Approved GI Product Esomeprazole Strontium Delayed-Release Capsules
RedHill was granted the exclusive rights to promote Esomeprazole Strontium Delayed-Release (DR) Capsules to gastroenterologists in certain U.S. territories
Esomeprazole Strontium DR Capsules 49.3 mg is an FDA-approved, proprietary, prescription proton pump inhibitor (PPI), indicated for adults for the treatment of gastroesophageal reflux disease (GERD) and other gastrointestinal (GI) conditions
RedHill expects to initiate the U.S. promotion of Esomeprazole Strontium DR Capsules 49.3 mg in the coming weeks
Esomeprazole Strontium DR Capsules 49.3 mg will be the third commercial GI product to be promoted by RedHill in the U.S.
RedHill`s GI-focused sales force currently promotes two GI specialty products in the U.S., Donnatal® and EnteraGam®, setting the stage for the potential launch of RedHill`s late clinical-stage GI products, if approved by the FDA
PPIs are one of the most commonly prescribed class of medications in the U.S., with an estimated market value exceeding $20 billion in 2016
TEL-AVIV, Israel and RALEIGH, N.C., Aug. 17, 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, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced that it has entered into a commercialization agreement with ParaPRO LLC ("ParaPRO"), an Indiana-based specialty pharmaceutical company, granting RedHill the exclusive rights to promote Esomeprazole Strontium Delayed-Release Capsules to gastroenterologists in certain U.S. territories.
Esomeprazole Strontium DR Capsules 49.3 mg is a prescription proton pump inhibitor (PPI) indicated for adults for the treatment of gastroesophageal reflux disease (GERD), risk reduction of NSAID-associated gastric ulcer, H. pylori eradication to reduce the risk of duodenal ulcer recurrence and for pathological hypersecretory conditions, including Zollinger-Ellison syndrome1. Esomeprazole Strontium DR Capsules 49.3 mg is a proprietary prescription drug approved by the FDA under a New Drug Application (NDA).
Craig Miller, RedHill`s VP U.S. Business Operations, Market Access, said: "RedHill`s U.S. commercial operations, headquartered in Raleigh, NC, include a gastrointestinal (GI)-focused sales force of 40 sales representatives promoting Donnatal®2 and EnteraGam®3 in select U.S. territories. We are excited to promote a third GI specialty commercial product and to offer patients an additional therapeutic option. Esomeprazole Strontium DR Capsules 49.3 mg complements RedHill`s rapidly growing U.S. GI specialty commercial product portfolio. RedHill is pursuing additional commercial opportunities in the specialty GI area to further expand its commercial presence in the U.S. We thank our new partner ParaPRO for their trust and cooperation, and are looking forward to a fruitful partnership."
Patrick O`Shea, ParaPRO`s VP of Marketing, added: "Our partnership with RedHill will generate a synergistic effort to commercialize the benefits of Esomeprazole Strontium DR Capsules 49.3 mg, and address the unmet need for therapeutic consistency we believe is sought by both healthcare practitioners and patients."
Under the terms of the agreement, RedHill is not required to make any upfront or milestone payments, and the parties will share the revenues generated from the promotion of Esomeprazole Strontium DR Capsules 49.3 mg by RedHill based on an agreed upon split between them. The initial term of the commercialization agreement is for three years. RedHill expects to initiate the U.S. promotion of the product in the coming weeks.
PPIs are one of the most commonly prescribed class of medications in the U.S., with an estimated market value exceeding $20 billion in 20164.
RedHill currently promotes two GI specialty products in the U.S., Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) and EnteraGam® (serum-derived bovine immunoglobulin/protein isolate, SBI).
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. (CXRX) (CXR.TO) ("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.
