RedHill Biopharma Ltd, 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 announced that it has initiated promotion of Esomeprazole Strontium Delayed-Release (DR) Capsules 49.3 mg(1) in the U.S.
RedHill’s U.S. commercial operations, headquartered in Raleigh, NC, includes a gastrointestinal-focused sales force of approximately 40 sales representatives promoting three gastrointestinal (GI)-specialty products, Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide)(2), EnteraGam® (serum-derived bovine immunoglobulin/protein isolate, SBI)(3) and Esomeprazole Strontium DR Capsules 49.3 mg in select U.S. territories. RedHill’s U.S. commercial operations are expected to pave the way for the potential future launch of RedHill’s late clinical-stage GI products, if approved by the U.S. Food and Drug Administration (FDA).
Esomeprazole Strontium DR Capsules 49.3 mg is a prescription proton pump inhibitor (PPI) drug product 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 syndrome(4). Esomeprazole Strontium DR Capsules 49.3 mg is a proprietary prescription drug approved by the FDA under a New Drug Application (NDA).PPIs are one of the most commonly prescribed classes of medications in the U.S., with an estimated market value exceeding $20 billion in 2016(5).
Valerie Graceffa, RedHill’s VP, U.S. Sales and Marketing, said: “We are excited to initiate the promotion of a third GI-specialty product. Esomeprazole Strontium DR Capsules 49.3 mg was selected as a strategic fit for RedHill’s growing GI-focused product portfolio, which our sales force has been actively promoting in select U.S. territories since June 2017. Our sales team has been well trained and is eager to consult gastroenterologists on the new product and provide patients with an additional therapeutic option.”
RedHill has a commercialization agreement with ParaPRO LLC (“ParaPRO”), an Indiana-based specialty pharmaceutical company, granting RedHill the exclusive rights to promote Esomeprazole Strontium DR Capsules to gastroenterologists in certain U.S. territories. Under the terms of the agreement, RedHill was not required to make any upfront, nor future 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 four years. ParaPRO has also initiated its promotion of Esomeprazole Strontium DR Capsules 49.3 mg.
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® for the term of the agreement. 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 Esomeprazole Strontium Delayed-Release Capsules 49.3 mg(6)
Esomeprazole Strontium Delayed-Release Capsules 49.3 mg is indicated for adults:
for the short-term treatment (4-8 weeks) of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD) and/or in healing and symptomatic resolution of erosive esophagitis (EE).
to reduce the risk of stomach ulcers in some people taking non-steroidal anti-inflammatory drugs (NSAIDs) (controlled studies did not extend beyond 6 months).
in combination with amoxicillin 1000 mg and clarithromycin 500 mg is indicated for the treatment of patients with a stomach infection (Helicobacter pylori) and duodenal ulcer disease.
is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
About RedHill Biopharma Ltd.
RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) is a specialty biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. RedHill promotes three gastrointestinal products in the U.S. - Donnatal®, a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis, and EnteraGam®, a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools, and Esomeprazole Strontium Delayed-Release Capsules 49.3 mg, a prescription proton pump inhibitor indicated for adults for the treatment of gastroesophageal reflux disease (GERD) and other gastrointestinal conditions. RedHill’s clinical-stage pipeline includes: (i) TALICIA™ (RHB-105)- an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study and an ongoing confirmatory Phase III study; (ii) RHB-104- an oral combination therapy for the treatment of Crohn's disease with an ongoing first Phase III study, a completed proof-of-concept Phase IIa study for multiple sclerosis, and a planned pivotal Phase III study for nontuberculous mycobacteria (NTM) infections; (iii) BEKINDA® (RHB-102)- a once-daily oral pill formulation of ondansetron with successful top-line results in a Phase III study for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106- an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA® (ABC294640)- a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON - a Phase II-stage first-in-class, orally-administered protease inhibitor, targeting pancreatic cancer and other solid tumors and (vii) RIZAPORT® (RHB-103) - an oral thin film formulation of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in two EU member states under the European Decentralized Procedure (DCP).
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