RedHill Biopharma announces U.S. commercialization agreement for FDA-approved GI product Esomeprazole Strontium Delayed-Release Capsules.

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, has entered into a commercialization agreement with ParaPRO LLC, 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 syndrome.¹ 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., 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.

References

1. For more information, please see the prescribing information: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=53240ab5-98e7-4050-b640-e09c1271899a&type=display
2. Donnatal^® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) is a prescription drug, classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.  For more information, please see the prescribing information: http://www.donnatal.com/wp-content/uploads/2015/02/2015-02-18-Risk-Benefit-information-DTC-REV.-SE.pdf.
3. EnteraGam^® (serum-derived bovine immunoglobulin/protein isolate, SBI) is a commercially-available medical food, intended for the dietary management of chronic diarrhea and loose stools due to specific intestinal disorders, which must be administered under medical supervision.
4. Symphony Health.

(Source: Nasdaq)

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