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21 Aug 2017

RedHill Biopharma announces US commercialization agreement for FDA-approved GI product

Esomeprazole Strontium DR capsules 49.3 mg is an FDA-approved, proprietary, prescription proton pump inhibitor, indicated for adults for the treatment of gastroesophageal reflux disease and other gastrointestinal conditions.

RedHill Biopharma has entered into a commercialization agreement with ParaPRO, an Indiana-based specialty pharmaceutical company, granting RedHill the exclusive rights to promote Esomeprazole Strontium Delayed-Release Capsules to gastroenterologists in certain US 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. 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 US Business Operations, Market Access, said: “RedHill’s US commercial operations, headquartered in Raleigh, NC, include a gastrointestinal (GI)-focused sales force of 40 sales representatives promoting Donnatal and EnteraGam in select US 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 US GI specialty commercial product portfolio. RedHill is pursuing additional commercial opportunities in the specialty GI area to further expand its commercial presence in the US. 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 3 years. RedHill expects to initiate the US promotion of the product in the coming weeks.

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