RedHill Biopharma announces exclusive US co-promotion agreement with Concordia for GI drug Donnatal

RedHill Biopharma Ltd., a specialty biopharmaceutical company primarily focused on the development and commercialisation of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced the signing of an exclusive co-promotion agreement with a subsidiary of Concordia International Corp., an international specialty pharmaceutical company focused on generic and legacy pharmaceutical products and orphan drugs.

The deal has granted RedHill certain US promotion rights for Donnatal®, a prescription oral drug used with other drugs in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis (inflammation of the small bowel).

Under the terms of the agreement, RedHill will be responsible for certain promotional activities related to Donnatal®. Concordia will continue to be responsible for the manufacturing and supply of Donnatal® in all territories.

Donnatal® accounted for 7.7% of Concordia’s consolidated revenues in the first half of 2016. RedHill and Concordia will share the revenues generated from the promotion of Donnatal® by RedHill based on an agreed upon split between them.

The initial term of the co-promotion agreement with Concordia is for three years. RedHill expects to initiate gradual promotion of Donnatal® in the coming months.

Dror Ben-Asher, Chief Executive Officer of RedHill, said: “We are pleased to partner with Concordia for the US promotion of Donnatal®, a trusted brand among physicians for symptoms of IBS and acute enterocolitis. With a core US commercial team in place, we plan to initiate promotional activities in the US in the coming months with a specialty gastrointestinal sales force. RedHill’s strategic transition into a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company with commercial presence in the US, is planned to support potential future commercialisation of our Phase III-stage potential blockbusters BEKINDA® for gastroenteritis and other GI indications, RHB-105 for H. pylori infection and RHB-104 for Crohn’s disease, if approved by FDA.”

“This agreement is a cost-effective approach to promoting Donnatal® in a manner consistent with our long-term strategic focus on operational excellence,” said Allan Oberman, Chief Executive Officer of Concordia. “RedHill’s commercial team is highly motivated and has previous experience in gastroenterology sales. We look forward to partnering with them to market Donnatal® to more key prescribers who we believe can help raise the product’s profile and potentially allow us to reach more patients in the US”