RedHill Biopharma Announces Exclusive US Co-Promotion Agreement With Concordia

RedHill Biopharma Ltd. recently 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, granting 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 3 years. RedHill expects to initiate gradual promotion of Donnatal in the coming months.

“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 commercialization 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,” said Dror Ben-Asher, Chief Executive Officer of RedHill.

“This agreement is a cost-effective approach to promoting Donnatal in a manner consistent with our long-term strategic focus on operational excellence,” added 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.”

Irritable bowel syndrome (IBS) is a chronic multifactorial disorder characterized by recurrent abdominal pain or discomfort associated with altered bowel function. Certain factors that may alter gastrointestinal function can contribute to IBS symptoms, including stress, prior gastroenteritis and changes in the gut microbiome. However, the etiology of IBS is not understood, and the underlying cause of IBS remains unknown. IBS negatively impacts patients’ quality of life and can affect patients physically, emotionally, socially, and economically. IBS is one of the most common gastrointestinal disorders. It is estimated that at least 30 million Americans suffer from IBS. The US potential market for IBS treatments is estimated to exceed $2.3 billion by 2020. Studies estimate that IBS affects 10% to 15% of US adults, with about twice as many women as men and most often occurs in people younger than age 45.

Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide), a prescription drug, is classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Donnatal slows the natural movements of the gut by relaxing the muscles in the stomach and intestines and acts on the brain to produce a calming effect. Donnatal comes in two formulations: immediate release Donnatal Tablets, and immediate-release Donnatal Elixir, a fast acting liquid. Donnatal is contraindicated in patients who have glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract, paralytic ileus, unstable cardiovascular status, severe ulcerative colitis, myasthenia gravis, hiatal hernia with reflux esophagitis, or known hypersensitivity to any of the ingredients. Patients who are pregnant or breast-feeding or who have autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia or hypertension should notify their doctor before taking Donnatal®. Side effects may include: dryness of the mouth, urinary retention, blurred vision, dilation of pupils, rapid heartbeat, loss of sense of taste, headache, nervousness, drowsiness, weakness, dizziness, insomnia, nausea, vomiting, and allergic reactions which may be severe. For more information, including prescribing information, visit www.donnatal.com.