Sucampo Pharmaceuticals, Inc. (SCMP) announced that the Medicines and Healthcare Products Regulatory Agency (:MHRA) served a notice to its wholly owned subsidiary, Sucampo Pharma Europe, Ltd., refusing to approve a Marketing Authorization Application (MAA) for a type II variation of Amitiza in the U.K. The company is looking to get Amitiza approved for the treatment of opioid- induced constipation (:OIC) in patients suffering from chronic non-cancer pain.
Amitiza is already approved in the U.K. for the treatment of chronic idiopathic constipation (:CIC) and associated symptoms in adults when response to diet and other non-pharmacological measures are inappropriate.
According to the MHRA, the efficacy information provided by Sucampo is not sufficient for approval of the OIC indication. The company said that it intends to work with the MHRA to determine the path forward.
We note that Amitiza is already approved in the U.S. for the OIC indication and is the first and only oral medication for the treatment of OIC in adults suffering from chronic non-cancer pain. In 2013, as reported by Takeda Pharmaceutical Company Limited (TKPYY) for royalty calculation purposes, net U.S. sales generated by Amitiza were $282.1 million.
Meanwhile, Sucampo and partner R-Tech Ueno are conducting a phase III study on Rescula for the treatment of retinitis pigmentosa. Rescula has an orphan drug designation for this indication in both the U.S. and the E.U.
We expect investor focus to remain on pipeline updates from the company and Amitiza’s performance.