Sucampo Pharmaceuticals, Inc.
) 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
) 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.
Sucampo carries a Zacks Rank #3 (Hold). Some better-ranked
stocks in the health care sector include
Lannett Company, Inc.
). Both stocks carry a Zacks Rank#1 (Strong Buy).
LANNETT INC (LCI): Free Stock Analysis Report
SUCAMPO PHARMAC (SCMP): Free Stock Analysis
SHIRE PLC-ADR (SHPG): Free Stock Analysis
TAKEDA PHARMACT (TKPYY): Get Free Report
To read this article on Zacks.com click here.