ROCKVILLE, Md., July 11, 2016 (GLOBE NEWSWIRE) — Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ:SCMP), a global biopharmaceutical company, today announced the decision to discontinue the development of cobiprostone based on the results of a prespecified futility analysis of the Phase 2a study of an oral spray formulation of cobiprostone for the prevention of oral mucositis in patients that are undergoing radio chemotherapy for head and neck cancer. The futility analysis indicated that the clinical benefit of cobiprostone was insufficient to support continuation of the study. There were no safety concerns identified and cobiprostone demonstrated a well-tolerated safety profile consistent with earlier Phase 1 studies.
“Based on these results, we have decided to terminate the ongoing oral mucositis study and discontinue further development of cobiprostone,” said Peter Kiener, D. Phil, Chief Scientific Officer of Sucampo. “We will continue to focus on our life cycle management programs for lubiprostone, our partnership with Cancer Prevention Pharmaceuticals for its Phase 3 compound in the orphan indication familial adenomatous polyposis, and continuing to build a development pipeline through business development.”
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is focused on the development and commercialization of medicines that meet major unmet medical needs of patients worldwide. Sucampo has two marketed products – AMITIZA, its lead product, and RESCULA – and a pipeline of product candidates in clinical development. A global company, Sucampo is headquartered in Rockville, Maryland, and has operations in Japan, Switzerland and the U.K. For more information, please visit www.sucampo.com.
The Sucampo logo and the tagline, The Science of Innovation, are registered trademarks of Sucampo AG. AMITIZA is a registered trademark of Sucampo AG.
Sucampo Forward-Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, and other statements that are not historical facts. The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the impact of pharmaceutical industry regulation and health care legislation; Sucampo’s ability to accurately predict future market conditions; dependence on the effectiveness of Sucampo’s patents and other protections for innovative products; the effects of competitive products on Sucampo’s products; and the exposure to litigation and/or regulatory actions.
No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Sucampo undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Sucampo’s business, particularly those mentioned in the risk factors and cautionary statements in Sucampo’s most recent Form 10-K as filed with the Securities and Exchange Commission on March 11, 2016, as amended, as well as its filings with the Securities and Exchange Commission on Forms 8-K and 10-Q since the filing of the Form 10-K, all of which Sucampo incorporates by reference.
Sucampo Pharmaceuticals, Inc.
Senior Vice President, Investor Relations and Corporate Affairs