Sucampo Provides Update on Cobiprostone Development Program
July 11 2016 - 7:30AM
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.
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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.
Contact:
Sucampo Pharmaceuticals, Inc.
Silvia Taylor
Senior Vice President, Investor Relations and Corporate Affairs
1-240-223-3718
staylor@sucampo.com
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