Japan's First Prescription Medicine for Chronic Constipation
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) (SPI) and Abbott (NYSE:ABT)
today announced that Sucampo Pharma, Ltd., a wholly owned subsidiary of
SPI, has received approval from the Ministry of Health, Labor and
Welfare in Japan for AMITIZA® (lubiprostone), a prescription
medicine for the treatment of chronic constipation (excluding
constipation caused by organic diseases).
"We are very pleased to receive Japan's first-ever approval for a
prescription medicine for chronic constipation as it helps us achieve
our objective of bringing medicines with novel mechanisms of action to
patients with unmet medical needs on a global basis," said Ryuji Ueno,
M.D., Ph.D., Ph.D., Sucampo's Chairman and Chief Executive Officer. "We
look forward to working with Abbott to meet the needs of these patients
In 2009, Sucampo and Abbott Japan Co. Ltd. entered into a license,
commercialization and supply agreement for AMITIZA in Japan.
About the AMITIZA Development Program in Japan
Sucampo submitted a marketing application to the Japanese
Pharmaceuticals and Medical Devices Agency for approval to market
AMITIZA in September 2010. The application included data from a Phase 3
efficacy trial in 124 Japanese patients as well as from a long-term
open-label safety trial in 209 Japanese patients who received
lubiprostone for up to 48 weeks. The application also included data from
previous trials conducted in the United States, Canada and Europe.
About Chronic Constipation (excluding constipation caused by organic
Thousands of people in Japan live daily with the pain and discomfort of
chronic constipation, yet many do not seek physician care. Medical
attention could mean early diagnosis and effective, long-term treatment.
AMITIZA (lubiprostone) is a prostone, a local activator of type-2
chloride ion channels (ClC-2) in cells lining the small intestine. By
increasing intestinal fluid secretion, lubiprostone increases motility
in the intestine, thereby facilitating the passage of stool and
alleviating symptoms associated with chronic constipation. Additionally,
activation of ClC-2 by lubiprostone has been shown to stimulate recovery
of mucosal barrier function via the restoration of tight junction
protein complexes in ex vivo studies of ischemic porcine
AMITIZA is approved in the United States for the treatment of two
constipation-related indications and in Switzerland for one
AMITIZA is a registered trademark of Sucampo Pharmaceuticals, Inc.
About Sucampo Pharmaceuticals
Sucampo Pharmaceuticals, Inc., an international pharmaceutical company,
is focused on the discovery, development and commercialization of
proprietary drugs based on prostones. The therapeutic potential of
prostones, which occur naturally in the human body as a result of
enzymatic (15-PGDH) transformation of certain fatty acids, was first
identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals'
Chairman and Chief Executive Officer. Dr. Ueno founded Sucampo
Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding Chief
Executive Officer and currently Advisor, International Business
Development, and a member of the Board of Directors. For more
information, please visit www.sucampo.com.
Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The
company employs approximately 91,000 people and markets its products in
more than 130 countries.
Sucampo Forward-Looking Statements
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, product potential,
future financial and operating results, 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 risk of new and changing
regulation and health policies in the US and internationally 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 presentation 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
Form 10-K for the year ended Dec. 31, 2011, which the Company
incorporates by reference.
Sucampo Pharmaceuticals, Inc.
Silvia Taylor, 1-240-223-3718
Kate de Santis, 1-240-223-3834
A. Limoncu, +41-61-487-0644