Sucampo and Abbott Announce Launch of AMITIZA in Japan
Product is Japan’s Only Prescription Medicine for Chronic Constipation
BETHESDA, Md. -- November 26, 2012
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) (SPI) and Abbott (NYSE: ABT)
today announced the availability of AMITIZA^® (lubiprostone) in Japan, a
prescription medicine for the treatment of chronic constipation not caused by
organic diseases. AMITIZA was approved by the Ministry of Health, Labor and
Welfare (MHLW) in Japan in June.
“Millions of patients in Japan have been suffering from chronic constipation,
without efficacious and well-tolerated, long-term treatment options. We are
pleased to bring AMITIZA’s experience of six years and over six million
prescriptions in the United States to the Japanese market, to benefit the
healthcare providers and patients who need it,” says Ryuji Ueno, M.D., Ph.D.,
Ph.D., Sucampo’s Chairman and Chief Executive Officer.
“Chronic constipation is a medical condition affecting several million people
in Japan and is one of the most common digestive condition complaints.
Healthcare providers will now have a prescription option to help treat this
condition more effectively and longer term, compared to currently approved
over-the-counter medications,” says Akihiko Honda, General Manager, Abbott
AMITIZA may significantly advance the treatment of chronic constipation and
will be the only prescription option available in Japan for this condition.
The medicine is the world’s first chloride channel activator approved for
therapeutic use, and has a unique mode of action that induces natural bowel
movement frequency that is more in line with normal bowel habits.
Abbott will promote and distribute AMITIZA in Japan under the terms of the
2009 license, commercialization and supply agreement with Sucampo.
About Chronic Constipation (excluding constipation caused by organic diseases)
According to MHLW epidemiology data, millions of people in Japan may live
daily with the pain and discomfort of chronic constipation, yet not seek
physician care. Medical attention could mean early diagnosis and effective,
AMITIZA (lubiprostone) is a prostone, a local activator of type-2 chloride ion
channels (ClC-2) in cells lining the small intestine. By increasing water
secretion, lubiprostone softens stools and 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 intestine.
AMITIZA is approved in the United States for the treatment of two
constipation-related indications, and in Switzerland and the United Kingdom
for one constipation-related indication.
AMITIZA is a registered trademark of Sucampo Pharmaceuticals, Inc.
About the AMITIZA Development Program in Japan
Under the direction of Sucampo AG (SAG), a wholly owned subsidiary of SPI
which holds all of SPI’s patents and intellectual property, Sucampo Pharma,
Ltd. (SPL), a wholly owned subsidiary of SPI located in Japan, conducts
clinical trials and seeks marketing approvals in that market for SAG’s
products and compounds. SPL 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 Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is a global pharmaceutical company focused on
innovative research, discovery, development and commercialization of
proprietary drugs based on prostones. The therapeutic potential of prostones
was first discovered by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo’s Chairman,
Chief Executive Officer, and co-founder. Prostones, naturally occurring fatty
acid metabolites that have emerged as promising compounds with unique
physiological activities, can be targeted for the treatment of unmet or
underserved medical needs. 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
In Japan, Abbott employees are devoted to the manufacture, development,
distribution, and marketing of pharmaceuticals and medical products, including
nutrition, devices, diagnostics, and products for vision care. Abbott's main
offices in Japan are located in Tokyo, Fukui, and Chiba. News releases issued
by Abbott Japan and Abbott Headquarters are available at www.abbott.co.jp and
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
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
Sucampo Pharmaceuticals, Inc.
Kate DeSantis, 1-240-223-3834
Abbott (in Japan)
Sayako Kitamura, +81-3-4588-3818
Abbott (outside Japan)
Ilke A. Limoncu, +41-61-487-0644
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