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Sucampo Pharmaceuticals Initiates Phase 2, Dose-Finding Trial of Cobiprostone for the Prevention of NSAID-Induced Ulcers in Arthritis Patients



    Sucampo Pharmaceuticals, Inc., (Nasdaq: SCMP), an emerging
    pharmaceutical company developing prostone-based therapies for
    age-related and other diseases, today announced that it has enrolled
    the first patient in a multi-center Phase 2, dose-finding trial
    evaluating one of its clinical compounds, cobiprostone (SPI-8811), for
    the prevention of ulcers and other gastrointestinal injuries in
    arthritis patients treated with nonsteroidal anti-inflammatory drugs
    (NSAIDs).

    "While NSAIDs are among the most commonly used medications in the
    world, accounting for more than 70 million prescriptions in the U.S.
    alone, unfortunately these drugs also are responsible for significant
    gastrointestinal complications," said Byron Cryer, M.D., of University
    of Texas Southwestern Medical Center. "We need to develop therapies
    which can effectively prevent NSAID-induced gastrointestinal ulcers."

    The double-blinded, randomized, placebo-controlled trial will
    assess cobiprostone's safety and efficacy in preventing NSAID-induced
    gastric and duodenal ulcers, erosions and dyspeptic symptoms in
    patients with arthritis. The trial plans to enroll approximately 120
    patients with osteoarthritis and/or rheumatoid arthritis at up to 15
    sites in the United States.

    The primary efficacy endpoint for the trial is the overall
    incidence of gastric ulcers during study treatment. The study will
    also evaluate secondary endpoints including overall incidence of
    duodenal ulcers; the change in the number of ulcers and/or erosions
    (gastric and duodenal) by patient; time-to-onset analysis of ulcer
    and/or erosion development; and the severity of overall
    gastrointestinal injury by using a standardized grading scale.

    Cobiprostone is a functional fatty acid and a member of a class of
    compounds called prostones. It is a locally acting chloride-channel
    activator that works on ion channels located in the liver and the
    gastrointestinal tract. Cobiprostone has been evaluated in two Phase 1
    trials in healthy volunteers, and in three Phase 2 proof-of-concept
    trials.

    "Based on our pre-clinical experience with cobiprostone, which has
    shown the ability to inhibit gastric ulcer formation induced by an
    NSAID, and its favorable safety profile to date, we believe this
    compound has the potential to become the standard of care to prevent
    GI complications associated with NSAID use if it is approved," said
    Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals' founder,
    chairman and chief executive officer.

    About NSAID-Induced Gastric Ulcers

    NSAIDs are among the most commonly used drugs worldwide. Although
    the analgesic, anti-pyretic and anti-inflammatory properties of NSAIDs
    are very effective for the treatment of pain and inflammation,
    long-term use can cause gastrointestinal injury ranging from upset
    stomach to ulcer formation and gastrointestinal bleeding. While the
    COX-2 (cyclooxygenase-2) inhibitors subclass of NSAIDs appears to
    offer a reduced incidence of gastrointestinal injury, there are
    concerns regarding the potential risk of increased cardiovascular
    complications. Currently, misoprostol is the only the U.S. Food and
    Drug Administration (FDA) approved drug for reducing the risk of
    NSAID-induced gastric ulcers; however, the drug is frequently
    associated with diarrhea and abdominal pain. Proton pump inhibitors
    are extensively prescribed to treat existing gastric ulcers but have
    not been approved specifically to prevent ulcer development.
    Furthermore, there is cause for concern with calcium absorption
    interference by these agents in elderly patients and linkages to
    osteoporosis. H2-receptor antagonists have also been prescribed for
    preventing NSAID-induced gastric injury, but with limited success.

    About Sucampo Pharmaceuticals, Inc.

    Sucampo Pharmaceuticals, Inc., an emerging pharmaceutical company
    based in Bethesda, MD, focuses on the development and
    commercialization of drugs based on prostones, a class of compounds
    derived from functional fatty acids that occur naturally in the human
    body. The therapeutic potential of prostones 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
    advisor, international business development. Sucampo Pharmaceuticals'
    first product, AMITIZA(R) (lubiprostone), received marketing approval
    from the FDA in January 2006 for the treatment of Chronic Idiopathic
    Constipation in adults. To learn more about Sucampo Pharmaceuticals
    and its products, visit www.sucampo.com.

    Forward-Looking Statements

    Any statements in this press release about future expectations,
    plans and prospects for Sucampo Pharmaceuticals are forward-looking
    statements made under the provisions of The Private Securities
    Litigation Reform Act of 1995. Forward-looking statements may be
    identified by the words "project," "believe," "anticipate," "plan,"
    "expect," "estimate," "intend," "should," "would," "could," "will,"
    "may" or other similar expressions. Actual results may differ
    materially from those indicated by such forward-looking statements as
    a result of various important factors, including risks relating to:
    the outcome of Sucampo Pharmaceuticals' Phase 2 trial of cobiprostone
    for the prevention of NSAID-induced ulcers in arthritis patients;
    Sucampo Pharmaceuticals' ability to secure additional funding to
    conduct future clinical development of cobiprostone; Sucampo
    Pharmaceuticals' dependence on its co-marketing alliance with Takeda
    Pharmaceutical Company Ltd. and Takeda Pharmaceuticals North America;
    and Sucampo Pharmaceuticals' ability to obtain, maintain and enforce
    patent and other intellectual property protection for its discoveries.
    These and other risks are described in greater detail in Sucampo
    Pharmaceuticals' filings with the Securities and Exchange Commission
    (SEC), including the quarterly report on Form 10-Q for the period
    ended June 30, 2007, the final prospectus relating to Sucampo
    Pharmaceuticals' initial public offering and other periodic reports
    filed with the SEC. Any forward-looking statements in this press
    release represent Sucampo Pharmaceuticals' views only as of the date
    of this release and should not be relied upon as representing its
    views as of any subsequent date. Sucampo Pharmaceuticals anticipates
    that subsequent events and developments will cause its views to
    change. However, while Sucampo Pharmaceuticals may elect to update
    these forward-looking statements publicly at some point in the future,
    Sucampo Pharmaceuticals' specifically disclaims any obligation to do
    so, whether as a result of new information, future events or
    otherwise.