Empresas y finanzas

Sucampo Pharma Europe Announces the Filing of a Marketing Authorisation Application of Lubiprostone in the United Kingdom with Eight Additional European Countries to Follow



    Sucampo Pharma Europe, Ltd., a wholly-owned subsidiary of Sucampo
    Pharmaceuticals, Inc. (NASDAQ: SCMP), today announced the filing of a
    Marketing Authorisation Application (MAA) for lubiprostone in the
    United Kingdom. The MAA is for lubiprostone, 24 mcg, for the
    indication of Chronic Idiopathic Constipation in adults. Lubiprostone
    was previously developed by Sucampo Pharmaceuticals, Inc. for the
    treatment of chronic idiopathic constipation in adults in the United
    States.

    Using the decentralised procedure, the United Kingdom, through its
    Medicines and Healthcare Products Regulatory Agency, will serve as the
    reference member state with additional applications being filed with
    the concerned member states of Belgium, Denmark, France, Germany,
    Ireland, the Netherlands, Spain and Sweden.

    Individuals with chronic idiopathic constipation are distinguished
    as having abdominal bloating, infrequent bowel movement, straining at
    defecation, hard or lumpy stools for at least three months and not
    having these symptoms caused by other diseases or medication usage.
    Lubiprostone, 24 mcg, approved in the United States in January 2006
    under the trade name AMITIZA(R) is the only approved product for the
    treatment of chronic idiopathic constipation in adults in the United
    States, and has been shown in clinical studies to provide a rapid and
    sustained relief of chronic idiopathic constipation and the associated
    symptoms. Lubiprostone, through a novel mechanism of action,
    selectively activates type-2 chloride channels in the intestinal
    lumen, which facilitates intestinal fluid secretion that enhances
    intestinal motility and passage of stool. Additionally, lubiprostone
    has been shown in ex-vivo studies by the activation of chloride
    channels to stimulate recovery of mucosal barrier function through the
    restoration of tight junction complexes. Lubiprostone has demonstrated
    long-term safety and efficacy for treatment of chronic idiopathic
    constipation for up to one year. Furthermore, lubiprostone
    demonstrated efficacy in all adults of both genders including those
    over 65 years of age.

    "The lack of effective prescription products for this indication
    provides a unique opportunity for Sucampo to introduce lubiprostone to
    Europe as a treatment for chronic idiopathic constipation," said
    Sucampo Pharmaceuticals Chairman and Chief Executive Officer Ryuji
    Ueno, M.D., Ph.D., Ph.D. "The filing of the application for
    lubiprostone represents one step in Sucampo´s planned expansion for
    this compound to the international community."

    Other than the United States and Canada, Sucampo Pharmaceuticals
    retains all commercial rights for lubiprostone for Europe and the rest
    of the world. Sucampo Pharmaceuticals´ drug AMITIZA(R) (lubiprostone)
    was a 2006 Scrip Awards finalist for the "Best New Small-Molecule
    Drug" category.

    About Sucampo Pharma Europe, Ltd.

    Sucampo Pharma Europe, Ltd., a wholly-owned subsidiary of Sucampo
    Pharmaceuticals, Inc., is a specialty biopharmaceutical company based
    in Oxford, United Kingdom with a branch office in Basel Switzerland.
    The European operation is focused on developing, commercialising and
    marketing AMITIZA(R) (lubiprostone) within Europe, the Middle East,
    and Africa as well as the development of other pipeline products based
    upon prostones. The therapeutic potential of prostones, which are
    bio-lipids that occur naturally in the human body, was first
    identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals´
    chairman and chief executive officer. Dr. Ueno along with Sachiko
    Kuno, Ph.D., founding chief executive officer and advisor,
    international business development, established the European
    operations in 2002 as part of an ongoing expansion of Sucampo
    Pharmaceuticals, Inc. as a global company in research and development
    of its drugs based on prostones. To learn more about Sucampo Pharma
    Europe, Ltd., visit www.sucampoeurope.com.

    About Sucampo Pharmaceuticals, Inc.

    Sucampo Pharmaceuticals, Inc., a specialty biopharmaceutical
    company based in Bethesda, MD, focuses on the development and
    commercialization of medicines based on prostones. The therapeutic
    potential of prostones, which are bio-lipids that occur naturally in
    the human body, 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 is marketing AMITIZA(R) (lubiprostone) in
    the U.S. for chronic idiopathic constipation in adults and is
    developing the drug for additional gastrointestinal disorders with
    large potential markets. In addition, the company has a robust
    pipeline of compounds with the potential to target underserved
    diseases affecting millions of patients worldwide. Sucampo
    Pharmaceuticals has two wholly owned subsidiaries: Sucampo Pharma
    Europe, Ltd. headquartered in Oxford, UK with a branch office in
    Basel, Switzerland, and Sucampo Pharma, Ltd. located in Tokyo and
    Osaka, Japan. 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, Inc. 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 results of clinical trials with respect to Sucampo
    Pharmaceuticals´ products under development; the timing and success of
    submission, acceptance and approval of regulatory filings; Sucampo
    Pharmaceuticals´ dependence on the commercial success of AMITIZA;
    Sucampo Pharmaceuticals´ ability to obtain additional funding required
    to conduct its discovery, development and commercialisation programs;
    Sucampo Pharmaceuticals´ dependence on its co-marketing alliance with
    Takeda Pharmaceutical Company Limited; 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 the "Risk Factors" section of Sucampo
    Pharmaceuticals´ Quarterly Report on Form 10-Q filed with the
    Securities and Exchange Commission for the quarter ended September 30,
    2007. 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, it specifically
    disclaims any obligation to do so, whether as a result of new
    information, future events or otherwise.

    AMITIZA(R) is a registered trademark of Sucampo Pharmaceuticals,
    Inc.