PHILADELPHIA, Pennsylvania and BASINGSTOKE, England, February 3
/PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ)
announced today that it has submitted Marketing Authorization Applications to
European Regulatory Agencies for SPD476, an investigational compound being
studied for the induction and maintenance of clinical and endoscopic
remission in patients with active mild-to-moderate ulcerative colitis. If
approved, SPD476 would offer a once-daily mesalazine treatment for active
mild to moderate ulcerative colitis.
    "The European submissions for SPD476 represent the achievement of another
important milestone for Shire," said Shire Chief Executive Matthew Emmens.
"Currently there is no once-daily oral treatment for ulcerative colitis so we
look forward to offering patients the efficacy and convenience of SPD476."
    Last year the mesalazine market segment for ulcerative colitis, in which
SPD476 will compete, was worth around $1.6 billion.
    As previously announced, Shire submitted a New Drug Application for
SPD476 to the U.S. Food & Drug Administration in December 2005. Shire also
recently filed a New Drug Submission for SPD476 with Health Canada.
    SPD476 is the only ulcerative colitis treatment that utilizes novel MMX
Multi Matrix SystemTM (MMX) drug delivery technology to provide delayed and
extended release of mesalazine throughout the colon. Shire has licensed from
Giuliani S.p.A. the exclusive rights to develop and commercialize SPD476 in
the US, Canada, Europe (excluding Italy) and the Pacific Rim. Giuliani S.p.A.
retains the development and commercialization rights to SPD476 in Italy. MMX
was developed by Cosmo S.p.A.
    Notes to editors
    SPD476
    SPD476 is a novel, high-dose 5-aminosalicylic acid (5-ASA; mesalazine) in
a delayed and extended release formulation (MMX) being studied for the
induction and maintenance of remission of active, mild-to-moderate ulcerative
colitis. The most common adverse events reported in SPD476 Phase III studies
were flatulence, nausea or headaches, which were not dose related and
occurred in less than 3% of patients receiving SPD476.
    SHIRE PLC
    Shire's strategic goal is to become the leading specialty pharmaceutical
company that focuses on meeting the needs of the specialist physician. Shire
focuses its business on central nervous system, gastrointestinal, general
products and human genetic therapies - all being areas in which Shire has a
commercial presence. The structure is sufficiently flexible to allow Shire to
target new therapeutic areas to the extent opportunities arise through
acquisitions. Shire believes that a carefully selected portfolio of products
with strategically aligned and relatively small-scale sales forces will
deliver strong results. Shire's strategy is to develop and market products
for specialty physicians. Shire's in-licensing and merger and acquisition
efforts are focused on products in niche markets with strong intellectual
property protection either in the US or Europe.
    For further information on Shire, please visit the Company's website:
http://www.shire.com.
    Giuliani S.p.A.
    Giuliani S.p.A., founded in 1889, is a privately owned specialty
pharmaceutical company with Headquarters in Milan, Italy. It develops new
products with high unmet medical need and substantial market opportunity. It
is focused on developing and marketing products for the treatment and
management of gastrointestinal (ulcerative colitis and Crohn's disease),
metabolic (food intolerance) and dermatological (hair loss) disorders.
    Cosmo S.p.A.
    The formulation for SPD476 was developed by Cosmo SpA. Cosmo also owns
the drug delivery and process patents covering this compound. Cosmo SpA is an
R&D based pharmaceutical company. Its R&D covers advanced drug delivery with
applications in gastro intestinal disorders, new chemical entities and
biotechnology. In addition, it manufactures pharmaceuticals and offers
development services to other pharmaceutical companies. Cosmo is based in
Lainate (Milan), Italy, where its production plant and principal R&D
laboratories are situated. Its biotechnology R&D is located in La Jolla,
California, USA.
    "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995
    Statements included herein that are not historical facts are
forwarding-looking statements. Such forward-looking statements involve a
number of risks and uncertainties and are subject to change at any time. In
the event such risks or uncertainties materialize, Shire plc's results could
be materially affected. The risks and uncertainties include, but are not
limited to; risks associated with the inherent uncertainty of pharmaceutical
research, product development, manufacturing and commercialization; the
impact of competitive products, including, but not limited to, the impact of
those on Shire plc's Attention Deficit and Hyperactivity Disorder ("ADHD")
franchise; patents, including but not limited to, legal challenges relating
to Shire plc's ADHD franchise; government regulation and approval, including
but not limited to the expected product approval dates of DAYTRANATM
(MTS/METHYPATCH) (ADHD), SPD503 (ADHD), SPD465 (ADHD), SPD476 (ulcerative
colitis), ELAPRASE TM (idursulfase) (Hunter syndrome) and NRP104 (ADHD),
including its scheduling classification by the Drug Enforcement
Administration in the United States; Shire plc's ability to benefit from the
acquisition of Transkaryotic Therapies Inc.; Shire plc's ability to secure
new products for commercialization and/or development; and other risks and
uncertainties detailed from time to time in Shire plc's and its predecessor
registrant Shire Pharmaceuticals Group plc's filings with the US Securities
and Exchange Commission, including Shire Pharmaceuticals Group plc's Annual
Report on Form 10-K for the year ended December 31, 2004.

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