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Shire Announces Strategic Partnership for ADHD Medicines in Japan With Shionogi & Co., Ltd.

November 18, 2011

NYON, Switzerland and PHILADELPHIA, November 18, 2011 /PRNewswire/ –

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, announces that it has entered into an agreement
with Shionogi & Co. Ltd. of Japan to co-develop and co-commercialize certain
of Shire’s Attention Deficit Hyperactivity Disorder (ADHD) medicines in
Japan. Shionogi will pay a one time fee and share costs with Shire in
exchange for rights to jointly co-develop and co-commercialize the products
upon approval for the Japanese market. Specific terms of the agreement are
not being disclosed.

Shire is a recognized leader in the area of ADHD treatment and support,
with a portfolio of medicines and resources to help ADHD patients and their
families. Shionogi & Co., Ltd. is one of the leading Japanese pharmaceutical
companies with an expertise in developing medicines for the central nervous
system, among other therapeutic areas. Working together with the Shionogi
team, Shire believes the path to regulatory approval, market development and
commercialization for ADHD medicines will be more effective and efficient.

“Providing support for ADHD patients, their families and the medical
community who treat these patients is at the heart of our approach at Shire,
and this agreement with Shionogi underscores our commitment to helping
patients diagnosed with ADHD,” said Mike Yasick, Senior Vice President of
Shire’s ADHD business. “We look forward to working with the Shionogi team on
efforts to enhance awareness in Japan about the impact undiagnosed and
untreated ADHD can have on our societies, and the value that new treatment
options can deliver for ADHD patients.”

Senior Vice President of Shire’s International Specialty Pharma
business, Gian Piero Reverberi added, “Our agreement with Shionogi further
demonstrates Shire’s commitment to enabling greater patient access to
Shire’s growing portfolio of specialist therapeutics around the globe and
specifically to the Japanese market.”

ABOUT ADHD

Attention deficit hyperactivity disorder (ADHD) is a psychiatric
behavioral disorder that manifests as a persistent pattern of inattention
and/or hyperactivity-impulsivity that is more frequent and severe than is
typically observed in individuals at a comparable level of development.[1]

Globally, ADHD is one of the most common childhood psychiatric
disorders.[2, 1] In Japan, the prevalence of ADHD is almost 8%[4] or in
excess of one million school aged children. The Japanese ADHD market is one
of the world’s most rapidly growing ADHD markets.[3]

The specific etiology of ADHD is unknown, and there is no single
diagnostic test for this disorder.[2] Adequate diagnosis requires the use of
medical and special psychological, educational, and social resources,
utilizing diagnostic criteria specified in the Diagnostic and Statistical
Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR(R)) or
International Classification of Diseases, 10th revision (ICD-10).[1,2]

Although there is no cure for ADHD, there are accepted treatments that
have been demonstrated to improve symptoms.[2] Standard treatments include
educational approaches, psychological therapies that may include behavioral
modification, and/or medication.[2]

SHIRE PLC

Shire’s strategic goal is to become the leading specialty
biopharmaceutical company that focuses on meeting the needs of the
specialist physician. Shire focuses its business on attention deficit
hyperactivity disorder, human genetic therapies, gastrointestinal diseases
and regenerative medicine as well as opportunities in other therapeutic
areas to the extent they arise through acquisitions. Shire’s in-licensing,
merger and acquisition efforts are focused on products in specialist markets
with strong intellectual property protection and global rights. Shire
believes that a carefully selected and balanced portfolio of products with
strategically aligned and relatively small-scale sales forces will deliver
strong results.

For further information on Shire, please visit the Company’s website:

http://www.shire.com.

“SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995

Statements included herein that are not historical facts are
forward-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, the Company’s results could
be materially adversely affected. The risks and uncertainties include, but
are not limited to, risks associated with: the inherent uncertainty of
research, development, approval, reimbursement, manufacturing and
commercialization of the Company’s Specialty Pharmaceutical and Human
Genetic Therapies products, as well as the ability to secure and integrate
new products for commercialization and/or development; government regulation
of the Company’s products; the Company’s ability to manufacture its products
in sufficient quantities to meet demand; the impact of competitive therapies
on the Company’s products; the Company’s ability to register, maintain and
enforce patents and other intellectual property rights relating to its
products; the Company’s ability to obtain and maintain government and other
third-party reimbursement for its products; and other risks and
uncertainties detailed from time to time in the Company’s filings with the
Securities and Exchange Commission.

SHIONOGI & CO. LTD.

Shionogi & Co., Ltd. (Shionogi) are an Osaka based Japanese
pharmaceutical company. Shionogi’s policy is to strive constantly to provide
medicine of the best possible kind essential for the protection of the
health of the people. Shionogi’s mission, based on this policy, is to
deliver pharmaceuticals that offer the greatest possible level of
satisfaction to patients, their families, and healthcare providers and that
improve quality of life for patients and their families. Global revenues are
derived from diverse therapeutic areas including Anti infectives,
Cardiovascular, Respiratory & Allergy, CNS & Pain.

For further information on Shionogi please visit the company’s website:

http://www.shionogi.co.jp/index_e.html

        1) American Psychiatric Association. Diagnostic and
          Statistical Manual of Mental Disorders. 4th ed., Text Revision
          (DSM-IV-TR (R)). Washington, DC: American Psychiatric Association;
          2000:85-93.
        2) Pliszka S and the AACAP Work Group on Quality Issues. Practice
          parameter for the assessment and treatment of children and adolescents
          with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc
          Psychiatry. 2007;46(7):894-921.
        3) Source IMS data 2nd Quarter 2011
        4) ADHD-Related Behavior Among Non-Referred Children: Parents'
          Ratings o f DSM-III-R Symptoms,Yasuko Kanbayashi, MD,Yojiro Nakata,
          MA,Kazuko Fujii, BSoc,Michiko Kita, MD.National Institute of Mental
          Health, National Center of Neurology and Psychiatry, Japan Kayo Wada,
          MA, Saitama College of Health

Notes to editors

For further information please contact:

        Investor
        Relations       Eric Rojas (erojas@shire.com)            +1-781-482-0999
                        Sarah Elton-Farr (seltonfarr@shire.com)  +44-1256-894-157
        Media           Jessica Mann (jmann@shire.com)           +44-1256-894-280
                        Matthew Cabrey (mcabrey@shire.com)       +1-484-595-8248
                        Nicole Barraud (nbarraud@shire.com)
                                                                 +41-22-419-4056

SOURCE Shire plc


Source: PR Newswire