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

Shionogi and Shire to jointly develop and commercialize ADHD medicines in Japan  

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^®) 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 ®). 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 2^nd 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