Shire plc, the global specialty biopharmaceutical company, and Shionogi & Co. Ltd. of Japan has entered into an agreement to co-develop and co-commercialize certain of its 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.”

ADHD is a psychiatric behavioural 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.

Globally, ADHD is one of the most common childhood psychiatric disorders. In Japan, the prevalence of ADHD is almost 8 per cent or in excess of one million school aged children. The Japanese ADHD market is one of the world’s most rapidly growing ADHD markets.

The specific etiology of ADHD is unknown, and there is no single diagnostic test for this disorder. 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).

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