LEXINGTON, Massachusetts, February 10, 2016 /PRNewswire/ --
This press release is intended for U.S. and EU audiences only.
A separate press release has been prepared for use in Japan.
With submission, Shire continues to strengthen its presence in Japan
Shire plc (LSE: SHP, NASDAQ: SHPG) and Shionogi & Co., Ltd. recently announced that Shionogi submitted a New Drug Application (NDA) for the manufacturing and marketing in Japan of S-877503 (guanfacine hydrochloride prolonged release tablets),* for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children. The Japanese clinical studies were conducted in children 6 to 12 years old with this disorder.
Shire and Shionogi, under a co-development and commercialization licensing contract signed in 2011, have been developing S-877503 as an investigational pediatric ADHD candidate. Shionogi is a Japan-based pharmaceutical company focused on the research and development of treatments for various therapeutic areas, including central nervous system disorders and infectious diseases.
“This NDA is significant for patients, Shire and Shionogi. If approved, Shire will have another key product available in Japan, increasing patient access to more of our medicines in a market incredibly important on the world’s stage,” said Philip J. Vickers, Ph.D., Head of Research & Development, Shire. “Fortunately, we have a strong partner for our ADHD development and commercialization efforts in Shionogi, who has been central to our growth in Japan. Shire has a number of pipeline products, in addition to S-877503, intended for Japan, so we’re excited about the possibilities for addressing more unmet patient needs in this country.”
Shire Japan KK, Shire’s local operating company (LOC), also has investigational candidates in the pipeline for hereditary angioedema, short-bowel syndrome, convulsive seizures and hypoparathyroidism. The LOC offers two therapies of its own on the Japanese market - one for Gaucher disease and the other for thrombocythemia - and partners with several other companies to develop new products for the Japanese market.
New therapeutic options for ADHD are needed in Japan. Multiple medicines for the disorder are approved and sold in the United States and Europe. However, only two ADHD medicines have been approved in Japan, where the anticipated regulatory review process for an NDA is approximately 12 months.
About S-877503
The mode of action of S-877503 in ADHD is not fully established. Preclinical research suggests S-877503 modulates signalling in the prefrontal cortex and basal ganglia through direct modification of synaptic noradrenalin transmission at the alpha2A-adrenergic receptors. This proposed mode of action is different than the other ADHD medicines currently available in Japan.
Guanfacine hydrochloride prolonged release tablets are marketed in the United States, EU and Canada. For more information on the product labelling in these markets, refer to the U.S. Prescribing Information, EU Summary of Product Characteristics (SmPC) and Canadian Product Monograph, respectively. In the United States, generic versions of guanfacine hydrochloride prolonged release tablets (or INTUNIV) are available for the treatment of ADHD.
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*. U.S. and EU brand name: INTUNIV® (guanfacine extended-release tablets in U.S.; guanfacine hydrochloride prolonged release tablets in EU). Canadian brand name: INTUNIV XR® (guanfacine hydrochloride extended-release tablets)
About ADHD in children and adolescents
ADHD is a common psychiatric disorder in children and adolescents and is recognized by the World Health Organization (WHO). The core symptoms are inattention, hyperactivity and impulsivity. Worldwide, prevalence of ADHD is estimated to be between 5.29% and 7.1%, and just under 5% for children and adolescents (<18 years). While the exact origin of ADHD is unknown, it is recognized that the disorder may be caused by the interplay between genetic and environmental factors.
About Shionogi & Co., Ltd.
Shionogi & Co., Ltd. is a major research-driven pharmaceutical company dedicated to placing the highest value on patients based on its corporate philosophy of “supply the best possible medicine to protect the health and wellbeing of the patients we serve.” Shionogi’s research and development currently targets two therapeutic areas: infectious diseases and pain/CNS disorders. In addition, Shionogi is engaged in new research areas such as obesity/geriatric metabolic disease and oncology/immunology. Contributing to the health and QOL of patients around the world through development in these therapeutic areas is Shionogi’s primary goal.
For more information, please visit http://www.shionogi.co.jp/en/
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