Updated on 12 February 2016
Shire plc and Shionogi & Co Ltd have 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. 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, 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.