May 27, 2016

Announcement of Additional Clinical Trial of "KPS-0373 (Development Code)" for the Treatment of Spinocerebellar Ataxia

Kissei Pharmaceutical Co., Ltd.

Kissei Pharmaceutical Co., Ltd. [Head Office: Matsumoto-city, Nagano, Japan; Chairman and CEO: Mutsuo Kanzawa (hereinafter referred to as "Kissei")] announced today that it has decided to conduct an additional phase III clinical trial of the investigational drug for the treatment of spinocerebellar ataxia under development (Development Code: KPS-0373, hereinafter referred to as the "Agent").

On the basis of the results of the phase III clinical trial conducted from 2013 to 2015, Kissei aims at submitting a marketing authorization application of the Agent within this year. However, as a result of discussions with the Pharmaceuticals and Medical Devices Agency, Kissei concluded that, in addition to the currently available data, further accumulation of data with an additional phase III clinical trial was required.

Kissei will continue to focus on the development of the Agent to offer patients a new option for the treatment of spinocerebellar ataxia by conducting the additional phase III clinical trial at an early date.

About Spinocerebellar Ataxia: Spinocerebellar ataxia is a neurodegenerative disease of unknown etiology with the manifestation of symptoms including ataxia due to cerebellar or spinal degeneration. It has been designated as an intractable disease by the Ministry of Health, Labour and Welfare, and there are 30,000 or more recognized patients in Japan.

About KPS-0373 (generic name: rovatirelin): Rovatirelin is a derivative of thyrotropin-releasing hormone (TRH) discovered by Shionogi & Co., Ltd. It is expected to activate the nervous system by promoting the release of monoamine neurotransmitters such as acetylcholine and dopamine after binding to TRH receptors distributed in the central nervous system.