TOKYO, JAPAN, and SANTA CLARA, CA, July 9, 2012 -- Astellas Pharma Inc. (Tokyo: 4503) and XenoPort, Inc. (NASDAQ: XNPT) announced today that Regnite(R) (gabapentin enacarbil) Extended-Release Tablets will be launched in Japan on July 10, 2012.
Regnite is approved in Japan for the treatment of moderate-to-severe primary restless legs syndrome (RLS). Astellas’ promotional efforts will focus on sleep and neurology specialists. Approximately 1,200 Astellas sales representatives will participate in the promotion of Regnite.
Discovered by XenoPort, Regnite is dosed once-daily and delivers a new chemical entity that utilizes naturally-occurring, high-capacity, nutrient transporters in the gastrointestinal tract to achieve efficient absorption into the body. Once absorbed, Regnite is rapidly converted into gabapentin, a compound thought to work by binding to certain calcium channels in nerve terminals. Regnite provides dose-proportional and extended exposure of gabapentin. The approved daily dose of Regnite for the treatment of RLS is 600 mg per day. The National Health Insurance (NHI) drug price per 300 mg tablet of Regnite is 98.50 yen.
Regnite was approved on January 18, 2012 by the Japanese Ministry of Health, Labour and Welfare for the treatment of RLS in Japan.
[About Restless Legs Syndrome]
Restless legs syndrome is a neurological condition that is characterized by unpleasant and sometimes painful sensations in the legs that result in a compelling urge to move and can result in distressing symptoms that disrupt sleep and significantly impact daily activities. These restless legs syndrome-related symptoms typically begin or worsen during periods of rest or inactivity, particularly when lying down or sitting, and may be temporarily relieved by movement. It is estimated that there are approximately 2.1 million people in Japan with RLS.
[Astellas/XenoPort Collaboration Arrangement]
In 2005, Astellas obtained exclusive rights to develop and commercialize Regnite in Japan, Korea, the Philippines, Indonesia, Thailand and Taiwan. XenoPort has received payments of $65 million to date under the collaboration agreement. XenoPort is eligible to receive potential additional clinical and regulatory milestone payments totaling up to $20 million. Under the agreement, XenoPort is also eligible to receive royalties on net sales of Regnite in the Astellas territory at a royalty rate in the high-teens on a percentage basis.
For more information, please visit http://www.astellas.com/en/corporate/news/pdf/120709_eg.pdf
- « Prev
- Next »