TOKYO, JAPAN and SANTA CLARA, CA - January 17, 2012 -Regnite®
(gabapentin enacarbil) has received marketing approval in
Japan for the treatment of moderate-to-severe primary
restless legs syndrome (RLS).
Ronald W. Barrett, Ph.D., chief executive officer of
XenoPort, stated, "We are very pleased that Regnite has been
approved in Japan. We believe that Regnite can offer
treatment benefits to RLS patients whose condition is severe
enough to need medical treatment. We thank Astellas for
all of its efforts to make Regnite available to RLS patients
in Japan."
The New Drug Application (NDA) filing for Regnite employed a
bridging strategy based on data supporting safety and
efficacy from the successful Phase 2 study in RLS patients
and long-term safety study conducted by Astellas in Japan, as
well as the RLS clinical program conducted by XenoPort in the
United States and supporting pharmacokinetic studies
conducted by XenoPort in Japanese subjects. Each of the
efficacy studies showed that treatment with Regnite was
associated with improvement in the International Restless
Legs Syndrome rating scale score compared to
placebo. Improvement over placebo was also observed on
the investigator-rated clinical global impression of
improvement scale. The most commonly reported adverse
events for Regnite were somnolence and dizziness, which were
generally transient and mild to moderate in severity.
Yoshihiko Hatanaka, president & chief executive officer of
Astellas, said, "Astellas expects to provide an additional
option for RLS therapy by introducing Regnite, which has a
different type of mechanism of action than the existing
therapy for RLS in Japan."
About Regnite
Discovered by XenoPort, Regniteonce-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,
RegniteRegnite provides dose-proportional and
extended exposure of gabapentin. is rapidly converted into
gabapentin, a compound thought to work by binding to certain
calcium channels in the central and peripheral nervous
system. (gabapentin enacarbil) is dosed
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 approximately 2.1 million
people in Japan suffer from RLS.
Astellas/XenoPort Collaboration Arrangement
In 2005, Astellas obtained exclusive rights to develop and
commercialize Regnitenet sales of
Regnitein the Astellas territory at a royalty
rate in the mid-teens on a percentage basis.in Japan, Korea,
the Philippines, Indonesia, Thailand and
Taiwan. XenoPort has received payments of $55 million to
date under the collaboration agreement. The approval of
Regnitein Japan entitlesXenoPort to an additional milestone
payment of $10 million. XenoPort is eligible to receive
potential additional clinical and regulatory milestone
payments totaling up to $20 million.
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