XenoPort, Inc. (Nasdaq:XNPT) announced today that Astellas Pharma Inc.
plans to file a new drug application (NDA) in Japan for XP13512 (known
as ASP8825 by Astellas) as a potential treatment for moderate-to-severe
primary restless legs syndrome (RLS) in the second half of its 2009
fiscal year, which ends on March 31, 2010. The evidence of efficacy for
the NDA filing will be based on data from Astellas’ successful Phase 2
study in RLS patients conducted in Japan and XenoPort’s clinical program
conducted in the United States. Based on the outcome of a Pharmaceutical
and Medical Devices Agency (PMDA) consultation meeting, Astellas has
concluded that Phase 3 clinical studies in Japan will not be required
for the NDA filing.
“With no approved drugs in Japan for the treatment of RLS, we are
pleased that Astellas is pursuing what is known as a “bridging strategy”
to potentially accelerate the availability of a treatment for RLS
patients in Japan,” said Ronald W. Barrett, Ph.D., XenoPort’s chief
executive officer. “We are working diligently with Astellas to permit
them to move aggressively to file the NDA in Japan by the end of March
2010. We thank our Astellas colleagues for their creative development
strategy on this project.”
XenoPort also announced today that Astellas does not intend to continue
the development of XP13512 in Japan as a potential treatment for painful
diabetic neuropathy under the current circumstances. As reported
previously, a planned interim analysis of a Phase 2 clinical trial of
XP13512 in Japanese patients with painful diabetic neuropathy indicated
that continuation of the study was not likely to demonstrate a
statistically significant advantage of XP13512 over placebo on the
primary endpoint of the study. There were no safety concerns identified
in the interim analysis.
Astellas Collaboration
Astellas holds exclusive rights to develop and commercialize XP13512 in
Japan, Korea, the Philippines, Indonesia, Thailand and Taiwan. Under the
terms of the Astellas collaboration agreement, XenoPort received an
initial license payment of $25 million in December 2005 and has received
milestone payments of $18 million to date. XenoPort is eligible to
receive potential clinical and regulatory milestone payments totaling up
to an additional $42 million.
