TOKYO & SANTA CLARA, Calif.--(BUSINESS WIRE)--Mar. 2, 2009--
Astellas Pharma Inc. (Astellas) and XenoPort, Inc. (NASDAQ:XNPT) today
announced preliminary top-line results from a Phase 2 clinical trial of
ASP8825/XP13512 for the treatment of symptoms in moderate-to-severe
primary restless legs syndrome (RLS) patients. The trial was conducted
by Astellas in Japan. ASP8825/XP13512 demonstrated statistically
significant improvements compared to placebo on the primary endpoint of
the trial and was well tolerated.
This 12-week, double-blind, placebo-controlled Phase 2 clinical trial
(Study 8825-CL-0003) enrolled 474 patients who were diagnosed with RLS.
Patients were treated with 600, 900 or 1200 mg of ASP8825/XP13512 or
placebo, given once per day after the evening meal. The primary endpoint
for the clinical trial was the change from baseline for the
International RLS (IRLS) rating scale score at end of treatment.
Treatment with 1200 mg of ASP8825/XP13512 was associated with a
statistically significant improvement in the primary endpoint compared
to placebo. Statistically significant improvements over placebo were
also observed on some secondary endpoints, including the
investigator-rated clinical global impression of improvement scale
(CGI-I), which achieved statistical significance for each of the 600 mg,
900 mg and 1200 mg dosing cohorts.
The most commonly reported adverse events for ASP8825/XP13512 were
somnolence and dizziness, which were generally transient and mild to
moderate in severity. There were no treatment-emergent serious adverse
events during the study period in ASP8825/XP13512-treated subjects.
“We believe that there is a substantial unmet medical need for a
medicine to treat RLS patients and are very pleased with the quality and
consistency of data in this Phase 2 trial showing statistically
significant improvements,” said Masafumi Nogimori, president and chief
executive officer of Astellas. “We look forward to meeting with the
regulatory agency to discuss the development path for ASP8825/XP13512
and continuing our great partnership with XenoPort.”
“We are pleased by the outcome of this trial, which is consistent with
the results of XenoPort’s trials of ASP8825/XP13512 conducted in RLS
patients in the U.S.,” said Ronald W. Barrett, Ph.D., chief executive
officer of XenoPort. “We look forward to working with Astellas to
advance the development of ASP8825/XP13512 within the Astellas territory
and moving closer to achieving our objective of making a new therapy
available to RLS sufferers throughout the world.”
Astellas/XenoPort Collaboration Arrangement
In 2005, Astellas obtained exclusive rights to develop and commercialize
ASP8825/XP13512 in Japan, Korea, the Philippines, Indonesia, Thailand
and Taiwan. XenoPort has received payments of $40 million to date under
the collaboration agreement. In addition, XenoPort is eligible to
receive clinical and regulatory milestone payments totaling up to $45
million. XenoPort is also eligible to receive royalties on any sales of
ASP8825/XP13512 in the Astellas territory at a royalty rate in the
mid-teens on a percentage basis.
About Astellas
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical
company dedicated to improving the health of people around the world
through the provision of innovative and reliable pharmaceutical
products. The organization is committed to becoming a global
pharmaceutical company by combining outstanding R&D and marketing
capabilities and continuing to grow in the world pharmaceutical market.
For more information about Astellas Pharma Inc., please visit our
website at www.astellas.com.
About XenoPort
XenoPort, Inc. is a biopharmaceutical company focused on developing a
portfolio of internally discovered product candidates that utilize the
body’s natural nutrient transport mechanisms to improve the therapeutic
benefits of existing drugs. XenoPort is developing its lead product
candidate in collaboration with Astellas and GlaxoSmithKline, or GSK.
GSK has filed with the U.S. Food and Drug Administration a new drug
application for XP13512 (known as Solzira™ in the U.S. and
ASP8825 in the Astellas territory) for the treatment of RLS. XenoPort’s
product candidates are also being studied for the potential treatment of
gastroesophageal reflux disease, migraine headaches, neuropathic pain,
spasticity related to spinal cord injury, acute back spasms and
Parkinson’s disease. To learn more about XenoPort, please visit the Web
site at www.XenoPort.com.
Forward-Looking Statements
This press release contains “forward-looking” statements, including,
without limitation, all statements related to XenoPort’s and its
partners’ future clinical development and commercialization of
ASP8825/XP13512 and the timing thereof; and XenoPort’s potential receipt
of milestone payments and royalties and the timing thereof. Any
statements contained in this press release that are not statements of
historical fact may be deemed to be forward-looking statements. Words
such as “believe,” “eligible,” “potential,” “will,” “would” and similar
expressions are intended to identify forward-looking statements. These
forward-looking statements are based upon XenoPort's current
expectations. Forward-looking statements involve risks and
uncertainties. XenoPort's actual results and the timing of events could
differ materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which include,
without limitation, the uncertain results and timing of clinical trials;
XenoPort’s or its partners’ ability to successfully conduct clinical
trials in the anticipated timeframes, or at all; the uncertainty of the
regulatory approval process and regulatory requirements; XenoPort’s
dependence on its current and additional collaborative partners; and the
uncertain therapeutic and commercial value of XenoPort’s compounds.
These and other risk factors are discussed under the heading “Risk
Factors” in XenoPort’s Annual Report on Form 10-K filed with the
Securities and Exchange Commission on February 26, 2009. XenoPort
expressly disclaims any obligation or undertaking to release publicly
any updates or revisions to any forward-looking statements contained
herein to reflect any change in the company's expectations with regard
thereto or any change in events, conditions or circumstances on which
any such statements are based.
XNPT2C
XenoPort is a registered trademark
Solzira is a trademark of GSK
Source: XenoPort, Inc.
Astellas
Corporate Communications, +81-3-3244-3201
http://www.astellas.com
or
XenoPort
Jackie
Cossmon, +1-408-616-7220
ir@XenoPort.com
