Astellas and XenoPort Announce Positive Results from Phase 2 Trial of ASP8825/XP13512 in Japan for Restless Legs Syndrome
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.
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.
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.
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.
XenoPort is a registered trademark
Solzira is a trademark of GSK
Posted: March 2009