http://www.businesswire.com/news/home/20091106005972/en
LONDON & RESEARCH TRIANGLE PARK, N.C. & SANTA CLARA, Calif.--(Business Wire)--
GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) today announced
that the U.S. Food and Drug Administration (FDA) has extended the original
Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug
Application (NDA) for GSK1838262/XP13512 (gabapentin enacarbil) to February 9,
2010. The original PDUFA date for this NDA review was November 9, 2009.
The FDA determined that a Risk Evaluation and Mitigation Strategy (REMS) was
necessary for GSK1838262. In response to FDA`s request, GSK submitted a proposed
REMS. The FDA accepted this submission as a solicited major amendment to the
GSK1838262 NDA. The FDA has the option to extend the PDUFA goal date when a
sponsor submits a major amendment that provides a substantial amount of new data
not previously reviewed by the FDA.
GlaxoSmithKline - one of the world`s leading research-based pharmaceutical and
healthcare companies - is committed to improving the quality of human life by
enabling people to do more, feel better and live longer. For further information
please visit www.gsk.com.
XenoPort 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 partnership with
Astellas Pharma Inc. and GSK. XenoPort`s product candidates are being studied
for the potential treatment of restless legs syndrome, gastroesophageal reflux
disease, migraine headaches, neuropathic pain, spasticity related to spinal cord
injury and Parkinson`s disease. To learn more about XenoPort, please visit the
Web site at www.XenoPort.com.
GlaxoSmithKline cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995, GSK cautions investors that any forward-looking statements
or projections made by GSK, including those made in this announcement, are
subject to risks and uncertainties that may cause actual results to differ
materially from those projected. Factors that may affect GSK' s operations are
described under 'Risk Factors' in the 'Business Review' in the company' s Annual
Report on Form 20-F for 2008.
XenoPort Forward-Looking Statement
This press release contains "forward-looking" statements, including, without
limitation, all statements related to the PDUFA goal date extension. 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 "potential"
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 uncertainty of the FDA approval process
and other regulatory requirements; XenoPort' s dependence on its current and
additional collaborative partners; and the therapeutic and commercial value of
the company' s compounds. These and other risk factors are discussed under the
heading "Risk Factors " in XenoPort' s Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission on November 4, 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.
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
GlaxoSmithKline Enquiries:
UK Media enquiries:
Philip Thomson, (020) 8047 5502
Claire Brough, (020) 8047 5502
Alexandra Harrison, (020) 8047 5502
or
US Media enquiries:
Kevin Colgan, 919-483-2839
Holly Russell, 919-483-2839
Mary Anne Rhyne, 919-483-2839
Sarah Alspach, 215-751-7709
or
European Analyst/Investor enquiries:
David Mawdsley, (020) 8047 5564
Sally Ferguson, (020) 8047 5543
Gary Davies, (020) 8047 5503
or
US Analyst/Investor enquiries:
Tom Curry, 215-751-5419
Jen Baxter, 215-751-7002
or
XenoPort Enquiries:
XenoPort Analyst/Investor and Media enquiries:
Jackie Cossmon, 408-616-7220
Copyright Business Wire 2009
