GSK and XenoPort Resubmit New Drug Application for Solzira(TM) in Restless Legs Syndrome
January 09 2009 - 8:30AM
PR Newswire (US)
LONDON, RESEARCH TRIANGLE PARK, N.C. and SANTA CLARA, Calif., Jan.
9 /PRNewswire-FirstCall/ -- GlaxoSmithKline and XenoPort, Inc.
announced today that GSK has resubmitted the New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) requesting
approval of Solzira(TM) (gabapentin enacarbil) Extended Release
Tablets for the treatment of moderate-to-severe primary Restless
Legs Syndrome (RLS). The FDA had requested that the data in a
single study be reformatted. In addition, GSK conducted a review of
other clinical studies taking this input into account. The
withdrawal was not related to the content of the filing.
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
http://www.gsk.com/. Solzira - is a new chemical entity that is
designed to improve upon the pharmacokinetics of gabapentin by
taking advantage of high-capacity transport mechanisms in the
gastrointestinal tract to improve absorption. XenoPort - is a
biopharmaceutical company focused on developing a portfolio of
internally discovered product candidates that utilise 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. As
announced today, GSK has resubmitted to the FDA an NDA for Solzira
for the treatment of moderate-to-severe primary 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 http://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 2007. XenoPort
Forward-Looking Statement This press release contains
"forward-looking" statements, including, without limitation, all
statements related to the therapeutic and commercial potential of
XenoPort's product candidates. 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 ability of
the company to successfully conduct clinical trials of its product
candidates, and the results thereof; 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 for the quarter ended September 30, 2008, filed with the
Securities and Exchange Commission on November 6, 2008. 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.
DATASOURCE: GlaxoSmithKline; XenoPort, Inc. CONTACT: UK, Philip
Thomson, Alice Hunt, David Outhwaite, or Stephen Rea, all at
(020)-8047-5502, or US, Nancy Pekarek, Holly Russell or Mary Anne
Rhyne, all at +1-919-483-2839, or Sarah Alspach, +1-215-751-7709,
or European Analysts and Investors, David Mawdsley,
(020)-8047-5564, or Sally Ferguson, (020)-8047-5543, or Gary
Davies, (020)-8047-5503, or US Analysts and Investors, Tom Curry,
+1-215-751-5419, or Jen Hill, +1-215-751-7002, all of
GlaxoSmithKline; or XenoPort Analysts, Investors and Media, Jackie
Cossmon of XenoPort, +1-408-616-7220 Web Site: http://www.gsk.com/
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