Published: August 09, 2011
Regulatory Update: GSK and XenoPort Submit Supplemental New Drug Application to FDA for Horizant in Postherpetic Neuralgia
LONDON & RESEARCH TRIANGLE PARK, N.C. & SANTA CLARA, Calif. - (BUSINESS WIRE) - GlaxoSmithKline (NYSE:GSK)(LSE:GSK) and XenoPort, Inc. (Nasdaq: XNPT)
announced today that a supplemental New Drug Application (sNDA) has been
submitted to the U.S. Food and Drug Administration (FDA) requesting
approval of Horizant (gabapentin enacarbil) Extended-Release Tablets
for the management of postherpetic neuralgia (PHN) in adults. The sNDA
has been submitted to the FDA by GSK.
Notes to Editors
Horizant is not approved or licensed anywhere in the world for
PHN. For information about the current licensed indication for Horizant,
which is in the United States only, please visit http://www.gsk.com/products/prescription-medicines/horizant.htm
for full Prescribing Information and Medication Guide.
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based
pharmaceutical and healthcare companies and is committed to improving
the quality of human life by enabling people to do more, feel better and
live longer. For more information, visit GlaxoSmithKline at www.gsk.com.
About XenoPort
XenoPort is a biopharmaceutical company focused on developing a
portfolio of internally discovered product candidates that utilize the
body's nutrient transport mechanisms to improve the therapeutic benefits
of existing drugs. Horizant is XenoPort's first approved product.
GlaxoSmithKline holds commercialization rights and certain development
rights for gabapentin enacarbil in the United States. Gabapentin
enacarbil is also being developed in partnership with Astellas Pharma
Inc. for the potential treatment of Restless Legs Syndrome in Japan.
XenoPort holds all other world-wide rights and has co-promotion and
certain development rights to gabapentin enacarbil in the United States.
XenoPort's pipeline of product candidates includes potential treatments
for patients with neuropathic pain, spasticity and Parkinson's disease.
To learn more about XenoPort, please visit the Web site at www.XenoPort.com.
GlaxoSmithKline Forward-Looking Statement
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 2010.
XenoPort is a registered trademark of XenoPort, Inc.
Horizant is a U.S. trademark of GSK.

GlaxoSmithKline Enquiries:
UK Media enquiries:
David
Mawdsley, (020) 8047 5502
Stephen Rea, (020) 8047 5502
Sarah
Spencer, (020) 8047 5502
Janet Morgan, (020) 8047 5502
David
Daley, (020) 8047 5502
or
US Media enquiries:
Nancy
Pekarek, 919-483-2839
Mary Anne Rhyne, 919-483-2839
Kevin
Colgan, 919-483-2839
Sarah Alspach, 919-483-2839
or
European
Analyst/Investor enquiries:
Sally Ferguson, (020) 8047 5543
Gary
Davies, (020) 8047 5503
Ziba Shamsi, (020) 8047 3289
or
US
Analyst/ Investor enquiries:
Tom Curry, 215-751-5419
Jeff
McLaughlin, 215-751-7002
or
XenoPort Enquiries:
Analyst/Investor
and Media enquiries:
Jackie Cossmon, 408-616-7220
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