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Issued: London, UK, Research Triangle Park, NC & Santa Clara, CA

GlaxoSmithKline (NYSE and 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

 

 

 

US Media enquiries:

Nancy Pekarek

(919) 483 2839

 

Mary Anne Rhyne

(919) 483 2839

 

Kevin Colgan

(919) 483 2839

 

Jennifer Armstrong

(919) 483 2839

 

 

 

European Analyst/Investor enquiries:

Sally Ferguson

(020) 8047 5543

 

Gary Davies

(020) 8047 5503

 

Ziba Shamsi

(020) 8047 3289

 

 

 

US Analyst/ Investor enquiries:

Tom Curry

(215) 751 5419

 

Jeff McLaughlin

(215) 751 7002

XenoPort Enquiries: 

Analyst/Investor and Media enquiries:  Jackie Cossmon  (408) 616 7220

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