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GlaxoSmithKline receives positive opinion in Europe from the CHMP for Nimenrix®

Issued: Friday 17 February 2012, London UK

GlaxoSmithKline (GSK) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for Nimenrix® (MenACWY-TT) for active immunisation against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y.

A CHMP positive opinion is one of the final steps before regulatory approval. As part of its assessment, CHMP reviewed immunogenicity and safety data from more than 8000 patients aged 1 year and above. The clinical program included 17 clinical studies conducted in 17 countries worldwide.

Thomas Breuer, Senior Vice-President, Head of Global Vaccine Development at GSK commented: "GSK has over 20 years experience in developing meningococcal vaccines. This positive opinion represents a major milestone in our development programme and we look forward to receiving the final decision from the EMA in the coming months".

About Nimenrix® -
Nimenrix® is a candidate conjugate vaccine for active immunisation of individuals from 12 months of age against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W -135 and Y.

About Neisseria meningitidis -
Neisseria meningitidis is a highly contagious disease and can be easily transmitted with potentially disabling and in severe cases, even potentially life-threatening consequences. While there are currently no reliable global prevalence figures a recent WHO report suggests that in the African meningitis belt, which is inhabited by around 300 million people, meningococcal disease can occasionally reach rates of up to 1000 cases per 100,000 populations during the dry season. Incidence in Europe and the Americas is approximately 0.2 - 14 cases per 100,000 population and 0.3 - 4 cases per 100,000 respectively1.

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

GlaxoSmithKline Biologicals - (GSK Biologicals), GlaxoSmithKline’s vaccines business, is one of the world’s leading vaccine companies and a leader in innovation. The company is active in vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development - both in the prophylactic and therapeutic fields. Headquartered in Belgium, GSK Biologicals has 14 manufacturing sites strategically positioned around the globe. In 2010, GSK Biologicals distributed 1.43 billion doses of vaccines to 179 countries in both the developed and the developing world.

Through its accomplished and dedicated workforce, GSK Biologicals applies its expertise to the discovery of innovative vaccines that contribute to the health and well-being of people of all generations around the world.

GlaxoSmithKline Enquiries:

UK Media enquiries:

David Mawdsley

+44 (0) 20 8047 5502

(London)

 

Stephen Rea

+44 (0) 20 8047 5502

(London)

 

Sarah Spencer

+44 (0) 20 8047 5502

(London)

 

David Daley

+44 (0) 20 8047 5502

(London)

 

 

 

 

US Media enquiries:

Kevin Colgan

+1 919 483 2839

(North Carolina)

 

Mary Anne Rhyne

+1 919 483 2839

(North Carolina)

 

Sarah Alspach

+1 919 483 2839

(Washington, DC)

 

Jennifer Armstrong

+1 919 483 2839

(Philadelphia)

 

 

 

 

Analyst/Investor enquiries:

Sally Ferguson

+44 (0) 20 8047 5543

(London)

 

Tom Curry

+ 1 215 751 5419

(Philadelphia)

 

Gary Davies

+ 44 (0) 20 8047 5503

(London)

 

Ziba Shamsi

+ 44 (0) 20 8047 3289

(London)

 

Jeff McLaughlin

+ 1 215 751 7002

(Philadelphia)

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 2010.

Reference:

  1. WHO. Weekly epidemiological record, No 47, 2011, 86, 521-540