FORM 6-K
 

 

SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549

 

Report of Foreign Issuer

 

Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
 

For period ending May 2009
 

GlaxoSmithKline plc
(Name of registrant)
 
 

 

980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address of principal executive offices)
 
 

Indicate by check mark whether the registrant files or
will file annual reports under cover Form 20-F or Form 40-F
 
 

Form 20-F x Form 40-F
 

 --

Indicate by check mark whether the registrant by furnishing the
information contained in this Form is also thereby furnishing the
information to the Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934.
 
 
Yes No x
  --

 

 

• The vaccine will comprise antigen of the recently isolated A (H1N1) influenza strain and also contain GSK's proprietary adjuvant system AS03. An adjuvant system can be added to the antigen at time of administration. In clinical studies using the H5N1 influenza strain, an adjuvanted formulation has been shown to stimulate a higher immune response while using a smaller amount of antigen as compared to a formulation without adjuvant. The adjuvant system therefore helps to increase the number of vaccine doses that can be produced.

  ¹

  In addition, in clinical studies with the H5N1 influenza strain, the adjuvanted vaccine demonstrated the potential to provide protection even if the influenza strain drifts (changes slightly).

  ^2,3

  
  
  
  
• The new 

  candidate 

  vaccine will require regulatory approval.  

  In 2008, GSK received a European licence for

   

  a 

  pandemic vaccine based on a 'mock-up' dossier.  

  This approval, which was based on data involving the H5N1 

  influenza 

  strain, is expected to enable faster registration of this new A (H1N1) influenza vaccine

   and is currently being discussed with European regulatory authorities

  .

• To date, GSK has received 

  interest from several g

  overnment

  s aiming to 

  stockpile

   

  the new candidate 

  adjuvanted 

  vaccine as a precautionary measure

  . These include:

• Supplying

  the UK Government with 60

   million doses of the candidate 

  A (H1N1) 

  adjuvanted

   influenza vaccine.
• The French Government intend to purchase 50 million doses of the candi

  date A (H1N1) influenza vaccine.

• The Government of 

  Belgium

   intend to purchase 12.6 million doses of the candidate A (H1N1) influenza vaccine in order to stockpile and to protect, when needed, the total Belgian population.

• A

  n agreement with the Government of Finland to 

  supply 5.3 million doses of H1N1 antigen, which is expected to be used in conjunction with the government's existing stockpile of GSK's adjuvant system. 

• GSK has made substantial investments to expand capacity for its adjuvant system. As part of the company's commitment to maximising global manufacturing capacity of a pandemic vaccine, GSK is 

  ready to engage

   in discussions with companies and governmental agencies that can combine 

  the adjuvant system 

  with alternatively sourced antigen

  .

• GSK is committed to addressing the needs of developing countries with use of this 

  candidate adjuvanted 

  vaccine

  .

   

   GSK 

  will convert its 

  intended donation

   to the WHO of 50 million doses of H5N1 pre-pandemic vaccine to the new candid

  ate A (H1N1) adjuvanted influenza vaccine

   

  once production begins

  .

• In the future, as capacity increases, GSK will supply the 

  candidate A (H1N1) 

  adjuvanted

   

  influenza 

  vaccine to developing countries under a tiered-pricing policy

   

  based on World Bank classifications

   

  and GAVI eligibility

  .

    

• Adjuvants, from the Latin word adjuvare meaning 'to help', are compounds used to enhance a vaccine's ability to elicit a strong, durable, protective immune response making them more effective. Until recently, vaccine research and development focused nearly exclusively on the antigen, the target molecule that is selected to trigger a specific immune response in the body to protect against a particular disease. It is now widely accepted that adjuvants can also contribute substantially to the immune response induced by a vaccine.

• GSK is continuing discussions with other governments and public health authorities to 

  increase production and supply of

   its

   anti-viral medication, 

  Relenza

  .

   

  Relenza

   

  can both treat influenza (flu, infection caused by influenza virus) and reduce the chance of getting flu in the community and household settings. The flu is a highly contagious and potentially fatal disease caused by influenza types A and B. While some antiviral medications only protect against influenza A, 

  Relenza

   is effective against both influenza A and B. 

  Relenza

   is approved for the prophylaxis and treatment of influenza in children and adults. 

• Relenza

   is an inhaled medicine delivered as a dry powder through a device called a 

  Diskhaler

   to the surface of the upper respiratory tract, and may shorten the amount of time a person is sick if used within two days of onset of illness. 

  Relenza

   belongs to a group of medicines called neuraminidase inhibitors. These medications attack the influenza virus itself - not just the symptoms - and prevent it from spreading inside your body.

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 Ann ual Report on Form 20-F for 2008 .

Enquiries:
UK Media enquiries:	Philip Thomson	(020) 8047 5502
	David Outhwaite	(020) 8047 5502
	Stephen Rea	(020) 8047 5502
US Media enquiries:	Nancy Pekarek	( 919 )  483   2839
	Mary Anne Rhyne	(919) 483 2839
	Kevin Colgan	(919) 483 2839
	Sarah Alspach	(919) 483 2839
European Analyst/Investor enquiries:	David Mawdsley	(020) 8047 5564
	Sally Ferguson	(020) 8047 5543
	Gary Davies	(020) 8047 5503
US Analyst/ Investor enquiries:	Tom Curry	(215) 751 5419
	Jen Hill Baxter	(215) 751 7002

Registered in  England  &  Wales : No. 3888792

Registered Office: 980 Great West Road Brentford, Middlesex TW8 9GS

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorised.
 
 

GlaxoSmithKline plc
(Registrant)
 
 

Date: May 15, 2009

By: VICTORIA WHYTE

------------------

Victoria Whyte
Authorised Signatory for and on
behalf of GlaxoSmithKline plc