gsk201303076k1.htm
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 March 2013
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
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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
Issued: Thursday 7 March 2013, London UK - LSE Announcement
Regulatory update - GSK announces regulatory submission for albiglutide in Europe
GlaxoSmithKline plc (LSE: GSK) today announced the submission of a Marketing Authorisation Application (MAA) for albiglutide, with the proprietary name EPERZAN™, to the European Medicines Agency (EMA). Albiglutide is an investigational once-weekly treatment for adult patients with type 2 diabetes which is not yet approved anywhere in the world. On 14th January 2013, GSK announced the submission of a regulatory application in the United States for albiglutide.
About albiglutide
Albiglutide, a GLP-1 receptor agonist, is an investigational biological product for the treatment of type 2 diabetes designed for once-weekly subcutaneous dosing. GLP-1 is a peptide that is normally secreted from the gastrointestinal tract during a meal which in turn helps release insulin to control blood sugar elevations after eating. In people with type 2 diabetes, GLP-1 secretion in response to a meal is reduced or absent. GLP-1 is rapidly degraded while albiglutide has been developed to have a longer duration of action by being comprised of two copies of modified human GLP-1 fused in series to human albumin.
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
V A Whyte
Company Secretary
7 March 2013
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GlaxoSmithKline Enquiries:
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Alex Harrison
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US Media enquiries:
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Analyst/Investor enquiries:
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Sally Ferguson
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Lucy Budd
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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 'Financial review & risk' section in the company's Annual Report 2011 included as exhibit 15.2 to the company's Annual Report on Form 20-F for 2011.
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Registered in England & Wales:
No. 3888792
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Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
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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: March 07, 2013
By: VICTORIA WHYTE
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Victoria Whyte
Authorised Signatory for and on
behalf of GlaxoSmithKline plc