Blueprint
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 25 November 2016
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
Issued:
25 November 2016, London UK
GSK announces EU regulatory submission of candidate vaccine for
prevention of shingles
- Follows regulatory
submissions in US and Canada
GlaxoSmithKline
plc (LSE/NYSE: GSK) today announced the regulatory submission of a
Marketing Authorisation Application (MAA) to the European Medicines
Agency (EMA) seeking approval for its candidate shingles vaccine,
ShingrixTM, for the prevention
of herpes zoster (shingles) in people aged 50 years or
over.
The
candidate vaccine is a non-live, recombinant vaccine to help
prevent shingles and its complications. The phase III clinical
trial programme showed that by reducing the incidence of shingles,
the candidate vaccine also reduced the overall incidence of
postherpetic neuralgia (PHN), a form of chronic pain associated
with shingles. Regulatory approval is being sought for the vaccine
to be given intramuscularly in two doses, with a two-to-six month
interval between doses.
The
regulatory submission for the candidate vaccine is based on a
comprehensive phase III clinical trial programme evaluating its
efficacy, safety and immunogenicity in more than 37,000 people.
This includes the ZOE-50 and ZOE-70 studies published in the New
England Journal of Medicine in April 2015 and September 2016,
respectively.1,2
Dr Emmanuel Hanon, Senior Vice President and Head of Vaccines
R&D, GSK said: "Shingles is a common but serious
condition that results from the reactivation of the virus that
causes chicken pox and can cause lasting pain and other
complications. The probability of developing shingles increases
with age and it is estimated that up to one in every three people
will develop shingles during their life. GSK's shingles candidate
vaccine has consistently shown high efficacy in older people in its
phase III development programme. Today's file submission puts us a
step closer to making this vaccine available to help protect more
people from shingles and the complications associated with
it."
The
candidate vaccine is one of the more than 40 assets profiled to
investors at GSK's R&D event in November 2015 and belongs to
the company's vaccines portfolio - one of six core areas of
scientific research and development alongside oncology,
immuno-inflammation, and infectious, respiratory and rare
diseases.
The
submission to the EMA follows regulatory submissions to the US Food
and Drug Administration (FDA) in October of this year and to Canada
regulatory authorities earlier this month, with a Japan submission
planned for 2017.
About
the phase III study programme
Involving more than
37,000 subjects globally, the phase III programme evaluated the
efficacy, safety and immunogenicity of two doses of GSK's candidate
shingles vaccine given intramuscularly two months apart in older
adults. Data from all the completed studies has been included in
the regulatory file, including:
●
The ZOE-50 (ZOster Efficacy in adults aged 50 years
and over) (NCT01165177) trial of 16,160 adults aged 50 years and
older studied overall vaccine efficacy against shingles compared to
placebo. The data were published in April 2015 in the
NEJM.1
●
The ZOE-70 (ZOster Efficacy in adults aged 70 years
and over) (NCT01165229) trial of more than 14,800 adults aged 70
years and older studied overall vaccine efficacy against shingles
compared to placebo. Additionally, a pooled analysis of data from
the ZOE-70 and ZOE-50 trials assessed
overall
vaccine efficacy in reducing the risk of developing shingles and
PHN in people aged 70 years and over. These data were published in
September 2016 in the NEJM.2
A
clinical study is also underway to evaluate revaccination in
subjects who have previously been vaccinated against shingles with
the currently available live-attenuated vaccine. Additional trials
are underway in solid and haematological cancer patients,
haematopoietic stem cell and renal transplant recipients and
HIV-infected people. These studies will provide additional
information on the candidate vaccine's safety and ability to
stimulate immune responses in populations at high risk of shingles
because of the weakening of their immune system.
About the candidate vaccine
The
candidate vaccine is a non-live, recombinant vaccine to help
prevent herpes zoster and its complications and combines
glycoprotein E, a protein found on the varicella zoster virus (VZV)
that causes shingles, with an adjuvant system, AS01B, which is
intended to enhance the immunological response to the
antigen3.
GSK intends to register the product as ShingrixTM, subject to
approval by relevant regulatory review bodies.
About
shingles
Shingles typically
presents as a painful, itchy rash that develops on one side of the
body, as a result of reactivation of latent chickenpox virus
(varicella zoster virus or VZV). Data from many countries indicates
that more than 90% of adults have been infected with varicella
during childhood. The individual lifetime risk of developing
shingles is approximately one in three for people in the USA;
however, this increases to one in two people aged 85 and over. A
person's risk for shingles increases sharply after 50 years of age
due to a natural age-related decline in immune system function, or
as a consequence of an underlying immunocompromising
condition.4
The
most common complication from shingles is post-herpetic neuralgia,
defined as a localised pain of significant intensity persisting at
least 90 days after the appearance of the acute shingles rash.
Other complications of shingles include ophthalmologic,
neurological and cutaneous disease, which can result in severe
disability.5
References
1.
Lal et al., N Engl J Med 2015; 372:2087-2096 Efficacy of an
Adjuvanted Herpes Zoster Subunit Vaccine in Older
Adults.
2.
Cunningham et al., N Engl J Med 2016; 375: 1019-32. Efficacy of the
herpes zoster subunit vaccine in adults 70 years of age or
older.
3.
The GSK proprietary AS01 adjuvant system contains QS-21
Stimulon® adjuvant licensed from Antigenics LLC, a wholly
owned subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and
liposomes.
4. Shingles (Herpes
Zoster) Clinical Overview. US Centers for Disease Control and
Prevention. Accessed at: http://www.cdc.gov/shingles/hcp/clinical-overview.html
on 6 Sept 2016.
5.
Cohen et al., N Engl J Med 2013;369:255-63 Clinical practice:
Herpes zoster.
GSK - 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.
|
GSK enquiries:
|
|
|
|
|
UK
Media enquiries:
|
David
Mawdsley
|
+44 (0)
20 8047 5502
|
(London)
|
|
|
Catherine
Hartley
|
+44 (0)
20 8047 5502
|
(London)
|
|
|
Melinda
Stubbee
|
+44 (0)
20 8047 5502
|
(London)
|
|
US
Media enquiries:
|
Sarah
Alspach
|
+1 202
715 1048
|
(Washington,
DC)
|
|
|
Sarah
Spencer
|
+1 215
751 3335
|
(Philadelphia)
|
|
|
Mary
Anne Rhyne
|
+1 919
483 0492
|
(North
Carolina)
|
|
|
Karen
Hagens
|
+1 919
483 2863
|
(North
Carolina)
|
|
|
Gwynne
Oosterbaan
|
+1 215
751 7468
|
(Philadelphia)
|
|
|
|
|
|
|
Analyst/Investor
enquiries:
|
Tom
Curry
|
+ 1 215
751 5419
|
(Philadelphia)
|
|
|
Gary
Davies
|
+44 (0)
20 8047 5503
|
(London)
|
|
|
James
Dodwell
|
+44 (0)
20 8047 2406
|
(London)
|
|
|
Jeff
McLaughlin
|
+1 215
751 7002
|
(Philadelphia)
|
|
|
|
|
|
|
|
|
|
|
|
Cautionary statement regarding forward-looking statementsGSK
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. Such factors
include, but are not limited to, those described under Item 3.D
'Risk factors' in the company's Annual Report on Form 20-F for
2015.
|
|
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: November
25, 2016
By: VICTORIA
WHYTE
----------------------
Victoria Whyte
Authorised
Signatory for and on
behalf
of GlaxoSmithKline plc