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
21
June 2017
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.
Issued:
21 June 2017, London UK - LSE
GSK presents positive results from Phase III revaccination study of
its candidate shingles vaccine Shingrix at CDC's Advisory
Meeting
Study conducted in individuals who had previously received current
standard of care
GSK
[LSE/NYSE: GSK] today will be presenting new results from a
clinical study showing that its candidate vaccine for the
prevention of herpes zoster (shingles) in people aged 50 years or
older, Shingrix (HZ/su) , induces a strong immune response in older
adults who have previously been vaccinated against shingles with
the currently available live-attenuated zoster vaccine (ZVL)
.
The results of the
Zoster-048 study will be presented today at the US Centers for
Disease Control and Prevention's Advisory Committee on Immunization
Practices (ACIP) meeting.
The
study met its primary objective of demonstrating non-inferior
immune response (i.e. antibody concentrations). People who received
the ZVL vaccine at least 5 years prior to being vaccinated with
Shingrix showed a similar immune response to people without
previous exposure to the ZVL vaccine. In addition, Shingrix was
well-tolerated in both study groups when assessed up to one month
after the second dose of Shingrix.
GSK is
sharing these data on safety, local and systemic reactions, and
immunogenicity with the US Food and Drug Administration (FDA) and
expects that the data could eventually inform a policymaking
decision regarding revaccination for protection against shingles
with Shingrix. The ongoing study of 430 adults aged 65 years and
older was designed as a prospective, group-matched, non-randomised,
open-label, multicentre trial in those previously vaccinated with
ZVL at least 5 years earlier and in previously unvaccinated
subjects.
The
current standard of care ZVL provides protection against shingles,
but studies suggest that this protection wanes over time.
1,
2
Dr. Thomas Breuer, Senior Vice President and Chief Medical
Officerof GSK Vaccines said:
" We are encouraged by these
results, which indicate that Shingrix can be an option for adults
over 50 years of age, who previously received the currently
available vaccine and are seeking to benefit from revaccination
with Shingrix, if recommended ."
Zoster-048
is focused on the immune response and safety of Shingrix, rather
than efficacy, and builds on previously released clinical trial
data where the immunogenicity and efficacy were tested
simultaneously. The most common local and systemic reactions were
in line with previous observations and no clinically significant
safety signs were observed.
In two
separate phase III studies, ZOE-50 and ZOE-70, Shingrix
demonstrated
efficacy against shingles above 90%, independent of age (>50,
>70, >80 years of age), as well as sustained efficacy over
the entire follow-up period of 4 years.
3,4
The
study presented today has been submitted for publication in a
peer-reviewed scientific journal.
The
candidate shingles vaccine, Shingrix, was submitted for regulatory
approval to the FDA in October 2016, to Canadian regulatory
authorities and the European Medicines Agency in November 2016, and
to Japanese regulatory authorities in April 2017. Shingrix is not
currently approved for use anywhere in the world.
About the Zoster-048 study
The
prospective, group-matched, non-randomised, open-label, multicentre
Zoster-048 (NCT02581410) trial of 430 adults aged 65 years and
older assessed the safety, local and systemic reactions, and
immunogenicity of Shingrix in older adults (65 years and above) who
have previously been vaccinated against shingles with the currently
available live-attenuated zoster vaccine at least 5 years earlier
and in previously unvaccinated subjects.
The
phase III programme, involving more than 37,000 subjects globally,
previously evaluated the efficacy, safety and immune response of
two doses of GSK's candidate shingles vaccine given intramuscularly
two months apart in older adults. Data from the completed studies,
ZOE-50 and ZOE-70, were previously presented to the US Centers for
Disease Control and Prevention's Advisory Committee on Immunization
Practices and published in a peer-reviewed medical journal.
3 ,
4
Additional
trials are underway in solid and haematological cancer patients,
haematopoietic stem cell and renal transplant recipients. 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 (shingles) and its complications and combines
glycoprotein E, a protein found on the varicella zoster virus
(VZV), with an adjuvant system, AS01
B
, which is
intended to enhance the immunological response to the antigen.
5
The name
"Shingrix" has not yet been approved for use by any regulatory
authority .
Notes to editors
Zoster
Vaccine Live (ZVL), Zostavax
®
, is a
registered trademark of Merck Sharpe & Dohme corp.
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 VZV
during childhood. The individual lifetime risk in the US of
developing shingles is approximately one in three; however, this
increases to one in two in people aged 85 and over. A person's risk
for shingles increases after 50 years of age due to a natural
age-related decline in immune system function.
6
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.
7
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:
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UK
Media enquiries:
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David
Mawdsley
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+44 (0)
20 8047 5502
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(London)
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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David
Daley
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+44 (0)
20 8047 5502
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(London)
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Melinda
Stubbee
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+44 (0)
20 8047 5502
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(London)
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US
Media enquiries:
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Sarah
Alspach
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+1 202
715 1048
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(Washington,
DC)
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Sarah
Spencer
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+1 215
751 3335
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(Philadelphia)
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Mary
Anne Rhyne
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+1 919
483 0492
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(North
Carolina)
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Jenni
Ligday
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+1 202
715 1049
|
(Washington,
DC)
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Karen
Hagens
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+1 919
483 2863
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(North
Carolina)
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Gwynne
Oosterbaan
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+1 215
751 7468
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(Philadelphia)
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Analyst/Investor
enquiries:
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Sarah
Elton-Farr
|
+44 (0)
20 8047 5194
|
(London)
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Tom
Curry
|
+ 1 215
751 5419
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(Philadelphia)
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Gary
Davies
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+44 (0)
20 8047 5503
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Cautionary
statement regarding forward-looking statements
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. Such factors
include, but are not limited to, those described under Item 3.D
'Principal risks and uncertainties' in the company's Annual Report
on Form 20-F for 2016.
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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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1
Morrison, et al. Clin Infect Dis. 2015 ; 60(6): 900-9.
Long-term persistence of zoster vaccine efficacy.
2
Tseng, et al. J Infect Dis.2016 ; 213(12): 1872-5.
Declining Effectiveness of Herpes Zoster Vaccine in Adults Aged
≥60 Years.
3
Lal, et al. N Engl J Med. 2015; 372: 2087-96. Efficacy of
an Adjuvanted Herpes Zoster Subunit Vaccine in Older
Adults.
4
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.
5
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.
6
Harpaz, et al. MMWR Recomm Rep.2008; 57(5): 1-30.
Prevention of herpes zoster: recommendations of the Advisory
Committee on Immunization Practices.
7
Cohen, et al. N Engl J Med.2013; 369(3): 255-63. Clinical
practice: Herpes zoster.
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.
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GlaxoSmithKline plc
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(Registrant)
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Date: June
21, 2017
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By: VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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