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 15 September 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
22.00
BST, 14 September 2016, London UK
GSK's
candidate shingles vaccine shows high efficacy against shingles and
its complications in adults aged 70 years and over in phase III
study published in NEJM
GSK
on track to file regulatory applications in 2016
GSK
(LSE/NYSE: GSK) today announced the publication of detailed results
from a randomised phase III study (ZOE-70) of its investigational
shingles vaccine, Shingrix™, showing 90% efficacy in adults
aged 70 years and older that is maintained for at least four
years1.
The results were published in the New England Journal of Medicine
(NEJM).
The
study, from which headline results were reported in October 2015,
showed that the two-dose
candidate shingles vaccine had 90% efficacy (95% confidence
interval: 84-94%) compared to placebo in people over 70 years
old. Vaccine efficacy
was maintained across the various age groups included in the study,
ranging between 90% in people aged 70-79 years (95% confidence
interval: 83-94%) and 89% in those aged 80 years and
above1 (95% confidence
interval: 74-96%)1.
The
high efficacy is in line with the results of the ZOE-50 trial, a
study in people over 50 years old which was presented and published
last year showing a 97% efficacy (95% confidence interval:
93-99%)2.
A pooled analysis of data from both trials showed the vaccine
demonstrated 91% efficacy against shingles (95% confidence
interval: 86-95%) in adults aged 70 years and older compared to
placebo1.
This efficacy was maintained with an 88% reduction in the risk of
shingles (95% confidence interval: 73-95%) in the fourth year after
vaccination.
The
risk of serious adverse events, potential immune-mediated diseases
or deaths observed in ZOE-70 was similar in people receiving
Shingrix and placebo. The most commonly
reported local adverse reaction was pain at the injection site and
the most frequently reported systemic adverse reaction was
fatigue. The majority of
injection site and systemic reactions occurred within seven days of
vaccination, with most lasting 1-3 days, and generally were
mild-to-moderate in intensity1.
In
addition, a pooled analysis of data from the ZOE-70 and ZOE-50
trials showed that the candidate vaccine effectively reduced the
risk of subsequent chronic neuropathic pain, also known as
postherpetic neuralgia (PHN)1 which is the most
common, and often severe, complication of shingles3,4. The candidate
vaccine was shown to be 89% (95% confidence interval: 68-97%)
efficacious in preventing PHN in people aged 70 years and older and
91% efficacious (95% confidence interval: 75-98%) in people aged 50
years and over1.
Dr
Emmanuel Hanon, Senior Vice President, Vaccines Research and
Development, GSK, said:
"This
is the first time that such high efficacy has been demonstrated in
a vaccine candidate for older people and it is remarkable,
as
we know that these people frequently have an age-related weakening
of their immune system. If approved, this
candidate vaccine could be an important tool for the prevention of
shingles and the pain associated with it, which would significantly
impact the health and quality of life of so many
people."
Anthony
Cunningham, Executive Director of the Westmead Institute for
Medical Research in Australia and Principal Investigator of the
ZOE-70 study said:
"These
data show that this investigational vaccine
maintains high efficacy against herpes zoster in people
over 70 and 80 years of age, the age groups who are most
affected by the disease. Importantly, it also prevents a
common and feared complication of herpes zoster, prolonged pain, or
post herpetic neuralgia in these groups."
Based
on these and the previously reported ZOE-50 data2, GSK expects to
start submitting regulatory applications for the candidate vaccine
for the prevention of shingles in people 50 years and above later
this year.
About
Shingrix
Shingrix is a non-live, adjuvanted, subunit
(HZ/su) candidate vaccine to help prevent herpes zoster and its
complications. The candidate vaccine 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
antigen5.
Additional trials
to evaluate the ability of Shingrix to help prevent shingles are
ongoing in healthy people aged 50 and older and in adults with
compromised immune systems. These studies will provide additional
information with respect to the efficacy and safety profile of the
candidate vaccine as well as its ability to stimulate immune
responses in other populations and in specific
circumstances.
Notes
to editors
The
name Shingrix is not yet approved for use by regulatory authorities
in most countries, including the US Food and Drug Administration
(FDA).
About the ZOE-70 trial
The
ZOE-70 (ZOster Efficacy in adults aged 70 years and over)
(NCT01165229) study is a randomised, observer-blind,
placebo-controlled (saline solution) multicentre, multinational
(North America, Europe, Latin America, Asia-Pacific) phase III
trial involving more than 14,800 adults aged 70 years and older.
Two doses were given intramuscularly two months apart. The study,
which started in August 2010 in parallel with the ZOE-50 trial,
includes subjects in the age ranges 70-79 and ≥80 years. The
primary objective of ZOE-70 is overall vaccine efficacy against
shingles in people 70 years and over, compared to placebo. The
co-primary objectives of the pooled analysis over both studies are
the assessment of overall vaccine efficacy in reducing the risk of
developing shingles and PHN in people aged 70 years and over, using
pooled data from both ZOE-70 and ZOE-50 studies.
About
the ZOE-50 trial
The
ZOE-50 (ZOster Efficacy in adults aged 50 years and over)
(NCT01165177) study is a randomised, observer-blind,
placebo-controlled (saline solution) multicentre, multinational
(North America, Europe, Latin America, Asia-Pacific) phase III
trial involving 16,160 adults aged 50 years and older. The study
started in August 2010. Two doses were given intramuscularly two
months apart. The primary objective of this study is the overall
vaccine efficacy against shingles in people aged 50 years or older,
compared to placebo. The study includes subjects in the age ranges
50-59, 60-69, 70-79, and ≥80 years.
About
the phase III study programme
Involving more than
37,000 subjects globally, the phase III programme for GSK's
candidate shingles vaccine evaluates its efficacy, safety and
immunogenicity. In addition to older adults, the candidate vaccine
is being evaluated in immunocompromised patient populations,
including solid and haematological cancer patients, haematopoietic
stem cell and renal transplant recipients and HIV-infected
people.
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, VZV). Anyone who has been infected with
VZV is at risk of developing shingles, with age and altered immune
system being recognised as the main risk factors3,4. Complications
from shingles can include PHN, (the most common complication),
scarring, vision complications, secondary infection and nerve
palsies3,4.PHN is often
defined as a localized pain of significant intensity persisting at
least 90 days after the appearance of the acute shingles
rash4.
Data
from many countries indicate that older adults (aged 50 and over)
are at highest risk for shingles as more than 90% of older adults
have been infected with wild type VZV3. A person's risk for
shingles increases sharply after 50 years of age3. Risk of
complications, including PHN and hospitalisation, also increase
with age3.
The individual lifetime risk of developing shingles is
approximately one in three for people in the USA; however, for
individuals aged 85 and over, this risk increases to one in two
people3,4.
References
1.
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.
2.
Lal et al., N Engl J Med 2015; 372:2087-2096 Efficacy of an
Adjuvanted Herpes Zoster Subunit Vaccine in Older
Adults
3.
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
4.
Cohen et al., N Engl J Med 2013;369:255-63 Clinical practice:
Herpes zoster.
5.
The GSK proprietary AS01 adjuvant system contains QS-21
Stimulon® adjuvant licensed from Antigenics Inc, a
wholly owned
subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and
liposomes
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.
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Media enquiries:
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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
'Risk factors' in the company's Annual Report on Form 20-F for
2015.
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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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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: September
15, 2016
By: VICTORIA
WHYTE
----------------------
Victoria Whyte
Authorised
Signatory for and on
behalf
of GlaxoSmithKline plc