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 24 October 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:
24 October 2016, London UK - LSE Announcement
GSK announces US regulatory submission of candidate vaccine for
prevention of shingles
- Regulatory
submissions in the EU and Canada remain on track for
2016
GlaxoSmithKline
plc (LSE/NYSE: GSK) today announced that it has submitted a
Biologics License Application (BLA) for its candidate shingles
vaccine, ShingrixTM, to the United
States Food and Drug Administration (FDA), seeking approval 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.
Dr Emmanuel Hanon, Senior Vice President and Head of Vaccines
R&D, GSK said: "Shingles is a common and potentially
serious condition. It can cause lasting pain and other
complications such as scarring or visual impairment, which can
severely impact the quality of people's lives. The risk of
developing shingles increases with age and it is estimated that up
to one in every three people is at risk. 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
regulatory submission for Shingrix 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
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.
Regulatory
submissions in the European Union and Canada are on track for 2016
and planned for Japan in 2017. GSK's shingles candidate vaccine is
not currently approved for use anywhere in the world.
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:
●
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 Shingrix
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. The name
Shingrix has been approved by the European Medicines
Agency.
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.
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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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Catherine
Hartley
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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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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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Tom
Curry
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+ 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
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.
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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: October
24, 2016
By: VICTORIA
WHYTE
----------------------
Victoria Whyte
Authorised
Signatory for and on
behalf
of GlaxoSmithKline plc