UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of May 2022
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: 31 May 2022, London UK - LSE announcement
GSK to acquire clinical-stage biopharmaceutical company Affinivax,
Inc.
●
GSK
to pay $2.1 billion upfront and up to $1.2 billion in potential
development milestones
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Proposed
acquisition provides access to next-generation 24-valent
pneumococcal vaccine candidate in phase II development and highly
innovative, MAPSTM technology
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Supports
development of a strong portfolio of innovative vaccines and
specialty medicines
GSK plc (LSE/NYSE: GSK) today announced that it has entered into a
definitive agreement to acquire Affinivax, Inc. (Affinivax), a
clinical-stage biopharmaceutical company based in Cambridge,
Boston, Massachusetts, for a $2.1 billion upfront payment and up to
$1.2 billion in potential development milestones. Affinivax is
pioneering the development of a novel class of vaccines, the most
advanced of which are next-generation pneumococcal
vaccines.
Pneumococcal
disease includes pneumonia, meningitis, bloodstream infections, and
milder diseases such as sinusitis and otitis media and remains a
significant unmet medical need despite the availability of current
pneumococcal vaccines. There are many different pneumococcal
serotypes. The number of serotypes in current vaccines is limited
due to the degree of immunological interference observed when using
existing conjugation technologies.
Affinivax
has developed the Multiple Antigen Presenting System (MAPS), a
novel technology that supports higher valency than conventional
conjugation technologies, enabling broader coverage against
prevalent pneumococcal serotypes and potentially creating higher
immunogenicity than current vaccines. Affinivax's most advanced
vaccine candidate (AFX3772) includes 24 pneumococcal
polysaccharides plus two conserved pneumococcal proteins (compared
to up to 20 serotypes in currently approved vaccines). A 30-plus
valent pneumococcal candidate vaccine is also in pre-clinical
development.
Dr Hal Barron, Chief Scientific Officer and President
R&D, GSK, said: "The
proposed acquisition further strengthens our vaccines R&D
pipeline, provides access to a new, potentially disruptive
technology, and broadens GSK's existing scientific footprint in the
Boston area. We look forward to working with the many talented
people at Affinivax to combine our industry-leading development,
manufacturing, and commercialisation capabilities to make this
exciting new technology available to those in
need."
In the adult phase I/II clinical trials, AFX3772 was well tolerated
in participants and demonstrated good immune responses compared to
the current standard of care. In July 2021, the US Food and Drug
Administration granted Breakthrough Therapy designation for AFX3772
to prevent S. pneumoniae invasive disease and pneumonia in adults
50 years and above. Phase III is expected to start in the short
term. Phase I/II clinical trials to assess the use of the vaccine
in paediatrics are planned to begin later this year.
"Affinivax grew out of our founders' scientific and personal vision
to drive vaccine innovation to make a meaningful impact on people's
lives, in both developed and developing
countries," said Steven Brugger, CEO of
Affinivax, Inc. "Over the past
eight years, we have taken that vision from the initial development
of our MAPS™ vaccine platform at Boston Children's Hospital
to a pipeline of novel vaccines with our lead vaccine candidate in
late-stage clinical studies. We are proud that GSK has recognized
our team's accomplishments and are confident that GSK is an ideal
new home for our MAPS platform and the team behind its success.
GSK's significant capabilities will enable continued advances with
MAPS to improve existing vaccines - as is the case with our lead
Streptococcus pneumoniae MAPS vaccine program - and develop
vaccines that combat novel and resistant infectious diseases for
which there are no effective immunization strategies available
today."
Financial considerations
Under the terms of the agreement, GSK will acquire 100% of the
outstanding shares of Affinivax. The consideration for the
acquisition comprises an upfront payment of $2.1 billion to be paid
upon closing and two potential milestone payments of $0.6 billion
to be paid upon the achievement of certain paediatric clinical
development milestones. The transaction is subject to customary
closing conditions, including the expiration or early termination
of the waiting period under the Hart-Scott- Rodino Anti-Trust
Improvements Act of 1976. The transaction is expected to close in
the third quarter of 2022.
GSK will account for the transaction as a business
combination.
New GSK reaffirms its full-year 2022 guidance and the medium-term
outlook for 2021-2026 of more than 5% sales and 10% adjusted
operating profit CAGR* at CER**.
* CAGR: Compound Annual Growth Rate; **CER: Constant Exchange
Rate
Pneumococcal disease
The bacterium Streptococcus pneumoniae causes pneumococcal disease.
There are multiple types of pneumococcal disease, including
bloodstream infections (sepsis), pneumonia, meningitis, and other
milder diseases such as sinusitis and otitis media. A significant
unmet medical need remains despite the availability of current
vaccines. Pneumococcal pneumonia causes an estimated 150,000
hospitalisations each year in the United States; pneumococcal
meningitis and bacteremia killed approximately 3,250 people in the
United States in 2019[i].
MAPSTM technology
platform
Multiple Antigen Presenting System (MAPS) is a novel and highly
efficient vaccine technology platform that enables the precise,
high-affinity binding of disease-relevant polysaccharides to
disease-relevant protein antigens in a single vaccine. Immunisation
with the resulting polysaccharide-protein complexes induces a broad
and potentially protective B-cell (antibody) response to the
polysaccharides and a separate B-cell and T-cell immune response to
the proteins. The distinctive plug-and-play nature of MAPS enables
the targeting of a broad range of infectious diseases.
The
initial use of the technology has been directed primarily toward
preventing pneumococcal disease. Applicability of the technology
has also been demonstrated for additional infectious disease
pathogens, including those that cause hospital-acquired
infections.
About GSK
GSK is a science-led global healthcare company. For further
information please visit www.gsk.com/about-us.
GSK enquiries:
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Media
enquiries:
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Tim
Foley
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+44 (0)
20 8047 5502
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(London)
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Simon
Moore
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+44 (0)
20 8047 5502
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(London)
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Kathleen
Quinn
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+1 202
603 5003
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(Washington
DC)
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Analyst/Investor
enquiries:
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Nick
Stone
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+44 (0)
7717 618834
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(London)
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Sonya
Ghobrial
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+44 (0)
7392 784784
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(Consumer)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Mick
Readey
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+44 (0)
7990 339653
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(London)
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Josh
Williams
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+44 (0)
7385 415719
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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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Frannie
DeFranco
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+1 215
751 4855
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(Philadelphia)
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GSK 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 in GSK's Annual
Report on Form 20-F for 2021 and any impacts of the COVID-19
pandemic. The assumptions and basis for GSK's 2022
Guidance and Outlook are set out on page 43 of GSK's first quarter
2022 earnings release and page 69 of the GSK 2021 Annual
Report. Definitions of Adjusted results, CER growth, CAGR and new
GSK are set out on pages 42 of GSK's first quarter
2022 earnings release and pages 56 and 59 of the GSK 2021
Annual Report.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
[i] US
Centers for Disease Control and Prevention
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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GSK plc
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(Registrant)
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Date: May
31, 2022
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By:/s/ VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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