TIDMGSK
RNS Number : 3650N
GSK PLC
31 May 2022
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
-- Proposed acquisition provides access to next-generation
24-valent pneumococcal vaccine candidate in phase II development
and highly innovative, MAPS(TM) technology
-- 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(TM) 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] .
MAPS (TM) 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:
Media enquiries: Tim Foley +44 (0) 20 8047 (London)
5502
Simon Moore +44 (0) 20 8047 (London)
5502
Kathleen Quinn +1 202 603 5003 (Washington
DC)
Analyst/Investor Nick Stone +44 (0) 7717 618834 (London)
enquiries:
Sonya Ghobrial +44 (0) 7392 784784 (Consumer)
James Dodwell +44 (0) 20 8047 (London)
2406
Mick Readey +44 (0) 7990 339653 (London)
Josh Williams +44 (0) 7385 415719 (London)
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Frannie DeFranco +1 215 751 4855 (Philadelphia)
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
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