REG - GSK PLC - GSK to acquire Affinivax, Inc.

GSKAnnouncement

31/05/2022 07:00

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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™ 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  (#_edn1) .

 

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 (https://www.gsk.com/en-gb/about-us/) .

 

 

 GSK enquiries:
 Media enquiries:             Tim Foley         +44 (0) 20 8047 5502  (London)
                              Simon Moore       +44 (0) 20 8047 5502  (London)
                              Kathleen Quinn    +1 202 603 5003       (Washington DC)

 Analyst/Investor enquiries:  Nick Stone        +44 (0) 7717 618834   (London)
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                              James Dodwell     +44 (0) 20 8047 2406  (London)
                              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  (#_ednref1) US Centers for Disease Control and Prevention

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