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 2025
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(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 . . . . . . . .
Issued: 14 May 2025, London UK
GSK to acquire efimosfermin, a phase III-ready potential
best-in-class specialty medicine to treat and prevent progression
of steatotic liver disease (SLD)
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Affecting
up to 5% of the global population, SLD represents an area of
significant unmet medical need with limited treatment
options
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Phase
II data show potential of efimosfermin to reverse liver fibrosis,
demonstrated in metabolic dysfunction-associated steatohepatitis (a
form of SLD)
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Unique
properties offer potential for efimosfermin to be a new
standard-of-care
●
Significantly
expands GSK's hepatology pipeline aimed at addressing steatotic and
viral drivers of liver disease, offering multiple development
options and potential first launch in 2029
GSK plc (LSE/NYSE: GSK) and Boston Pharmaceuticals, a leading
clinical stage biopharmaceutical company developing highly targeted
therapies for patients with serious liver diseases, today announced
that they have entered into an agreement under which GSK will
acquire Boston Pharmaceuticals' lead asset, efimosfermin alfa.
Efimosfermin is a phase III-ready, potential best-in-class,
investigational specialty medicine to treat and prevent progression
of steatotic liver disease (SLD). Under the agreement, GSK will pay
$1.2 billion upfront, with potential for additional success-based
milestone payments totalling $800 million.
Efimosfermin is a novel, once-monthly fibroblast growth factor 21
(FGF21) analog therapeutic in clinical development for the
treatment of metabolic dysfunction-associated steatohepatitis
(MASH), including cirrhosis, and future development in
alcohol-related liver disease (ALD), both forms of SLD. Given
efimosfermin's direct antifibrotic mechanism of action and GSK's
data-driven insights from work in human genetics and disease
phenotyping, it has potential to address more advanced stages of
SLD and opportunity in combination with GSK'990, a siRNA
therapeutic in development for other subsets of patients with
SLD.
The acquisition of efimosfermin is highly aligned to GSK's R&D
focus on science related to the immune system and is further
evidence of the company's intent to build on its deep understanding
of fibrosis and auto-inflammation to develop precision
interventions that stop and reverse disease
progression.
SLD represents an area of significant unmet medical need affecting
approximately 5% of the global population with limited therapeutic
options for patients.1 SLD,
including MASH and ALD, is characterised by the accumulation of fat
in the liver (steatosis), with associated inflammation and
fibrosis. ALD affects about 26 million patients globally, and
together with MASH, is the leading cause of liver transplant in the
US, representing a significant burden and cost on healthcare
utilisation.1,3 Substantial
and disproportionate costs are associated with end-stage liver
disease. Interventions that reduce moderate-to-advanced fibrosis to
prevent progression of cirrhosis, liver cancer, hospitalisations
and transplant could save the US healthcare system between $40 -
100 billion over the next two decades.4
Recent data from a phase II trial of efimosfermin, designed to
assess the efficacy and safety of a monthly subcutaneous dose in
participants with biopsy-confirmed moderate-to-advanced (F2 or F3)
MASH, showed that efimosfermin rapidly and significantly reversed
liver fibrosis and stopped its progression, with a manageable
tolerability profile. These data suggest potentially greater
fibrosis improvement compared to that seen with other therapeutic
approaches and with benefit expected independent of background
glucagon-like peptide-1 (GLP-1) therapy. In addition, efimosfermin
could offer triglyceride reduction and improved glycaemic control,
important considerations for MASH patients who frequently face
cardiometabolic co-morbidities. Efimosfermin's unique properties,
including low immunogenicity and an extended half-life, also offer
the potential for a monthly dosing regimen and improved patient
convenience. Full data from the trial was presented at the American
Association for the Study of Liver Diseases
(AASLD) Meeting in
November 2024.5
Tony Wood, Chief Scientific Officer, GSK said: "The
FGF21 class has shown some of the most exciting data in MASH
including first-in-disease evidence of cirrhosis reversal, and
efimosfermin has the potential to define a new standard-of-care
with its monthly dosing and tolerability profile. Efimosfermin will
significantly expand our hepatology pipeline and provide us the
opportunity to develop a new potential best-in-class medicine with
first launch expected in 2029. It complements GSK'990, also in
development for ALD and MASH, offering GSK options to develop both
monotherapy and potential combinations to improve patient
outcomes."
Elias Zerhouni MD, Chair of the Board, Boston Pharmaceuticals,
said: "I
am very proud of today's agreement with GSK, a company I know and
admire with proven expertise in liver disease, and the outstanding
work of the Boston Pharmaceuticals team. This would not have been
possible without the impressive, sustained and long-term strategic
commitment to leading science and biotechnology ventures from the
Bertarelli family, and the expertise of Ernesto Bertarelli, which
led to the development of efimosfermin as a potential best-in-class
therapy. We are delighted that GSK, a global leader, recognised
efimosfermin's potential to address a growing global public health
concern and unmet medical need. Together, we look forward to
efimosfermin's ongoing journey to become a best-in-class treatment
for patients with SLD."
The addition of efimosfermin further strengthens GSK's hepatology
pipeline of specialty medicines aimed at addressing both viral
(chronic hepatitis B) and steatotic (SLD) drivers of fibrotic liver
diseases.
Financial considerations
Under the terms of the agreement, GSK will acquire BP Asset IX,
Inc., a subsidiary of Boston Pharmaceuticals, to access
efimosfermin. GSK will pay up to $2 billion of total cash
consideration, comprising an upfront payment of $1.2 billion and up
to $800 million in success-based milestone payments. GSK will also
be responsible for success-based milestone payments as well as
tiered royalties for efimosfermin owed to Novartis Pharma
AG.
GSK will account for the transaction as a business combination.
This transaction is subject to customary conditions, including
applicable regulatory agency clearances under the Hart-Scott-Rodino
Act in the US.
For GSK, Evercore Partners International LLP is acting as exclusive
financial advisor and Cleary Gottlieb Steen & Hamilton LLP as
legal counsel.
For Boston Pharmaceuticals, Centerview Partners LLC is acting as
exclusive financial advisor and Sullivan & Cromwell LLP as
legal counsel.
About efimosfermin alfa
Efimosfermin is an investigational, once-monthly subcutaneous
injection of a long-acting variant of FGF21 that is designed to
regulate key metabolic pathways to decrease liver fat, ameliorate
liver inflammation, and reverse liver fibrosis in patients with
MASH. Efimosfermin is currently in trials for moderate to
advanced fibrosis, including cirrhosis and is not available for
prescription anywhere in the world.
About Boston Pharmaceuticals
Boston Pharmaceuticals is a clinical-stage biopharmaceutical
company that leverages an experienced and committed drug
development team to advance a portfolio of highly differentiated
therapies that may address important unmet medical needs in serious
liver diseases. Boston Pharmaceuticals is a portfolio company
of B-Flexion, a private, entrepreneurial investment firm which
manages the combined funds and investments associated with the
Bertarelli family and also partners with sophisticated capital to
meet the shared goal of delivering exceptional value over the
generations, while also contributing positively to
society.
About GSK
GSK is a global biopharma company with a purpose to unite science,
technology, and talent to get ahead of disease together. Find out
more at gsk.com.
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GSK enquiries
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Media:
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Tim
Foley
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+44 (0)
20 8047 5502
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(London)
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Sarah
Clements
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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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Lyndsay
Meyer
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+1 202
302 4595
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(Washington
DC)
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Investor
Relations:
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Constantin
Fest
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+44 (0)
7831 826525
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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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Mick
Readey
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+44 (0)
7990 339653
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(London)
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Steph
Mountifield
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+44 (0)
7796 707505
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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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Boston Pharma enquiries
Media: Sasha Damouni Ellis +1 (646) 240
2311; [email protected] (New
York)
David Patti +1 (908) 421 5971; [email protected] (New
York)
B-Flexion enquiries
Media: Blair Hennessy +1 (646) 757
0632; [email protected] (New
York)
Emma Prenn-Vasilakis +1 (917) 763
6685; [email protected] (Boston)
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 the "Risk
Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q1 Results for 2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
1
Global Burden of Disease Study 2017 Cirrhosis collaborators.
2020
2 Allen
et al. Postgraduate Medicine. 2024, Vol 136, No. 3,
229-245.
3
Younossi et al. Hepatol Commun. 2023 Dec 22;8(1):e0352
4
Wallace, Carolyn et al. Journal of Hepatology, Volume 0, Issue
0
5 Hepatology (2004) Late-Breaking
Abstract Supplement p28-30 TLM2024LBA_20241115A.pdf
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
14, 2025
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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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