REG - GSK PLC - GSK to acquire efimosfermin

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RNS Number : 6104I  GSK PLC  14 May 2025

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)

 

·   Affecting up to 5% of the global population, SLD represents an area of
significant unmet medical need with limited treatment options

·   Phase II data show potential of efimosfermin to reverse liver fibrosis,
demonstrated in metabolic dysfunction-associated steatohepatitis (a form of
SLD)

·   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
(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.aasld.org%2Fliver-meeting-tlm-2024&esheet=54153544&newsitemid=20241115839453&lan=en-US&anchor=The+Liver+Meeting&index=2&md5=38f3d60bb9c25e70dfe6d5258d344615)
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.

 

 GSK enquiries
 Media:               Tim Foley          +44 (0) 20 8047 5502  (London)
                      Sarah Clements     +44 (0) 20 8047 5502  (London)
                      Kathleen Quinn     +1 202 603 5003       (Washington DC)
                      Lyndsay Meyer      +1 202 302 4595       (Washington DC)

 Investor Relations:  Constantin Fest    +44 (0) 7831 826525   (London)
                      James Dodwell      +44 (0) 20 8047 2406  (London)
                      Mick Readey        +44 (0) 7990 339653   (London)
                      Steph Mountifield  +44 (0) 7796 707505   (London)
                      Jeff McLaughlin    +1 215 751 7002       (Philadelphia)
                      Frannie DeFranco   +1 215 751 4855       (Philadelphia)

 

Boston Pharma enquiries

 

Media: Sasha Damouni Ellis +1 (646) 240 2311; sasha@damounigroup.com
(mailto:sasha@damounigroup.com)  (New York)

David Patti +1 (908) 421 5971; dpatti@dspharmacommunications.com
(mailto:dpatti@dspharmacommunications.com)  (New York)

 

B-Flexion enquiries

 

Media: Blair Hennessy +1 (646) 757 0632; blair.hennessy@h-advisors.global
(mailto:blair.hennessy@h-advisors.global)  (New York)

Emma Prenn-Vasilakis +1 (917) 763 6685; emma.prenn-vasilakis@h-advisors.global
(mailto:emma.prenn-vasilakis@h-advisors.global)  (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:

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Registered Office:

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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
(https://www.aasld.org/sites/default/files/2024-11/TLM2024LBA_20241115A.pdf)

 

 

 

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