-- Strategic Partnership Strengthens Gilead’s
Inflammation Research Portfolio with the Addition of LEO Pharma’s
Preclinical Oral STAT6 Program, Including Targeted Protein
Degraders --
-- Gilead Will Have Exclusive Global Rights to
the STAT6 Program, and LEO Pharma Will Have the Option to
Co-Commercialize for Dermatology Indications Outside the U.S.
--
-- LEO Pharma to Maintain Global Rights to
Topical Formulations of the STAT6 Program in Dermatology --
Gilead Sciences, Inc. (Nasdaq: GILD) and LEO Pharma today
announced a strategic partnership to accelerate the development and
commercialization of LEO Pharma’s small molecule oral STAT6 (signal
transducer and activator of transcription 6) programs for the
potential treatment of patients with inflammatory diseases.
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the full release here:
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STAT6 is the specific transcription factor required for IL-4 and
IL-13 cytokine signaling, which are clinically validated targets
for Th2 mediated inflammatory conditions such as atopic dermatitis,
asthma, and COPD, amongst many others. Targeting STAT6 has shown
potential preclinically to treat a broad population of patients and
provide an oral alternative to those currently treated with
injectable biologics.
Under this partnership, Gilead will acquire LEO Pharma’s
comprehensive preclinical oral STAT6 small molecule inhibitors and
targeted protein degraders. Gilead will lead further development
efforts for the oral programs, while LEO Pharma will lead
development for potential topical formulations of STAT6
inhibitors.
“As we continue to expand our inflammation portfolio, we're
committed to developing next-generation therapies to support
long-term remission in patients with inflammatory diseases through
mechanisms that block major pathogenic pathways, eliminate
pathogenic cells, tolerize the immune system, and restore cell
function,” said Flavius Martin, M.D., Executive Vice President,
Research, Gilead Sciences. “By partnering with LEO Pharma, we hope
to explore the potential of the STAT6 pathway to bring forward an
oral option for patients suffering from chronic inflammatory
conditions.”
“STAT6 holds potential for treating various inflammatory
diseases, including outside dermatology. This strategic partnership
with Gilead will enable us to accelerate the development of the
STAT6 program and maximize its potential in dermatology and
beyond,” said Christophe Bourdon, CEO of LEO Pharma. “This
partnership acknowledges LEO Pharma’s scientific capabilities and
strengthens our commitment to innovate for people with skin
diseases.”
Terms of the Agreement
Gilead will have global rights to develop, manufacture, and
commercialize the small molecule oral STAT6 program. LEO Pharma
will have the option to potentially co-commercialize oral programs
for dermatology outside the United States. LEO Pharma will hold
exclusive global rights to STAT6 topical formulations in
dermatology.
LEO Pharma is eligible to receive up to $1.7 billion in total
payments, including an upfront payment of $250 million. In
addition, LEO Pharma may also receive tiered royalties ranging from
high single-digit to mid-teens on sales of oral STAT6 products.
Gilead may receive tiered royalties ranging from high single-digit
to mid-teens on sales of topical STAT6 products.
Gilead does not exclude acquired IPR&D expenses from its
non-GAAP financial measures. This transaction with LEO Pharma is
expected to reduce Gilead’s GAAP and non-GAAP 2025 EPS by
approximately $0.15 - $0.17.
Bank of America Securities acted as financial advisors to LEO
Pharma in this transaction and Latham Watkins LLP acted as legal
advisors.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has
pursued and achieved breakthroughs in medicine for more than three
decades, with the goal of creating a healthier world for all
people. The company is committed to advancing innovative medicines
to prevent and treat life-threatening diseases, including HIV,
viral hepatitis, COVID-19, cancer, and inflammation. Gilead
operates in more than 35 countries worldwide, with headquarters in
Foster City, Calif.
About LEO Pharma
LEO Pharma is a global company dedicated to advancing the
standard of care through innovation for the benefit of people with
skin conditions. LEO Pharma is co-owned by majority shareholder the
LEO Foundation and, since 2021, Nordic Capital. LEO Pharma offers a
broad portfolio of treatments, serving 100 million patients
annually. Headquartered in Denmark, LEO Pharma has a global team of
4,000 people. In 2023, the company generated net sales of $1.6
billion. Read more at www.leo-pharma.com.
Gilead Forward-Looking
Statements
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including Gilead’s ability to realize the anticipated benefits from
the partnership; difficulties or unanticipated expenses in
connection with the partnership and the potential effects on
Gilead’s earnings; the ability of Gilead to initiate, progress or
complete clinical trials within currently anticipated timelines or
at all, and the possibility of unfavorable results from ongoing or
additional trials, including those involving programs developed
pursuant to the partnership; the ability of Gilead to file
applications for regulatory approval or receive regulatory
approvals in a timely manner or at all for the investigational
programs developed pursuant to the partnership, and the risk that
any such approvals may be subject to significant limitations on
use; the possibility that Gilead may make a strategic decision to
discontinue development of any of the investigational programs
developed pursuant to the partnership, and therefore these programs
may never be successfully commercialized; and any assumptions
underlying any of the foregoing. These and other risks,
uncertainties and other factors are described in detail in Gilead’s
Quarterly Report on Form 10-Q for the quarter ended September 30,
2024, as filed with the U.S. Securities and Exchange Commission.
These risks, uncertainties and other factors could cause actual
results to differ materially from those referred to in the
forward-looking statements. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. The reader is cautioned that any such forward-looking
statements are not guarantees of future performance and involve
risks and uncertainties and is cautioned not to place undue
reliance on these forward-looking statements. All forward-looking
statements are based on information currently available to Gilead,
and Gilead assumes no obligation and disclaims any intent to update
any such forward-looking statements.
Gilead and the Gilead logo are trademarks of
Gilead Sciences, Inc., or its related companies. The LEO Pharma
name and logo are trademarks of LEO Pharma.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on X/Twitter
(@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
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version on businesswire.com: https://www.businesswire.com/news/home/20250111983856/en/
Gilead Info Jessica Smith,
Media public_affairs@gilead.com
Jacquie Ross, Investors investor_relations@gilead.com
LEO Pharma Info Jeppe
Ilkjaer, Media jeilk@leo-pharma.com
Christian Soerup Ryom, Investors chsoe@leo-pharma.com
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