– Companies to Develop Highly Specific
Inhibitors of Local TGFβ Activation –
Gilead Sciences, Inc. (NASDAQ: GILD) and Scholar Rock Holding
Corporation (NASDAQ: SRRK) announced today that the companies have
entered into a strategic collaboration to discover and develop
highly specific inhibitors of transforming growth factor beta
(TGFβ) activation for the treatment of fibrotic diseases.
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Under the collaboration, Gilead has exclusive options to license
worldwide rights to product candidates that emerge from three
Scholar Rock TGFβ programs: inhibitors that target activation of
latent TGFβ1 with high affinity and specificity, inhibitors that
selectively target activation of latent TGFβ1 localized to
extracellular matrix, and a third TGFβ discovery program. Scholar
Rock is responsible for antibody discovery and preclinical research
through product candidate nomination, after which, upon exercising
the option for a program, Gilead will be responsible for the
program’s preclinical and clinical development and
commercialization. Scholar Rock retains exclusive worldwide rights
to discover, develop, and commercialize certain TGFβ inhibitors for
oncology and cancer immunotherapy.
“Gilead is committed to developing innovative therapies that
address a range of fibrotic diseases, including non-alcoholic
steatohepatitis and diabetic kidney disease,” said John
McHutchison, MD, AO, Chief Scientific Officer and Head of Research
and Development, Gilead Sciences. “We are excited to work with
Scholar Rock to investigate this novel approach to TGFβ inhibition
as an important aspect of our research programs in fibrotic
diseases.”
In connection with the collaboration agreement, Scholar Rock
will receive $80 million in upfront payments, comprised of $50
million cash and $30 million purchase of Scholar Rock Holding
Corporation common stock. In addition, Scholar Rock will receive a
one-time milestone payment of $25 million upon the successful
completion of specific preclinical studies and be eligible to
receive up to an additional $1,425 million in potential payments
aggregated across all three programs based on the successful
achievement of certain research, development, regulatory and
commercialization milestones. Scholar Rock would also receive high
single-digit to low double-digit tiered royalties on sales of
potential future products originating from the collaboration.
“Gilead’s commitment to developing innovative therapies for
fibrotic diseases makes the company an ideal partner to maximize
the value of candidates from our TGFβ program,” said Nagesh
Mahanthappa, Ph.D, President and CEO of Scholar Rock. “This
collaboration also emphasizes our belief in the tremendous
potential of Scholar Rock’s broad pipeline of highly specific
modulators targeting the TGFβ superfamily, with potential
applications in a wide range of serious diseases, including
neuromuscular disorders, cancer, fibrosis and anemia.”
Fibrosis is a debilitating pathological feature of many diseases
that scars tissues and vital organs and is a major cause of
morbidity and mortality. TGFβ-driven signaling is thought to be a
central regulator of fibrosis. Inhibitors of TGFβ signaling
discovered through Scholar Rock’s proprietary platform have been
shown to selectively prevent the activation of the growth factor in
the fibrotic matrix in vitro and in preclinical models. By
targeting the disease microenvironment, these highly specific
inhibitors of TGFβ activation may offer a novel approach to
suppressing pro-fibrotic signaling in multiple organs.
About Scholar Rock
Scholar Rock is a clinical-stage biopharmaceutical company
focused on the discovery and development of innovative medicines
for the treatment of serious diseases in which signaling by protein
growth factors plays a fundamental role. Scholar Rock is
creating a pipeline of novel product candidates with the potential
to transform the lives of patients suffering from a wide range of
serious diseases, including neuromuscular disorders, cancer,
fibrosis and anemia. Scholar Rock’s newly elucidated understanding
of the molecular mechanisms of growth factor activation enabled it
to develop a proprietary platform for the discovery and
development of monoclonal antibodies that locally and selectively
target these signaling proteins at the cellular level. Scholar Rock
believes its focus on biologically validated growth factors may
facilitate a more efficient development path. For more information,
please visit www.ScholarRock.com or follow Scholar Rock
on Twitter (@ScholarRock) and LinkedIn
(https://www.linkedin.com/company/scholar-rock/).
Scholar Rock® is a registered trademark of Scholar Rock,
Inc.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City,
California. For more information on Gilead Sciences, please visit
the company’s website at www.gilead.com.
Scholar Rock Forward-Looking
Statement
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995, including, but not limited to, statements regarding Scholar
Rock’s future expectations, plans and prospects, including without
limitation, Scholar Rock’s expectations regarding the potential of
the TGFβ program and Scholar Rock’s collaboration with Gilead. The
use of words such as “may,” “might,” “will,” “should,” “expect,”
“plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,”
“future,” “potential,” or “continue,” and other similar expressions
are intended to identify such forward-looking statements. All such
forward-looking statements are based on management’s current
expectations of future events and are subject to a number of risks
and uncertainties that could cause actual results to differ
materially and adversely from those set forth in or implied by such
forward-looking statements.
These risks and uncertainties include those risks more fully
discussed in the section entitled “Risk Factors” in Scholar Rock’s
Quarterly Report on Form 10-Q for the quarter ended September
30, 2018, as well as discussions of potential risks, uncertainties,
and other important factors in Scholar Rock’s subsequent filings
with the Securities and Exchange Commission. Any
forward-looking statements represent Scholar Rock’s views only as
of today and should not be relied upon as representing its views as
of any subsequent date. All information in this press release
is as of the date of the release, and Scholar
Rock undertakes no duty to update this information unless
required by law.
Gilead Forward-Looking
Statement
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 the risk that the parties may not realize the potential
benefits of this collaboration and Gilead may fail to develop
and/or commercialize any product candidates from the TGFβ program.
All statements other than statements of historical fact are
statements that could be deemed forward-looking statements. These
risks, uncertainties and other factors could cause actual results
to differ materially from those referred to in the forward-looking
statements. The reader is cautioned not to rely on these
forward-looking statements. These and other risks are described in
detail in Gilead’s Quarterly Report on Form 10-Q for the quarter
ended September 30, 2018, as filed with the U.S. Securities and
Exchange Commission. All forward-looking statements are based on
information currently available to Gilead, and Gilead assumes no
obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please
visit the company’s website at www.gilead.com, follow Gilead on
Twitter (@GileadSciences) or call Gilead Public Affairs at
1-800-GILEAD-5 or 1-650-574-3000.
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version on businesswire.com: https://www.businesswire.com/news/home/20181219005363/en/
Gilead Contacts
Investors:Sung Lee+1 650-524-7792
Media:Arran Attridge+1 650-425-8975
Scholar Rock Contacts
Investors/Media:Catherine Huchu@scholarrock.com+1
917-601-1649
Media:Kathryn MorrisKathryn@theyatesnetwork.com+1
914-204-6412
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