Collaboration will Continue to Focus on
Discovery and Development of Novel Biologic Therapeutics Across a
Range of Therapeutic Areas
Merck to Return GDF15 Receptor Agonist
Program to NGM
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, and NGM Biopharmaceuticals, Inc. (NGM) today announced that
Merck has exercised its option to extend the research phase of the
companies’ broad, strategic collaboration for an additional
two-year period from March 2020 to March 2022. The collaboration,
originally announced in February 2015, is focused on discovering,
developing and commercializing novel biologic therapeutics across a
wide range of therapeutic areas. Under the terms of the original
agreement, Merck had the option to extend the initial five-year
research and early development phase of the collaboration for an
additional two-year period and retains one additional two-year
extension option that is exercisable in 2021.
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“We are pleased that Merck has extended its collaboration with
NGM, ensuring that the important work we are doing together to
discover and develop novel medicines across a range of therapeutic
areas and high unmet needs will continue,” said Dr. David
Woodhouse, chief executive officer of NGM. “The deep resources and
scientific autonomy provided by this collaboration have enabled NGM
to amplify the output of our powerful discovery engine and maximize
our ambitious research and development goals. Together, we have
progressed several potential first-in-class drug candidates into
clinical development, including NGM313, now known as MK-3655, and
we look forward to sustaining this productivity on behalf of
patients.”
“Merck and NGM scientists have established a strong
collaboration based on our mutual commitment to scientific
excellence and the pursuit of novel meaningful therapeutics for the
treatment of disease,” said Dr. Joe Miletich, senior vice
president, preclinical and early development, Merck Research
Laboratories. “We look forward to continuing this productive
collaboration.”
During the two-year extension period, Merck will continue to
fund NGM’s research and development efforts at similar levels to
the original collaboration terms and, in lieu of the $20 million
extension fee payable to NGM, Merck will make additional payments
totaling up to $20 million in support of NGM’s research and
development activities during the two-year extension period in 2021
and 2022.
As part of the collaboration, the companies previously announced
in January 2019 that Merck exercised its option to license NGM313,
an investigational monoclonal antibody agonist of the
β-Klotho/FGFR1c receptor complex for the treatment of nonalcoholic
steatohepatitis (NASH) discovered by NGM. Merck’s one-time option
to license NGM313 (now renamed MK-3655) was triggered by NGM’s
completion of a proof-of-concept clinical study of NGM313. Merck
intends to advance MK-3655 into a Phase 2b study to evaluate the
effect of MK-3655 on liver histology and glucose control in NASH
patients with or without diabetes.
NGM’s fibroblast growth factor 19 (FGF19) program, including its
lead clinical asset NGM282, currently in Phase 2 studies for the
treatment of NASH, is excluded from the agreement and remains
wholly owned by NGM.
Merck and NGM also announced today that Merck will terminate its
license to NGM’s growth differentiation factor 15 (GDF15) receptor
agonist program, which is being developed for the treatment of
obesity, effective May 31, 2019. As part of the original
collaboration agreement, Merck received an exclusive worldwide
license to NGM’s GDF15 analogs, including NGM386 and NGM395,
protein variants of GDF15 with potential for once-daily and
once-weekly or less frequent dosing, respectively. In 2018, Merck
completed dosing of a Phase 1 multiple ascending dose clinical
trial evaluating NGM386 in otherwise healthy overweight/obese
subjects. Preliminary data from this study indicate that while
NGM386 was generally well tolerated, treatment with the drug for 28
days did not result in body weight loss relative to placebo.
Upon license termination, Merck will grant to NGM an exclusive
license under Merck’s intellectual property related to the GDF15
receptor agonist program for further development and
commercialization of products, subject to the payment of a low
single digit royalty on any future product sales back to Merck.
Merck’s decision to terminate the GDF15 program, a right stipulated
in the agreement, does not impact the remainder of the
collaboration arrangement.
“We continue to believe that the biology of GDF15 and its
cognate receptor, GFRAL, can play an important role in human
disease with potential effects on lipolysis and energy expenditure
in metabolic disease states. Upon transition of the programs back
to NGM, we will conduct an analysis of the clinical data and make a
decision about whether to pursue further development of NGM386
and/or NGM395,” said Dr. Woodhouse.
About Merck
For more than a century, Merck, a leading global
biopharmaceutical company known as MSD outside of the United States
and Canada, has been inventing for life, bringing forward medicines
and vaccines for many of the world’s most challenging diseases.
Through our prescription medicines, vaccines, biologic therapies
and animal health products, we work with customers and operate in
more than 140 countries to deliver innovative health solutions. We
also demonstrate our commitment to increasing access to health care
through far-reaching policies, programs and partnerships. Today,
Merck continues to be at the forefront of research to advance the
prevention and treatment of diseases that threaten people and
communities around the world - including cancer, cardio-metabolic
diseases, emerging animal diseases, Alzheimer’s disease and
infectious diseases including HIV and Ebola. For more information,
visit www.merck.com and connect with us on Twitter,
Facebook, Instagram, YouTube and LinkedIn.
About NGM Biopharmaceuticals, Inc.
NGM is a clinical stage biopharmaceutical company focused on
developing novel therapeutics based on scientific understanding of
key biological pathways underlying cardio-metabolic, liver,
oncologic and ophthalmic diseases. The company leverages its
biology-centric drug discovery approach to uncover novel mechanisms
of action and generate proprietary insights that enable it to move
rapidly into proof-of-concept studies and deliver potential
first-in-class medicines to patients. NGM aspires to operate one of
the most productive research and development engines in the
biopharmaceutical industry, with multiple programs in clinical
development. Visit www.ngmbio.com for more
information.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and
uncertainties. There can be no guarantees with respect to
pipeline products that the products will receive the necessary
regulatory approvals or that they will prove to be commercially
successful. If underlying assumptions prove inaccurate or
risks or uncertainties materialize, actual results may differ
materially from those set forth in the forward-looking
statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the
company’s 2018 Annual Report on Form 10-K and the
company’s other filings with the Securities and Exchange Commission
(SEC) available at the SEC’s Internet site (www.sec.gov).
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Merck MediaPam Eisele(267) 305-3558Claire Gillespie(267)
305-0932NGM Media:Liz Melone(617) 256-6622media@ngmbio.comorMerck
Investor:Teri Loxam(908) 740-1986Michael DeCarbo(908) 740-1807NGM
Investor:ir@ngmbio.com
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