Gilead Sciences and Novo Nordisk Announce Intent to Initiate a Clinical Collaboration in NASH
April 12 2019 - 4:00AM
Business Wire
Gilead Sciences, Inc. (NASDAQ: GILD) and Novo Nordisk A/S
(NASDAQ Copenhagen: NOVO B) today announced that the companies
intend to collaborate on a clinical trial combining compounds from
their respective pipelines in nonalcoholic steatohepatitis (NASH).
The intended clinical trial will be a proof of concept study
combining Novo Nordisk’s semaglutide (GLP-1 analogue) and Gilead’s
cilofexor (FXR agonist) and firsocostat (ACC inhibitor) for the
treatment of patients with NASH. The companies are also exploring
the potential to collaborate on preclinical research to advance
understanding of the disease.
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NASH is a chronic and progressive liver disease characterized by
fat accumulation and inflammation in the liver, which can lead to
scarring or fibrosis, that impairs liver function. If left
untreated, individuals living with NASH may face serious
consequences, including end-stage liver disease, liver cancer and
the need for liver transplantation, and are at a significantly
higher risk of liver-related mortality.
“NASH is a complex disease that often affects people with
diabetes and metabolic syndrome. Currently, patients living with
NASH have limited treatment options. We are excited to work with
Novo Nordisk on this important collaboration, which would bring
together Novo Nordisk’s broad expertise related to diabetes and
metabolism and Gilead’s expertise in both liver disease and
combination therapies,” said John McHutchison, AO, MD, Chief
Scientific Officer and Head of Research and Development at Gilead
Sciences. “We look forward to working with the Novo Nordisk team to
explore opportunities to advance our complementary research
capabilities and approaches in NASH to help address this
significant unmet need for patients.”
“We are very pleased about the potential to enter into this
clinical collaboration with Gilead, which would combine Novo
Nordisk’s semaglutide program in NASH with Gilead’s clinical
programs to provide novel approaches for the treatment of NASH. By
combining the leading molecular science and clinical expertise of
our two companies within the rapidly expanding liver and metabolic
diseases, we aim to develop innovative, new and effective
combination therapies to help people with NASH,” said Mads
Krogsgaard Thomsen, Chief Science Officer and Executive Vice
President of Novo Nordisk.
Cilofexor and firsocostat, alone or in combination, are
investigational compounds and are not approved by the U.S. Food
& Drug Administration (FDA) or any other regulatory authority.
Safety and efficacy have not been established for these agents.
Semaglutide has not been approved by the FDA or any other
regulatory authority for the treatment of patients living with
NASH.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 95
years of innovation and leadership in diabetes care. This heritage
has given us experience and capabilities that also enable us to
help people defeat obesity, hemophilia, growth disorders and other
serious chronic diseases. Headquartered in Denmark, Novo Nordisk
employs approximately 43,200 people in 80 countries, and markets
its products in more than 170 countries. For more information on
Novo Nordisk, please visit the company’s website at
www.novonordisk.com.
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.
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 possibility that the parties may not enter into the
proposed collaboration in a timely manner or at all and the parties
may make a strategic decision to discontinue the collaboration at
any time. There is also the possibility of unfavorable results from
the preclinical research and clinical trials involving combinations
of the parties’ compounds for the treatment of NASH. 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 Annual Report on Form 10-K for the year ended
December 31, 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/20190412005104/en/
Gilead
ContactsInvestors:Sung Lee+1 650-524-7792
Media:Arran Attridge+1 650-425-8975
Novo Nordisk
ContactsInvestors:Peter Hugreffe Ankersen+45 3075
9085
Media:Mette Kruse Danielsen+45 3079 3883
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