FOSTER CITY, Calif. & BAGSVÆRD, Denmark–(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.
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.
Contacts
Gilead Contacts
Investors:
Sung
Lee
+1 650-524-7792
Media:
Arran Attridge
+1 650-425-8975
Novo Nordisk Contacts
Investors:
Peter
Hugreffe Ankersen
+45 3075 9085
Media:
Mette Kruse Danielsen
+45 3079 3883