THOUSAND OAKS, Calif.,
Nov. 23, 2020 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced the Company has provided notice to
Cytokinetics of termination of its collaboration and its intention
to transition the development and commercialization rights for
omecamtiv mecarbil and AMG 594. Omecamtiv mecarbil, an
investigational selective cardiac myosin activator, was studied in
GALACTIC-HF, a Phase 3 clinical trial in patients with chronic
heart failure with reduced ejection fraction (HFrEF), and AMG 594,
a novel mechanism selective cardiac troponin activator, is in Phase
1 development for HFrEF and other types of heart failure.
Primary results of GALACTIC-HF were recently presented
at the American Heart Association Scientific Sessions and
simultaneously published in the New England Journal of
Medicine. The trial demonstrated a statistically significant
effect of treatment with omecamtiv mecarbil to reduce risk of the
primary composite endpoint of cardiovascular (CV) death or heart
failure events (heart failure hospitalization and other urgent
treatment for heart failure) compared to placebo in patients
treated with standard of care. No reduction in the secondary
endpoint of time to CV death was observed.
"Cardiovascular disease is one of the most significant public
health issues in the world which means patients need more
innovation, not less. Our commitment to cardiovascular disease
remains steadfast, and we look forward to continuing to work
closely with the cardiovascular community as we focus on advancing
our innovative therapies, including our Lp(a) inhibitor
olpasiran (AMG 890), which is currently in Phase 2," said
David M. Reese, M.D., executive vice president of Research and
Development at Amgen. "We are grateful to the
investigators and patients who participated in GALACTIC-HF.
Unfortunately, the results of GALACTIC-HF did not meet the high bar
we had set for the program."
Amgen thanks Cytokinetics and Servier for their productive
collaboration over many years, and will work closely with them to
facilitate a smooth transition of omecamtiv mecarbil. Servier
provides funding and strategic support for the program.
About Amgen
Amgen is committed to
unlocking the potential of biology for patients suffering from
serious illnesses by discovering, developing, manufacturing and
delivering innovative human therapeutics. This approach begins by
using tools like advanced human genetics to unravel the
complexities of disease and understand the fundamentals of human
biology.
Amgen focuses on areas of high unmet medical need and leverages
its expertise to strive for solutions that improve health outcomes
and dramatically improve people's lives. A biotechnology pioneer
since 1980, Amgen has grown to be one of the
world's leading independent biotechnology companies, has
reached millions of patients around the world and is developing a
pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow
us on www.twitter.com/amgen.
Amgen Forward-Looking Statements
This news release
contains forward-looking statements that are based on the current
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potentially prevent or treat COVID-19), or the Otezla® (apremilast)
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potential treatment for COVID-19, and other
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those discussed below and more fully described in
the Securities and Exchange Commission reports filed
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and any subsequent periodic reports on Form 10-Q and current
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and governmental effort to mitigate against the spread of such
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and Amgen's clinical trial operations, and any such events may
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or should be drawn regarding the safety or effectiveness of the
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products. The products are not approved for the investigational
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CONTACT: Amgen, Thousand Oaks
Jessica Akopyan, 805-447-0974
(media)
Trish Rowland,
805-447-5631(media)
Arvind Sood, 805-447-1060
(investors)
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