Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that
Amgen has elected to terminate the Collaboration and Option
Agreement, dated December 20, 2006 between the companies (the
“Agreement”) and thereby end its collaboration with Cytokinetics,
effective May 20, 2021, and intends to transition development and
commercialization rights for omecamtiv mecarbil and AMG 594 to
Cytokinetics. Omecamtiv mecarbil is an investigational cardiac
myosin activator, developed for the potential treatment of heart
failure with reduced ejection fraction (HFrEF), and was recently
studied in GALACTIC-HF, a positive Phase 3 cardiovascular outcomes
clinical trial. AMG 594, a novel mechanism cardiac troponin
activator, is in Phase 1 development for HFrEF and other types of
heart failure.
“We believe this is an important pivot point and
opportunity for our company, as we reclaim omecamtiv mecarbil
following positive Phase 3 clinical trial results,” said Robert I.
Blum, Cytokinetics’ President and Chief Executive Officer. “In one
of the largest heart failure clinical trials ever conducted, our
novel mechanism drug candidate demonstrated positive efficacy in a
diverse patient population with high unmet need and without an
imbalance in the overall incidence of adverse events. We look
forward to rapidly advancing next steps for omecamtiv mecarbil,
which we expect will include discussions with regulatory
authorities. We believe we are well prepared to press forward given
our strong balance sheet and pioneering leadership in the
development of muscle-directed therapies.”
Terms of Termination
Pursuant to the terms of the Agreement, upon the
effective date of Amgen’s termination, research, development and
commercialization rights for compounds, including omecamtiv
mecarbil and AMG 594, will transition to Cytokinetics. In addition,
Amgen will have certain obligations set forth in the Agreement,
including: cooperating with Cytokinetics and its designee(s) to
facilitate a reasonably smooth, orderly and prompt transition of
the programs, including transfer and assignment to Cytokinetics of
specified regulatory filings, data and other information; if
requested by Cytokinetics, transferring inventory of compounds to
Cytokinetics at Cytokinetics’ expense; to the extent possible and
requested by Cytokinetics, assigning relevant third-party
manufacturing agreements to Cytokinetics; and granting to
Cytokinetics exclusive and non-exclusive licenses to certain
intellectual property rights. Cytokinetics will have no trailing
royalty payment obligations to Amgen for either omecamtiv mecarbil
or AMG 594. With Cytokinetics’ consent, Amgen granted a sublicense
to Les Laboratoires Servier and Institut de Recherches
Internationales Servier (“Servier”) to commercialize omecamtiv
mecarbil in Europe and the Commonwealth of Independent States,
including Russia. Cytokinetics is party to a letter agreement with
Amgen and Servier entered into in 2016, which provides that if
Amgen’s rights to omecamtiv mecarbil are terminated, (i) the
sublicensed rights previously granted by Amgen to Servier with
respect to omecamtiv mecarbil, will remain in effect post
termination of the Agreement and become a direct license or
sublicense of such rights by Cytokinetics to Servier, on
substantially the same terms as those in the Option, License and
Collaboration Agreement between Amgen and Servier, and (ii) Amgen
will, at Cytokinetics’ election, transfer to Cytokinetics or its
designee (including Servier) certain ongoing development
activities.
GALACTIC-HF:
Results and Next Steps
Primary results from GALACTIC-HF
(Global Approach to
Lowering Adverse
Cardiac Outcomes Through
Improving Contractility in
Heart Failure), the Phase 3
event-driven cardiovascular outcomes clinical trial of omecamtiv
mecarbil, were recently presented at the American Heart Association
(AHA) Scientific Sessions 2020, and were simultaneously published
in the New England Journal of Medicine.1
GALACTIC-HF, one of the largest Phase 3 global
cardiovascular outcomes trials in heart failure ever conducted,
enrolled 8,256 patients who were at risk of hospitalization and
death, despite being well treated on standard of care therapy.
After a median duration of follow-up of 21.8 months, 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 and no other secondary endpoints were met in accordance
with the prespecified statistical analysis. The effect of omecamtiv
mecarbil was generally consistent across prespecified subgroups and
with a potentially greater treatment effect suggested in patients
with a lower left ventricular ejection fraction.
Cytokinetics has received positive feedback from
key heart failure opinion leaders on the primary results, with
particular interest in the potential role of omecamtiv mecarbil in
the treatment of advanced heart failure patients who remain at risk
for hospitalization despite being treated with standard of care
regimens. The company will be conducting market research to gain
additional feedback from physicians and payors to inform the
potential path forward. Cytokinetics expects to seek regulatory
feedback regarding a potential registration path for omecamtiv
mecarbil, subject to cooperation and transitions from Amgen. In
parallel, Cytokinetics plans to conduct commercial readiness
assessments and to evaluate potential partnering opportunities,
including co-promotion options in North America as well as
licensing in other territories.
Conference Call and Webcast
Information
Members of Cytokinetics' senior management team
will host a conference call and webcast today, November 23, 2020,
at 8:30 AM Eastern Time. The webcast can be accessed through the
Investors & Media section of the Cytokinetics website at
www.cytokinetics.com. The live audio of the conference call can
also be accessed by telephone by dialing either (866) 999-CYTK
(2985) (United States and Canada) or (706) 679-3078 (international)
and typing in the passcode 2184075.
An archived replay of the webcast will be
available via Cytokinetics' website until December 7, 2020. The
replay will also be available via telephone by dialing (855)
859-2056 (United States and Canada) or (404) 537-3406
(international) and typing in the passcode 2184075 from November
23, 2020 at 11:30 AM Eastern Time until December 7, 2020.
About Cytokinetics
Cytokinetics is a late-stage biopharmaceutical
company focused on discovering, developing and commercializing
first-in-class muscle activators and next-in-class muscle
inhibitors as potential treatments for debilitating diseases in
which muscle performance is compromised and/or declining. As a
leader in muscle biology and the mechanics of muscle performance,
the company is developing small molecule drug candidates
specifically engineered to impact muscle function and
contractility. Cytokinetics is preparing for regulatory
interactions for omecamtiv mecarbil, its novel cardiac muscle
activator, following positive results from GALACTIC-HF, a large,
international Phase 3 clinical trial in patients with heart
failure. Cytokinetics is conducting METEORIC-HF, a second Phase 3
clinical trial of omecamtiv mecarbil. Cytokinetics is also
developing CK-274, a next- generation cardiac myosin inhibitor, for
the potential treatment of hypertrophic cardiomyopathies (HCM).
Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of
CK-274 in patients with obstructive HCM. Cytokinetics is also
developing reldesemtiv, a fast skeletal muscle troponin activator
for the potential treatment of ALS and other neuromuscular
indications following conduct of FORTITUDE-ALS and other Phase 2
clinical trials. The company is considering potential advancement
of reldesemtiv to Phase 3 pending ongoing regulatory interactions.
Cytokinetics continues its over 20-year history of pioneering
innovation in muscle biology and related pharmacology focused to
diseases of muscle dysfunction and conditions of muscle
weakness.
For additional information about Cytokinetics,
visit www.cytokinetics.com and follow us on Twitter, LinkedIn,
Facebook and YouTube.
Forward-Looking Statements
This press release contains forward-looking
statements for purposes of the Private Securities Litigation Reform
Act of 1995 (the "Act"). Cytokinetics disclaims any
intent or obligation to update these forward-looking statements and
claims the protection of the Act's Safe Harbor for forward-looking
statements. Examples of such statements include, but are not
limited to, statements relating to the GALACTIC-HF clinical trial;
statements relating to the METEORIC-HF clinical trial;
Cytokinetics’ activities to advance the development of omecamtiv
mecarbil; the potential benefits of omecamtiv mecarbil,
including its ability to represent a novel therapeutic strategy to
increase cardiac muscle function and restore cardiac
performance; the potential approval of omecamtiv mecarbil by
the FDA or any other regulatory authority; Amgen’s fulfillment of
its undertakings regarding transition of the omecamtiv mecarbil and
AMG 594 programs to Cytokinetics; any decision on the part of
Servier to maintain or terminate its sublicense in respect of
omecamtiv mecarbil prior to the effectiveness of the termination of
the Amgen-Cytokinetics collaboration; Cytokinetics' and its
partners' research and development activities; the design, timing,
results, significance and utility of preclinical and clinical
results; and the properties and potential benefits
of Cytokinetics' other drug candidates. Such statements
are based on management's current expectations, but actual results
may differ materially due to various risks and uncertainties,
including, but not limited to, potential difficulties or delays in
the development, testing, regulatory approvals for trial
commencement, progression or product sale or manufacturing, or
production of Cytokinetics' drug candidates that could
slow or prevent clinical development or product
approval; Cytokinetics' drug candidates may have adverse
side effects or inadequate therapeutic efficacy; the FDA or foreign
regulatory agencies may delay or limit Cytokinetics' or
its partners' ability to conduct clinical
trials; Cytokinetics may be unable to obtain or maintain
patent or trade secret protection for its intellectual property;
the nature of Amgen's decisions and activities with respect to the
transfer of rights to develop and commercialize omecamtiv mecarbil
and AMG 594 to Cytokinetics; standards of care may change,
rendering Cytokinetics' drug candidates obsolete;
competitive products or alternative therapies may be developed by
others for the treatment of
indications Cytokinetics' drug candidates and potential
drug candidates may target; and risks and uncertainties relating to
the timing and receipt of payments from its partners, including
milestones and royalties on future potential product sales
under Cytokinetics' collaboration agreements with such
partners. For further information regarding these and other risks
related to Cytokinetics' business, investors should
consult Cytokinetics' filings with the Securities
and Exchange Commission.
Contact:CytokineticsDiane WeiserSenior Vice
President, Corporate Communications, Investor Relations(415)
290-7757
References
- Teerlink J et al. NEJM. 2020
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