Cytokinetics Announces Next-Generation Fast Skeletal Muscle Activator Entering IND-Enabling Studies
September 08 2016 - 7:30AM
Triggers Milestone Payment from
Astellas; Expands Portfolio of Skeletal
Muscle Activators
Cytokinetics, Inc. (Nasdaq:CYTK) today announced the initiation of
IND-enabling studies for a next-generation fast skeletal muscle
activator under Cytokinetics’ collaboration with Astellas. The
initiation of IND-enabling studies triggers a $2 million milestone
payment from Astellas to Cytokinetics under the terms of the
collaboration agreement between the companies established in June
2013, expanded in 2014, and again in 2016.
“Moving an additional potential drug candidate
into IND-enabling studies expands our growing portfolio of skeletal
muscle activators and provides an opportunity to explore an array
of potential clinical applications of this class of compounds,”
said Fady I. Malik, Cytokinetics’ Executive Vice President and Head
of Research & Development. “We’re proud of the success we have
achieved in our collaborative research program with Astellas and
pleased that we share a mutual commitment to continue discovery in
parallel with our development programs.”
About Cytokinetics and Astellas
Collaboration
In 2013, Astellas and Cytokinetics formed a
partnership focused on the research, development, and
commercialization of skeletal muscle activators. The primary
objective of the collaboration is to advance novel therapies for
diseases and medical conditions associated with muscle impairment
and weakness. Under the collaboration, Cytokinetics exclusively
licensed to Astellas the rights to co-develop and potentially
co-commercialize CK-2127107, a fast skeletal troponin activator, in
non-neuromuscular indications.
In 2014, Astellas and Cytokinetics agreed to expand
the collaboration to include certain neuromuscular indications,
including spinal muscular atrophy (SMA), and to advance CK-2127107
into Phase 2 clinical development, initially in SMA. Under the
amended collaboration, Astellas has exclusive rights to co-develop
and commercialize CK-2127107 and other fast skeletal troponin
activators in non-neuromuscular indications and certain
neuromuscular indications (including SMA) and other novel mechanism
skeletal muscle activators in all indications, subject to certain
Cytokinetics’ development and commercialization rights;
Cytokinetics may co-promote and conduct certain commercial
activities in North America and Europe under agreed scenarios.
In July 2016, Cytokinetics and Astellas announced
further expansion of the collaboration to include amyotrophic
lateral sclerosis (ALS). Through this expansion, Cytokinetics
granted Astellas an option right for the development and
commercialization of tirasemtiv; if Astellas exercises the option,
Astellas will receive exclusive worldwide commercialization rights
outside of Cytokinetics’ commercialization territory of North
America, Europe and other select countries. The companies also
agreed to amend their collaboration agreement to enable the
development of CK-2127107 for the potential treatment of ALS and to
extend their joint research focused on the discovery of additional
next-generation skeletal muscle activators through 2017.
About Cytokinetics
Cytokinetics is a late-stage biopharmaceutical
company focused on discovering, developing and commercializing
first-in-class muscle activators 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 increase muscle function
and contractility. Cytokinetics’ lead drug candidate is tirasemtiv,
a fast skeletal muscle troponin activator, for the potential
treatment of ALS. Tirasemtiv has been granted orphan drug
designation and fast track status by the U.S. Food and Drug
Administration and orphan medicinal product designation by the
European Medicines Agency for the potential treatment of ALS.
Cytokinetics retains the right to develop and commercialize
tirasemtiv. Cytokinetics is collaborating with Amgen Inc. to
develop omecamtiv mecarbil, a novel cardiac muscle activator, for
the potential treatment of heart failure. Cytokinetics is
collaborating with Astellas Pharma Inc. to develop CK-2127107, a
fast skeletal muscle activator, for the potential treatment of
spinal muscular atrophy and COPD. Amgen holds an exclusive license
worldwide to develop and commercialize omecamtiv mecarbil and
Astellas holds an exclusive license worldwide to develop and
commercialize CK-2127107. Both licenses are subject to
Cytokinetics' specified development and commercialization
participation rights. For additional information about
Cytokinetics, visit http://www.cytokinetics.com/.
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 Cytokinetics’ and its partners’
research and development activities, including the conduct, design,
enrollment and progress of the Phase 2 clinical trial of CK-2127107
in patients with SMA; the significance and utility of preclinical
study and clinical trial results; and the properties and potential
efficacy and safety profile of CK-2127107 and 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,
further clinical development of tirasemtiv in ALS patients will
require significant additional funding, and Cytokinetics may
be unable to obtain such additional funding on acceptable terms, if
at all; the FDA and/or other regulatory authorities may not accept
effects on slow vital capacity as a clinical endpoint to support
registration of tirasemtiv for the treatment of ALS; 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,
including risks that current and past results of clinical trials or
preclinical studies may not be indicative of future clinical trial
results, patient enrollment for or conduct of clinical trials may
be difficult or delayed, Cytokinetics' drug candidates may have
adverse side effects or inadequate therapeutic efficacy, the U.S.
Food and Drug Administration or foreign regulatory agencies may
delay or limit Cytokinetics' or its partners' ability to conduct
clinical trials, and Cytokinetics may be unable to obtain or
maintain patent or trade secret protection for its intellectual
property; Amgen's and Astellas' decisions with respect to the
design, initiation, conduct, timing and continuation of development
activities for omecamtiv mecarbil and CK-2127107, respectively;
Cytokinetics may incur unanticipated research and development and
other costs or be unable to obtain additional financing necessary
to conduct development of its products; Cytokinetics may be unable
to enter into future collaboration agreements for its drug
candidates and programs on acceptable terms, if at all; 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:
Cytokinetics
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(415) 290-7757
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Apr 2023 to Apr 2024