Cytokinetics Announces Early Termination of Hart-Scott-Rodino Waiting Period for Expanded Collaboration With Astellas
September 29 2016 - 7:30AM
Cytokinetics, Inc. (Nasdaq:CYTK) today announced that the Federal
Trade Commission has granted early termination of the waiting
period under the Hart-Scott-Rodino Antitrust Improvements Act of
1976 (HSR Act) in connection with the 2016 amendment to the License
and Collaboration Agreement initially executed between Cytokinetics
and Astellas Pharma Inc., in 2013 and amended in 2014. In July
2016, the companies expanded the collaboration related to the
research, development and commercialization of skeletal muscle
activators. With the termination of the applicable waiting
period under the HSR Act, the 2016 amendment is deemed effective as
of Sept. 26, 2016 and the upfront payment of $65 million from
Astellas to Cytokinetics is due and payable within 30 days.
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 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. In connection
with the expanded collaboration, the companies also agreed to
extend their joint research program through 2016.
Through the amendment, effective Sept. 26, 2016,
Cytokinetics granted Astellas an option right for the development
and commercialization of tirasemtiv, an investigational skeletal
muscle activator that is the subject of an ongoing Phase 3 clinical
trial, VITALITY-ALS. If Astellas exercises its option, the parties
will enter into a global partnership in which Cytokinetics will
continue to develop and commercialize tirasemtiv in North America,
Europe, and other select countries, and Astellas will develop and
commercialize tirasemtiv in other countries. The companies also
amended the 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.
Under the 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 ALS) 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.
Additional details can be found in Cytokinetics’
Form 8-K filed with the Securities and Exchange Commission on July
27, 2016.
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, subject to an option held
by Astellas Pharma Inc. Cytokinetics is also
collaborating with Astellas to develop CK-2127107, a fast skeletal
muscle activator, for the potential treatment of spinal muscular
atrophy, chronic obstructive pulmonary disease and
ALS. Cytokinetics is collaborating with Amgen
Inc. to develop omecamtiv mecarbil, a novel cardiac
muscle activator, for the potential treatment of heart
failure. 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; the potential benefits of
Cytokinetics’ expanded collaboration with Astellas; and the receipt
of milestone payments from Astellas. 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 U.S. Food and Drug Administration
(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 FDA 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; Astellas’ decisions with respect to
the design, initiation, conduct, timing and continuation of
development activities for CK-2127107 and tirasemtiv, including
Astellas’ decisions with respect to its option to enter into a
global collaboration for the development and commercialization of
tirasemtiv; Cytokinetics may incur unanticipated research and
development and other costs or be unable to obtain additional
financing necessary to conduct development of its products;
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
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