Cytokinetics, Inc. (Nasdaq:CYTK) (“Cytokinetics”) and Astellas
Pharma Inc. (TSE:4503) (“Astellas”) today announced that
Cytokinetics and Astellas have expanded their collaboration in
skeletal muscle activators to include amyotrophic lateral sclerosis
(ALS). Through this expansion, Cytokinetics has granted
Astellas an option right for the development and commercialization
of tirasemtiv, an investigational skeletal muscle activator. The
companies have 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.
“We are pleased to further expand our productive
and successful collaboration with Astellas in the area of skeletal
muscle activators and to align our interests with regard to
tirasemtiv and ALS,” said Robert I. Blum, Cytokinetics’ President
and Chief Executive Officer. “Advancing tirasemtiv and CK-2127107
for the potential treatment of ALS reinforces our shared commitment
to deliver on the promise of fast skeletal troponin activation for
people living with ALS who are fighting this dreadful disease.”
“The expansion of our collaboration illustrates
Astellas’ commitment to muscle disease as an important and focused
therapeutic area for research as announced in our strategic plan,”
said Yoshihiko Hatanaka, Astellas' President and Chief Executive
Officer. “ALS is a disease with significant unmet needs worldwide,
and we are excited to expand our collaboration with Cytokinetics to
include promising drug candidates in ALS which reflect our shared
interests in muscle biology.”
Option on Tirasemtiv and Expanded
Collaboration Agreement
Upon execution of the amended agreement,
Cytokinetics will receive $65 million in committed capital from
Astellas which includes upfront payments for Astellas’ option right
exercisable for tirasemtiv and amended terms of the companies’
collaboration agreement to include ALS for CK-2127107.
Astellas’ decision regarding its option for
tirasemtiv will depend on its review of results from VITALITY-ALS
and potentially other considerations by Astellas including the
registration and marketing authorization of tirasemtiv in the
United States and Europe. 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.
Cytokinetics may receive over $100 million in payments associated
with the exercise of the option plus additional milestone payments
and escalating double-digit royalties on Astellas’ sales of
tirasemtiv in its territory. Astellas may be eligible to
receive royalties that can reach double-digits on Cytokinetics’
sales of tirasemtiv in its territory.
Under this amendment of the collaboration
agreement, Cytokinetics and Astellas have also agreed on a
development plan for CK-2127107 in ALS. Cytokinetics will
receive approximately $30 million in additional sponsored research
and development funding through 2017 which includes Astellas’
sponsorship of Cytokinetics’ conduct of the Phase 2 clinical
development of CK-2127107 in ALS as well as the continuing research
collaboration. Afterwards, Astellas and Cytokinetics will
collaborate in the design and conduct of a potential registration
program for CK-2127107 in ALS and the companies will share
associated development costs. Cytokinetics would be eligible
for additional milestone payments and royalties on sales based on
the further development and commercialization of CK-2127107 for
ALS.
The effectiveness of the amended agreement is
subject to clearance under the Hart-Scott-Rodino Antitrust
Improvements Act.
Cytokinetics Conference Call /
Webcast
Cytokinetics will host a conference call on July
27, 2016 at 8:30 a.m. Eastern Time. The conference call will
be simultaneously webcast and will be accessible in the Investors
& Media section of Cytokinetics' Web site; for further
information please go to www.cytokinetics.com. The live audio
of the conference call is also accessible via telephone to
investors, members of the news media and the general public by
dialing either (866) 999-2985 (CYTK) (United States and Canada) or
(706) 679-3078 (International) and typing in the passcode
55539648. An archived replay of the webcast will be available
via Cytokinetics' website until August 3, 2016. The replay
will also be available via telephone from July 27, 2016 at 11:30
a.m. Eastern Time until August 3, 2016 by dialing (855) 859-2056
(United States and Canada) or (404) 537-3406 (International) and
typing in the passcode 55539648.
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.
Under the recently 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 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.
About Tirasemtiv and
CK-2127107
Tirasemtiv and CK-2127107 have demonstrated
pharmacological activity that may lead to new therapeutic options
for diseases associated with muscle weakness and fatigue.
Tirasemtiv is a novel skeletal muscle activator that selectively
activates the fast skeletal muscle troponin complex by increasing
its sensitivity to calcium and, in preclinical studies and early
clinical trials, demonstrated increases in skeletal muscle force in
response to neuronal input and delays in the onset and reductions
in the degree of muscle fatigue. Tirasemtiv has been studied in
clinical trials that have enrolled over 1000 people
internationally. Tirasemtiv is the subject of VITALITY-ALS, an
ongoing Phase 3 clinical trial designed to confirm and extend
findings on measures of respiratory function and muscle strength
from prior studies. CK-2127107, a next-generation skeletal muscle
activator has been the subject of five Phase 1 clinical trials in
healthy volunteers, which evaluated safety, tolerability,
bioavailability, pharmacokinetics and pharmacodynamics.
CK-2127107 is being studied in Phase 2 studies in patients
with SMA and chronic obstructive pulmonary disease (COPD).
About ALS
Amyotrophic lateral sclerosis (ALS) is a
progressive degenerative neuromuscular disease that afflicts
approximately 30,000 people in the United States and a comparable
number of patients in Europe[1]. Approximately 6,000 new cases of
ALS are diagnosed each year in the United States[2]. In people
living with ALS, motor neurons progressively die and the brain can
no longer communicate with the muscles through the spinal cord. As
muscles are used less and less frequently, they can atrophy,
causing people with ALS to lose the ability to perform everyday
activities, such as walking, speaking, and eating. The average life
expectancy of an ALS patient is approximately three to five years
after diagnosis and only 10% of patients survive for more than 10
years. Death is usually due to respiratory failure because of
diminished strength in the skeletal muscles responsible for
breathing. Few treatment options exist for these patients,
resulting in a high unmet need for new therapies to address
functional deficits and disease progression.
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 Astellas’ option. 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, chronic
obstructive pulmonary disease and ALS. 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/.
About Astellas Pharma Inc.
Astellas Pharma Inc., based in Tokyo, Japan, is
a company dedicated to improving the health of people around the
world through the provision of innovative and reliable
pharmaceutical products. We focus on Urology, Oncology, Immunology,
Nephrology and Neuroscience as prioritized therapeutic areas while
advancing new therapeutic areas and discovery research leveraging
new technologies/modalities. We are also creating new value by
combining internal capabilities and external expertise in the
medical/healthcare business. Astellas is on the forefront of
healthcare change to turn innovative science into value for
patients. For more information, please visit our website at
www.astellas.com.
Cytokinetics 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, COPD and ALS and the VITALITY-ALS Phase 3
clinical trial of tirasemtiv in patients with ALS; the significance
and utility of preclinical study and clinical trial results; and
the properties and potential efficacy and safety profile of
CK-2127107, tirasemtiv 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; 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.
Astellas Forward-Looking
Statements
This press release includes forward-looking
statements based on assumptions and beliefs in light of the
information currently available to management and subject to
significant risks and uncertainties. Forward-looking statements
include all statements other than statements of historical fact,
including plans, strategies and expectations for the future.
Statements made in the future tense, and words such as
“anticipate,” “expect,” “project,” “continue,” “believe,” “plan,”
“estimate,” “pro forma,” “intend,” “potential,” “target,”
“forecast,” “guidance,” “outlook,” “seek,” “assume,” “will,” “may,”
“should,” and similar expressions are intended to qualify as
forward-looking statements. Forward-looking statements are
based on estimates and assumptions made by management that are
believed to be reasonable, though they are inherently uncertain and
difficult to predict. Investors and security holders are
cautioned not to place undue reliance on these forward-looking
statements.
Actual results may differ materially depending
on a number of factors. This press release contains
information on pharmaceuticals (including compounds under
development), but this information is not intended to make any
representations or advertisements regarding the efficacy or
effectiveness of these pharmaceuticals nor provide medical advice
of any kind.
[1] Amyotrophic Lateral Sclerosis Association. (2016). Media
Facts and Key Facts. Retrieved from:
http://www.alsa.org/news/media/quick-facts.html and
http://www.alsa.org/about-als/facts-you-should-know.html
Contact:
Cytokinetics
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(415) 290-7757
Astellas
Corporate Communications
TEL: 03-3244-3201 FAX: 03-5201-7473
http://www.astellas.com/en
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