Cytokinetics Joins Global Movement to Raise Awareness for Rare Diseases
February 27 2015 - 7:30AM
SOUTH SAN FRANCISCO, CA, February 27, 2015
- Cytokinetics, Incorporated (Nasdaq: CYTK)
announced today that it is joining forces on February 28 with
patients and health care advocates in the United States and
globally to raise awareness for Rare Disease Day®.
Rare Disease Day is dedicated to elevating public understanding of
rare diseases and calling attention to the special challenges faced
by patients with rare diseases and the support community around
them.
"Cytokinetics is proud to stand
alongside patients and caregivers representing the rare disease
community," stated Robert I. Blum, Cytokinetics' President &
Chief Executive Officer. "We applaud the tireless work of NORD and
EURORDIS, two outstanding organizations that perform extraordinary
work every day in support of education, advocacy, research and the
care of patients suffering from rare diseases. Cytokinetics
is dedicated to the discovery and development of novel therapeutics
that modulate muscle function for the treatment of severe illnesses
and conditions, including rare neuromuscular diseases."
Rare Disease Day, which takes
place every year on the last day of February, was established in
Europe in 2008 by the European Organisation for Rare Diseases
(EURORDIS), the organization representing rare disease patients in
Europe, and is now observed in more than 80 nations. In the United
States, Rare Disease Day is sponsored by the National Organization
for Rare Disorders (NORD), a leading independent, non-profit
organization committed to the identification, treatment, and cure
of rare diseases. According to EURORDIS, a disease or disorder is
defined as rare in Europe when it affects less than 1 in 2000. Rare
diseases may affect 30 million European Union citizens.
According to the National Institutes of Health (NIH), a disease is
rare if it affects fewer than 200,000 people. Nearly 1 in 10
Americans live with a rare disease-affecting 30 million people -
and two-thirds of these patients are children. There are more than
7,000 rare diseases and only approximately 450 FDA-approved medical
treatments. For more information about Rare Disease Day in the
U.S., go to www.rarediseaseday.us. For information about
global activities, go to www.rarediseaseday.org. To search
for information about rare diseases, visit NORD's website,
www.rarediseases.org.
Cytokinetics is developing two
drug candidates for the potential treatment of rare diseases.
The company is developing tirasemtiv, a
fast skeletal troponin muscle activator, as a potential treatment
for patients with amyotrophic lateral sclerosis (ALS). In
addition, the company is collaborating with Astellas Pharma Inc. to
develop CK-2127107, a structurally distinct fast skeletal troponin
muscle activator, as a potential treatment for patients with spinal
muscular atrophy (SMA).
About Amyotrophic
Lateral Sclerosis
Amyotrophic lateral sclerosis (ALS) is a progressive
neurodegenerative disease that afflicts approximately 25,000 people
in the United States and a comparable number of patients in Europe.
Approximately 5,600 new cases of ALS are diagnosed each year in the
United States. 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 patients with ALS, resulting in a high unmet need for new
therapeutic options to address the symptoms and modify disease
progression.
About Spinal
Muscular Atrophy
Spinal Muscular Atrophy (SMA) is a
severe neuromuscular disease that occurs in 1 in every 6000 to
10,000 live births each year and is one of the most common fatal
genetic disorders. Spinal muscular atrophy manifests in
various degrees of severity as progressive muscle weakness
resulting in respiratory and mobility impairment. There are four
types of SMA based on time of initial onset of muscle weakness and
related symptoms: Type I (Infantile), Type II (Intermediate), Type
III (Juvenile) and Type IV (Adult Onset). Life expectancy and
disease severity varies from Type I patients, who have the worst
prognosis and a life expectancy of generally less than 2 years from
birth to Type IV patients, who have a normal life span but with
gradual weakness in proximal muscles of the extremities resulting
in mobility issues. Few treatment options exist for these
patients, resulting in a high unmet need for new therapeutic
options to address symptoms and modify disease progression.
About Cytokinetics
Cytokinetics is a clinical-stage
biopharmaceutical company focused on the discovery and development
of novel small molecule therapeutics that modulate muscle function
for the potential treatment of serious diseases and medical
conditions. Cytokinetics is developing tirasemtiv, a fast skeletal muscle activator, as a
potential treatment for amyotrophic lateral sclerosis (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 is collaborating with Amgen Inc. to develop omecamtiv mecarbil, a cardiac muscle activator, for the
potential treatment of heart failure. Cytokinetics is collaborating
with Astellas Pharma Inc. to develop CK-2127107, a skeletal muscle
activator, for the potential treatment of spinal muscular atrophy.
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. All of
these drug candidates have arisen from Cytokinetics' muscle biology
focused research activities and are directed towards the
cytoskeleton. The cytoskeleton is a complex biological
infrastructure that plays a fundamental role within every human
cell. Additional information about Cytokinetics can be obtained at
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' research and development activities; the potential
size of markets for tirasemtiv and CK-2127107; and the properties
and potential benefits of tirasemtiv, 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; 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 trials 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:
Joanna L. Goldstein
Cytokinetics
Manager, Investor Relations & Corporate
Communications
(650) 624-3000
This
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The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Cytokinetics, Inc. via Globenewswire
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