Cytokinetics Joins Global Movement to Raise Awareness for Rare Diseases
(Thomson Reuters ONE) -
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 announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Cytokinetics, Inc. via GlobeNewswire
[HUG#1897903]
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Datum: 27.02.2015 - 13:30 Uhr
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News-ID 374903
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