CV Therapeutics Files Application for European Marketing Approval of Ranolazine for Treatment of Chronic Angina
March 30 2004 - 7:00AM
PR Newswire (US)
CV Therapeutics Files Application for European Marketing Approval
of Ranolazine for Treatment of Chronic Angina Company Announces
Appointment of President for CVT Europe and Establishment of
European Office in United Kingdom PALO ALTO, Calif., March 30
/PRNewswire-FirstCall/ -- CV Therapeutics, Inc. announced today
that a Marketing Authorization Application (MAA) seeking approval
of ranolazine for the treatment of chronic angina has been filed
with the European Agency for the Evaluation of Medicinal Products
(EMEA). The MAA for ranolazine, a new chemical entity, has been
filed for review under the EMEA centralized procedure by the
company's new European subsidiary, CV Therapeutics Europe, Ltd.
"Angina is a tremendous problem around the world,and our submission
of an MAA for ranolazine marks an important milestone for CVT as we
examine potential commercialization activities in Europe," said
Louis G. Lange, M.D., Ph.D., chairman and chief executive officer
of CV Therapeutics. Chronic anginais a serious and debilitating
heart condition, usually associated with coronary artery disease
and marked by repeated and sometimes unpredictable attacks of chest
pain. It affects approximately 6.9 million people in the five
largest markets in Europe. To support current and potential
activities in Europe, CV Therapeutics has established a European
subsidiary based in the United Kingdom and appointed Huw Jones,
Ph.D., as president of CV Therapeutics Europe, Ltd. Dr. Jones is
responsible for managingEuropean operations and evaluating
commercialization opportunities for ranolazine, and other CV
Therapeutics products, in Europe. "Cardiovascular disease is the
leading cause of death in Europe and CVT's broad pipeline of unique
potential cardiovascular therapies offers the opportunity to
improve patient care and realize significant European commercial
potential," Jones said. Dr. Jones held various positions at Elan
Pharmaceuticals from 1997 to 2001, including senior vice president,
northern Europe. In this role, Dr. Jones was responsible for
managing operations in the United Kingdom, Germany, France and
other European countries. From 1986 to 1997, Dr. Jones held various
positions at SmithKline Beecham Pharmaceuticals, including
marketing director, UK. During his career to date, Dr. Jones has
supervised product launches in several European countries and
co-founded Daffodil Consulting LLP, a consulting company focusing
on providing strategic advice and senior management to companies
wishing to enter the European healthcare market. Dr. Jones received
a Ph.D. in pharmacology from the University of Birmingham, UK in
1986. CV Therapeutics Europe, Ltd. has also appointed David
Rowley-Jones, MA, MB BChir, MRCP as non-executive director. Dr.
Rowley-Jones spent 17 years at SmithKline Beecham Pharmaceuticals,
including roles as vice president, UK medical and regulatory and
senior vice president, worldwide strategic marketing. Dr.
Rowley-Jones established Athena Neurosciences Europe in 1994 and
subsequently Elan Pharmaceuticals' commercial organization in
Europe. He co-founded Daffodil Consulting LLP in 2001. About CV
Therapeutics CV Therapeutics, Inc., headquartered in Palo Alto,
California, is a biopharmaceutical company focused on applying
molecular cardiology to the discovery, development and
commercialization of novel, small molecule drugs for the treatment
of cardiovascular diseases. CV Therapeutics currently has four
compounds in clinical development. Applications for the approval of
ranolazine for the treatment of chronic angina have been submitted
to the FDA and EMEA. Regadenoson, a selective A2A-adenosine
receptor agonist, is being developed for potential use as a
pharmacologic stress agent in cardiac perfusion imaging studies.
Tecadenoson, an A1-adenosine receptor agonist, is being developed
for the potential reduction of rapid heart rate during atrial
arrhythmias. Adentri(TM), an A1-adenosine receptor antagonist for
the potential treatment of congestive heart failure, is licensed to
Biogen, Inc. (now Biogen Idec Inc.). For more information, please
visit CV Therapeutics' website at http://www.cvt.com/. CV
Therapeutics is a development-stage company. None of the company's
products have been approved for marketing by the FDAor any foreign
regulatory authorities. Any products of the company discussed here
are currently under investigation in clinical trials subject to
United States Investigational New Drug applications, and as
applicable, appropriate clinical trial applications to regulatory
authorities outside the United States. Except for the historical
information contained herein, the matters set forth in this press
release, including statements as to development and
commercialization of the company's products, are forward-looking
statements within the meaning of the "safe harbor" provisions of
the Private Securities Litigation Reform Act of 1995. These
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially, including,
early stage of development; regulatory review and approval of our
products; the timing of clinical trials; the dependence on
collaborative and licensing agreements; commercialization of our
products; and other risks detailed from time to time in CVT's SEC
reports, including its most recent Annual Report on Form 10-K, and
its most recent Quarterly Report on Form 10-Q. CVT disclaims any
intent or obligation to update these forward-looking statements.
DATASOURCE: CV Therapeutics, Inc. CONTACT: investors, Dan
Spiegelman, SVP & Chief Financial Officer, +1-650-384-8509, or
Christopher Chai, Treasurer & Executive Director, Investor
Relations, +1-650-384-8560, or media, John Bluth, Director,
Corporate Communications, +1-650-384-8850, all of CV Therapeutics,
Inc.; or media, Alisha Parr/Gayle Sawyer of Packer Forbes
Communications, +44 (0) 208-772-1551, for CV Therapeutics, Inc. Web
site: http://www.cvt.com/
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