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 PALO ALTO,
California, March 30 /PRNewswire/ -- - Company Announces
Appointment of President for CVT Europe and Establishment of
European Office in United Kingdom CV Therapeutics, Inc. (Nasdaq:
CVTX) 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 angina is 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
presidentof CV Therapeutics Europe, Ltd. Dr. Jones is responsible
for managing European 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 TherapeuticsEurope,
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 ofcardiovascular 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 www.cvt.com. CV Therapeutics is a development-stage
company. None of the company's products have been approved for
marketing by the FDA or 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 mostrecent Quarterly
Report on Form 10-Q. CVT disclaims any intent or obligation to
update these forward-looking statements. Web site:
http://www.cvt.com PALO ALTO, California, March 30 /PRNewswire/ --
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. FCMN
Contact: andrea.huch@cvt.com
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