Ranexa(R) Now Available in United Kingdom and Germany
March 03 2009 - 8:30AM
Marketwired
CV Therapeutics, Inc. (NASDAQ: CVTX) and the Menarini Group
(Menarini) announced today the commercialization of Ranexa�
(ranolazine prolonged-release tablets) to physicians in the United
Kingdom (UK) and Germany.
"The launch of Ranexa marks an important and novel addition to
the treatment of ischemia in Europe," said professor John Camm,
chair of clinical cardiology at St. George's University of London.
"The COURAGE study and other recent data have highlighted the
important role of medical therapy in the treatment of angina.
Ranexa, which works in a fundamentally different way from other
medicines, is an important new advance."
Ranexa is a first-in-class medicine approved for use in Europe
as add-on therapy for the symptomatic treatment of patients with
stable angina pectoris who are inadequately controlled or
intolerant to first-line antianginal therapies. Ranexa is approved
for use in Europe in 375 mg, 500 mg and 750 mg doses, administered
twice daily.
"The Menarini team is eager to begin the introduction of
Ranexa," said Domenico Simone, Menarini Group general manager.
"Ranexa addresses a significant unmet medical need for patients and
our team is extremely excited to begin discussing Ranexa with
physicians in the UK and Germany."
The commercial introduction of Ranexa in other licensed European
territories is expected following formal pricing and reimbursement
authorizations in those countries.
CV Therapeutics Inc./Menarini Group Collaboration
CV Therapeutics has granted Menarini exclusive rights to Ranexa�
in 68 countries, including the 27 countries of the European Union
(EU), the Commonwealth of Independent States, and select countries
of Central and South America.
Menarini will be responsible for commercial activities and
pursuing regulatory and pricing approvals. As part of the
agreement, Menarini has committed to provide certain minimum levels
of physician details and promotional spending for Ranexa for a
specified period of time in certain major countries. The agreement
provides mechanisms for the parties to collaborate and share the
costs of joint development of Ranexa.
In addition to upfront and milestone payments and potential
development expense reimbursement, CV Therapeutics is entitled to
receive royalties on sales of Ranexa in the territories covered by
the agreement.
About Angina
There are currently 48-50 million angina prescriptions written
annually in the largest five EU member countries (UK, Germany,
France, Spain and Italy). 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.
About Menarini
Menarini, with its significant pan-European presence, makes the
most physician calls for cardiovascular products and has the fourth
largest pharmaceutical sales team for delivering medical
information to physicians in Europe.
The Menarini Group is one of the largest privately owned
pharmaceutical companies, and is headquartered in Florence, Italy.
Menarini employs approximately 12,500 people, with a strong
presence throughout Europe, CIS, Africa and in South and Central
America. The company has expertise in successfully developing and
commercializing in-licensed drug products from major companies in a
broad range of therapeutic areas. The Group's total revenue exceeds
EUR 2.6 billion.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California,
is a biopharmaceutical company primarily focused on applying
molecular cardiology to the discovery, development and
commercialization of novel, small molecule drugs for the treatment
of cardiovascular diseases. CV Therapeutics Europe Ltd. is the
company's European subsidiary based in the United Kingdom.
CV Therapeutics' approved products in the United States include
Ranexa� (ranolazine extended-release tablets), indicated for the
treatment of chronic angina, and Lexiscan� (regadenoson) injection
for use as a pharmacologic stress agent in radionuclide myocardial
perfusion imaging in patients unable to undergo adequate exercise
stress.
Except for the historical information contained herein, the
matters set forth in this press release, including statements as to
research and development and commercialization of 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 operating losses and fluctuations in operating results;
capital requirements; regulatory review and approval of our
products; the conduct and timing of clinical trials;
commercialization of products; market acceptance of products;
product labeling; concentrated customer base; reliance on strategic
partnerships and collaborations; uncertainties in drug development;
uncertainties regarding intellectual property and other risks
detailed from time to time in CV Therapeutics' SEC reports,
including its Annual Report on Form 10-K for the year ended
December 31, 2008. CV Therapeutics disclaims any intent or
obligation to update these forward-looking statements.
Investor and Media Contact John Bluth Executive Director
Corporate Communications & Investor Relations CV Therapeutics,
Inc. (650) 384-8850
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