In total, the agreement grants rights to Menarini for Ranexa in 68
countries, including the 27 countries of the European Union (EU), the
Commonwealth of Independent States, and select countries of Central and
In the agreement, Menarini has committed to make an upfront payment of
Menarini will be responsible for commercial activities and pursuing regulatory and pricing approvals. As part of the agreement, Menarini has committed to provide minimum levels of physician details and promotional spending for Ranexa for a specified period of time.
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. Under the terms
of the agreement, Menarini is expected to launch Ranexa in
"Menarini is a successful and growing organization which leads the
European pharmaceutical industry in physician detailing and cardiovascular
experience. Their proven ability to launch and promote cardiovascular products
suggests they are exceptionally well positioned to launch Ranexa to both
specialists and primary care physicians," said
In the past decade, Menarini has expanded its presence in the European
Union and the other licensed territories, growing revenues more than 150
percent to
Global pharmaceutical companies such as AstraZeneca, Bristol Meyers
Squibb, Daiichi Sankyo, Eli Lilly, Glaxo Smith Kline, Johnson & Johnson,
Merck, Novartis, and Pfizer have selected Menarini to sell some of their most
important brands in
"Ranexa represents an important first in class product which we believe
will help meet the substantial unmet needs of patients across
Ranexa(R) (ranolazine prolonged release tablets) is approved for use in
The approved European labeling reflects data from the MERLIN TIMI-36 and other recently reported studies, including data showing statistically significant reductions in ventricular arrhythmias with Ranexa. The labeling also notes that the ability of Ranexa to reduce cellular calcium overload is expected to improve myocardial relaxation and decrease left ventricular diastolic stiffness.
In the United Sates, Ranexa(R) (ranolazine extended-release tablets) is indicated for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs. In the U.S., CV Therapeutics is seeking changes to the approved product labeling for Ranexa to include a first line angina indication, a significant reduction in cautionary language, and the potential addition of promotable claims for the reduction of hemoglobin A1c and ventricular arrhythmias in patients with coronary artery disease.
Conference Call
Company management will webcast a conference call on
About Angina
There are currently 48-50 million angina prescriptions written annually in
the largest five EU member countries (UK,
About Menarini
The Menarini Group is one of the largest privately owned pharmaceutical
companies, and is headquartered in
About CV Therapeutics
CV Therapeutics, Inc., headquartered in
CV Therapeutics' approved products in
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; special protocol
assessment agreement; 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 Quarterly Report on Form 10-Q for the
quarter ended
SOURCE CV Therapeutics, Inc.