- Upfront, milestone payments and promotional investment totaling up to $385 million plus royalties - PALO ALTO, Calif., Sept. 12
PALO ALTO, Calif., Sept. 12 /PRNewswire-FirstCall/ -- CV Therapeutics,
Inc. (Nasdaq: CVTX) announced today that it has entered into an agreement
granting exclusive rights to Ranexa(R) (ranolazine prolonged release tablets)
in Europe and other countries to the Menarini Group. 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.
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 South
America.
In the agreement, Menarini has committed to make an upfront payment of $70
million in consideration of the rights granted and in recognition of the R&D
investments made by CV Therapeutics. In addition, Menarini will potentially
make additional payments and investments totaling up to $315 million (based on
the current currency exchange rate) for commercial and development milestones
and promotional and detailing commitments. The commercial milestones are
primarily linked to sales levels and the development milestones are linked to
approval of Ranexa in Europe for certain additional indications that are
jointly developed. The agreement provides mechanisms for the parties to
collaborate and share the costs of joint development of Ranexa.
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 Germany and the UK
in the first quarter of 2009 with commercial launch in the other licensed
territories expected following formal pricing and reimbursement authorizations
in those countries.
"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 Louis G. Lange, chairman and
chief executive officer of CV Therapeutics.
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 euro 2.5 billion in 2007.
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 Europe, including atorvastatin (Lipitor(R)), sitagliptin
(Januvia(R)), esomeprazole (Nexium(R)), fluticasone/salmeterol (Advair(R)),
nebivolol (Nebilet(R)) and olmesartan (Benicar(R)).
"Ranexa represents an important first in class product which we believe
will help meet the substantial unmet needs of patients across Europe, Central
America and South America," said Alberto Aleotti, chairman and chief executive
officer of Menarini.
Ranexa(R) (ranolazine prolonged release tablets) is 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 375 mg, 500 mg and 750 mg
doses, administered twice daily.
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 September 12, 2008 at
8:00 a.m. EDT, 5:00 a.m. PDT, on the Company's website. To access the live
webcast, please log on to the Company's website at www.cvt.com and go to the
Investor Information section. Alternatively, domestic callers may participate
in the conference call by dialing (866) 524-6241, and international callers
may participate in the conference call by dialing (706) 679-3061. Webcast and
telephone replays of the conference call will be available approximately two
hours after the completion of the call through Friday, September 19, 2008.
Domestic callers can access the replay by dialing (800) 642-1687, and
international callers can access the replay by dialing (706) 645-9291; the PIN
access number is 64328875.
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
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 euro 2.5 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 Ltd. is
the company's European subsidiary based in the United Kingdom.
CV Therapeutics' approved products in the United States include Ranexa(R)
(ranolazine extended-release tablets), indicated for the treatment of chronic
angina in patients who have not achieved an adequate response with other
antianginal drugs, and Lexiscan(TM) (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; 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 June 30, 2008. CV Therapeutics disclaims any intent or
obligation to update these forward-looking statements.
SOURCE CV Therapeutics, Inc.
