CV Therapeutics and Solvay Pharmaceuticals Enter Into Co-Promotion Agreement for ACEON(R) (perindopril erbumine) Tablets
December 06 2004 - 4:02PM
PR Newswire (US)
CV Therapeutics and Solvay Pharmaceuticals Enter Into Co-Promotion
Agreement for ACEON(R) (perindopril erbumine) Tablets Solvay
Pharmaceuticals to Seek Potential Label Expansion Based on EUROPA
Data MARIETTA, Ga. and PALO ALTO, Calif., Dec. 6
/PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (NASDAQ:CVTX) and
Solvay Pharmaceuticals, Inc. announced today that the companies
have entered into a co-promotion agreement for ACEON(R)
(perindopril erbumine) Tablets, an angiotensin converting enzyme
(ACE) inhibitor with tissue activity approved in the United States
for the treatment of hypertension. The co-promotion agreement
covers the United States and extends through at least 2010. CV
Therapeutics will be responsible for brand marketing activities and
for establishing a cardiology focused sales force to promote the
product. Solvay Pharmaceuticals will continue to handle the
manufacturing and distribution of the product, and its primary care
sales force will also continue to promote the product. Solvay
Pharmaceuticals will book all sales of ACEON(R) and CV Therapeutics
will receive a royalty on all sales above a pre-specified baseline.
There are no upfront payments by either party associated with the
co-promotion agreement. "Our agreement with CV Therapeutics to
deploy a cardiology-focused sales force to promote ACEON(R),
combined with Solvay Pharmaceuticals' more broadly focused primary
care sales force, will allow us to maximize the potential for this
important product," said Harold H. Shlevin, Ph.D., president and
chief executive officer of Solvay Pharmaceuticals, Inc. "This
includes the possible expansion of the ACEON(R) label to include
the results of the EUROPA study." "ACEON(R) presents a compelling
product opportunity with potential label expansion based on the
EUROPA study and significant synergies with the physician
population we believe could be prescribing Ranexa(TM), upon
potential approval. The rapid completion of enrollment of our
approval-enabling ERICA trial with Ranexa has accelerated our
overall commercialization timing," said Louis G. Lange, M.D.,
Ph.D., chairman and chief executive officer of CV Therapeutics.
Solvay Pharmaceuticals plans to submit a supplemental new drug
application to the U.S. Food and Drug Administration (FDA) seeking
an expansion of the ACEON(R) label based on the data from the
EUROPA study. The EUROPA trial (European Trial on Reduction of
Cardiac Events with Perindopril in Stable Coronary Artery Disease)
was a multicenter, randomized, double-blind, placebo-controlled
trial in 12,218 patients with stable coronary disease and without
heart failure or substantial hypertension for at least three years.
The study was designed to assess the ability of perindopril to
reduce cardiovascular death, myocardial infarction, and cardiac
arrest. The results from EUROPA were published in the Lancet on
September 6, 2003. In Europe, perindopril is marketed under the
brand name Coversyl(R). Perindopril is one of the leading ACE
inhibitors in Europe. About ACE Inhibitors ACE inhibitors act to
reduce hypertension by interfering with the conversion of
angiotensin I to artery-constricting, angiotensin II. Blocking the
production of angiotensin II results in arterial vasodilation and
an accompanying reduction in blood pressure. ACE inhibitors
currently are recommended as first-line therapy for hypertension in
certain patient populations, because of their safety and efficacy.
Most recently, the Seventh Report of the Joint National Committee
on Prevention, Detection, Evaluation, and Treatment of High Blood
Pressure has recommended ACE inhibitors as one of the initial
therapy choices for compelling indications such as heart failure,
postmyocardial infarction, high coronary disease risk, diabetes,
chronic kidney disease and recurrent stroke prevention. ACEON(R) is
only indicated for the treatment of hypertension. Certain ACE
inhibitors, including ACEON(R), which have been shown to have an
enhanced affinity for the tissues, are known as tissue-ACEs. About
ACEON(R) ACEON(R) is an ACE inhibitor indicated for the treatment
of essential hypertension. It offers continuous 24-hour blood
pressure control with once-daily dosing for hypertensive patients.
ACEON(R) may be used alone or with other classes of
antihypertensives. ACEON(R) is contraindicated in patients known to
be hypersensitive to this product or to any other ACE inhibitors
and in patients with a history of angioedema related to previous
treatment with an ACE inhibitor. When used in pregnancy during the
second and third trimesters, ACE inhibitors can cause injury and
even death to the developing fetus. When pregnancy is detected,
ACEON(R) should be discontinued as soon as possible. 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 has entered into an
agreement with Solvay Pharmaceuticals to co-promote ACEON(R)
(perindopril erbumine) for the treatment of hypertension and
currently has four clinical development drug candidates. CV
Therapeutics has received an approvable letter from the FDA
relating to its new drug application for Ranexa for the potential
treatment of chronic angina, and has submitted an application for
the approval of ranolazine for the potential treatment of chronic
angina to the European Medicines Agency. Regadenoson is a selective
A2A-adenosine receptor agonist for potential use as a pharmacologic
stress agent in cardiac perfusion imaging studies. Tecadenoson is a
selective A1-adenosine receptor agonist for the potential reduction
of rapid heart rate during atrial arrhythmias. Adentri(TM) is a
selective A1-adenosine receptor antagonist for the potential
treatment of heart failure and has been licensed to Biogen Idec
Inc. For more information, please visit CV Therapeutics' website at
http://www.cvt.com/. Ranexa, regadenoson, tecadenoson and Adentri
have not been approved for marketing by the FDA or any foreign
regulatory authorities. These products 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. About Solvay Pharmaceuticals, Inc.
Solvay Pharmaceuticals, Inc.
(http://www.solvaypharmaceuticals-us.com/) of Marietta, Georgia
(USA), is a research-driven pharmaceutical company that seeks to
fulfill unmet medical needs in the therapeutic areas of cardiology,
gastroenterology, mental health, women's health and a select group
of specialized markets including men's health. It is a part of the
global Solvay Pharmaceuticals organization whose core activities
consist of discovering, developing and manufacturing medicines for
human use. Solvay Pharmaceuticals is a subsidiary corporation of
the worldwide Solvay Group of chemical and pharmaceutical companies
headquartered in Brussels, Belgium. Except for the historical
information contained herein, the matters set forth in this press
release, including statements as to development, clinical studies,
regulatory review, and commercialization of CV Therapeutics'
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 conduct and timing of
clinical trials; the dependence on collaborative and licensing
agreements; commercialization of CV Therapeutics' 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, Christopher Chai,
Treasurer & Executive Director, Investor Relations,
+1-650-384-8560, or media, John Bluth, Senior Director, Corporate
Communications, +1-650-384-8850, both of CV Therapeutics; or
Gabrielle Braswell, Manager, Public Affairs, Solvay
Pharmaceuticals, Inc., +1-770-578-5637 Web site:
http://www.solvaypharmaceuticals-us.com/ Web site:
http://www.cvt.com/
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