CV Therapeutics and Solvay Pharmaceuticals Enter Into
2004-12-06 16:02 (New York)
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 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. (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. |
