CV Therapeutics, Inc. and Solvay Pharmaceuticals, Inc. have entered into a co-promotion agreement for Aceon (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.

According to the agreement, 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 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, 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, president and chief executive officer of Solvay Pharmaceuticals, Inc. "This includes the possible expansion of the Aceon label to include the results of the EUROPA study," he added.

"Aceon 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, upon potential approval. The rapid completion of enrolment of our approval-enabling ERICA trial with Ranexa has accelerated our overall commercialization timing," said Louis G. Lange, chairman and chief executive officer of CV Therapeutics.

Solvay Pharmaceuticals plans to submit a supplemental new drug application to the US FDA seeking an expansion of the Aceon label based on the data from the EUROPA study, the statement said.

The EUROPA trial 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. Perindopril is one of the leading ACE inhibitors in Europe.