CV Therapeutics Inc and Quintiles Transnational Corp have modified their commercialization agreement for Ranexa. The modified agreement provides CV Therapeutics with complete commercialization rights for Ranexa, including the opportunity to hire and train a dedicated cardiovascular sales force. Quintiles and its commercial sales and marketing subsidiary, Innovex, will continue to have a commercialization services relationship relating to Ranexa and also will become a preferred provider of their full range of pharmaceutical services for CV Therapeutics.
Under the modified agreement, Quintiles also will receive a warrant for 200,000 shares of CV Therapeutics common stock. These modifications supercede the terms of the prior agreement, signed in May 1999, which included payments from CV Therapeutics to Innovex of a fee based on a percentage of sales in the first five years of Ranexa sales, and a royalty in the sixth and seventh years.
In December 2002, CV Therapeutics submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for the treatment of chronic angina. If approved, Ranexa would represent the first new class of anti-anginal therapy in the United States in more than 20 years.
None of CV Therapeutics' products have been approved for marketing by the FDA or other foreign regulatory agencies. Any products of the company discussed here 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. CV Therapeutics' products have not been determined to be safe or effective in humans for any uses.