First, it has to pass AC, than FDA, than to market.
This explain their cash needs(~$200M).
Press Release Source: CV Therapeutics, Inc.
CV Therapeutics and Quintiles Modify Ranexa(TM) Sales and Marketing Agreement
Thursday July 10, 4:15 pm ET
PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, N.C., July 10
/PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX - News) and Quintiles
Transnational Corp. (Nasdaq: QTRN - News), announced today that the companies have
modified their commercialization agreement for Ranexa(TM). 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.
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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.
"Today, with more than $450 million in cash, strong Phase III data, and an established employee base, CV Therapeutics is in an exceptional position to control and support the launch of Ranexa. We were not in this position when we signed the original deal with Innovex in 1999," said Louis G. Lange, M.D., Ph.D., Chairman and Chief Executive Officer of CV Therapeutics.
"We are delighted to have the opportunity to secure the flexibility to carefully select a highly qualified CV Therapeutics sales force that we can educate and train. We will now be able to maximize our investment in Ranexa and enjoy the return on that added investment," Lange added. "We look forward to continuing our positive strategic relationship with Quintiles and Innovex."
Quintiles Chairman Dennis Gillings, Ph.D., said: "Our work with CV Therapeutics has come to represent an important milestone in the evolution of our strategic partnering with innovative biotech and pharmaceutical companies. We look forward to building on our operational relationship with CV Therapeutics on Ranexa, and continuing to work with them to bring other new medicines for the treatment of cardiovascular diseases to patients."
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. |
