Palo Alto, CA and Research Triangle Park, NC (May 8, 2000) - CV Therapeutics, Inc. (Nasdaq: CVTX) and Innovex, a business unit of Quintiles Transnational Corp. (Nasdaq: QTRN), were honored with the Breakthrough Alliance Award of 1999 for their commercialization agreement to market ranolazine, CVT's lead product candidate. The award, sponsored by Recombinant Capital and International Biomedicine Partners and voted on by pharmaceutical and biotechnology executives, was presented at the Allicense 2000 conference, in Basel, Switzerland.
"We are pleased to have received validation from our biotechnology and pharmaceutical peers for the novel approach we have selected for commercializing ranolazine," said Dan Spiegelman, SVP and Chief Financial Officer, CV Therapeutics and an architect of the agreement. "Partnering with Innovex on a risk-sharing basis will allow CVT to retain most of the profits from the sales of ranolazine, if approved, while minimizing the financial risk typically associated with launching a company's first product."
Under this agreement, signed in May 1999, Innovex will conduct pre-launch activities, hire and train a dedicated cardiology sales force to launch and promote ranolazine, and provide post launch marketing and sales services. Innovex will provide these services for at least three years after launch, and two additional years if certain minimum sales levels are met. In return CVT will pay Innovex a percentage of ranolazine revenues ranging from 25% - 33%.
"Our agreement with CVT reflects Innovex's ability to listen carefully to our customers and craft solutions that meet their specific needs," said John Monahan, Executive Vice President, Innovex Americas. "We look forward to working with CVT to successfully launch ranolazine upon regulatory approval."
Innovex, the world leader in commercial solutions for the healthcare industry, currently has a worldwide sales force of approximately 9000 sales representatives. As a result of the interest in the CVT and Innovex agreement, Innovex has developed a special unit that will focus on the needs of biotechnology and emerging companies. The new unit is headed by John Parsons, Vice President, Emerging Markets.
"These companies are at a crossroads, and our performance-based commercialization model allows these companies to focus on their core business - discovering and developing innovative new drugs and biologics - while Innovex provides the resources to maximize commercial success at launch and accelerate the drive to peak sales," Parsons said.
Ranolazine is the first in a new class of compounds known as partial Fatty Acid Oxidation (pFOX) inhibitors for the potential treatment of chronic angina, and is currently in Phase III clinical trials. Ranolazine has not been approved for marketing by the Food and Drug Administration or other foreign agencies. Ranolazine is presently being investigated in clinical trials subject to a United States Investigational New Drug application and applicable foreign authority submissions. CV Therapeutics has not yet submitted a New Drug Application to the FDA or equivalent application to any other foreign regulatory authorities for ranolazine to assess its safety and efficacy in humans.
About CVT
Statements in this press release concerning the development, potential application and commercialization of ranolazine are forward-looking statements that involve risks and uncertainties. Actual results could differ materially. Factors that could cause or contribute to such differences are more fully discussed in CVT's Annual Report on Form 10-K for the year ended December 31, 1999.
CV Therapeutics, Inc., headquartered in Palo Alto, CA, 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. CVT is currently conducting clinical trials for two of its products. Ranolazine, the first in a new class of compounds known as partial fatty acid oxidation (pFOX) inhibitors for the potential treatment of angina, is in Phase III clinical trials. CVT-510, an A1 adenosine receptor agonist, for the potential treatment of atrial arrhythmias, is in Phase II clinical trials. For more information, please visit CV Therapeutics' web site at www.cvt.com.
About Quintiles Transnational and Innovex
Innovex, a business unit of Quintiles Transnational Corp., is the worldwide leader in providing pharmaceutical and biotechnology companies integrated solutions to enhance the commercial success of their products. Quintiles Transnational improves healthcare by bringing new medicines to patients faster and providing knowledge-rich medical and drug data to advance the quality and cost effectiveness of healthcare.
Headquartered near Research Triangle Park, North Carolina, Quintiles employs a global workforce operating from offices in 31 countries. Quintiles Transnational is a member of the S&P 500, Fortune 1000 and Nasdaq 100. For more information visit www.quintiles.com.
Information in this press release contains "forward-looking statements." These statements involve risks and uncertainties that could cause actual results to differ materially, including without limitation, actual operating performance, the ability to maintain large client contracts or to enter into new contracts. Additional factors that could cause actual results to differ materially, including the affect of recent acquisitions, are discussed in Quintiles Transnational Corp.'s recent filings with the Securities and Exchange Commission, including but not limited to its S-3 and S-4 Registration Statements, its Annual Report on Form 10-K, its Form 8-Ks, and its other periodic reports, including Form 10-Qs.