By Jim Shrine
CV Therapeutics Inc. took a new collaborative approach to marketing its angina drug, through a type of outsourcing arrangement that will bring in $15 million upon approval and save the company $110 million in sales costs during the first five years the product is on the market.
CV Therapeutics¿ deal with Innovex Inc., a subsidiary of Research Triangle Park, N.C.-based Quintiles Transnational Corp., centers solely on the small molecule ranolazine. That drug candidate is nearing the end of the first of two pivotal Phase III trials for chronic stable angina. It is the first from a class of drugs for that indication designed to treat angina without reducing heart rate or blood pressure.
Quintiles made a $5 million equity investment at market prices when the deal was signed, and agreed to pay $10 million upon product launch. Sales and marketing services provided by Innovex over five years would cost CV Therapeutics about $110 million, the company estimated, making this deal the equivalent of a $125 million commercialization financing.
¿This represents a third path for young biotech companies to grow up,¿ said Louis Lange, the company¿s chairman and CEO, pointing out the others are partnerships with pharmaceutical companies and developing marketing capabilities internally. ¿This is closer to going at it alone, but you reduce the risk of that quite substantially.
¿It provides us with pharma-like margins and allows us to retain 90 percent of the profit,¿ Lange added. ¿It transfers big chunks of the risk, financing and execution of commercialization to professionals in the area. It¿s a giant risk-transference mechanism, when we need it most.¿
Innovex will launch and market ranolazine in the U.S. on a performance basis that won¿t exceed 33 percent of revenues. The compensation to Innovex for years three through five is expected to equal 25 percent to 30 percent of total revenues.
CV Therapeutics, of Palo Alto, Calif., retains all product rights and books all revenues. It also has the final say on all strategic issues related to sales of the product and has the option after five years to convert the Innovex sales force to a CV Therapeutics sales force.
First Pivotal Study To Finish In Early June
David Stack, president and general manager of Inno vex, said he, too, is pleased about the opportunity to launch the first from a new class of anti-angina drugs to hit the market in more than 20 years.
¿The fee structure gives us the potential for much greater return on our investment, if sales meet the minimum sales levels specified in the agreement,¿ Stack said in a news release. ¿We have the opportunity to exceed twice our normal margins. The agreement allows for Innovex to change the size of the sales force if sales are lower or higher than the minimum sales levels specified in the agreement.¿
Innovex is Quintiles¿ sales and marketing services division. It has built more than 30 sales teams ranging in size from five people to 500. With 2,700 salespeople, it would be the sixth-largest pharmaceuticals sales force in the U.S. And Innovex has sold seven cardiovascular products.
Commercialization of ranolazine is still a few years away, however. A second pivotal study, expected to take a year and a half, is scheduled to start this quarter.
Completion of the first pivotal study is expected in early June, Lange said. That trial of 152 patients involves monotherapy treatment four times over five or six weeks. Patients get drug three times and placebo once, serving as their own controls, then compare times on the treadmill. About 75 percent to 80 percent of patients who completed the study and are participating in an open-label follow-up chose to stay on ranolazine, Lange said. Data should be available by the end of the summer, he said.
The second pivotal study will be similar except that patients will take a beta blocker or calcium channel blocker with ranolazine. That study should be completed by the end of the next year, Lange said.
Nitrates, in addition to calcium channel and beta blockers, make up the third commonly used anti-angina class of drug. All three lower blood pressure and all but nitrates reduce the heart rate. Since ranolazine does neither, ¿we think that translates into use by a lot of patients underserved by current therapies,¿ Lange said.
Ranolazine is designed to let the heart burn glucose rather than fat for energy, thereby reducing its demand for oxygen without reducing heart rate, blood pressure or pumping ability in chronic stable angina. About 7.2 million patients in the U.S. suffer from angina. Ranolazine targets about 2.4 million of those patients, Lange said.
The company has no plans to market its product in Europe and would expect to form a more traditional collaboration with a pharmaceutical partner for marketing there, Lange said.
A final part of the new deal calls for Quintiles to make available to CV Therapeutics a $10 million secured credit facility upon the FDA¿s acceptance of a new drug application. That would be used to fund Innovex¿s pre-launch activities.
As of March 31, CV Therapeutics had about $39 million in cash and 11.2 million shares outstanding. Its stock (NASDAQ:CVTX) gained 21.87 cents Tuesday to close at $4.375. n