At the 75th American Heart Association's Scientific Sessions in Chicago, CV Therapeutics Inc. presented data from a Phase III trial of a drug that exceeded the company's expectations in its ability to convert an abnormally rapid heart rhythm back to normal.
But release of positive Phase III data for tecadenoson (CVT-510) isn't all that Louis Lange, CV Therapeutics' chairman and CEO, is excited about these days.
His Palo Alto, Calif.-based company is weeks away from filing a new drug application for Ranexa, a chronic angina treatment, and the company has seen positive results in a Phase II study of CVT-3146, a pharmacologic stress agent for use in cardiac perfusion imaging studies.
Add that to the fact that the company will end the year with more than $400 million in cash, cash equivalents and marketable securities, and you have a recipe for success, Lange told BioWorld Today.
"We've got a lot of freedom - independence," Lange said. "We're building a tier-one company and have the tripod to build it on, which is a great team, cash and technology that is product focused."
The pending NDA for Ranexa (ranolazine), a member of a new class of drugs called partial fatty acid oxidation inhibitors, is the most imminent important company achievement.
It was just last year at the AHA meeting that CV Therapeutics presented its successful Phase III CARISA (Combined Assessment of Ranolazine In Stable Angina) data and said that the company was on a direct path to submit the NDA in late 2002. The company said it is still on track with that timeline. CARISA met its primary efficacy endpoint, showing ranolazine produced a statistically significant increase in patients' symptom-limited exercise duration compared to placebo. (See BioWorld Today, Nov. 15, 2001.)
Based on FDA guidelines under the Prescription Drug User Fee Act, Lange expects a decision on Ranexa in 15 months. Ranexa is partnered with Innovex, a subsidiary of Quintiles Transnational, of Research Triangle Park, N.C., for sales and marketing. Terms of the deal give CV Therapeutics the lion's share of the profits and control of the sales force after five years, Lange said.
Meanwhile, Lange thinks he has another winner with tecadenoson.
"We exceeded our endpoints," he said. "This was a 181-patient, placebo-controlled trial and p' values for all the groups had three zeros in front - it really exceeded our expectations."
Indeed, the company said all five dosing regimens of tecadenoson studied in a Phase III trial of patients with paroxysmal supraventricular tachycardia - an abnormally rapid heart rhythm - converted back into a normal heart rhythm (p<0.0005 vs. placebo). Tecadenoson is a selective A1-adenosine receptor agonist, and the company believes it is potentially the first in a new class of selective adenosine analogues developed to treat abnormal heart rhythms.
In order to get a product like tecadenoson to market, Lange said companies commonly conduct two pivotal Phase III trials. But he said CV Therapeutics has not given guidance on a second Phase III.
"We haven't decided what we are doing from here," Lange said. "Our next step is getting the NDA submitted for Ranexa this year, so this is an important interlude - to be here in Chicago at the AHA - but we need to get back where we've got a lot of people who are still at home working on the NDA."
Lange's group also presented at the meeting positive data on CVT-3146, a selective A2A-adenosine receptor agonist being developed with Fujisawa Healthcare Inc., a subsidiary of Fujisawa Pharmaceutical Co. Ltd., of Osaka, Japan.
CV Therapeutics said CVT-3146 demonstrated a dose-dependent increase in coronary blood flow velocity in an open-label Phase II study of 36 patients undergoing cardiac catheterization. The study was designed to evaluate the effect of a single rapid intravenous bolus of CVT-3146 on coronary blood flow velocity over a dose range.
"This is really excellent Phase II data showing you can replace exercise with drug to increase coronary blood flow in the stress daily perfusion tests," he said. "Forty percent of the 6.5 million tests done are with drug now, and this 3146 is a designer drug - the old drugs are really nonspecific."
Lange said the company is committed to initiating a Phase III trial of CVT-3146 sometime in 2003. He added that Fujisawa is paying 75 percent of development costs, plus milestones and double-digit royalties.
CV Therapeutics' stock (NASDAQ:CVTX) closed Wednesday at $25.01, up $1.01.