forbes: New Drug Takes Aim At Stents
Matthew Herper, 03.27.07, 11:40 AM ET
NEW ORLEANS - Tiny biotech CV Therapeutics saw unexpected benefits from its Ranexa drug in a 6,000-patient clinical trial, even though the study failed to meet its main goal.
But the fate of the drug, which even many CVT (nasdaq: CVTX - news - people ) bulls say is likely to be used relatively rarely, depends partly on how doctors react to a much more watched clinical trial.
Ranexa competes directly with heart stents, tiny metal tubes used to hold open arteries in a procedure called angioplasty. One of the major uses of these devices is to treat chest pain and windedness caused by heart problems. This condition, known as angina, is also the use for which Ranexa was approved.
A large study called COURAGE, released yesterday and presented today, showed that stents were not more effective at saving angina patient's lives than drugs alone. Ranexa was not included in COURAGE, but the new hope for the drug is that as doctors treat angina better, they will turn to Ranexa more often.
Both studies were presented here at the annual meeting of the American College of Cardiology.
"I was telling my colleagues earlier, it's as good" as angioplasty, said Salim Yusuf, a well known cardiologist at McMaster University in Canada, who discussed Ranexa from the podium here at the meeting. His co-discussant tempered those comments, saying that stents actually have more benefits in the population studied in the Ranexa clinical trial.
The CV Therapeutics study was designed to prove Ranexa prevented heart problems including heart attacks and death in patients who already had serious heart trouble. The drug didn't do that, and because it failed in its main goal, scientists consider other conclusions from the study as interesting questions, not definitive answers.
After the release of results of the Ranexa efficacy study three weeks ago, CV Therapeutics shares plunged 10%. They rebounded 10% in Tuesday trading after the COURAGE data on stents was released at the conference.
The new information may increase the prescribing of Ranexa, which CVT is advertising heavily here at ACC using big banners on the side of convention buses. Ranexa prevented chest pain by several different measures.
More surprisingly, it seemed to prevent heart rhythm disturbances called arrhythmias. Theoretical problems with the drug were supposed to cause an increase in this problem, which Ranexa actually appears to treat. That might help CVT get an expanded FDA label for the drug.
The big question is whether putting those safety concerns to rest will cause doctors to prescribe the drug. Even many fans of the company see sales of only a few hundred million dollars a year. Doubters note that chest pain is well treated with stents, and most patients just don't need another drug.
For CV Therapeutics, the question really is whether these mixed results can convince doctors to use the drug more often--and whether, given the wide use of stents and other anti-angina drugs--there is much of a market at all. Given Wall Street's relatively low expectations, it seems the biotech at least has a shot. |
