Bristol-Myer's Heart-Drug Results
Deal Blow to Company's Prospects
By RON WINSLOW and GARDINER HARRIS
Staff Reporters of THE WALL STREET JOURNAL
ATLANTA -- Two large-scale clinical trials delivered a major blow to Bristol-Myers Squibb Co.'s experimental heart drug Vanlev, casting doubts about its potential to achieve blockbuster sales and sending the company's shares plummeting.
In one study of more than 5,700 heart patients, Vanlev failed to beat Merck & Co.'s Vasotec in reducing death or hospital admissions due to worsening heart failure. In the second study, of 25,000 patients with high blood pressure, the drug proved better than Vasotec, but it caused a rare but potentially dangerous side effect known as angioedema three times as often as the other medicine.
The results mean that while the drug is effective in treating both conditions, Bristol-Myers will have a much tougher time than many analysts and cardiologists had hoped in establishing a clear benefit over competitors and charging a premium price. Vasotec is now available as a pennies-per-pill generic drug.
Bristol-Myers has been dealing with a series of setbacks recently. The Vanlev findings come on the heels of the FDA's refusal to review the application for Erbitux, a cancer drug Bristol-Myers is developing with Imclone Systems Inc., a New York biotechnology company. While Erbitux still could be approved, it is easily a year off. Meanwhile, generic competition is ravaging sales of some of its biggest sellers, including cancer drug Taxol and diabetes drug Glucophage.
Several analysts downgraded the stock. "We're left with a company with a litany of problems and a management that has zero credibility," said Barbara Ryan, an analyst with Deutsche Banc Alex. Brown. "I think some heads will roll and they will be very vulnerable to take-out."
Trading in its shares was delayed until 11:53 a.m. EST, when they opened 15% below Tuesday's closing price. As of 4 p.m. in New York Stock Exchange composite trading Wednesday, the shares closed at $41.08, down 16%, or $7.57.
Some analysts now wonder whether Vanlev will even get approved for sale by the U.S. Food and Drug Administration. Former Bristol-Myers Chairman and Chief Executive Charles Heimbold predicted several years ago that Vanlev would eventually yield $3 billion a year in sales. Now, $500 million in yearly sales would be a stretch, analysts say.
"I'm not even sure Vanlev gets to market," said Bihag Patel, an analyst at Banc One Investment Advisors in Columbus, Ohio, which in a recent filing said it owned more than 13 million shares. "I think you have to pull Vanlev out of your models entirely."
Bristol-Myers didn't have any specific comment on its plans for the drug or what the impact of the results would be on the company. But investigators who directed the company-sponsored studies -- and presented the results during the annual scientific meeting of the American College of Cardiology -- said they believed Vanlev would still be an important treatment for both heart failure and hypertension. They added that Bristol-Myers had assured them it plans to invest significant resources in additional studies of the drug.
Both the company and the investigators said they needed to analyze the data -- the data on heart failure have been available for only a few days -- to determine what course to take. Researchers are combing the results to find certain categories of patients who might benefit from Vanlev and to determine how to avoid patients who might be at especially high risk of the side effects.
Bristol-Myers mounted the study on high blood pressure two years ago after withdrawing its FDA application for Vanlev because a few patients developed angioedema, a swelling of the head and neck that in rare instances can cause patients to have difficulty breathing. The side effect was particularly troublesome because hypertension is widespread and the drug potentially would be prescribed to millions.
In the new study, patients taking Vanlev had their blood pressure reduced by an average three milligrams of mercury more than Vasotec -- an improvement that could lead to a 10% to 20% reduction in strokes, heart attacks and other cardiovascular events, said Michael A. Webber, a researcher at State University of New York Health Science Center, Brooklyn, and a leader of the study.
But over 24 weeks, 2.17% of patients taking Vanlev experienced angioedema, compared with 0.68% of patients on Vasotec. All patients fully recovered, researchers said. Black patients had a much higher incidence of angioedema -- 5.54% compared with 1.62% with the other drug.
In the heart-failure study, patients taking Vanlev were only 6% less likely to die or be hospitalized than patients taking Vasotec, a difference that wasn't considered statistically significant. "We can conclude that the two drugs are equivalent," said Milton Packer, a heart-failure expert at Columbia College of Physicians and Surgeons, New York, who led the study. |
