NEW YORK -- Bristol-Myers Squibb has withdrawn its application for federal approval of a highly touted blood pressure medication that was expected to be the industry's next blockbuster.
The company made the surprising decision Wednesday in response to the Food and Drug Administration's concerns that the drug, Vanlev, might cause severe reactions, such as swelling in the face, throat and lips, in a small number of patients.
Bristol-Myers now says it will conduct more studies on the drug, and wait until early next year to reapply for federal approval.
"We remain bullish on this drug," said Richard Lane, the president of the company's Worldwide Medicines Group, based in Princeton, N.J.
The company's shares tumbled 22 percent on the news Wednesday. In early afternoon trading today, the stock was down an additional $1 to $49.93 3/4 , even though the company's first-quarter earnings rose to $1.22 billion, beating Wall Street forecasts. Last year, first-quarter earnings were $1.07 billion.
The FDA had been reviewing Vanlev since December and was expected to approve it by June.
The drug has been studied in nearly 7,000 patients, with some staying on the drug up to two years, Bristol-Myers said.
A little more than 1 percent of patients experienced the swelling problem, including four patients who needed to have a tube inserted down their throat because they had trouble breathing, the company said. All four survived.
While the swelling problem, known as angioedema, is a rare side effect of some blood pressure drugs, the FDA seemed more concerned with the severe cases in which breathing tubes were needed, the company said.
The swelling problems, which were mainly seen in black people, occurred with patients shortly after they started taking the pill, the company said. As a result, the company will look into starting patients on a lower dosage to reduce the risk.
"We hope to show the four cases of severe angioedema were statistical anomalies, and not a signal of increased risk," Lane said.
Vanlev was designed to simultaneously inhibit two key enzymes which regulate blood pressure.
Studies released last fall showed Vanlev outperformed two mainstays of blood pressure control, a top-selling ACE inhibitor and a calcium-channel blocker.
Vanlev appeared to do a better job of lowering both systolic and diastolic pressure.
Systolic is the pressure in the arteries when the heart beats, while diastolic is the pressure between beats. Systolic is the first and larger of the two numbers. Ideal blood pressure is less than 140 over 90.
Like standard ACE inhibitors, Vanlev blocks angiotensin converting enzyme, which raises blood pressure. However, the medicine also stops another enzyme called neutral endopeptidase. By doing this, the medicine protects the body's supply of other helpful substances that make blood vessels relax and prevent dangerous overgrowth of heart muscle.
Hypertension, or high blood pressure, affects more than 600 million people worldwide. Three of four people with high blood pressure in the United States are not at or below the recommended target goal, which puts them at increased risk of heart attack, stroke, heart failure, and kidney disease.
Bristol-Myers, which has its corporate headquarters in New York, was counting on Vanlev sales to make up for falling sales of its current top drug, Pravachol, a cholesterol-lowering pill. It also was hoping that revenues from Vanlev would help offset anticipated lower sales of its cancer drug Taxol, which is facing patent challenges.
Analysts had estimated Vanlev could make more than $2 billion in sales by 2004, projecting it would be the company's top-selling drug.
Bristol-Myers rival Pfizer Inc. makes the leading hypertension drug, Norvasc, which had sales of more than $3 billion last year.
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