Bristol seeks expanded blood pressure drug use

NEW YORK (CNNMoney.com) -- FDA advisors are expected to vote Wednesday on whether a Bristol-Myers Squibb blood pressure drug can be used by a wider patient population.

Bristol's (up $0.03 to $28.49, Charts) blockbuster combination pill, Avalide, is currently approved to treat hypertension patients who have failed other treatments. Bristol is trying to get Avalide approved by the Food and Drug Administration as a "first-line" drug for patients who have not been previously treated.

An FDA advisor released documents recommending approval of Avalide for this wider patient population, a good sign that the drug could get a positive vote from the advisory panel Wednesday. The nonbinding vote will then be taken into consideration by the FDA when it decides at a later date whether to approve the drug for this use. The FDA follows the advice of its panels most of the time.

If Avalide gets an additional approval from the FDA, then it would allow drug reps to advertise it for this use. But the FDA decision is unlikely to have much impact on Bristol, said Jon LeCroy, analyst for Natexis Bleichroeder.

LeCroy said that many doctors already prescribe Avalide "off-label" for the wider population.

"[Avalide] is a big drug for them but any changes to prescribing behavior are probably going to be small," said LeCroy. "I'm sure it's heavily used for first-line already."

Avalide is a combo containing another Bristol drug, Avapro. Bristol reported that sales for these drugs totaled $1.1 billion in 2006.

Avalide and Avapro compete with Merck's (down $0.34 to $49.98, Charts) blood pressure drugs Hyzaar and Cozaar, which together totaled $3.2 billion in 2006 sales.

Hypertension is a common ailment. Nearly one-third of American adults suffer from high blood pressure, placing them at risk of stroke and heart failure, according to the National Heart Lung and Blood Institute.

Investors will get a better idea of Avalide's more recent sales activity April 26, when Bristol releases first-quarter earnings.

Bristol, based in New Brunswick, N.J., is the sixth-largest U.S. drugmaker in terms of sales, behind Johnson & Johnson (up $1.97 to $64.99, Charts), Pfizer (down $0.04 to $26.90, Charts), Merck, Abbott Laboratories (up $0.16 to $59.04, Charts), Wyeth (down $0.39 to $56.43, Charts).

LeCroy does not own any shares of Bristol stock and Natexis Bleichroeder does not conduct business with the company.

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