Drug Delay Pummels Bristol-Myers Shares

Bristol-Myers Squibb Co. shares fell 22% on Wednesday after the company said safety concerns led it to delay seeking U.S. approval of its Vanlev blood pressure pill, which analysts expected to have $2 billion a year in sales.

Bristol-Myers plunged $14.19 to close at $50.94 in New York Stock Exchange trading. It withdrew a Food and Drug Administration application after regulators raised concerns about cases of swelling of the face, throat or tongue in patients who tried Vanlev. The condition, called angioedema, occurs rarely with other heart pills and can be life-threatening if swelling blocks the airways.

Investors were counting on Vanlev sales as court decisions make it likely Bristol-Myers will face generic-drug competition in the U.S. for its $1.5-billion-a-year cancer drug Taxol.

“This is a big negative,” said John Schroer, a manager with Invesco Capital Management, a Bristol-Myers shareholder. “Vanlev just blew up, and they’ve lost on Taxol.”

The Vanlev setback comes little more than a month after Bristol-Myers withdrew FDA applications for two colon cancer pills, including one called Orzel. Analysts at the time said this setback was minor because of the prospects for Vanlev. Bristol-Myers had done much to stoke expectations, promoting Vanlev research at medical meetings. Late Wednesday, Bristol-Myers said it would refile its Orzel application today.

Vanlev was the only drug near regulatory approval with sales potential comparable to recent record-setting new drugs, such as Celebrex, a painkiller that reached $1.5 billion in sales in its first year.

Bristol-Myers changed its informed consent document for Vanlev studies about three months ago to warn of a higher risk of angioedema among black patients, said Bernard Wagman, senior attending cardiologist at the Washington Hospital Center.

“They must have had at least an inkling--enough to change the informed consent,” said Wagman, who ran three Vanlev studies.

Shares of makers of competing blood pressure drugs rose.

Pfizer Inc., maker of the world’s top-selling high blood-pressure drug Norvasc with $3 billion in 1999 sales, gained $1.75 to $41.31 on the NYSE. Merck & Co., which sells several high blood-pressure drugs, rose $2.75 to $69, also on the NYSE.