By SUSANNAH RODGERS
(AP) LONDON
Anglo-Swedish pharmaceuticals company AstraZeneca PLC said Wednesday it received an approvable letter from the U.S. Food & Drug Administration for a cholesterol-reducing drug, but the company's subsequent silence sparked concerns about the drug's full approval.
AstraZeneca received the FDA letter for the drug Crestor earlier than expected, but the company refused to be drawn on its contents and wouldn't bring forward its expected Crestor launch date.
An approvable letter usually indicates the FDA is prepared to approve a drug, but brings up any remaining issues that need to be resolved before full approval. Issues can range from label changes, to more complex data demands that could take time.
A spokeswoman for AstraZeneca said the company is reviewing the letter. There has been no change to existing guidance for the drug's launch, which is unlikely to be in the third quarter of 2002, she said.
The letter came ahead of an expected end-June date. However, it brought only limited cheer as it's unclear what the FDA's remaining demands are, if any. There was also disappointment that AstraZeneca hasn't brought forward its launch guidance.
Crestor has been heralded as a potential blockbuster, generating sales of more than $1 billion. This could fill a vital gap should AstraZeneca lose patent protection on its best-selling medicine, Losec, which it's defending in an ongoing New York court case.
Cholesterol-reducing drugs are seen as a key growth area given the surge in incidence of obesity and other heart disease precursors in richer countries, where most worldwide drug sales take place.
But Crestor is set to enter a competitive arena, where Pfizer Inc.'s Lipitor and Merck & Co.'s Zocor among others are already making inroads. Analysts say the key to Crestor's market share is an FDA go-ahead for the drug to be prescribed in high doses.
"People would like to know what's in the letter," said Nomura Securities analyst James Millett, who wants to hear in particular what dosage has been approved.
Millett is keeping the stock at "buy," however, and said the letter was a relief: "With this uncertainty removed, it looks like people are buying back in," he said.
Navid Malik, at Williams de Broe, said while the news is good and much needed, and slightly ahead of schedule, it's light on detail, in a market where it's extremely important that AstraZeneca gets the right dosage to compete with Lipitor.
Shares of AstraZeneca finished at $42.76 Tuesday on the New York Stock Exchange, down 80 cents, or 1.8 percent.
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