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Nexium gets pre-approval
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October 5, 2000: 2:23 p.m. ET
AstraZeneca's new ulcer drug moves a step closer to FDA approval
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NEW YORK (CNNfn) - AstraZeneca PLC has moved a step closer toward bringing a key new drug in its pipeline to the U.S. market, after the Food and Drug Administration issued an "approvable letter" for the company's next-generation ulcer drug, Nexium.
The Anglo-Swedish drug company hopes Nexium will compensate for lost sales of the company's blockbuster ulcer treatment Prilosec (known as Losec outside the United States), the world's best-selling drug, with nearly $6 billion in sales last year.
Prilosec is expected to lose exclusivity on some of its U.S. patents in 2001, opening the door to cheaper, generic competitors. The drug already has lost its patent protection in some European countries.
The FDA confirmed Thursday that it sent the London-based company an "approvable letter" earlier this week for Nexium. Such documents indicate that the federal agency is prepared to approve experimental drugs, pending the resolution of any outstanding issues.
 Neither the FDA nor an AstraZeneca spokeswoman would comment on the contents of the letter, citing standard confidentiality practices in the drug review process.
But AstraZeneca spokeswoman Rachel Bloom-Baglin said the company is still targeting a U.S. launch date of early 2001 for the drug. Nexium already is on the market in Sweden.
AstraZeneca says Nexium is more effective and potent than Prilosec, but some analysts have questioned its sales potential. Some are dubious over whether Nexium's formulation is significantly different from the company's existing product and whether doctors will prescribe the new version rather than generic rivals to Prilosec.
The company's American depositary receipts gained 13 cents to $51.75 in Thursday afternoon trading on the New York Stock Exchange. The stock is trading near 52-week highs. 
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AstraZeneca
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