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Drug Maker Says Data Boost Hopes for Crestor

September 03, 2002|From Reuters

LONDON — Europe's second-biggest drug maker, AstraZeneca, presented new clinical data Monday showing its experimental cholesterol-lowering drug Crestor was more effective than its biggest rival across a wide range of doses.

The Anglo-Swedish firm told a medical conference in Berlin that its biggest new drug hope produced an 8.4% greater reduction in LDL-cholesterol--or harmful cholesterol--than Pfizer Inc.'s Lipitor, the world's top-selling drug.

Previous trial data had focused on individual dose comparisons.

Crestor, which has been deemed approvable by the Food and Drug Administration pending further discussion on dose and label, is a key plank of AstraZeneca's bid to reduce its reliance on ulcer pill Losec, a $6-billion-a-year bestseller that is facing the threat of cheap, generic competition.

But its progress has been delayed by regulators seeking more information about its use at high doses.

Shares in AstraZeneca, which have been hit hard recently by the delays to Crestor and problems with its experimental cancer drug Iressa, were the biggest gainers in the FTSE 100 index, gaining 3.6%. The stock is down nearly 50% from April's peak, however.

AstraZeneca said last month that it would provide the FDA with new clinical data in the first quarter of 2003 and no longer would seek approval for the highest Crestor dose--80 milligrams--after rare cases of muscle problems.

Analysts said this put back the likely launch of the treatment in the key U.S. market to the third or fourth quarter of next year, about one year later than initially expected.

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