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Astra says R&D strong
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December 12, 2000: 11:03 a.m. ET
Drug maker says it will apply for approval of cholesterol drug in 2Q
By Staff Writer Martha Slud
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NEW YORK (CNNfn) - Pharmaceutical firm AstraZeneca PLC said Tuesday it plans to seek regulatory approval by the middle of next year for an experimental cholesterol-lowering treatment that could rival Pfizer Inc.'s blockbuster Lipitor.
In a meeting with industry analysts in Sweden, the Anglo-Swedish drug firm said it would file for approval of the drug, called Crestor, in the second quarter of 2001. If the drug is approved, it could go on the market as early as 2002.
Recent clinical trials of Crestor showed some benefits over rival drugs, the company said. Late-stage Phase III data detailing head-to-head comparisons with Lipitor, the best-selling cholesterol drug, will be released at a medical conference in March.
"The profile [of the drug] looks tremendous," AstraZeneca Chief Executive Officer Tom McKillop said in a telephone interview with CNNfn.com following the company's presentation.
AstraZeneca (AZN: Research, Estimates) is aggressively seeking new drugs to make up for lost sales of ulcer treatment Prilosec, the world's best-selling medication with sales of $5.9 billion last year. The drug, known as Losec outside the United States, has lost patent protection in several key markets.
"We will have 14 new candidate drugs in development this year, so that's a really excellent performance," McKillop said.
The company has introduced a next-generation ulcer drug, Nexium, in Sweden, the U.K. and Germany.
AstraZeneca's executive vice president for gastrointestinal treatments, Martin Nicklasson, said Nexium has registered strong sales so far. He said the company remains on track to launch the drug early next year in the United States and more than 20 other countries. The company declined to provide any sales forecast.
The company also plans to file for regulatory approval of Casodex, a prostate cancer treatment, early next year. That's about two years earlier than initially projected.
On the downside, AstraZeneca also disclosed that an oral anti-thrombin medicine under development failed to prove superiority over other drugs in a clinical study looking at the medicine as a preventative treatment for venous thrombolism following orthopedic surgery.
McKillop told CNNfn.com that this was not a major setback, saying that venous thrombolism was viewed as only a minor indication for the drug. He said the main treatment indications for the drug are deep-vein thrombosis and stroke prevention.
"The main indications are still on track," he said.
The company also plans to submit regulatory applications next year for experimental breast cancer treatment Faslodex, lung cancer drug Iressa and Viozan, for chronic obstructive pulmonary disease.
In afternoon trading in London, AstraZeneca shares fell 38 pence to 3,222. In New York, American depositary receipts slipped 88 cents to $47.31. 
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AstraZeneca
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