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Cancer drug on fast track
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October 5, 2000: 11:58 a.m. ET
Coulter and SmithKline Beecham get FDA priority review for Bexxar
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NEW YORK (CNNfn) - An experimental cancer drug developed by biotech firm Coulter Pharmaceutical Inc. and SmithKline Beecham PLC received priority review status from U.S. regulators Thursday, meaning the treatment could be approved within six months of its application for review.
The news helped boost shares of South San Francisco, Calif.-based Coulter (CLTR: Research, Estimates), which is set to share equally in profits from the proposed drug with SmithKline. Coulter shares rose $1.56 to $30.63, while American depositary receipts of London-based SmithKline traded up 12 cents at $67.56.
The medication, Bexxar, is designed to treat relapsed or low-grade B-cell non-Hodgkin's lymphoma, a form of cancer that affects the blood and lymphatic tissues. If approved, the treatment could be the first approved radioimmunotherapy to go on the market. The drug is based on a targeted approach that gives a greater concentration of radiation to tumor cells while minimizing the radiation to normal tissue.
 "We are pleased that Bexxar has been awarded priority review status," Coulter President and CEO Michael F. Bigham said. "The commitment by the FDA for an expeditious review of our license application moves us one important step closer to providing this novel therapy to patients."
The U.S. Food and Drug Administration gives priority review to proposed treatments that target life-threatening diseases or unmet medical needs. The priority review process is not designed to make approval easier, but can reduce the time to rule on whether a new drug should go on the market.
Under the partnership, Coulter and SmithKline are jointly developing the drug. Coulter holds the rights to Bexxar outside the United States.
SmithKline Beecham is set to merge with cross-town rival Glaxo Wellcome PLC (GLX: Research, Estimates) in a deal expected to close by the end of the year. The merger would create the world's largest drug maker. 
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