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"We have acknowledged that Galida was in a class with a high degree of uncertainty, and the decision to discontinue is disappointing," David Brennan, the company's CEO, said Thursday. "We remain committed to further strengthening AstraZeneca's pipeline of new medicines both from our own research efforts and through the continued pursuit of external opportunities to enhance our business." Analysts weren't betting heavily on Galida, and the stock fell only 26 cents to $54.58 by early afternoon. However, the drug's cancellation highlights what some analysts say is AstraZeneca's biggest weakness -- a paucity of promising new products in late-stage clinical development. Though the company is seeking regulatory approval for new uses of existing drugs, no applications for experimental treatments are scheduled for filing with the Food and Drug Administration this year. In October, AstraZeneca asked the FDA to approve Symbicort, an asthma drug already available in 93 foreign markets. Next year, AstraZeneca expects to seek FDA approval for a stroke drug and a drug to prevent the build-up of fat and calcium in arteries. Both were developed by other companies. Otherwise, all of AstraZeneca's FDA applications for experimental products are scheduled for 2008 or later. The company decided to stop work on Galida after reviewing the results of four Phase 3 clinical trials and one Phase 2 trial. Phase 3 is the last round of clinical testing before a company submits a product for regulatory review. After talking to outside experts, the company concluded that "the overall benefit/risk profile is unlikely to offer patients significant advantage over currently available therapy." AstraZeneca also says certain tests exhibited a signal for potential kidney problems. It added that "there is no immediate safety concern" for the 2,245 patients in the clinical trials. Tests showed Galida was effective in controlling blood-sugar and cholesterol levels, but they also found an increase in the level of serum creatinine in the blood. Serum creatinine is a waste product. If the level is too high, it can indicate impaired kidney function, a urinary tract obstruction or congestive heart failure.
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