October 31, 2006
Subpoenas and setbacks for AstraZeneca
AstraZeneca unveiled a series of legal woes and a pipeline snag Thursday during its third-quarter earnings call.
The UK-based drugmaker said it received subpoenas from regulators in California and Alaska seeking information on the company’s marketing practices behind the antipsychotic medication Seroquel.
AstraZeneca said the subpoena from the California attorney general seeks information on Seroquel’s marketing and sale in that state, as well as information about the drug’s status on California’s drug formulary.
Alaska’s attorney general sent a separate subpoena to AstraZeneca in September seeking information about Seroquel’s safety, efficacy and marketing practices, the drugmaker said.
Seroquel is approved to treat schizophrenia and manic episodes associated with bipolar disorder. In 2005, the drug generated worldwide sales of $2.8 billion.
Separately, AstraZeneca received an informal inquiry from the US Securities and Exchange Commission seeking information about payments it made to doctors and government officials outside the US. The company did not specify which countries. Meanwhile, AstraZeneca said its developmental drug NXY-059, designed to protect patients from the brain damage caused by stroke, has failed in a large clinical trial.
The hopes of stroke specialists were riding on the drug, co-developed with the small California biotech Renovis, after NXY-059 achieved success in an initial late-stage clinical trial. AstraZeneca said Thursday that results from a second trial of 3,200 patients showed no effect in reducing disability in stroke patients as compared with placebo.
The NXY-059 setback follows AstraZeneca’s decision earlier this year to scrap development of its experimental blood-thinning drug Exanta, which failed to win FDA approval in 2004 because of liver concerns.
In May, AstraZeneca discontinued its program behind its developmental Type II diabetes treatment Galida, following cancer and heart failure concerns.