Drugmaker AstraZeneca P.L.C. said yesterday that it had set aside $520 million as part of a tentative agreement to resolve an investigation by federal prosecutors in Philadelphia into the company's marketing practices.
The London company, whose U.S. headquarters are in Wilmington, also announced a 22 percent increase in third-quarter net income, helped by initial sales of its H1N1 flu vaccine.
Expected increases in H1N1 vaccine sales led the company to boost its full-year profit forecast to $6.20 to $6.40 a share, from $5.70 to $6 a share.
The U.S. Attorney's Office in Philadelphia would not comment on its inquiry into AstraZeneca's promotion of its antipsychotic drug Seroquel. The investigation focuses on whether AstraZeneca promoted the drug, which is approved to treat schizophrenia and bipolar disorder, as a treatment for other illnesses.
In a statement, company spokesman Tony Jewell said: "The investigation also related to selected physicians who participated in clinical trials involving Seroquel."
Yesterday, AstraZeneca said it had reached an agreement "in principle" to settle the probe. The company said it would not comment on whether it would admit to wrongdoing as part of the settlement.
Philadelphia investigators are part of a federal team that has brought cases against many drug companies for marketing products for unapproved uses. Doctors can prescribe a drug for any reason, but a company can promote it only for uses approved by the U.S. Food and Drug Administration.
In January, the Philadelphia U.S. Attorney's Office announced a $1.4 billion settlement with Eli Lilly & Co. over its efforts to market its antipsychotic, Zyprexa, to treat dementia and Alzheimer's disease, both unapproved uses.
AstraZeneca reported net income of $2.12 billion for the three months that ended Sept. 30, up from $1.74 billion in the same period a year earlier. Revenue rose 5.5 percent to $8.2 billion, supported by strong demand for the company's cholesterol drug Crestor alongside sales of the H1N1 vaccine and reduced generic competition.
Sales of the H1N1 nasal spray vaccine totaled $152 million in the quarter. AstraZeneca's chief financial officer, Simon Lowth, said the company was on track to deliver the 40 million doses ordered by the U.S. government by early next year.
Investors remain concerned about the company's drug pipeline, especially after AstraZeneca this week pulled its lung-cancer drug Zactima from regulatory clearance lists in the United States and European Union after disappointing trial results.
Seroquel sales were up 12 percent at $1.23 billion over the year-earlier quarter.
AstraZeneca's American depositary receipts closed yesterday at $45.75, up 58 cents (1.28 percent).