Seroquel settlement: $68.5M

WASHINGTON - AstraZeneca will pay $68.5 million in a multistate settlement over allegations that it promoted its blockbuster psychiatric drug, Seroquel, for insomnia, Alzheimer's, and other unapproved uses.

The New Jersey Attorney General's Office announced the agreement Thursday, describing it as the largest multistate consumer-protection pharmaceutical settlement. New Jersey will receive $1.85 million in the deal, which includes 36 other states and the District of Columbia.

Pennsylvania is part of the settlement, but state officials did not respond to a request for information about how much it would receive. Delaware will get $1.4 million.

The settlement is separate from a $520 million agreement AstraZeneca reached with the federal government last year over the marketing of Seroquel, said Tony Jewell, a company spokesman.

"While we deny the allegations, AstraZeneca believes it is important to bring these matters to a close and move forward with our business of providing medicines to patients," he said. It intends to "vigorously defend" itself in remaining lawsuits, he said.

Those were filed by individuals and by about seven states, including South Carolina and Mississippi.

The states in the settlement alleged that salespeople for AstraZeneca promoted Seroquel for off-label, or unapproved, uses and did not disclose side effects of the pill, which include weight gain, muscle spasms, and increases in blood sugar.

"Consumers rightfully expect pharmaceutical companies to engage in responsible marketing efforts . . . consistent with approved purposes," said Thomas Calcagni of New Jersey's Division of Consumer Affairs.

The Food and Drug Administration has approved Seroquel to treat schizophrenia, bipolar disorder, and depression, though most prescriptions are for off-label uses.

The drug, approved in 1997, is AstraZeneca's second-best-selling product, with U.S. sales of $5.3 billion last year. (Anticholesterol medication Crestor was its top drug, with $5.7 billion in sales.) But Seroquel's success has been marred by frequent allegations that the company illegally marketed it and downplayed its risks.

Its side effects have resulted in thousands of lawsuits by patients. The drugmaker had settled nearly 25,000 personal-injury lawsuits related to Seroquel by the end of 2010, with 3,950 remaining.

Pharmaceutical companies are barred from marketing drugs for unapproved uses, though doctors are free to prescribe them as they choose.

AstraZeneca is an Anglo-Swedish company that has its U.S. headquarters near Wilmington.

Seroquel was the fifth-best-selling drug in the United States in 2009, according to research firm IMS Health. It sells for more than $4 a pill and is taken once or twice a day.

The settlement announced Thursday stemmed from a three-year investigation led by the Attorney General of New Jersey. As part of the agreement AstraZeneca must publish any gifts or payments it makes to physicians on a public website. The company also agreed to make sure that payment incentives to sales representatives do not encourage off-label promotion.