Seroquel

AZ nabs more uses for Seroquel XR

Tracy Staton — Thu, 13 Nov 2008 10:26:35 -0500

It's a good-news kind of week for AstraZeneca. The drugmaker announced new indications for its antipsychotic med Seroquel XR in Europe: for bipolar depression and for moderate-to-severe manic episodes. That makes Seroquel "currently the only atypical antipsychotic approved to treat the spectrum of mood episodes associated with bipolar disorder and the only licensed treatment for bipolar depression in the EU," AZ said in a statement.

The drug recently snared a similar set of approvals from FDA, part of AstraZeneca's push to broaden the schizophrenia med's use to a bigger market. Already Seroquel is the company's second-biggest seller with $4 billion in 2007 sales. The approval for bipolar disorder is a useful addition that will underpin the drug's sales momentum, Evolution Securities analyst Peter Cartwright told Dow Jones.

Key to boosting that revenue, or even simply hanging onto it, is supplanting plain old Seroquel with the once-daily Seroquel XR. The older version is already under attack from generics makers even though it's not scheduled to go off patent till 2011. The longer-acting formulation enjoys more patent protection.

- read AZ's release
- see the story in the Chicago Tribune
- get more from Dow Jones

Judge throws out RICO class action

Tracy Staton — Tue, 11 Nov 2008 10:48:55 -0500

Do RICO claims against drugmakers have a real chance? The answer appears to be yes and no. A federal judge in Florida threw out a case pitting several union health benefit funds against AstraZeneca over Seroquel. The funds claimed that they were hoodwinked by an off-label marketing campaign that misrepresented Seroquel's safety and efficacy. And they sued the drugmaker under the Racketeering Influenced Corrupt Organizations act.

The Florida judge, Anne Conway, said the RICO claims wouldn't stand as a class action because doctors determining whether any misrepresentations about Seroquel influenced prescribing behavior would require questioning the physicians one by one--and patient by patient. That ruling conflicts with another in a RICO case involving Eli Lilly; Judge Jack Weinstein allowed the class-action RICO claims to proceed.

One expert told Pharmalot that Conway's ruling should cheer drugmakers fearing RICO-based class actions. "These two decisions are both at the trial court level, so they're less significant than appellate decisions would be," said Mark Herrman, an attorney at Jones Day who defends drugmakers. "But they reflect a high-stakes game, because they speak to whether insurance companies can bring RICO class actions by saying that drug companies misrepresented the benefits of their drugs, increasing the insurers' payments."

- see the Pharmalot article

AZ bids for yet another Seroquel use

Tracy Staton — Tue, 21 Oct 2008 11:06:32 -0400

AstraZeneca is taking its Seroquel-broadening mission further into Europe with an application to market the atypical antipsychotic for generalized anxiety disorder. If European regulators approve the new use, Seroquel would be the first med in its class OK'd for anxiety.

The company says it's basing its application on five Phase III studies encompassing more than 3,500 patients. The data, presented at the American Psychiatric Association confab in May, showed "significantly greater symptom improvements" in the Seroquel patients versus those on placebo, the company said.

AstraZeneca is awaiting an FDA decision on using Seroquel to treat short-term anxiety and for long-term maintenance of the disorder. The company also has an application for major depressive disorder pending, both in the U.S. and in Europe.

- see the AstraZeneca release

Abbott faces more AIDS suits

Tracy Staton — Mon, 04 Aug 2008 10:37:39 -0400

Lawsuits, lawsuits, lawsuits. Two drugmakers' hometown newspapers offer a rundown on the litigation they face over sales tactics: For AstraZeneca, it's allegations of improperly marketing Seroquel, and for Abbott, more claims over its pricing of the AIDS med Norvir.

Yes, Abbott settled one big Norvir suit last week. But the Chicago Tribune calls that deal "likely its cheapest" it will manage in dispatching the constellation of suits it faces. They all accuse Abbott of hiking the price of Norvir to stifle competition from other drugs and drive patients to its combo drug Kaletra, which also contains Norvir. Inconveniently, some internal communications between execs plotting to "thwart their rivals in the lucrative HIV drug cocktail market" have come out in court documents, the newspaper notes.

As for AstraZeneca and Seroquel, the News-Journal offers a comprehensive look at the marketing allegations filed by three state attorneys general and at the thousands of patient lawsuits over the drug's side effects. With $4 billion in sales, Seroquel is AstraZeneca's second-biggest drug; the company says its success is based on the fact that it's effective in a wide range of mental illnesses. But the state lawsuits allege a variety of marketing infractions, including widespread off-label promotions. AstraZeneca denies the charges; we'll have to wait and see how the courts decide.

- read the story in the Chicago Tribune
- check out the News-Journal article

AZ stock leaps on Seroquel hearing news

Tracy Staton — Tue, 20 May 2008 09:53:43 -0400

Color AstraZeneca hopeful. A U.S. court hearing over Seroquel's patents has been bumped forward to today from June 4, boosting speculation that the drugmaker might just come out on top in the high-stakes case. (It hasn't hurt AstraZeneca's stock, either.) Today's hearing is to consider AstraZeneca's request for summary judgment in the case; a decision might not be handed down today, though.

Back in February, AstraZeneca announced it would seek an early decision in its Seroquel patent fight with generics giant Teva Pharmaceutical Industries. At risk: AstraZeneca's $4 billion antipsychotic drug, the company's second-biggest seller, accounting for an expected 28 percent of 2008 earnings. If the judge decides not to grant summary judgment, the Seroquel fight is set to go to trial in August.

- read the article at MarketWatch
- see the Forbes piece
- check out The Guardian's take

U.K. kids' antipsychotic use doubled

Tue, 06 May 2008 06:59:55 -0400

The number of U.K. kids taking antipsychotics has doubled in recent years, expert say, as use of the meds has broadened to hyperactive and autistic children. The increase was most marked among 7- to 12-year-olds, where the rate almost tripled from two per 10,000 children to 6 per 10,000 between 1992 to 2005. This in spite of the fact that most of the drugs aren't approved for use in kids, according to a new study in The Lancet.

What's more, American kids take antipsychotics at six times the rate of U.K. kids--45 of 10,000 used them in 2001 compared with 23 per 10,000 in 1996, according to a 2004 study. One of the authors of that research said that U.K. docs tend to be more conservative in prescribing psychiatric meds.

Side effects reported in children include weight gain, heart trouble, and nervous-system problems, the authors of the Lancet study said. "This highlights the need for long-term safety investigations and ongoing clinical monitoring," they said, "particularly if the prescribing rate of these medicines continues to rise."

- read the Associated Press story
- see the article in The Telegraph

ALSO: AstraZeneca presented data on its antipsychotic Seroquel XR to the American Psychiatric Association, saying that the med outperformed placebo in treating major depression and generalized anxiety disorder. In February AstraZeneca asked the FDA for a depression indication for the med and plans to submit an anxiety application this quarter. Report

Emerging markets drive global growth

Wed, 16 Apr 2008 06:59:56 -0400

Without emerging healthcare markets like China and India, global pharma would be in a world of hurt. The global market for meds reached $712 billion last year, according to a new report from IMS Health, up $178 billion over five years before. But the rate of growth is slowing--6.4 percent compared with 11.8 percent in 2001. And without the big engines in Asia, that figure would be lower still. China, South Korea, and India grew by 25.7 percent, 10.7 percent, and 13 percent respectively. Russia and Turkey, 20.2 percent and 17.2 percent. The U.S.? Just 3.8 percent.

The IMS report also included the top 10 sellers worldwide (drum roll, please):

Lipitor, $13.5 billion, Pfizer
Plavix, $7.3 billion, Sanofi-Aventis
Nexium, $7.2 billion, AstraZeneca
Seretide/Advair, $7.1 billion, GlaxoSmithKline
Enbrel, $5.3 billion, Amgen and Wyeth
Zyprexa, $5 billion, Eli Lilly
Risperdal, $4.9 billion, Johnson & Johnson (Janssen)
Seroquel, $4.6 billion, AstraZeneca
Singulair, $4.5 billion, Merck
Aranesp, $4.4 billion, Amgen

Note that Aranesp made the top 10 despite a 12.9 percent drop in sales on safety worries. And the biggest gainer of the year was Plavix, the anti-clotting med; it racked up a 20.5 percent increase in sales.

- see the item at Pharmalot

ALSO: In response to the growing overseas market, DIA is opening an office in India. Release

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Seroquel researcher got cash from AZ

Tue, 08 Apr 2008 06:59:56 -0400

Sen. Charles Grassley's hall of shame: The chairman of the Senate Finance Committee, who's been trying to rally support for a bill requiring drug and device makers to disclose anything of value given to doctors, raised the case of Dr. Melissa DelBello, a psychiatrist who got hundreds of thousands of dollars in travel expenses, consulting fees, and lecture payments from AstraZeneca. DelBello also happened to be lead author of a study that concluded kids did well on AstraZeneca's antipsychotic med Seroquel.

Here's the timeline: DelBello authored the study, published in 2002. In 2003, she got $100,000 from the drugmaker, or so she told the University of Cincinnati. In 2004, she reported $80,000. AstraZeneca's figures total $238,000.

Grassley was pretty peeved not only about the apparent conflict of interest--which AstraZeneca denied; DelBello wasn't available for comment--but also by the fact that DelBello also got NIH funding during the same period. University of Cincinnati said it applauds Grassley's "looking into this very important issue."

- read the WSJ Health Blog item
- see Grassley's Physician Payment Sunshine bill

Related Articles:
AZ takes steps to shore up Seroquel. Report
AZ's Seroquel receives additional approval. Report