This stinks to high heaven, and given AZN's past history I believe heads will roll this time, as opposed to simple civil fines. [Edit: just goes to show that BP lines FDA pockets and can literally get away with murder (for a while, at least), while small bios like AMRN get kicked to the curb. Money talks, and AMRN didn't play the game the right way.)
Feds launch probe of AstraZeneca's controversial late-stage Brilinta study
October 31, 2013 | By John Carroll
When EP Vantage went back to look over some of the bullish peak sales projections made for a new generation of medicines, its analysts pulled out AstraZeneca's blood-thinner Brilinta as one of the industry's top duds. Once expected to crest at $2.52 billion a year, most analysts now don't see it hitting the $1 billion blockbuster mark, with a poor impact in the U.S. market dragging down projections.
Now AstraZeneca ($AZN) has another Brilinta headache to deal with. In its third-quarter earnings release the company revealed that the U.S. Justice Department's civil division is probing PLATO, its big clinical trial of Brilinta. The feds demanded "documents and information" on the study. And the pharma giant noted briefly that it will be cooperating with investigators.
While the company offers no details about exactly what the feds are after, the PLATO study has been subjected to some harsh criticism from James DiNicolantonio, Pharm.D., and Dr. Ales Tomek, of Charles University in Prague. The two raised serious questions about the study results last summer in a report published in the International Journal of Cardiology. They highlighted concerns that study results reviewed by an independent CRO demonstrated a worse outcome for the drug--ticagrelor--than the clopidogrel arm compared to the positive results reported by AstraZeneca's investigators.
They also reported that almost half of the favorable results for Brilinta were drawn from just two Eastern European countries, Hungary and Poland. Reporting on cardiovascular events appeared to favor Brilinta and "an estimated 23 definite or possible cardiovascular events or deaths on ticagrelor (Brilinta) were either not submitted for adjudication, inactivated, deleted or were downgraded to 'softer' endpoints (this was not shown in the FDA review for clopidogrel), and four FDA reviewers voted for non-approval of ticagrelor."
"The FDA report highlights what appear to be multiple serious deficiencies in the reporting of the PLATO results, which clinicians will not have gleaned from the primary publication alone," they wrote, according to a report in MedPage Today. "Individual clinicians may therefore wish to carefully reconsider their practice of ticagrelor prescription for this indication. Guideline bodies should also evaluate the information in its totality."
Oh, and now the EMA is after them too:
EU watchdogs demand info on AstraZeneca's disputed Brilinta trial November 8, 2013 | By Tracy Staton
Last week, AstraZeneca ($AZN) succinctly disclosed that Department of Justice investigators are digging into its data on the blood thinner Brilinta. Now, European regulators are adding their shovels to the effort. If they're not satisfied with their findings, AstraZeneca's hopes for pumping up Brilinta sales could be in vain.
At issue is the PLATO trial, a pivotal study that helped lay the foundation for Brilinta's regulatory approval. The head-to-head trial against megablockbuster clot-fighter Plavix helped support a superiority claim on Brilinta's FDA label when its was approved in 2011. That gave AstraZeneca some extra marketing ammo. And that was important, given the fact that the Sanofi ($SNY) and Bristol-Myers Squibb ($BMY) drug--the standard of care--was about to go off patent. The study also gave AstraZeneca some pricing support; in setting a premium price for the drug in Europe, the company cited PLATO data as justification.
But how justified was it, really? The European Medicines Agency (EMA) said yesterday that it asked AstraZeneca for more information after the Justice Department's probe came to light. "The EMA takes seriously any information that may have an impact on the profile of a drug's benefits and risks," an EMA spokeswoman told Reuters. "At the moment we are at the point of trying to understand what is going on."
PLATO has come under fire before. Researchers have pointed to flaws in the study, with some suggesting that the data appeared to be fudged to benefit Brilinta. Last summer, a report in the International Journal of Cardiology said an independent group's review of PLATO data yielded a more negative picture than AstraZeneca's analysis.
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