AstraZeneca ($AZN) last fall acknowledged the U.S. Justice Department was probing its controversial late-stage study of the blood thinner Brilinta, but was circumspect about what might have set off the investigation. But according to The Wall Street Journal, it might stem from a complaint filed by Victor Serebruany accusing AstraZeneca of rigging the Brilinta study so that it appeared to outperform the competition.
Serebruany is controversial because he is a frequent critic of drug trials and has deep financial interests in the industry. As the newspaper points out, Dr. Serebruany's False Claims Act complaint would allow him to recover money from the drugmaker. But it also points out the DOJ has the option of joining his action against AstraZeneca and it says the feds have spoken with him about his accusations.
The court records in Dr. Serebruany's complaint are sealed, but The Journal has reviewed documents from the case and spoken with sources familiar with it. Some of his allegations are similar to others that have been made against the study, including those published by two scientists from Charles University in Prague. They pointed out that almost half of the favorable results for Brilinta were drawn from just two countries, Hungary and Poland. They also said that reporting on cardiovascular events appeared to favor Brilinta, to the point that some possible cardiovascular events or deaths were deleted or softened.
The trial has also drawn criticism because in the U.S. portion of the study, Brilinta did not perform as well as Plavix, the drug to which it was compared. AzstraZeneca's drug was linked to a 27% greater incidence of vascular deaths, heart attacks and stroke in that portion of the study.
Of course, the probe may go nowhere. Scientists at the FDA who reviewed the trial results decided that any problems with reporting of adverse events were probably too minor to affect the outcome of the trial. AstraZeneca has said that even if Poland and Hungary were factored out, the overall study showed an advantage for Brilinta.
The drug, so far, hasn't amounted to much. AstraZeneca reports full-year earnings Thursday, but in the third quarter it generated just $75 million in sales. The company still has a lot riding on Brilinta. CEO Pascal Soriot says he expects it to reach blockbuster levels and help the company through its tough times. Bernstein analyst Tim Anderson painted a gloomy picture for investors last fall of what it would mean if Brilinta does take off and then the probe resulted in the worse-case scenario, Brilinta being pulled from the market. He pointed out that with consensus models projecting $1.6 billion in sales for Brilinta--a drug with a 70% margin--if it were yanked it could erase 15% of the company's expected profits.
- here's The Wall Street Journal story (sub. req.)
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