AstraZeneca executives are sighing in relief.
The US government has cleared the company's PLATO clinical trial with no further action needed.
"We welcome the Department of Justice's decision not to pursue further action," said Pascal Soriot, chief executive officer of AstraZeneca. "We have always had absolute confidence in the integrity of the PLATO trial and we are proud of the important benefit Brilinta offers to patients around the world suffering from acute coronary syndrome. As one of AstraZenca's growth platforms, we are committed to delivering the full potential of this important medicine."
In October, the Department of Justice announced that it was launching an investigation over AstraZeneca's clinical trial for its new heart drug Brilinta. It was projected to be a $3.5 billion-a-year seller, but the investigation raised doubts about its value and the sales stalled.
"It's frustrating to think of the patients who probably should have been receiving Brilinta for the last nine months but potentially didn't because of this cloud hanging over the brand," said Tom Keith-Roach, vice president for the drug. "I think physicians, particularly in the US, will now see that a line has been drawn underneath any potential controversy surrounding the trial."
The DOJ's investigation was unusual for the department. Typically it focuses on the potential marketing misconduct of drugs rather than the data.
The PLATO study results were initially reported in 2009 and launched in 2011. However, the study has been criticized by medical experts.
The company expects the blood-thinning Brilinta drug to be effective in a number of patients besides its current acute coronary syndrome patients. The drug is currently undergoing clinical trials to prove those benefits.
The company expects to release the results of one of its clinical trials, PEGASUS, in December.
PEGASUS is assessing the effectiveness of Brilinta in patients who had heart attacks 1 to 3 years prior. If this trial proves effective, this would more than double the number of patients eligible to use Brilinta.
The drug's competitor, Sanofi SA's Plavix, is now available as a cheap generic, making Brilinta's demonstration as a unique drug effective in many groups of patients crucial for market success.
Brilinta was AstraZeneca's defense against a takeover bid by Pfizer earlier in 2014. Some analysts expect Pfizer to repeat its bid to buy the company later in the year.
Soriot is determined, however, to prove that AstraZeneca has a strong, independent future.
