* U.S. Department of Justice closing Brilinta trial probe
* No further action planned by U.S. authorities
* Company hopes for new data in Dec to support expanded use
* AstraZeneca also gets positive results with new antibiotic
(Adds executive interview on Brilinta prospects)
By Ben Hirschler
LONDON, Aug 19 The U.S. government has cleared
AstraZeneca Plc over a major clinical trial used to win
marketing approval for its important new heart drug Brilinta,
following an investigation which had cast a shadow over its
The drugmaker said on Tuesday the Department of Justice
(DoJ) was closing the probe into the 18,000-patient study and no
further action was planned.
AstraZeneca views Brilinta as a potential $3.5
billion-a-year seller, but news last October that the DoJ was
quizzing the company about the way it conducted the trial raised
doubts over its medical value, causing sales growth to stall.
"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," Tom Keith-Roach, vice president for the drug, told
"I think physicians, particularly in the U.S., will now see
that a line has been drawn underneath any potential controversy
surrounding the trial."
The DOJ move was highly unusual. The department has
traditionally focused on potential marketing misconduct by
drugmakers, rather than looking into the underlying data behind
the granting of a licence.
Concerns triggered by the probe had also knocked confidence
among some heart doctors in Germany and Australia.
AstraZeneca flagged up the promise of Brilinta in its
defence against an abortive $118 billion takeover bid by Pfizer
Inc earlier this year, although the drug registered only
modest sales of $216 million in the first half of 2014.
AstraZeneca also reported positive results on Tuesday with
an experimental antibiotic called ceftazidime-avibactam as a
treatment for hospitalised adult patients with complicated
Both pieces of news will be welcomed by Chief Executive
Pascal Soriot, who is determined to prove AstraZeneca has a
strong independent future after fending off Pfizer. Many
analysts believe Pfizer could repeat its bid to buy AstraZeneca
later this year.
EASTERN EUROPEAN PATIENTS
The results of the so-called PLATO study into Brilinta were
first reported at a medical meeting in 2009 and went on to form
the basis of successful new drug applications in the United
States, Europe and other markets. Brilinta was launched in 2011.
But various aspects of the study, which relied heavily on
patients recruited in eastern Europe, have been criticised over
the years by a number of medical experts. Poland and Hungary
together accounted for 21 percent of all subjects studied - more
than double the United States and Canada combined.
Two doctors, James DiNicolantonio of Ithaca, New York and
Ales Tomek of Charles University in Prague, raised several
questions about the conduct of the study in a paper in the
International Journal of Cardiology last year.
In particular, their analysis found that patients in the
PLATO trial who were monitored by AstraZeneca were reported as
having more beneficial effects from taking Brilinta than those
monitored by an independent clinical research organisation.
However, Lars Wallentin of Uppsala Clinical Research Center
in Sweden, the principal investigator on PLATO, strongly
defended the integrity of the study and AstraZeneca has always
insisted it is confident in Brilinta's profile.
NEW USES FOR MEDICINE
AstraZeneca's 2023 estimate for Brilinta sales of $3.5
billion assumes the blood-thinning drug works in a variety of
other settings beyond its current indication for acute coronary
A major development programme by the company is now under
way to prove the case, with a series of new clinical trials
expected to report results every year between 2015 and 2018.
Demonstrating Brilinta's unique value in multiple groups of
heart patients is crucial for commercial success, since the
product is competing with Sanofi SA's now off-patent
medicine Plavix, which is available as a cheap generic.
Keith-Roach said AstraZeneca hoped to report headline
results from one of these trials, known as PEGASUS, in December,
before presenting full findings from the 21,000-patient study to
a medical meeting in 2015.
PEGASUS is assessing the use of Brilinta in patients who
experienced a heart attack 1-3 years ago. If successful, this
group could more than double the number patients eligible to
receive the medicine.
Shares in AstraZeneca were 0.8 percent higher at 0950 GMT,
slightly outperforming a 0.4 percent rise in the European drugs
(Editing by David Holmes)