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 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 Reuters.
"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 license.
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 defense
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 hospitalized adult patients with complicated intra-abdominal
infections.
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 criticized 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.
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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 organization.
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 syndrome.
A major development program 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 (5.50 a.m.
EDT), slightly outperforming a 0.4 percent rise in the European
drugs sector.
(Editing by David Holmes)
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