* Darapladib misses primary endpoint in Phase III trial
* GSK says some success in secondary goals needs analysis
* Expectations had been low for new type of heart medicine
* Shares fall 1.2 percent
By Ben Hirschler
LONDON, Nov 12 An experimental GlaxoSmithKline
drug, designed to fight heart disease in a new way,
failed to meet its main goal in a major late-stage clinical
study, dealing a blow to one of the company's biggest new
Darapladib's inability to reduce the overall risk of heart
attacks and strokes in the first of two big Phase III studies is
disappointing, but not a huge surprise. Many analysts already
had low expectations for the project.
Shares in Britain's biggest drugmaker had fallen 1.2 percent
on the news by 1050 GMT on Tuesday, and Deutsche Bank analyst
Mark Clark said failure of the drug removed some "blue sky
fantasy" about potential multibillion-dollar sales.
GSK obtained full rights to darapladib, along with lupus
drug Benlysta, when it bought U.S. biotech firm Human Genome
Sciences last year for $3 billion.
The once-daily pill did produce statistically significant
reductions in serious coronary events in some of the pre-defined
secondary endpoints of the trial, which GSK said required more
Darapladib is designed to prevent heart attacks and strokes
in a completely different way from cholesterol-lowering statin
drugs by targeting an enzyme called Lp-PLA2 that is linked to
While some industry analysts have suggested it could become
a $10 billion-a-year seller, if it works, few have pencilled in
significant sales forecasts so far, given uncertainty about the
Current consensus forecasts point to annual sales of only
$605 million in 2018, according to Thomson Reuters Pharma.
Panmure Gordon downgraded GSK shares to "hold" from "buy" on
the latest news, which it said was the second big disappointment
in the year, following similarly negative results with the
company's MAGE-A3 cancer vaccine for melanoma in September.
It also predicted GSK would write down 150 million pounds
($240 million) of its investment in darapladib in the fourth
quarter, even though a second Phase III trial is continuing.
"Even if that trial was successful, we believe it will be
difficult to gain market registration on one trial alone," said
Panmure analyst Savvas Neophytou.
MORE DATA IN 2014
Patrick Vallance, GSK's head of pharmaceuticals R&D, said
the group would continue to investigate the role of Lp-PLA2
inhibition in coronary heart disease and other conditions, while
also poring over the latest trial results.
"We will now work to better understand the data, including
evaluation of the patient sub-groups, and await the outcome of a
second Phase III study of darapladib in acute coronary
syndrome," he said in a statement.
The first trial, known as STABILITY, enrolled nearly 16,000
patients with chronic coronary heart disease in 39 countries and
measured the differences in outcomes between giving them
darapladib or a placebo pill, in addition to standard drugs such
as statins, aspirin and blood pressure medicines.
A second 13,000-patient study, called SOLID-TIMI 52, is due
to complete in March 2014 and is looking at patients who have
already suffered an acute coronary event. It will assess if
darapladib can prevent a secondary attack.
Some medical experts believe darapladib may have a better
chance of success in the second study.
GSK has had some notable successes with its new drugs this
year, including approvals of medicines for cancer, lung disease
and HIV. But its failure to deliver positive results in more
ambitious projects like darapladib and MAGE-A3 may cast doubt
over its prowess in the most cutting-edge science.