UPDATE: Boehringer's Blood-Thinner May Edge Out Bayer's
28 Août 2009 - 5:46PM
Dow Jones News
German pharmaceutical company Boehringer Ingelheim is set to
unveil much anticipated results from a pivotal clinical trial of
its blood thinner Pradaxa, setting the stage for a showdown with
German rival Bayer AG's (BAY.XE) competing drug Xarelto.
Both are seen as blockbuster drugs - with potential to earn the
companies more than EUR1 billion each in peak sales. While both
drugs are approved for short-term use in Europe, the holy grail
they are competing for is approval for use in chronic conditions
such as stroke prevention, which would mean steady streams of
revenue.
Privately-owned Boehringer Ingelheim will present the results of
its stroke prevention study on Sunday afternoon at the European
Society of Cardiology in Barcelona. The RE-LY study compares
patients with atrial fibrillation, a common heart rhythm disorder,
on Pradaxa against those on the industry standard warfarin.
Commerzbank analyst Daniel Wendorff said a comparable study from
Bayer isn't expected until the second quarter of 2010, so the
Pradaxa study could be telling.
"If the data looks good then Pradaxa gets the advantage,"
Wendorff said.
But if the results don't meet expectations, Bayer would have
time to play catch up to Boehringer's lead of around a year.
Warfarin, best known by its brand name Coumadin, has been widely
prescribed for about 50 years. Its only competition has been
heparin and Sanofi-Aventis' (SNY) Lovenox, both of which must be
injected. Coumadin is made by Bristol-Myers Squibb Co. (BMY), while
generic versions are made by companies including Teva
Pharmaceutical Industries Ltd.'s (TEVA) Barr Pharmaceuticals Inc.,
Novartis AG's (NOVN.VX) Sandoz, Upsher-Smith Laboratories Inc. and
Cadila Healthcare's unit Zydus Pharmaceuticals (USA) Inc.
Analysts say the first of the new generation of oral
anticoagulants to make it to market have the potential to snare the
lion's share from warfarin, so they are keen to see how Pradaxa
fared in the study.
"It will probably have an effect on Bayer because Xarelto is its
most important competitive drug," said Merck Finck & Co.
analyst Carsten Kunold.
A Bayer spokeswoman declined to comment on Boehringer's upcoming
results.
Wendorff estimates that Bayer has the potential to earn EUR2.2
billion in peak sales from Xarelto, of which EUR550 million would
come from stroke prevention in patients with irregular
heartbeats.
Both Xarelto and Pradaxa have been approved in Europe for the
prevention of blood clots after total hip and knee
replacements.
Other competitors farther behind in development include
apixaban, being developed by Pfizer (PFE) and Bristol-Myers Squibb
(BMY), and betrixaban from Merck & Co. (MRK)
Bayer and its U.S. marketing partner Johnson & Johnson (JNJ)
have had some trouble getting swift U.S. approval for Xarelto from
the Food and Drug Administration.
In May, the FDA declined to approve the treatment, saying that
it needed more data, although it didn't ask for further clinical or
non-clinical testing of the drug. Bayer said it would file a full
response letter to the regulator, but not before the fourth quarter
at the earliest.
Both good and bad news from the Pradaxa study on Sunday could
hurt Bayer shares Monday, Merck Finck analyst Kunold said. Because
the two drugs are so similar, Kunold said the market could
interpret good results to mean Pradaxa is superior to Xarelto,
while negative news about side effects could also read across to
Xarelto.
Morgan Stanley analysts wrote in a note that Pradaxa may appear
superior to Xarelto based on the way the RE-LY trial was designed.
More than half of Boerhinger's test group were patients who had
never received warfarin previously, Morgan Stanley said.
The brokerage points out that results from another warfarin
trial published in The Lancet in 2006 showed patients who hadn't
taken warfarin previously experienced more side effects when taking
the drug for the first time compared with those who had taken it
before.
Boehringer said it included first-time warfarin patients in the
study for a sub-analysis and will present those findings at the
conference on Wednesday.
-By Allison Connolly, Frankfurt Bureau; +49 69 29725513,
allison.connolly@dowjones.com