Astra heart drug faces hurdles in tough EU market

* Brilinta first drug assessed by new German price system

* UK’s NICE due to issue guidance in October

* Reimbursement process faces delay in France

* Brilinta competes with branded and generic Plavix in EU

By Ben Hirschler

LONDON, April 6 (Reuters) – AstraZeneca’s (AZN.L: Quote, Profile, Research) big new
drug hope Brilinta faces an uphill fight in Europe as its maker
negotiates a series of hurdles that underscore the tough
pharmaceutical landscape across the continent.

The heart drug was approved in Europe in December and has so
far been launched, under the brand name Brilique, in Germany,
Britain, Denmark and Norway, with more launches expected in the
second half of 2011.

In all, it has been cleared for sale in more than 30
countries, although not yet in the all-important U.S. market,
where a decision is expected in July.

Brilinta — tipped as a $1 billion-plus seller — is a rival
to Sanofi-Aventis (SASY.PA: Quote, Profile, Research) and Bristol-Myers Squibb’s (BMY.N: Quote, Profile, Research)
blood thinner Plavix, the world’s second biggest selling
prescription drug, with annual sales of more than $9 billion.

It is a pivotal product for AstraZeneca, which needs to make
up for sales of older drugs being lost to generic competition.

AstraZeneca has priced Brilinta at a premium to Plavix — at
2.48 euros or 1.8 pounds for a day’s treatment of two pills —
after a clinical trial called PLATO showed it to be superior.

“In the PLATO trial, using Brilinta resulted in the lower
use of healthcare resources,” a company spokeswoman said. “On
the basis of the PLATO data, AstraZeneca believes Brilinta
should be priced at a premium to branded Plavix.”

Whether state-backed health systems will accept that pricing
argument remains to be seen.

The market for blood-thinning drugs in Europe is
increasingly competitive, following the launch of generic copies
of Plavix in the past 18 months, which slashed branded sales of
Plavix sales in Europe by 49.2 percent in 2010.

On top of that, AstraZeneca has to overcome a series of
cost-effectiveness hurdles in order to get Brilinta established
in Europe’s biggest markets.

GERMAN UNCERTAINTY

Brilinta has already had one setback in France, where the
company announced last month it had decided to withdraw the
reimbursement submission to the French Transparency Commission
and would resubmit in the coming months. [ID:nLDE72M22Z]

It also faces an uncertain time in Germany, where Brilinta
is the first drug from any company to be assessed under the
country’s new drug pricing system.

Under the so-called AMNOG scheme, introduced from Jan. 1,
drugs are only allowed free pricing for one year, during which
time a benefit assessment must be carried out.

If the review finds Brilinta offers additional therapeutic
benefits, an appropriate price will be negotiated. If not, it
will be grouped into a pricing band alongside cheap rivals.

In Britain, meanwhile, the cost-effectiveness watchdog NICE,
which decides whether medicines should be paid for on the state
health service, will hold its first meeting on Brilinta next
month and is not due to issue guidance until October.

Until it gets the verdict back from authorities in these key
European markets, AstraZeneca will not know for sure whether its
premium pricing strategy will be accepted by payers.

The drugmaker is not commenting on how the launches in
Europe are going, ahead of first-quarter results on April 28,
but Sanford Bernstein analyst Tim Anderson said in a recent note
he believed the uptake had been slow.
(Editing by David Cowell)

Astra heart drug faces hurdles in tough EU market