Roche said on
Friday it had won breakthrough therapy designation from the U.S. Food
and Drug Administration for an experimental hemophilia medicine, aiming
for a piece of the $11 billion hemophilia drug market.
The
Swiss drugmaker said its U.S.-based Genentech unit's ACE910 secured the
fast-track designation as the company prepares separate Phase III
trials in 2015 and 2016, the first in patients with hemophilia A with
factor VIII inhibitors and the second for patients without inhibitors.
It
represents a threat to more traditional treatments from Novo Nordisk
and Baxalta, the target of a $30 billion takeover attempt by Shire.
Hemophilia
A is a rare genetic disorder that prevents blood clotting. Patients
receive lifesaving infusions of clotting factors, but development of
inhibitors in many of those being treated interferes with efforts to
control their bleeding.
With the market for
hemophilia medications expected to grow to $11 billion next year,
Roche's ACE910 drug is closely watched because it could change the way
the disease is treated.
"FDA has
granted breakthrough therapy designation for ACE910, recognizing an
unmet need for patients with inhibitors and the promise of these early
data," Sandra Hornung, Roche's chief medical officer, said in a
statement.
Last year, Roche said early data indicated encouraging reduction in bleeding rates in all patients.
In 2012, U.S.
regulatory changes created the breakthrough therapy designation,
allowing the FDA to expedite development and review of drugs whose
preliminary clinical evidence indicates substantial improvement over
existing therapies.
(Reporting by John Miller. Editing by Jane Merriman)
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