Roche anemia drug CERA works as once-monthly dose

ZURICH (Reuters) – Swiss pharmaceutical group Roche Holding
AG on Sunday said late-stage studies of its new anemia drug
CERA showed the drug worked on a once-monthly dose for dialysis
patients.

CERA — which stands for continuous erythropoietin receptor
activator — acts to increase the production of red blood
cells.

Existing anti-anemia treatments require dialysis patients
to be treated as frequently as several times a week.

Roche said that for the first time clinical research,
presented at a medical conference in Glasgow, Scotland, showed
dialysis patients treated with short-acting and frequently
administered epoetin anti-anemia drugs could be directly
switched to a once-monthly treatment.

“Roche’s once-monthly CERA could have a positive impact on
the management of anemia in dialysis patients by reducing work
loads and offering greater efficiencies,” the group said in a
statement.

The results are part of Phase III studies on the drug.

Roche is developing CERA as a follow-up product to
NeoRecormon, its second-best selling drug in 2005 with sales of
2.3 billion Swiss francs ($1.87 billion).

Industry analysts had been eagerly awaiting the latest test
results, since many believe CERA could generate global sales of
over $2 billion annually.

Bear Stearns recently forecast 2010 CERA sales of $1.25
billion, not including potential revenues of $1.08 billion in
the United States, where Roche faces a patent dispute with
Amgen

.

In April, Roche asked U.S. and European regulators for
approval to market CERA as a treatment for renal anemia
associated with chronic kidney disease in patients who are on
dialysis as well as those who are not.

Results from the remaining Phase III studies will be
announced later this year, Roche said.

At the conference in Glasgow, studies also showed that CERA
had a unique mode of action for treatment of renal anemia,
which allowed it to work for longer in the body.

“We found that CERA has a loose interaction with these
receptors, which turns out to be an advantage as it enables the
drug to stimulate red blood cell production for longer,” Anton
Haselbeck, a scientist from Roche’s biotechnology center in
Penzberg, Germany, said in a statement.