(Adds details, Roche quotes, previous dateline ZURICH)
By Ransdell Pierson and Toni Clarke
NEW YORK/BOSTON Feb 23 Swiss drugmaker Roche
Holding AG ROG.VX said on Friday it had suspended enrollment
in a trial of an experimental anemia drug due to safety
concerns, a setback analysts said could delay the drug's U.S.
The news for Roche's drug, called Cera, deepens growing
safety concerns over a class of blockbuster medicines that also
includes Amgen Inc.'s (AMGN.O) Aranesp and Epogen, and Johnson
& Johnson's (JNJ.N) Procrit and Eprex.
Roche said it is temporarily suspending recruitment into a
mid-stage trial of Cera in anemic lung cancer patients because
of an "imbalance" of deaths across the four arms of the study,
which was conducted outside the United States.
The drugmaker did not reveal the number of deaths in each
of the study arms, three of which involved patients receiving
different doses of Cera and another that received Aranesp.
"We're not disclosing the numbers of deaths in the
treatment arms because the study is continuing with patients
already enrolled," said Roche spokeswoman Linda Dyson.
Sanford Bernstein biotech analyst Geoff Porges said Roche
officials suggested overall mortality was higher than that seen
in similar earlier trials, and that patients "were more
debilitated" than in prior similar trials.
Cera, like its rivals, is a form of the natural protein
erythropoietin, or EPO, which spurs the body to produce more
red blood cells.
"We believe this event adds an additional black cloud to
EPO drugs in cancer patients and may ultimately force
physicians to become more cautious in their EPO use and payors
to cut back on reimbursement," Jim Reddoch, an analyst with
Friedman, Billings, Ramsey said in a research note.
Roche said the deaths were unrelated to the study drugs and
there appeared to be no association of the events to excessive
levels of hemoglobin, the protein in red blood cells that
The company said the deaths were driven in part by the
progression of the cancer.
EPO TUMOR LINK?
Some doctors have speculated EPO may feed tumors and help
them grow, a possible explanation for higher death rates among
EPO users in some recent cancer trials. Roche's Dyson declined
to comment on the theory, or whether it was pertinent to the
Amgen, the world's biggest biotechnology company, has been
seeking to block Cera from entering the U.S. market and
competing with its largest products. Aranesp alone generates
annual sales of roughly $4 billion.
Roche has asked U.S. regulators to approve Cera -- under
the brand name Mircera -- to treat anemia in patients with
kidney disease. It may later seek approval to also market the
drug for cancer patients that are anemic, if ongoing trials
support that use.
Aranesp is approved to treat anemia in cancer as well as in
patients undergoing dialysis -- meaning those with advanced
The news could prompt greater scrutiny by regulators of the
safety of all EPO drugs, including Amgen's, especially when
given in higher doses. But it may make it less likely that Cera
will be approved by the U.S. Food and Drug Administration -- a
potential boon to Amgen.
"Approving Cera has to have fallen a few notches on the
FDA's to-do list," said Christopher Raymond, an analyst at R.W.
Baird & Co. "This is unequivocally good news for Amgen."
Amgen executives were not immediately available for
On Jan. 25 Amgen disclosed a higher risk of death among
cancer patients not undergoing chemotherapy who were treated
with Aranesp, compared with those receiving placebos.
The study involved patients with anemia and active cancer
who were not receiving chemotherapy or radiation -- a group of
seriously ill patients for whom Aranesp is not approved.
Amgen's setback last month comes on the heels of a study
that cast a negative light on Procrit, a J&J form of EPO, and
possible over-use of such medicines.
The FDA in November said it would review the study, which
showed that kidney disease patients treated more aggressively
with Procrit had a higher risk of cardiac complications and
Amgen shares closed down 51 cents to $66.23, while those of
J&J slipped 26 cents to $64.15, both on the New York Stock
(Additional reporting by Sam Cage in Zurich)