* Trial raises cardiovascular safety concerns
* Co developing drug with Takeda unit
* Data raises concerns on approvability: analysts
* Shares plummet as much as 69 pct
(Adds CEO comment, background)
By Krishnakali Sengupta
BANGALORE, June 21 Affymax Inc AFFY.O shares
plunged, as four late-stage studies of its experimental anemia
drug showed heart safety risks, raising doubts about the drug
getting regulatory approval.
Shares of the drugmaker dropped as much as 69 percent to
their lifetime low of $7.12 Monday on Nasdaq, clocking more
than 50-times higher volumes than its 10-day moving average. In
late afternoon trading, they had recovered only as far as
$7.43, down 67.7 percent on the day.
Shares of Amgen Inc (AMGN.O), whose drugs Epogen and
Aranesp were compared with Affymax's Hematide in the trials,
were up 2.8 percent at $56.76.
The trials met their main goal but showed a higher rate of
cardiovascular events, including death and stroke, in Hematide
patients who were suffering from chronic renal failure but were
not on dialysis.
The trials found that safety risks for Hematide were
similar to those of current drugs for kidney dialysis
The safety of anemia drugs has come under increased
scrutiny over the past few years after data emerged showing
that they could raise the risk of heart problems for some
Affymax had counted on Hematide's once-monthly dosing
regimen as an advantage over Amgen's Epogen and Aranesp, which
must be given more frequently.
Chief Executive Arlene Morris told Reuters that Affymax
will continue to analyze the data and will update investors in
the next several months.
The company said earlier this year it could file for U.S.
regulatory approval in the fourth quarter of this year, and
that forecast has not yet been updated, she said.
Morris said Affymax has no current plans to conduct
additional trials of Hematide.
"We remain very encouraged by the dialysis data," she
Data from the late-stage studies of the drug prompted at
least two brokerages to cut their ratings on the stock and
several analysts to raise doubts of Hematide getting approval
in the non-dialysis segment.
"This creates regulatory risk, in our view," said Geoff
Meacham, an analyst at J.P. Morgan. "Particularly in
non-dialysis, though there could also be read-through to the
more important dialysis segment as well."
However, filing for approval of the drug in the smaller
dialysis segment could be one way out of the tough spot for the
company, McNicoll, Lewis & Vlak analyst Christopher James
PiperJaffray analyst Ian Somaiya, who cut his rating on the
stock to "underweight" from "overweight," said he expects
further downside to the stock, once regulators review data from
The trial showed that in the non-dialysis group, frequency
of cardiovascular events for those taking Affymax's drug was
21.6 percent compared with 17.1 percent for those treated with
standard drugs, Affymax said.
Hematide, which Affymax is co-developing with Japan's
Takeda Pharmaceutical Co Ltd (4502.T), worked as well as the
Amgen drugs in maintaining target hemoglobin levels in each of
the four late-stage studies, the company said.
(Additional reporting by Vidya L. Nathan in Bangalore and
Deena Beasley in Los Angeles; Editing by Vyas Mohan, Aradhana
Aravindan and Gerald E. McCormick)