Amgen's Positive Bone Drug Data Missed Some High Expectations
04 August 2009 - 6:13PM
Dow Jones News
Amgen Inc. (AMGN) reported positive results from a second
late-stage study of denosumab's usefulness in preventing
complications from cancer's spread to bone, but the data
disappointed those with high expectations after strong results from
a similar study last month.
Nonetheless, the data should support the drug's potential
approval in this usage next year, likely adding annual sales of
more than $1 billion in addition to its expected approval as an
osteoporosis treatment in October, according to Wall Street
projections.
"[The study] still supports very strong positioning of denosumab
in the market place, with a clearly positive study outcome and high
likelihood of regulatory approval," wrote Sanford Bernstein analyst
Geoffrey Porges.
A month ago, the Thousand Oaks, Calif., biotech reported the
results of a similar denosumab trial that showed it was superior to
Novartis AG's (NVS) Zometa, the current market leader in this
area.
In the latest trial, denosumab met the main goal of showing it
was equally effective, or "non-inferior," to Zometa, but missed a
secondary goal of showing superiority.
Notably, though, denosumab showed comparable side effects to
Zometa, easing concerns that complications would emerge in the
cancer trials that use higher doses than osteoporosis uses.
Amgen shares recently were up 10 cents to $62.98, after trading
as low as $62.12. The stock isn't far from its 52-week high of
$66.51 reached in September.
The Food and Drug Administration is currently reviewing
denosumab for treating osteoporosis and bone loss caused by hormone
treatment in patients with breast and prostate cancer. The agency
is expected to make a decision in mid-October, and an advisory
panel of outside experts will review the application next week.
Leerink Swann analyst Joshua Schimmer, valuing Amgen shares at
$73, projects worldwide denosumab sales of more than $3 billion by
2014, including osteoporosis and cancer-related uses.
Amgen hasn't disclosed its regulatory filing plans for
preventing cancer-related skeletal complications, but Schimmer
expects a launch in the third quarter of 2010. He expects sales for
osteoporosis to begin in the first quarter.
Although the latest head-to-head study didn't show superiority
to Zometa, denosumab patients had a longer delay in occurrence of
the first skeletal event, but the difference wasn't statistically
significant.
Analysts highlight that the trial included a wide mix of
patients - all types of solid tumors, excluding breast and prostate
cancer, and a type of blood cancer called multiple myeloma - which
could make it harder to show superiority. The previous trial
included only breast cancer patients.
"These results are more similar to the breast cancer result than
different," Porges said.
Amgen expects to report the full details from the studies at a
medical meeting later this year. The results of a third similar
study in patients with prostate cancer will come in 2010.
The latest study showed serious side effects were consistent
with previous studies of the two drugs, but osteonecrosis of the
jaw, a serious problem that has been connected to bisphosphonates
like Zometa in the past, was seen infrequently in patients taking
both drugs. The condition hadn't appeared in previous studies of
denosumab.
Also balanced was the incidence of osteonecrosis of the jaw, a
serious problem that has been connected to bisphosphonates like
Zometa.
In the latest study, 10 patients had the condition, compared
with 11 patients receiving Zometa. In the breast cancer study, the
condition occurred in 20 denosumab patients and 14 Zometa patients,
a difference that wasn't statistically significant.
In late July, Amgen reached a deal with GlaxoSmithKline PLC
(GSK) that allows the European drug giant to sell denosumab to
osteoporosis patients in Europe and other overseas markets. Amgen
plans to sell the drug alone in all indications in the U.S., and in
cancer-related areas in most overseas markets.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169;
thomas.gryta@dowjones.com