It could have been worse. In fact, this morning, it
was.
Amgen (Nasdaq: AMGN) is down about 1% as I
write, having been down about 3% earlier. The stock's saving
grace? Amgen's announcement of a Food and Drug Administration
delay for its long-awaited osteoporosis drug, Prolia (its
treatment for postmenopausal osteoporosis), contained this
statement: "This letter does not require additional
pre-marketing clinical trials to complete the review of the
treatment indication."
The agency does want a new trial before it'll approve
Prolia for the
preventionof osteoporosis, but that's to be
expected, given the
resultsof the FDA advisory panel meeting.
To be approved to
treatosteoporosis, Amgen needs to give the FDA some
additional information, including more details on how it
plans to monitor side effects after the drug is approved.
Just by the FDA's request for that information, you can tell
that Amgen is on the home stretch.
The company didn't say how long it'll take to turn in the
requested information and get a response back from the FDA.
I'd guess a few months, at a minimum. This is welcome news
for other drugmakers of osteoporosis treatments, like
GlaxoSmithKline 's (NYSE: GSK) and Roche's
Boniva,
Procter & Gamble 's (NYSE: PG) and
sanofi-aventis ' (NYSE: SNY) Actonel, and
even generic-drug makers that sell versions of
Merck 's (NYSE: MRK) Fosamax.
The FDA's focus on safety with Prolia, including requiring
Amgen to have a Risk Evaluation and Mitigation Strategy (
REMS), could also be seen as a good sign for competitors.
The osteoporosis market is extremely competitive, and a
newcomer with a less-established side effect profile could be
at a disadvantage.
On the other hand, Prolia is likely to excel in treating
cancer patients whose tumors have spread to their bones. That
indication is a little farther behind in development, but the
data looks good so far, with Prolia
beating
Novartis ' (NYSE: NVS) Zometa in one trial.
With less competition in this indication, Prolia will likely
have an easier time marketing the drug.
And so it's back to
waitingfor Amgen's investors. Tick-tock. Tick-tock.
This article was originally published as
Still Waiting for Its Blockbusteron
Fool.com
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