) suffered a major setback when its phase III study, FOCUS (Car
mib for Advan
ed Refractory M
ltiple Myeloma European
tudy) on multiple myeloma treatment, Kyprolis did not meet its
The open-label study evaluated Kyprolis versus an active control
regimen of low-dose dexamethasone, or equivalent corticosteroids,
plus optional cyclophosphamide in patients suffering from relapsed
and advanced refractory multiple myeloma.
However, the study did not meet its primary endpoint of
improving overall survival (OS). The results from the study showed
that there was an increase in the incidence of renal adverse events
of all grades in the Kyprolis arm compared to the active control
arm and the label.
Concurrent with the trial news, Amgen also announced that it
initiated a voluntary recall for nine packaged lots of Aranesp (500
mcg) prefilled syringes due to the potential presence of cellulose
and/or polyester particles observed in a small number of syringes
during a routine quality examination. Amgen recalled the lots from
non-U.S. distributors, wholesalers and a number of hospital
We note that Kyprolis became a part of Amgen's portfolio
following its Oct 2013 acquisition of Onyx Pharmaceuticals.
Kyprolis gained accelerated approval in the U.S. in 2012 for the
treatment of patients with multiple myeloma who have received at
least two prior therapies including Velcade (bortezomib) and an
immunomodulatory agent (IMiD), and have demonstrated disease
progression on or within 60 days of completion of the last
The results from the trial were disappointing. Positive results
from the trial would have supported a regulatory filing in the
We expect shares to be hit by the disappointing results from the
Nevertheless, Amgen believes that the encouraging results
released earlier in the month from the other phase III trial,
ASPIRE, on Kyprolis will be sufficient to support regulatory
submissions around the world.
Amgen currently carries a Zacks Rank #3 (Hold). Some
better-ranked stocks in the industry include Allergan (
), Actelion Ltd. (
) and Gilead Sciences (
). All three stocks sport a Zacks Rank #1 (Strong Buy).
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