(Adds analyst comment, updates share price)
Aug 13 Amgen Inc's Kyprolis drug failed
to extend survival compared to standard care in a trial
involving patients with advanced multiple myeloma, a type of
blood cancer that develops in the bone marrow.
Shares of Amgen were down 2.1 percent at $124.65 in
after-hours trading on Wednesday.
"The negative results commercialization of this drug in
earlier lines of myeloma, as well as other indications raise
questions about the future development and ," Sanford Bernstein
analyst Geoffrey Porges said in a research note.
He also said the findings "place Kyprolis at a significant
regulatory and competitive disadvantage" to Pomalyst, a multiple
myeloma drug sold by Celgene Corp.
Amgen said the 315-patient, phase III trial also showed an
increase in bad kidney events for patients given Kyprolis when
compared to the control group and to the risks described on the
drug's current label.
The trial, known as FOCUS, included patients whose multiple
myeloma had relapsed and worsened despite at least three prior
RBC Capital Markets analyst Michael Yee said failure of the
trial "was widely expected," given that patients in the control
arm could eventually be treated with Kyprolis if their disease
He also said the incidence of kidney-related side effects is
"not a big concern" since the trial enrolled only very sick
Kyprolis, acquired by Amgen in its $10 billion takeover of
Onyx Pharmaceuticals, was approved in the United States for
treating advanced multiple myeloma based on data showing that
patients responded to the drug.
FOCUS was intended to show that the drug helped patients
live longer, something that European regulators generally
require before approving a drug.
Amgen said in a statement that it believes positive results
announced earlier this month from a separate study of Kyprolis
in patients with earlier-stage disease "will be sufficient to
support regulatory submissions around the world."
Separately, the Thousand Oaks, California, company said it
would recall nine lots of syringes pre-filled with anemia drug
Aranesp in several countries outside of the United States after
finding particulate matter in a small number of syringes during
a routine quality examination.
(Reporting by Deena Beasley; Editing by Paul Simao, Bernard