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 The drug, romosozumab, which would be sold under the brand name
Evenity if approved, is awaiting an approval decision by the Food
and Drug Administration.
But the new safety data, which cropped up in an otherwise successful
trial, will have to be taken into consideration, delaying any FDA
decision and leaving the product's future uncertain.
The news is a blow for both companies and the setback hit smaller
Belgium-based UCB hard on Monday, sending its shares down 13
percent. The problem adds to doubts about UCB's long-term growth
prospects, given looming biosimilar competition to its Cimzia
arthritis drug.
The companies did not disclose the nature and severity of the
heart-related side effects but Leerink analyst Geoffrey Porges said
he believed romosozumab now had only a 50/50 probability of coming
to market.
ISI Evercore analyst Umer Raffat in a research note called the new
data "clearly negative and very surprising".
Raffat said he was removing all sales of romosozumab from his Amgen
forecast models and expected company shares to trade 3 to 4 percent
lower on Monday.
The drug had been viewed as a potentially important future growth
driver for both Amgen and UCB, and the surprise heart problems and
delay in approval will likely not sit well with investors.
Analysts on average were forecasting annual sales of the drug to
reach about $720 million by 2023, according to Thomson Reuters data.
The two drugmakers themselves were measured in describing the
problem in a statement issued late on Sunday.
"The efficacy results from this study comparing Evenity to an active
control are robust. At the same time, the newly observed
cardiovascular safety signal will have to be assessed as part of the
overall benefit/risk profile for Evenity," Amgen research chief Sean
Harper said.
"Together with UCB, we will engage with global regulators and
medical experts in the field to conduct a thorough evaluation of
these data."
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Romosozumab, which is given as an injection, is also being
considered for approval in Canada and Japan. It is designed to
increase bone formation and density, thereby reducing the risk of
fractures.
The medicine met the primary and key secondary goals of a late-stage
study. The imbalance in heart-related side effects had not been
observed in an earlier Phase III study that had been the basis of
the regulatory submission seeking approvals.
In the new trial, romosozumab significantly reduced the incidence of
new vertebral fractures through 24 months as well as non-vertebral
fractures in postmenopausal women with osteoporosis at high risk for
fracture compared with Merck & Co's Fosomax.
Serious heart problems were reported, however, in 2.5 percent of
patients who received the Amgen drug, versus 1.9 percent in the
Fosomax group.
Patients in the study received romosozumab for 12 months followed by
treatment with Fosomax, known chemically as alendronate, compared
with those who received only Fosomax, a current standard of care.
(Additional reporting by Pawel Goraj; Editing by Peter Cooney and
Louise Heavens)
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