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 Roche is counting on emicizumab to wrest a share of the $11
billion-a-year haemophilia drug market now dominated by traditional
treatments from Novo Nordisk and Shire.
Nearly 63 percent of patients receiving emicizumab experienced zero
treated bleeds, compared with 5.6 percent of those getting so-called
bypassing agents, according to data released ahead of the
International Society on Thrombosis and Haemostasis (ISTH) industry
meeting in Berlin in July.
Some analysts called Monday's data release convincing, with
Jefferies saying it underpinned its $5 billion peak sales estimate
for the medicine.
"If full presentation of the data at the ISTH reassures on safety,
our mid-term EPS estimates and valuation could increase by 2 percent
to 4 percent," Jefferies' Jeffrey Holford wrote in a note to
investors.
Haemophilia patients' blood does not clot properly, requiring
life-saving infusions of clotting factors.
Development of resistance, or inhibitors, in some patients can
interfere with efforts to control bleeding, so Roche is hoping its
drug, also known as ACE910, will offer a new avenue of treatment.
Still, analysts continue to cite adverse events in Roche's studies
including thrombotic microangiopathy -- damage to blood vessels in
vital organs -- that accompanied repeated high doses of bypassing
agents given to counter bleeds that occurred despite emicizumab
treatment.
Although Roche has played down emicizumab's role in the
complications -- one death came after a patient refused a blood
transfusion for religious reasons, it has said -- analysts' concerns
linger.
Roche shares rose 0.4 percent by 0930 GMT, while the Stoxx European
health care sector index firmed 0.1 percent.
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SAFETY PERSPECTIVE
"From a safety perspective, treatment with this drug will require
physicians to carefully manage the use of bypassing agents," Bank
Vontobel's Stefan Schneider wrote. That "could limit uptake", he
said.
Roche plans to file emicizumab with the U.S. Food and Drug
Administration this year for approval for patients with inhibitors,
with follow-on submissions in 2018 including for patients without
resistance.
Deutsche Bank analysts said Monday's data suggested it would be
tough for emicizumab to make headway among those patients, however,
since clotting factors appeared to be more effective for them.
"Current therapy in the non-inhibitor setting provides a very high
hurdle to new entrants and we believe emicizumab's less than perfect
efficacy and observed thrombotic events will temper enthusiasm for
the drug," Deutsche Bank's Tim Race said.
(Reporting by John Miller, editing by Louise Heavens and Susan
Thomas)
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