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 Novartis said ofatumumab, already approved as Arzerra to treat
leukemia, reduced annual relapses better than Sanofi's Aubagio in
two head-to-head late-stage studies against relapsing forms of MS (RMS).
Detailed study results are due at an MS conference in Sweden next
month.
Novartis said it plans to start asking health authorities for
approvals by the end of the year.
Novartis shares rose 1.7% by 0845 GMT, compared with a rise of 0.5%
in the European drugs sector index.
The company's real target with ofatumumab is Ocrevus, the $2.4
billion-per-year MS blockbuster that Roche has said is its most
successful drug launch ever.
Ofatumumab and Ocrevus work similarly by targeting the immune
system's B cells that damage nerve tissue, potentially putting the
drugs on course for head-to-head competition when doctors choose
which one to prescribe.
Novartis managers have highlighted ofatumumab's prospects against
Ocrevus, pointing to its monthly home injections as a convenient
option for patients who with Ocrevus get twice-yearly infusions at
clinics.
"If approved, ofatumumab will potentially become a treatment for a
broad RMS population and the first B-cell therapy that can be
self-administered at home," said Novartis. The company is also
repurposing Arzerra for MS as it seeks to strengthen its
neurological drugs business, which already includes older MS drugs
Gilenya and recently approved Mayzent.
BRAGGING RIGHTS
Across the Rhine River from Novartis's Basel campus, Roche drugs
division head Bill Anderson has countered Novartis's ofatumumab
offensive, saying rivals' attempts to move in on the MS drugs market
had only boosted its own sales, helping it to capture a 17% market
share.
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Anderson has said that since Novartis's Mayzent launch in March,
Ocrevus has actually gained market share.
Zuercher Kantonalbank analysts highlighted Novartis's progress in
advancing an Ocrevus rival, but also saw shortcomings.
They pointed out that the studies compared ofatumumab not to Roche's
drug, but to Sanofi's Aubagio, whose annual sales after seven years
on the market are 1.65 billion euros ($1.84 billion).
"It would have been better to see a direct comparison between two MS
drugs with the same mechanism of action," ZKB's Michael Nawrath
wrote. "As it stands, we'll only be able to make an indirect
comparison of the data to predict whether the Novartis drug will be
a threat to the market leader and, at this time, the best MS
medicine, Ocrevus."
Nawrath rates Novartis "overweight."
In addition to relapsing MS, Ocrevus is the only approved treatment
for primary progressive MS characterized by steady advance of
debilitating symptoms, rather than periodic flare-ups.
(Reporting by John Miller; Editing by Michael Shields and Jane
Merriman)
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