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 The injectable antibody medicine is the first product to show
positive study results in both the progressive form of the disease
and more common relapsing forms, which analysts believe should make
it a compelling treatment for doctors.
Deutsche Bank's Tim Race said the surprise success in primary
progressive multiple sclerosis (PPMS) suggested the drug could
generate annual sales of around $5 billion.
That is well above current consensus forecasts of $720 million in
2020, according to Thomson Reuters Cortellis.
Chief Executive Severin Schwan had told Reuters in an interview
earlier this month that ocrelizumab's success in relapsing multiple
sclerosis (MS) already made it a "huge opportunity" and a positive
result in PPMS would be "pure upside".
The drugmaker now plans to file for regulatory approval for both
forms of MS in early 2016, implying ocrelizumab could reach the
market around a year later.
Results from a pivotal Phase III study of the drug in PPMS showed
that treatment with ocrelizumab significantly reduced the
progression of clinical disability and the effect was sustained for
at least 12 weeks.
The incidence of serious adverse events associated with ocrelizumab,
including serious infections, was also similar to placebo.
Safety is crucial to success. Because MS is caused by abnormal
immune system attacks on the protective sheath surrounding nerve
cells, treatments need to adjust the body's immune response, which
can lead to dangerous side effects.
CROWDED MARKET
The current market for MS drugs is worth around $20 billion a year,
derived from the approximately 85 percent of MS patients with
relapsing disease.
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Multiple treatments are already available, ranging from
long-established interferons such as Merck KGaA's Rebif, through new
tablets including Novartis' Gilenya and Biogen's Tecfidera, and
potent injectables such as Biogen's Tysabri and Sanofi's Lemtrada.
Roche, however, is confident its new drug has a better balance of
efficacy and safety than rivals.
Ocrelizumab is delivered twice-yearly via an intravenous drip. As an
antibody-based medicine it is likely to be expensive but Roche, the
world's biggest cancer drugs company, has not yet given any
indications on price.
Preliminary data from the PPMS clinical trial will be presented at
the annual congress of the European Committee for Treatment and
Research in Multiple Sclerosis on Oct. 10.
Roche shares rose 2 percent by 0800 GMT. The group also reported
results at the weekend for its new immunotherapy drug atezolizumab
in lung and bladder cancer, which may help it win quick regulatory
approval.
(Editing by David Holmes and Mark Potter)
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