* Ocrevus priced at $65k/year, less than competition
* First-ever drug approved for less common form of MS
* Biogen to get royalties for its share in drug
(Recasts story to focus on new treatment for PPMS, adds
company, analysts and MS Society comments)
By John Miller
ZURICH, March 29 Roche's multiple
sclerosis (MS) drug Ocrevus won U.S. approval, putting the
potential blockbuster back on track after a brief delay and
giving a lift to patients with a form of the disease that until
now had no approved treatment.
The drug, also known as ocrelizumab and administered via
infusion, becomes the first U.S. Food and Drug
Administration-approved medicine for the primary progressive
form of the neurological disease (PPMS).
Ocrevus, to have a list price of $65,000 annually,
undercutting rival Merck's Rebif by a quarter, is also
approved to treat the most common form of MS, known as
relapsing-remitting multiple sclerosis (RRMS).
Until now, patients suffering from PPMS were often relegated
to managing symptoms and working with rehabilitation specialists
as drugs including Teva's Copaxone, the most popular
MS drug, failed to make a difference.
In trials with Ocrevus, however, doctors found no evidence
of disease progression in 47 percent more PPMS patients compared
with a placebo.
"The FDA’s approval of Ocrevus is the beginning of a new era
for the MS community and represents a significant scientific
advance," said Sandra Horning, Roche's chief medical officer.
About 400,000 people have MS in the United States, according
the MS Foundation, with the 15 percent suffering from PPMS
largely without effective treatment options. PPMS is
characterized by worsening neurologic function, while the
more-common relapsing form comes and goes with attacks of new
and increasing symptoms.
Among RRMS patients, Roche has said 75 percent more patients
reached "no evidence of disease activity" status when taking
Ocrevus compared with those using Rebif.
Ocrevus works by reducing the immune system's assault on the
body's own neurons. Unlike some other MS drugs that target T
cells, Roche's new agent tackles B cells' role in driving
inflammation that is central to the neurological disease.
"This is a real game changer," said Cyndi Zagieboylo,
president of the National MS Society.
Shares in Roche -- which is counting on Ocrevus to offset
falling revenue from top-selling cancer drugs Rituxan, Avastin
and Herceptin that face impending competition from cheaper
biosimilar versions -- rose 0.24 percent to 253.60 francs.
While the FDA approval was largely expected, analysts said
the FDA's broad support, for both forms of the disease, was a
"The label is close to the best case," wrote Emmanuel
Papadakis, a Barclays analyst, adding Ocrevus does not include
health warnings accompanying other MS drugs including Biogen's
Tysabri and Sanofi's Lemtrada.
"Likewise, the U.S. list pricing point is clearly intended
to position Ocrevus competitively against both orals and
antibody options," Papadakis said.
Analysts forecast annual sales exceeding $3 billion by 2021,
according to Reuters data.
U.S.-based Biogen will also benefit, with Roche to pay the
part-owner of Ocrevus a royalty under a 2010 agreement.
The drug's U.S. entry had been delayed by three months when
the FDA in December pushed back its approval deadline, citing
Roche rival Novartis AG is also developing an MS
treatment, BAF312, for secondary progressive multiple sclerosis.
It could file for regulatory approval later this year, Novartis
has said, although the official target remains 2019.
Other companies also seeking new MS drugs include GeNeuro SA
(Additonal reporting by Akankshita Mukhopadhyay in Bengaluru
and Bill Berkrot in New York; Editing by Bill Rigby/Ruth