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 In early 2011 the U.S. regulator's concerns put an end to Merck's
development plans for the cladribine pill, now branded as Mavenclad,
but Merck later revived efforts by focusing on the most severely
affected patients and won approval in Europe in August this year.
Merck, whose products include high-tech chemicals, laboratory
equipment and cancer drugs, has now decided also to file for
approval with the U.S. Food and Drug Administration (FDA) in the
second quarter of 2018, the head of its healthcare division, Belen
Garijo, told Reuters.
"If Mavenclad is approved in the U.S., we see this opportunity as
one of the significant growth drivers in our MS franchise and we
would say that Mavenclad will in the longer term develop blockbuster
potential," she said.
The industry term blockbuster typically implies annual sales of at
least $1 billion, but Garijo would not elaborate on figures.
Mavenclad, alongside cancer immunotherapy treatment Bavencio, is a
central part of Merck's push to reinvigorate its drug development
business after years of setbacks.
The diversified group is also working on the sale of its consumer
healthcare unit to focus on the development of new drugs, with
sources telling Reuters late on Thursday that Perrigo <PRGO.N> is
preparing a bid, competing with Nestle <NESN.S> and the
private-equity owners of Stada <STAGn.DE>.
Merck said in September it was eyeing annual sales in the European
Union for Mavenclad, a latecomer to the market for oral treatments
against the neurological disease, of 500 million to 700 million
euros ($590 million to $823 million).
Bernstein analyst Wimal Kapadia, who anticipates 400 million euros
in annual peak sales in Europe, said: "If approved, we should assume
at least a similar expectation for the U.S."
Bryan Garnier analyst Hugo Solvet said: "The potential of the
product in the U.S. was not taken into account by the consensus nor
by the company in its 2022 guidance."
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The targeted patient group is characterized by highly active
relapsing MS. Among the relapsing-remitting type of MS, they account
for the roughly 60 percent of patients most severely affected by
neurological damage and disability.
"Our aspiration is to be able to serve the same patient group that
is now benefiting under the European registration. But of course the
label will have to be approved by the FDA," the Merck executive
said.
Biogen <BIIB.O>, Novartis <NOVN.S> and Sanofi <SASY.PA> have long
pulled ahead with novel MS treatments taken as a pill, gradually
replacing standard injection therapies and reaching a combined share
of the overall MS market of more than 40 percent.
If approved in the United States Mavenclad will also be up against
Roche's <ROG.S> Ocrevus, an infusion drug that has had U.S. approval
since March and which analysts expect to generate $1.5 billion in
sales next year.
But Garijo said Ocrevus was targeted mainly at primary progressive
MS, which Mavenclad was not developed for treating.
"Mavenclad seems to be a pretty effective MS drug and is tolerated
relatively well, but there is a fair amount of baggage associated
with the product and in a very competitive market," Bernstein's
Kapadia said.
($1 = 0.8926 euros)
(Reporting by Ludwig Burger; Editing by Emma Thomasson and Dale
Hudson)
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