* Tecfidera expected to become dominant oral MS treatment
* Sales of Tecfidera expected to top $3 billion by 2017
* Tecfidera expected to be launched within days
* Stock rises 3.2 percent to $182.68
(Adds analyst comment, background, stock price)
By Toni Clarke
WASHINGTON, March 27 U.S. regulators on
Wednesday approved a new multiple sclerosis drug made by Biogen
Idec Inc that is widely expected to become the No. 1
oral treatment for the disease, with annual sales topping $3
The drug, Tecfidera, activates a chemical pathway in the
body known as Nrf2 that helps protect nerve cells from damage
and inflammation. Following Wednesday's approval by the Food and
Drug Administration, Biogen said it will launch the drug within
the coming days.
Multiple sclerosis is a chronic condition that attacks the
central nervous system and can lead to numbness, weakness,
paralysis and blindness. It affects more than 2.1 million people
worldwide, according to the National Multiple Sclerosis Society.
"We expect a solid launch of Tecfidera, and our sense is
that there is a bolus of patients in the queue ready to
transition to therapy," Geoff Meacham, an analyst at J.P.
Morgan, said in a research note. "However, we believe that
Street expectations likely already account for this and then
Shares of Weston, Massachusetts-based Biogen rose 3.2
percent to close at $182.68 on Wednesday. The shares have more
than tripled over the past three years, mainly driven by high
hopes for Tecfidera, known chemically as dimethyl fumarate.
Biogen already sells the MS drugs Avonex and Tysabri, which
together account for about 30 percent of the market. Teva
Pharmaceutical Industries Ltd's drug Copaxone is the
current market leader, with a roughly 29 percent share and
annual sales last year of more than $4 billion.
Unlike Copaxone, Avonex and Tysabri, which are injected or
infused, Tecfidera comes in the more convenient form of a pill.
As such, it will compete with Novartis AG's MS pill
Gilenya, which, though first to market, has been dogged by heart
safety concerns. Gilenya holds an 8.5 percent share of the
market and generated worldwide sales of $1.2 billion last year.
Tecfidera will also compete with Sanofi's recently
approved MS pill Aubagio. Aubagio's label carries a boxed
warning -- the most serious kind of warning -- alerting
physicians to a potentially heightened risk of liver problems.
Novartis said in a statement that it welcomed additional
treatment options for people with MS, but warned that Tecfidera
may not perform as well in the market as in clinical trials.
"As with any new medication, real-world experience is
critical to gain an accurate understanding of a therapy's full
clinical profile," the company said. "It will be important to
see the clinical profile of dimethyl fumarate -- including
efficacy, safety, tolerability and adherence with its
twice-a-day dosing -- as it gains real-world experience."
Michael Yee, an analyst at RBC Capital Markets, said the
overall profile of Tecfidera looks "significantly better than
Tecfidera's side effects appear relatively benign,
consisting mainly of flushing, diarrhea and nausea. And its
label contains no boxed warnings. The FDA recommended only that
physicians monitor patients' infection-fighting white blood cell
count once a year.
"That's an excellent label," said Yee. "I expect the drug to
meet consensus of $300 million this year, and over five years it
can achieve greater than $3 billion in sales based on its
convenience and efficacy profile."
Tecfidera will be used to treat patients with
relapsing-remitting MS, a form of the disease in which flare-ups
are followed by periods of remission. About 85 percent of people
with MS are initially diagnosed with this form of the disease.
Combined clinical trial data showed Tecfidera cut the
average relapse rate by 49 percent after two years compared to
patients taking a placebo. The drug is expected to generate
sales of about $3 billion in 2017, according to data compiled by
Thomson Reuters Cortellis.
Last week European regulators recommended approval for
Tecfidera and Aubagio, but they declined to give Aubagio a "new
active substance" designation because it is similar to an older
drug. Without this designation, generic copies of the drug could
be launched in Europe in as little as three years. That could
hurt sales of most other MS drugs on the market.
Sanofi said it was disappointed by the decision and plans to
request a re-examination of the case.
(Reporting By Toni Clarke in Washington; additional reporting
by Bill Berkrot in New York; Editing by Tim Dobbyn, Bernard Orr
and Leslie Adler)