* Twice daily BG-12 dose cut relapse rate 44 pct
* Cut relapse rate 51 pct given three times daily
* Teva's Copaxone cut relapse rate 29 pct
* Biogen shares up more than 10 percent
By Toni Clarke
Oct 26 Biogen Idec Inc's experimental
drug BG-12 may be poised to become the world's leading
treatment for multiple sclerosis, based on data from a
late-stage clinical trial released on Wednesday, experts say.
The closely watched trial, known as CONFIRM, showed that
BG-12, when given twice a day, cut the annualized relapse rate
in patients with multiple sclerosis by 44 percent at two years
compared with a placebo. When given three times a day, it cut
the relapse rate by 51 percent.
Biogen's shares were up more than 10 percent as investors
bet the drug will, if approved, take share from existing
front-line therapies, including market-leader Copaxone, which
is made by Teva Pharmaceutical Industries Ltd .
"It looks like BG-12 is the best drug," said Eric Schmidt,
an analyst at Cowen and Co, who predicts peak annual sales of
about $3 billion. "There are still some things we don't know
about its long-term safety, but I think it's possible BG-12
will be the biggest MS treatment in the future."
Multiple sclerosis is a chronic, often disabling disease
that attacks the central nervous system and can lead to
numbness, paralysis and loss of vision.
The global market for multiple sclerosis is currently worth
about $12 billion, he said. About 2.5 million people are
estimated to have the disease worldwide.
Approval of BG-12, a pill, would consolidate Biogen's
position as the dominant force in multiple sclerosis. The
company already sells Avonex, which is given by injection, and
Tysabri, which is infused. Sales of Tysabri, widely considered
to be the most effective drug on the market, have been hurt due
to the drug's link with a potentially deadly brain disorder
known as progressive multifocal leukoencephalopathy, or PML.
BG-12's competitive advantage may lie in its safety
profile, which looks relatively clean based on two-year data,
analysts said. The most common side effects in the CONFIRM
trial, as well as an earlier trial known as DEFINE, were
flushing and gastrointestinal disturbances.
That could give it an advantage over Novartis AG's recently launched drug Gilenya, the first oral MS
drug to reach the market.
"There is a lot of burdensome monitoring that has to be
done with Gilenya, so I think BG-12 will be a much more
practical solution," said Bret Holley, an analyst at
Oppenheimer & Co.
Still, Christopher Raymond, an analyst at Robert W. Baird,
said in a research note that while CONFIRM means BG-12 will
likely be approved, "we continue to worry that the launch could
disappoint more bullish revenue projections."
He said Gilenya has seen rapid adoption since launch and
he believes a favorable BG-12 launch is already priced into
FROM CHEAP VALUE TO FAST GROWTH
Biogen's shares have more than doubled since hitting a year
low last October of $58.30, helped by a restructuring program
and optimism over BG-12.
The company's recovery has been dramatic. For several years
it fought proxy battles against activist investor Carl Icahn,
who recently sold most of his stake in Biogen.
"It's gone from a very cheap unloved value play to perhaps
the cleanest large cap growth story in all of healthcare," said
BG-12 is designed to treat relapsing-remitting MS, 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.
Doug Williams, Biogen's head of research and development,
said on a conference call that the profile of BG-12 gives it a
strong chance of being used in newly diagnosed patients.
"The risk-benefit profile of BG-12 is quite attractive," he
said. "It looks like a first-line therapy to me."
Investors had been waiting to see if the data would be
comparable to DEFINE, which posted unexpectedly strong results
showing BG-12 cut the annualized relapse rate by 53 percent
when given twice a day. The results of the two trials were
sufficiently similar to be considered positive.
The CONFIRM study, unlike DEFINE, tested BG-12 against
Teva's Copaxone. Copaxone cut the annualized relapse rate by 29
Biogen said that in CONFIRM, BG-12 also cut the rate of
disability progression by 21 percent when given twice a day and
by 24 percent given three times a day. That result was not
statistically significant and compares negatively with the
DEFINE trial, which showed a cut in the rate of disability
progression of 38 percent.
Biogen said the lack of statistical significance may be due
to an unexpectedly low rate of disease progression in the
placebo group. It said it is studying the data closely to
better understand the figures.
Copaxone cut the rate of disability progression 7 percent.
Analysts said the data, which will be presented in more
detail at a future medical meeting, look strong.
"We believe these data generally "confirm" BG-12's efficacy
and clearly show that it's likely a more effective drug than
Teva's Copaxone," Mark Schoenebaum, an analyst at ISI Group,
said in a research note. Schoenebaum estimates BG-12 could
generate peak sales of $4 billion.
Williams said the company expects to file for approval of
the drug in the first half of next year.
Biogen's shares were up 10.5 percent to $118.13 in
afternoon trading on Nasdaq. Earlier in the day the stock rose
to a year high of $119.75.