Biogen Idec (
) hit pay dirt with the launch of its potential blockbuster
multiple sclerosis drug Tecfidera.
The biotech drugmaker rang up $192 million in sales from
Tecfidera in the second quarter, its first report on the oral
therapy for MS since its U.S. launch in April.
Biogen said $110 million of Tecfidera sales came from
underlying patient demand, smashing consensus estimates for $75
million. Another roughly $82 million came from pre-ordered
"I think this was the best launch in the history of MS drug
launches," said Robert W. Baird & Co. analyst Chris Raymond.
"You've got the best of both worlds. It's an oral therapy for a
chronic disease, which is an advantage. Also, the incumbent oral
MS drugs, Gilenya and Aubagio, have safety-related
The National Multiple Sclerosis Society describes MS as a
chronic, often disabling disease attacking the central nervous
system -- made up of the brain, spinal cord and optic nerves. MS
can cause anything from numbness in limbs to paralysis or vision
loss. But the organization notes that new treatments and research
advances are giving new hope to people affected by MS.
Tecfidera's safety profile, Raymond adds, is "far superior to
anything that's out there."
The most common adverse reactions for Tecfidera are flushing
and gastro-intestinal issues such as abdominal pain, according to
Raymond expects Tecfidera to post $680 million in global sales
this year, $1.7 billion in 2014, and $2.8 billion in 2016.
Trio Of Oral MS Drugs
Tecfidera treats people with relapsing forms of MS, including
relapsing-remitting MS (
), the most common form of the disease. Patients take a Tecfidera
pill twice daily. Canada approved it in April, and Australia in
Tecfidera is the third oral treatment for MS to come to
market. Gilenya fromNovartis AG (
) won approval in 2010 and Aubagio fromSanofi (
) got the nod in 2012.
Tecfidera got off to a fast start in terms of the number of
physicians who prescribed it and the number of patients who went
on the treatment, Tony Kingsley, Biogen's executive vice
president of global commercial operations, told IBD.
More than 3,500 physicians have prescribed it. About 25% of
Tecfidera patients were not on a prior therapy, while about 75%
switched from a different disease-modifying MS therapy.
Sometimes physicians may be hesitant to prescribe a drug that
just launched, Kingsley says. "But the broad number of physicians
writing prescriptions and putting newly diagnosed patients on
Tecfidera are positive indicators about the broad acceptance of
the product in the market, and that people think it has a very
good profile," he said.
According to drug tracker IMS Health, Tecfidera outperformed
all other MS drugs in the first three months after its
"In the upcoming quarters, we expect Tecfidera
new-prescription volume to remain healthy, but (it) will moderate
to more closely reflect the underlying patient start-and-switch
dynamics of the MS market," Kingsley said on Biogen's
second-quarter conference call.
There is a wild card, however. In May, Biogen announced it was
granted a European patent that extends until 2028 and covers the
expected EU Tecfidera label dose of 480 milligrams. But the
company also said there was an expected delay to the launch in
the European Union as it continues talks with regulators to gain
clarity on Tecfidera's regulatory data protection.
"We won't know for a while if it has data exclusivity in
Europe," Raymond said. "If they don't get data protection it may
not be worth launching Tecfidera in the EU. That's a wild
He says sales in Europe represent $850 million, a big piece of
the $2.8 billion in Tecfidera sales he's modeling for 2016.
Tecfidera is Biogen's third disease-modifying therapy for MS.
Avonex, an injectable interferon, helps reduce the recurrence of
relapse for patients with relapsing MS. In the U.S., it is also
approved to slow disability progression. Tysabri is a treatment
approved for relapsing forms of MS in the U.S. and
relapsing-remitting MS in the EU.
Kingsley says Tysabri has an "established and powerful
efficacy -- (it's) the drug to choose when more efficacy is
needed." As a result, he adds, it has captured a meaningful
portion of the market, particularly with patients who have
aggressive forms of the disease.
In the second quarter, worldwide sales of Avonex were $774
million, and Tsyabri's were $387 million. Raymond says Avonex
annual sales are $3 billion.
Pre-launch surveys raised concerns because they indicated that
most of the patients who switched to Tecfidera had been taking
Avonex, he says. But a post-launch survey showed that only about
20% of the patients who switched to Tecfidera had been taking
Avonex and 27% had been taking Copaxone byTeva Pharmaceutical (
That showed Copaxone is the drug that's the "most vulnerable,"
Biogen's Kingsley doesn't see Tecfidera cannibalizing the
company's existing MS therapies.
"Over time, Avonex and Tysabri should continue to have growth
potential and perform well alongside of Tecfidera," he said. "It
is not a replacement for either of these."
Meanwhile, Biogen is faring handsomely on the financial front.
Overall sales in the second quarter climbed 21% to $1.72 billion,
smashing views for $1.62 billion. Earnings rose 26% to $2.30 a
share, sailing past estimates for $1.93.
Analysts polled by Thomson Reuters see full-year earnings
climbing 31% to $8.57 a share. That would be nearly triple the
11% growth seen in 2012. They estimate earnings will rise 28% in
Biogen is fourth largest by market cap in the
Medical-Biomed/Biotech industry group, afterGilead Sciences
(GILD),Amgen (AMGN) andCelgene (CELG). The group is ranked a
strong No. 4 of the 197 groups IBD tracks, and Biogen has a
Kingsley expects the oral category of MS therapies will "grow
meaningfully," and that Tecfidera will be the leader in the
He sees potential for Biogen to be the product leader in each
segment of the market for MS therapies.
"And as a franchise of MS products, we think we can grow
faster than the competition," he said.
Kingsley sees growth across Biogen's whole MS franchise.
"Tecfidera is an important piece of that," he said. "But we're
in a position where we have three products that among them meet a
broad range of needs with patients with relapsing-remitting
It "positions us for some sustained growth," Kingsley
Future MS Treatments
Biogen also has a healthy pipeline. Plegridy is a potential
launch in 2014. It's an MS injectable therapy, an interferon,
which is in the same family as Avonex. The interferon class of
treatments is often used as a first-line treatment for MS.
"If approved, we believe Plegridy could provide patients an
efficacious treatment option with less frequent dosing and an
innovative auto-injector, which may position it as a preferred
interferon treatment option," Biogen CEO George Scangos said on
the Q2 conference call.
Two other potential 2014 launches are Alprolix, a treatment
for hemophilia B, and Eloctate, a treatment for hemophilia A.