Coming off a year that ended well for Biogen, rumors of a merger with Sanofi arose following the appointment Mi- chel Vounatsos as its new chief executive officer on December 19, and the approval of Spinraza, a potential blockbuster
to treat spinal muscular atrophy, on December 23. A Sanofi-Bio-gen deal would create a 60% stronghold in the oral MS market.
Spinraza, which was developed by Ionis Pharmaceuticals and
licensed by Biogen, was approved under Priority Review by the
FDA and is the first treatment for spinal muscular atrophy in pediatric and adult patients. Analysts estimate that Spinraza could
generate revenues of as much as $428 million in 2017, with sales
potentially reaching $2 billion by 2020.
Also in December, Biogen presented positive data from the
Phase Ib PRIME study, showing its investigational drug aducanumab slows cognitive decline in patients in the early stages
of Alzheimer’s disease, while reducing the amyloid plaque levels
compared to the placebo group.
Aducanumab is currently being evaluated in two global Phase
III studies, ENGAGE and EMERGE, which are designed to evaluate its safety and efficacy in slowing cognitive impairment and
the progression of disability in early AD. The success of this drug
would add billions in annual sales to Biogen’s top line, but that’s
counting chickens before they hatch.
Moreover, Biogen recently paid Bristol Myers-Squibb $300
million upfront, plus as much as $410 million for milestones and
potential royalties, for BMS-986168, a Phase II-ready antibody
targeting extracellular tau, the protein that forms the deposits in
the brain associated with Alzheimer’s Disease and other neuro-
degenerative tauopathies such as Progressive Supranuclear Palsy.
Biogen plans to rapidly initiate Phase II studies for BMS-986168
in both indications.
In another asset acquisition, Biogen acquired Remedy Phar-
maceuticals’ Phase III candidate, CIRARA for the potential treat-
ment of large hemispheric infarction, a severe form of ischemic
stroke where brain swelling often leads to stroke-related mor-
bidity and mortality. The FDA recently granted CIRARA Orphan
Drug status, along with Fast Track designation.
Meanwhile, in the multiple sclerosis space, revenue from Bio-
gen’s top-selling drug, Tecfidera, reached nearly $4.0 billion, up
9%. Even though there was a slight softening in overall market,
particularly in the U.S., the European market continues to grow,
albeit at a slower pace.
Equally significant, Fampyra was granted marketing authori-
zation in the EU. As the first treatment to address both the unmet
need of walking improvement in MS, as well as clinical efficacy
in MS, it has potential to substantially impact this market. Biogen
has a license from Acorda Therapeutics for rights in all markets
outside the U.S.
In the way of strategic business ventures, Bioverativ, the spi-
noff of Biogen’s global hemophilia business, began trading Jan-
uary 2017. Sales of its hemophilia drugs, Eloctate and Alprolix
generated combined revenues of $847 million in 2016, up 53%.
Biogen’s pipeline aims to address some of the greatest challenges in medicine, including Alzheimer’s disease, Parkinson’s,
and ALS, let’s hope they succeed. We’ll have to see about Biogen
becoming a potential takeover target. CP
Headquarters: Cambridge, MA
YEAR ESTABLISHED: 2003
REVENUES: $11,449 (+6%)
NET INCOME: $3,703 (+4%)
R&D: $1,973 (-2%)
Spinraza spinal muscular atrophy
Fampyra improvement of walking in MS
Flixabi infliximab biosimilar to Remicade
DRUGS IN PHASE IIB AND BEYOND
Aducanumab Alzheimer’s disease
E2609 Alzheimer’s disease
Obinutuzumab non-Hodgkin’s lymphoma
EARLY RESEARCH PROJECTS
BIIB054 Parkinson’s disease
BIIB067 SOD-1-amyotrophic lateral sclerosis
DRUGS COMING OFF PATENT
DRUG INDICATION YEAR
Tysabri multiple sclerosis 2017-2020
Tecfidera multiple sclerosis 2018
TOP SELLING DRUGS
DRUG INDICATION 2016 SALES (+/-%)
Tecfidera multiple sclerosis $3,968 9%
Avonex multiple sclerosis $2,314 -12%
Tysabri multiplesclerosis $1,964 4%
Eloctate hemophilia $513 61%
Plegridy multiple sclerosis $482 42%