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Spinal Muscular Atrophy
SPINRAZA is the only approved treatment for
SMA. We are aware of other products in development
that, if successfully developed and approved, may
compete with SPINRAZA in the SMA market.
Psoriasis
FUMADERM competes with several different
types of therapies in the psoriasis market within
Germany, including oral systemics such as
methotrexate and cyclosporine.
Biosimilars
BENEPALI and FLIXABI, the two biosimilars we
currently manufacture and commercialize in the E.U.
for Samsung Bioepis, compete
with their applicable
reference products, ENBREL and REMICADE,
respectively, as well as other biosimilars of those
reference products.
Genentech Relationships in Other Indications
RITUXAN and GAZYVA in Oncology
RITUXAN and GAZYVA compete with a number of
therapies in the oncology market, including TREANDA
(bendamustine HCL), ARZERRA (ofatumumab),
IMBRUVICA (ibrutinib) and ZYDELIG (idelalisib).
We also expect that over time GAZYVA will
increasingly compete with RITUXAN in the oncology
market.
In addition, we are aware of other anti-CD20
molecules, including biosimilars, in development that,
if successfully developed and approved, may compete
with RITUXAN and GAZYVA in the oncology market.
RITUXAN in Rheumatoid Arthritis
RITUXAN competes with several different types
of therapies in the rheumatoid arthritis market,
including, among others, traditional disease-modifying
anti-rheumatic drugs such as steroids, methotrexate
and cyclosporine, TNF
inhibitors, ORENCIA
(abatacept), ACTEMRA (tocilizumab) and XELJANZ
(tofacitinib).
We are also aware of other products, including
biosimilars, in development that, if successfully
developed and approved, may compete with RITUXAN
in the rheumatoid arthritis market.
Research and Development Programs
A commitment to research is fundamental to our
mission. Our research efforts are focused on better
understanding the underlying biology of diseases so
we can discover and deliver
treatments that have the
potential to make a real difference in the lives of
patients with high unmet medical needs. By applying
our expertise in biologics and our growing capabilities
in small molecule, antisense, gene therapy, gene
editing and other technologies, we target specific
medical needs where we believe new or better
treatments are needed.
We intend to continue committing significant
resources to research and development opportunities.
As part of our ongoing research and development
efforts, we have devoted significant resources to
conducting clinical
studies to advance the
development of new pharmaceutical products and
technologies and to explore the utility of our existing
products in treating disorders beyond those currently
approved in their labels.
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19
The table below highlights our current research and development programs that are in clinical trials and the
current phase of such programs. Drug development involves a high degree of risk and investment, and the status,
timing and scope of our development programs are subject to change. Important factors that could adversely affect
our drug development efforts are discussed in Item 1A. Risk Factors included in this report.
Core
Growth
Areas
MS and Neuroimmunology
BIIB098 (monomethly fumarate prodrug)* - MS
Phase 3
Opicinumab (anti-LINGO-1) - MS
Phase 2
Alzheimer's Disease and Dementia
Phase 3
Elenbecestat (E2609)* - Alzheimer's
Phase 3
Phase 2
BIIB092 (anti-tau mAb) - Alzheimer's
Phase 1
BIIB076 (anti-tau mAb)* - Alzheimer's
Phase 1
BIIB080 (IONIS-MAPT
Rx
)* - Alzheimer's
Phase 1
Parkinson's Disease
and Movement Disorders
BIIB092 (anti-tau mAb) - PSP
Phase 2
BIIB054 (anti-
alpha
-synuclein mAb) - Parkinson's
Phase 2
Neuromuscular Disease Including SMA and ALS
BIIB067 (IONIS-SOD1
Rx
)* - ALS
Phase 1
Emerging
Growth
Areas
Pain
BIIB074 (Vixotrigine) - Trigeminal Neuralgia
Phase 2
BIIB074 (Nav1.7) - PLSR
#
Phase 2
Ophthalmology
BIIB087 (gene therapy)* - XLRS^
Phase 1/2
Acute Neurology
BIIB093 (glibenclamide IV) - LHI Stroke
Phase 2
Natalizumab - AI Stroke
Phase 2
Natalizumab - Epilepsy
Phase 2
Other
Dapirolzumab pegol (anti-CD40L)* - SLE
@
Phase 2
BG00011 (STX-100) - IPF
Phase 2
BIIB059 (anti-BDCA2) - SLE
@
Phase 2
* Collaboration programs
# Painful Lumbosacral Radiculophath (PLSR)
^ X-linked Retinoschisis (XLRS)
@ Systemic Lupus Erythematosus (SLE)
For information about certain of our agreements with collaborators and other third parties, please read the
subsection entitled “Business Relationships” below and Note 20, Collaborative
and Other Relationships, to our
consolidated financial statements included in this report.
Business
Relationships
As part of our business strategy, we establish
business relationships, including joint ventures and
collaborative arrangements with other companies,
universities and medical research institutions, to
assist in the clinical development and/or
commercialization of certain of our products and
product candidates and to provide support for our
research programs. We also evaluate opportunities for
acquiring products or rights to products and
technologies that are complementary
to our business
from other companies, universities and medical
research institutions.
Below is a brief description of certain business
relationships and collaborations that expand our
pipeline and provide us with certain rights to existing
and potential new products and technologies. For
additional information on certain of these
relationships, including their ongoing financial and
accounting impact on our business, please read Note
19, Investments in Variable Interest Entities, and Note
20, Collaborative and Other Relationships, to our
consolidated financial statements included in this
report.