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8
Emerging Growth Areas
Acute Neurology
Natalizumab ( 4-integrin inhibitor) - Acute Ischemic Stroke
• In August 2017 we completed enrollment in the Phase 2b ACTION2 study evaluating the effects of natalizumab
versus placebo on clinical measures of functional independence and activities of daily living in acute ischemic
stroke patients.
Natalizumab - Epilepsy
• In October 2017 we initiated the Phase 2 OPUS study evaluating the efficacy, safety
and tolerability of
natalizumab in drug-resistant focal epilepsy.
Biosimilars
Samsung Bioepis - Biogen's Joint Venture with Samsung Biologics
BENEPALI (Etanercept)
• In June 2017 we presented real-world evidence from investigator-initiated studies supported by us
demonstrating sustained efficacy and safety of, and high acceptance and adherence in patients initiating
treatment with, BENEPALI. These data were presented at the Annual European Congress of Rheumatology
(EULAR) in Madrid.
IMRALDI (Adalimumab)
• In June 2017 the CHMP of the EMA issued a positive opinion for IMRALDI, an adalimumab
biosimilar candidate
referencing HUMIRA.
• In August 2017 the EC granted a marketing authorization for IMRALDI.
Genentech Relationship
Anti-CD20 Therapies
OCREVUS (ocrelizumab)
• In March 2017 the FDA approved OCREVUS, a humanized anti-CD20 monoclonal antibody, for the treatment of
relapsing MS (RMS) and primary progressive MS (PPMS).
• In July 2017 OCREVUS was approved in Australia for the treatment of RMS and PPMS.
• In September 2017 OCREVUS was approved in Switzerland for the treatment of RMS and PPMS.
• In January 2018 the EC granted a marketing authorization for OCREVUS for the treatment of RMS and PPMS.
RITUXAN (rituximab)
• In March 2017 Roche announced that the FDA’s Oncologic Drugs Advisory Committee voted unanimously that
the benefit-risk of rituximab/hyaluronidase for subcutaneous (under the skin) injection was favorable for the
treatment of certain blood cancers. This new co-formulation includes the
same monoclonal antibody as
intravenous RITUXAN and hyaluronidase, a molecule that helps to deliver medicine under the skin.
• In June 2017 the FDA approved RITUXAN HYCELA (rituximab and hyaluronidase human) for subcutaneous
injection for the treatment of adults with previously untreated and relapsed or refractory follicular lymphoma,
previously untreated diffuse large B-cell lymphoma and CLL. This new treatment includes the same monoclonal
antibody as intravenous RITUXAN in combination with hyaluronidase human, an enzyme that helps to deliver
rituximab under the skin.
GAZYVA
• In November 2017 the FDA approved GAZYVA in
combination with chemotherapy, followed by GAZYVA alone in
those who responded, for people with previously untreated advanced follicular lymphoma. The approval is
based on results from the Phase 3 GALLIUM study, which showed superior progression-free survival for patients
who received this GAZYVA-based regimen compared with those who received a RITUXAN-based regimen as an
initial therapy.
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Other
Idiopathic
Pulmonary Fibrosis
BG00011 (STX-100)
• In October 2017 we reported that BG00011 (STX-100) achieved proof of biology in a Phase 2a study in
patients with idiopathic pulmonary fibrosis (IPF), a chronic irreversible and ultimately fatal disease characterized
by a progressive decline in lung function. We plan to initiate a Phase 2b study for BG00011 in 2018.
Marketed Products
The following graphs show our revenues by product and revenues from anti-CD20 therapeutic programs and
geography as a percentage of revenues for the years ended December 31, 2017, 2016 and 2015.
(1) Interferon includes AVONEX and PLEGRIDY
(2) Other includes ZINBRYTA, FAMPYRA, ELOCTATE, ALPROLIX,
FUMADERM, BENEPALI and FLIXABI
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10
Product
sales for TECFIDERA, AVONEX and TYSABRI and anti-CD20 therapeutic programs for RITUXAN each
accounted for more than 10% of our total revenues for the years ended December 31, 2017, 2016 and 2015. For
additional financial information about our product and other revenues and geographic areas where we operate,
please read Note 25, Segment Information, to our consolidated financial statements, Item 6. Selected Financial Data
and Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations included in this
report. A discussion of the risks attendant to our operations is set forth in Item 1A. Risk
Factors included in this
report.
Multiple Sclerosis and Neuroimmunology
We develop, manufacture and market a number of products designed to treat patients with MS. MS is a
progressive neurological disease in which the body loses the ability to transmit messages along nerve cells, leading
to a loss of muscle control, paralysis and, in some cases, death. Patients with active RMS experience an uneven
pattern of disease progression characterized by periods of stability that are interrupted
by flare-ups of the disease
after which the patient returns to a new baseline of functioning.
Our MS products and major markets include:
Product
Indication
Collaborator
Major Markets
Relapsing forms of MS in the U.S.
Relapsing-remitting MS (RRMS) in
the E.U.
None
U.S.
Canada
France
Germany
Italy
Spain
U.K.
Relapsing forms of MS
None
U.S.
France
Germany
Japan
Italy
Spain
U.K.
Relapsing forms of MS in the U.S.
RRMS in the E.U.
None
U.S.
France
Germany
Italy
Spain
U.K.
Relapsing forms of MS
Crohn's disease in the U.S.
None
U.S.
France
Germany
Italy
Spain
U.K.
Relapsing forms of MS
AbbVie Inc. (AbbVie)
U.S.
Germany
Walking ability for patients with MS Acorda Therapeutics, Inc.
(Acorda)
France
Germany