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4
For additional information on our collaboration
arrangement with Eisai, please read Note 20,
Collaborative and Other Relationships, to our
consolidated financial statements included in this
report.
Neurimmune Collaboration Agreement
In October 2017 we amended the terms of our
collaboration and license agreement with
Neurimmune Subone AG (Neurimmune). Under the
amended agreement, we made a $150.0 million
payment to Neurimmune, which is reflected as a
charge
to noncontrolling interests, in exchange for a
15% reduction in royalty rates payable on products
developed under the agreement, including on
potential commercial sales of aducanumab. Our
royalty rates payable on products developed under the
agreement, including on potential commercial sales of
aducanumab, will now range from the high single
digits to low-teens.
Under the amended agreement, we also have an
option that will expire in April 2018 to further reduce
our royalty rates payable on products developed under
the agreement, including on potential commercial
sales of aducanumab, by an additional 5% in
exchange for a $50.0
million payment to
Neurimmune.
For additional information on our collaboration
arrangement with Neurimmune, please read Note 19,
Investments in Variable Interest Entities, to our
consolidated financial statements included in this
report.
BIIB098 License Agreement
In November 2017 we entered into an exclusive
license and collaboration agreement with Alkermes
Pharma Ireland Limited, a subsidiary of Alkermes plc
(Alkermes), for BIIB098 (formerly known as ALKS
8700), an oral monomethyl fumarate (MMF) prodrug
in Phase 3 development for the treatment of relapsing
forms of MS.
Under
this agreement, we received an exclusive,
worldwide license to develop and commercialize
BIIB098 and will pay Alkermes a royalty on potential
worldwide net sales of BIIB098. Beginning in 2018 we
are responsible for all development expenses related
to BIIB098. Alkermes will maintain responsibility for
regulatory interactions with the FDA through the
potential approval of the New Drug Application (NDA)
for BIIB098 for the treatment of MS.
For additional information on our collaboration
arrangement with Alkermes, please read Note 20,
Collaborative and Other Relationships, to our
consolidated financial statements included in this
report.
Ionis Collaboration Agreement
In December 2017 we entered into a new
collaboration agreement
with Ionis Pharmaceuticals
Inc. (Ionis) to identify new antisense oligonucleotide
(ASO) drug candidates for the treatment of SMA.
Under this agreement, we have the option to license
therapies arising out of this collaboration and will be
responsible for the development and
commercialization of these therapies.
For additional information on our new
collaboration arrangement with Ionis, please read
Note 20, Collaborative and Other Relationships, to our
consolidated financial statements included in this
report.
Management Changes
During 2017 we appointed several new
executives, each of whom has significant experience
in the biopharmaceutical
industry and is a leader in
his or her functional area. These appointments
included:
• Michel Vounatsos, Chief Executive Officer;
• Jeffrey Capello, Executive Vice President and
Chief Financial Officer;
• Ginger Gregory, Executive Vice President and
Chief Human Resources Officer; and
• Chirfi Guindo, Executive Vice President and Head
of Global Marketing, Market Access and
Customer Innovation.
For additional information on these and our other
executive officers, please
read the subsection entitled
“Our Executive Officers” included in this report.
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5
Product/Pipeline Developments
Core Growth Areas
Multiple Sclerosis and Neuroimmunology
TECFIDERA (dimethyl fumarate)
• In April 2017 we presented new real-world data evidence supporting TECFIDERA at the 69
th
annual meeting of
the American Academy of Neurology (AAN) in Boston, MA.
We presented a comparison of real-world data that supported TECFIDERA’s strong efficacy relative to other oral
MS therapies, both in newly-treated MS patients and those previously treated with a prior disease modifying
therapy (DMT). Subgroup analyses of the open-label studies PROTEC and RESPOND assessed TECFIDERA in
early MS and early switch patients, respectively. Results showed that TECFIDERA significantly reduced the
annualized relapse rate over one
year in the early MS subgroups, including those who switched to TECFIDERA
from a prior DMT. Additional data presented at the AAN meeting affirmed the well-characterized, long-term safety
profile of TECFIDERA in patients treated for up to nine years.
TYSABRI (natalizumab)
• In February 2017 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) adopted a positive opinion to update the TYSABRI E.U. label with pediatric information to remove
the contraindication in pediatrics and to describe the results of the post-marketing meta-analysis of pediatric
data. The label update entitles us to apply for a six-month extension to the E.U. patent Supplementary
Protection Certificate.
• In April 2017 we presented new real-world data from the TYSABRI Observational Program that confirmed the
efficacy of TYSABRI and demonstrated that early and continued treatment leads to better clinical outcomes.
These data were presented at the 69
th
annual meeting of AAN in Boston, MA.
FAMPYRA (prolonged-release fampridine tablets)
• In May 2017 the European Commission (EC) granted a standard marketing authorization for FAMPYRA for
walking improvement in people with MS.
ZINBRYTA (daclizumab)
• In July 2017 the EMA announced that it had provisionally restricted the use of ZINBRYTA to adult patients with
highly active relapsing disease despite a full and adequate course of treatment with at least one DMT or with
rapidly evolving severe relapsing MS who are unsuitable for treatment with other DMTs.
These restrictions
followed the initiation of an EMA review (referred to as an Article 20 Procedure) of ZINBRYTA following the
report of a case of fatal fulminant liver failure, as well as four cases of serious liver injury.
• In October 2017, as part of the Article 20 Procedure of ZINBRYTA, the EMA Pharmacovigilance Risk
Assessment Committee (PRAC) completed its assessment and recommended a further set of restrictions on
the use of ZINBRYTA by MS patients.
• In November 2017 the CHMP adopted an opinion, confirming the PRAC's recommendations, for further
restrictions to minimize the risk of serious liver injury with ZINBRYTA, including restriction of its use to adult
patients with relapsing forms of MS who have had an inadequate response to at least two DMTs and for whom
treatment with any other DMT is contraindicated or otherwise unsuitable. In January 2018 the EC adopted a
final
and legally-binding decision, which concluded the Article 20 Procedure, confirming the CHMP opinion. As a
result of the CHMP's recommendation of these restrictions, we recorded net impairment charges related to
intangible assets, inventory, property, plant and equipment and prepaid tax assets, totaling approximately
$190.8 million. Offsetting these amounts was an unrecorded tax benefit related to certain ZINBRYTA related
assets totaling approximately $93.8 million.
Opicinumab (anti-LINGO-1)
• In October 2017 we initiated the Phase 2b clinical trial AFFINITY, designed to evaluate opicinumab as an
investigational add-on therapy in people with relapsing MS. The trial follows the comprehensive review of
SYNERGY, a Phase 2 trial, which identified a specific population that may be more likely to respond to
treatment.