Table
of Contents
56
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. 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 for
BIIB098 (formerly known as ALKS 8700), an oral 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 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 to identify new
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.
Business Environment
The biopharmaceutical industry and the markets
in which we operate are intensely competitive. Many
of our competitors are working to develop or have
commercialized products similar to those we market
or are developing and have considerable experience in
undertaking clinical trials and in obtaining regulatory
approval to market pharmaceutical products. In
addition, the commercialization of certain of our own
approved MS products, products of our collaborators
and pipeline product candidates may negatively
impact future sales of our existing MS products. Our
products may also
face increased competitive
pressures from the introduction of generic versions,
prodrugs of existing therapies or biosimilars of
existing products and other technologies.
Sales of our products are dependent, in large
part, on the availability and extent of coverage, pricing
and reimbursement from government health
administration authorities, private health insurers and
other organizations. Drug prices are under significant
scrutiny in the markets in which our products are
prescribed. Drug pricing and other health care costs
continue to be subject to intense
political and societal
pressures on a global basis.
In addition, our sales and operations are subject
to the risks of doing business internationally. For
example, the effects of the implementation of the
U.K.’s decision to voluntarily depart from the E.U.,
known as Brexit, remain unclear; compliance with any
resulting regulatory mandates may prove challenging
and the macroeconomic impact on our sales and
consolidated results of operations from these
developments remains unknown.
For additional information on our competition
and pricing risks that could negatively impact our
product sales, please read Item 1A. Risk
Factors and
Item 7A. Quantitative and Qualitative Disclosures About
Market Risk included in this report.