Biogen and Eisai amend collaboration agreements on Alzheimer’s
disease treatments
Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan)
announced today that the companies have amended their existing
collaboration agreement on aducanumab, which is commercialized in
the United States as ADUHELM® (aducanumab-avwa). Effective as of
January 1, 2023, Eisai will receive a tiered royalty based on net
sales of ADUHELM rather than sharing global profits and losses. The
royalty rate starts at 2% and reaches 8% when annual sales exceed
$1 billion. Effective immediately, Biogen’s existing final
decision-making rights on ADUHELM have converted to sole decision
making and commercialization rights worldwide. Overall, economic
arrangements for both companies in 2022 are expected to remain
materially unchanged with Eisai’s share of expenses capped at an
agreed amount for the costs related to development,
commercialization, and manufacturing of ADUHELM for the period from
January 1, 2022 to December 31, 2022. Once the tiered royalty model
commences on January 1, 2023, Eisai will not participate in
ADUHELM’s economics beyond these royalties.
The companies will continue to jointly develop and commercialize
the investigational therapy lecanemab. Eisai continues to serve as
the lead of lecanemab development and regulatory submissions
globally with both companies co-commercializing and co-promoting
the product, and Eisai having final decision-making authority. Both
companies share economics equally with Eisai booking all sales for
lecanemab and Biogen reflecting its 50% share of profits and
losses.
The supply agreement related to lecanemab has been extended from
five to 10 years. Biogen will manufacture the lecanemab drug
substance in its Solothurn, Switzerland facility with the goal of
providing reliable commercial supply worldwide.
“This amended collaboration agreement will increase operational
efficiency and agility in addressing market developments, including
the final determination of CMS on coverage of ADUHELM,” said Michel
Vounatsos, Chief Executive Officer at Biogen. “In addition, we are
pleased to be expanding our agreement with Eisai through a new
long-term manufacturing contract.”
“The collaboration between both companies has resulted in the
approval of ADUHELM in the U.S. as the first treatment to address a
defining pathology of Alzheimer’s disease, which is a significant
step into a new chapter of Alzheimer’s therapy.” said Haruo Naito,
Chief Executive Officer at Eisai Co., Ltd. “We believe this new
arrangement will be more effective and enable more focused
execution with the goal of maximizing the value of both ADUHELM and
lecanemab. Eisai will increase its focus on lecanemab and remains
committed to bringing a new treatment option expeditiously to
patients in need worldwide.”
About BiogenAs pioneers in neuroscience, Biogen
discovers, develops, and delivers worldwide innovative therapies
for people living with serious neurological diseases as well as
related therapeutic adjacencies. One of the world’s first global
biotechnology companies, Biogen was founded in 1978 by Charles
Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize
winners Walter Gilbert and Phillip Sharp. Today, Biogen has a
leading portfolio of medicines to treat multiple sclerosis, has
introduced the first approved treatment for spinal muscular
atrophy, and is providing the first and only approved treatment to
address a defining pathology of Alzheimer’s disease. Biogen is also
commercializing biosimilars and focusing on advancing the
industry’s most diversified pipeline in neuroscience that will
transform the standard of care for patients in several areas of
high unmet need.
In 2020, Biogen launched a bold 20-year, $250 million initiative
to address the deeply interrelated issues of climate, health, and
equity. Healthy Climate, Healthy Lives™ aims to eliminate fossil
fuels across the company’s operations, build collaborations with
renowned institutions to advance the science to improve human
health outcomes, and support underserved communities.
The company routinely posts information that may be important to
investors on its website at www.biogen.com. To learn more,
please visit www.biogen.com and follow Biogen on social
media
– Twitter, LinkedIn, Facebook, YouTube.
About EisaiEisai Co., Ltd. is a leading global
pharmaceutical company headquartered in Japan. Eisai’s corporate
philosophy is based on the human health care (hhc) concept, which
is to give first thought to patients and their families, and to
increase the benefits that health care provides to them. With a
global network of R&D facilities, manufacturing sites and
marketing subsidiaries, we strive to realize our hhc philosophy by
delivering innovative products to target diseases with high unmet
medical needs, with a particular focus in our strategic areas of
Neurology and Oncology.
Leveraging the experience gained from the development and
marketing of a treatment for Alzheimer’s disease, Eisai aims to
establish the “Eisai Dementia Platform.” Through this platform,
Eisai plans to deliver novel benefits to those living with dementia
and their families through constructing a “Dementia Ecosystem,” by
collaborating with partners such as medical organizations,
diagnostic development companies, research organizations, and
bio-ventures in addition to private insurance agencies, finance
industries, fitness clubs, automobile makers, retailers, and care
facilities. For more information about Eisai Co., Ltd., please
visit https://www.eisai.com.
Biogen Safe Harbor This news release
contains forward-looking statements, including statements made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, about the potential clinical effects
of ADUHELM and lecanemab; the potential benefits, safety and
efficacy of ADUHELM and lecanemab; the treatment of Alzheimer’s
disease; the anticipated benefits and potential of Biogen’s
collaboration arrangements with Eisai; clinical development
programs, the anticipated benefits and potential of Biogen’s
manufacturing of lecanemab, clinical trials and data readouts and
presentations; and risks and uncertainties associated with drug
development and commercialization. These statements may be
identified by words such as “aim,” “anticipate,” “believe,”
“could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,”
“possible,” “potential,” “will,” “would” and other words and terms
of similar meaning. Drug development and commercialization involve
a high degree of risk, and only a small number of research and
development programs result in commercialization of a product.
Results in early-stage clinical trials may not be indicative of
full results or results from later stage or larger scale clinical
trials and do not ensure regulatory approval. You should not place
undue reliance on these statements, or the scientific data
presented.
These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in
such statements, including without limitation unexpected concerns
that may arise from additional data, analysis or results obtained
during clinical trials; the occurrence of adverse safety events;
risks of unexpected costs or delays; the risk of other unexpected
hurdles; failure to protect and enforce Biogen’s data, intellectual
property and other proprietary rights and uncertainties relating to
intellectual property claims and challenges; risks associated with
current and potential future healthcare reforms; product liability
claims; third party collaboration risks; and the direct and
indirect impacts of the ongoing COVID-19 pandemic on Biogen’s
business, results of operations and financial condition. The
foregoing sets forth many, but not all, of the factors that could
cause actual results to differ from Biogen’s expectations in any
forward-looking statement. Investors should consider this
cautionary statement as well as the risk factors identified in
Biogen’s most recent annual or quarterly report and in other
reports Biogen has filed with the U.S. Securities and Exchange
Commission. These statements are based on Biogen’s current beliefs
and expectations and speak only as of the date of this news
release. Biogen does not undertake any obligation to publicly
update any forward-looking statements, whether as a result of new
information, future developments or otherwise.
MEDIA CONTACT(S):BiogenAshleigh Koss+ 1 908 205
2572public.affairs@biogen.comEisai Inc. (U.S.
Media) Public Relations Department TEL: +1 201 753 1945
Eisai Co., Ltd. (Media Outside the U.S.) Public
Relations Department TEL: +81 (0)3 3817 5120 |
INVESTOR CONTACT(S):BiogenMike Hencke+1 781 464
2442IR@biogen.com Eisai Co.,
Ltd. Investor Relations Department TEL: +81 (0)70 8688
9685 |
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