WOODCLIFF LAKE, N.J.,
Sept. 13, 2019 /PRNewswire/ -- Eisai
Co., Ltd. (Headquarters: Tokyo,
CEO: Haruo Naito, "Eisai") and
Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") today announced the
decision to discontinue the Phase III clinical studies (MISSION
AD1, AD2) on the investigational oral BACE (beta amyloid cleaving
enzyme) inhibitor elenbecestat (development code: E2609) in
patients with early Alzheimer's disease (AD). The decision is based
on the results of a safety review conducted by the Data Safety
Monitoring Board (DSMB), which recommended to discontinue these
trials due to unfavorable risk-benefit ratio. Detailed data of
these studies will be presented at future medical meetings.
Investigators are being informed of the decision and they will
be contacting their study participants to discontinue the
investigational treatment.
Dr. Lynn Kramer, Chief Clinical
Officer, Neurology Business Group, Eisai Co., Ltd., said: "We would
like to thank the patients and the families, as well as medical
professionals, that participated in the MISSION AD studies. Without
their contributions we would not be able to advance Alzheimer's
disease research. We are very disappointed with the news, and
intend to learn from these data and continue engaging with patients
and investigators, to pursue the discovery of new medicines for
Alzheimer's disease."
The Phase III clinical trial program for elenbecestat (MISSION
AD) consisted of two global Phase III clinical studies with
identical protocols, MISSION AD1 (Study 301) and MISSION AD2 (Study
302). Both studies were multicenter, placebo-controlled,
double-blind, parallel-group Phase III clinical studies designed to
assess the efficacy and safety of elenbecestat for treatment in a
total of about 2,100 patients with mild cognitive impairment (MCI)
or mild AD (collectively known as early AD) with confirmed amyloid
pathology in the brain. Patients were randomized to receive either
50 mg of elenbecestat or placebo daily during the treatment period
of 24 months, and the primary endpoint was the Clinical Dementia
Rating Sum of Boxes (CDR-SB).
As part of this decision, the long-term extension of the Phase
II clinical trial of elenbecestat (Study 202) will also be
discontinued. This determination does not impact the program of the
anti-amyloid beta (Aβ) protofibril monoclonal antibody BAN2401, and
the Phase III Clarity AD trial of BAN2401 will continue.
Biogen Safe Harbor Statement
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, regarding the Phase III
studies of elenbecestat; the clinical effects of elenbecestat; the
potential benefits, safety and efficacy of elenbecestat; the
clinical development program for elenbecestat; the identification
and treatment of Alzheimer's disease; the anticipated benefits and
potential of Biogen's collaboration arrangements with Eisai; the
potential of Biogen's commercial business and pipeline programs,
including BAN2401; the timing and scope of future clinical trials;
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," "goal," "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; regulatory authorities may require
additional information or further studies, or may fail or refuse to
approve or may delay approval of Biogen's drug candidates,
including BAN2401; the occurrence of adverse safety events; risks
of unexpected costs or delays; the risk of other unexpected
hurdles; uncertainty of success in the development and potential
commercialization of BAN2401 and/or other Biogen drug candidates;
failure to protect and enforce Biogen's data, intellectual property
and other proprietary rights and uncertainties relating to
intellectual property claims and challenges; product liability
claims; and third party collaboration risks. 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.
Contacts
|
Eisai Co.,
Ltd.
Public Relations
Department
TEL:
+81-(0)3-3817-5120
Investor Relations
Department
TEL:
+81-(0)3-3817-3016
|
Biogen
Inc.
Media
Contact:
David
Caouette
+1 617 679
4945
public.affairs@biogen.com
Investor
Contact:
Joe Mara
+1 781 464
2442
IR@biogen.com
|
Notes to Editors
1.
About Elenbecestat (generic name, development code: E2609)
Discovered by Eisai, elenbecestat is an investigational
next-generation oral candidate for the treatment of Alzheimer's
disease (AD) that inhibits BACE (beta amyloid cleaving enzyme). By
inhibiting BACE, a key enzyme in the production of Aβ peptides,
elenbecestat reduces Aβ production. It is hypothesized that
reducing amyloid plaque formations in the brain might exert disease
modifying effects and potentially slow the progression of AD.
2. About joint development agreement between Eisai and Biogen
for Alzheimer's disease
Eisai and Biogen are collaborating on the joint development and
commercialization of Alzheimer's disease treatments. Eisai serves
as the lead in the co-development of elenbecestat, a BACE
inhibitor, and BAN2401, an anti-amyloid beta (Aβ) protofibril
antibody, and the companies plan to pursue marketing authorizations
for BAN2401 worldwide. If approved, the companies will also
co-promote BAN2401 in major markets, such as the United States, the European Union and
Japan. Both companies will equally
split overall costs, including research and development expenses.
Eisai will book all sales for BAN2401 following marketing approval
and launch, and profits will be equally shared between the
companies.
3. About Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global research and development-based
pharmaceutical company headquartered in Japan. We define our corporate mission as
"giving first thought to patients and their families and to
increasing the benefits health care provides," which we call our
human health care (hhc) philosophy. With approximately
10,000 employees working across our global network of R&D
facilities, manufacturing sites and marketing subsidiaries, we
strive to realize our hhc philosophy by delivering
innovative products to address 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 Aricept®, a treatment for Alzheimer's disease and
dementia with Lewy bodies, Eisai has been working to establish a
social environment that involves patients in each community in
cooperation with various stakeholders including the government,
healthcare professionals and care workers, and is estimated to have
held over ten thousand dementia awareness events worldwide. As a
pioneer in the field of dementia treatment, Eisai is striving not
only to develop next generation treatments but also to develop
diagnosis methods and provide solutions.
For more information about Eisai Co., Ltd., please visit
www.eisai.co.jp.
4. About Biogen Inc.
At Biogen, our mission is clear: we are pioneers in neuroscience.
Biogen discovers, develops and delivers worldwide innovative
therapies for people living with serious neurological and
neurodegenerative 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, Kenneth Murray and
Nobel Prize winners Walter Gilbert
and Phillip Sharp, and today has the
leading portfolio of medicines to treat multiple sclerosis, has
introduced the first approved treatment for spinal muscular
atrophy, commercializes biosimilars of advanced biologics and is
focused on advancing research programs in multiple sclerosis and
neuroimmunology, neuromuscular disorders, movement disorders,
Alzheimer's disease and dementia, ophthalmology, immunology,
neurocognitive disorders, acute neurology and pain. For more
information about Biogen Inc., please visit www.biogen.com and
follow on the social media – Twitter, LinkedIn, Facebook,
YouTube.
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SOURCE Eisai Inc.