Biogen and Eisai to Discontinue Phase 3 ENGAGE and EMERGE Trials of
aducanumab in Alzheimer’s Disease
Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today
announced the decision to discontinue the global Phase 3 trials,
ENGAGE and EMERGE, designed to evaluate the efficacy and safety of
aducanumab in patients with mild cognitive impairment due to
Alzheimer’s disease and mild Alzheimer’s disease dementia. The
decision to stop the trials is based on results of a futility
analysis conducted by an independent data monitoring committee,
which indicated the trials were unlikely to meet their primary
endpoint upon completion. The recommendation to stop the studies
was not based on safety concerns.
“This disappointing news confirms the complexity of treating
Alzheimer’s disease and the need to further advance knowledge in
neuroscience. We are incredibly grateful to all the
Alzheimer’s disease patients, their families and the investigators
who participated in the trials and contributed greatly to this
research,” said Michel Vounatsos, Chief Executive Officer at
Biogen. “Biogen’s history has been based on pioneering innovation,
learning from successes and setbacks. Driven by our steadfast
commitment to patients and our strong business foundation, we will
continue advancing our pipeline of potential therapies in
Alzheimer’s disease and innovative medicines for patients suffering
from diseases of high unmet need.”
Detailed data from the ENGAGE and EMERGE studies will be
presented at future medical meetings to inform ongoing research.
ENGAGE and EMERGE are global Phase 3 multicenter, randomized,
double-blind, placebo-controlled, parallel-group studies designed
to evaluate the efficacy and safety of aducanumab. The primary
objective of the study was to evaluate the efficacy of monthly
doses of aducanumab as compared with placebo in slowing
cognitive and functional impairment as measured by changes in the
Clinical Dementia Rating-Sum of Boxes (CDR-SB) score. Secondary
objectives were to assess the effect of monthly doses
of aducanumab as compared to placebo on clinical progression
as measured by Mini-Mental State Examination (MMSE), AD Assessment
Scale-Cognitive Subscale (ADAS-Cog 13), and AD Cooperative
Study-Activities of Daily Living Inventory (ADCS-ADL-MCI).
As part of this decision, the EVOLVE Phase 2 safety study and
the long-term extension of the PRIME Phase1b study of aducanumab
will also be discontinued. Initiation of the aducanumab Phase 3
secondary prevention trial will be assessed while the data from
ENGAGE and EMERGE are further evaluated.
About Aducanumab
Aducanumab (BIIB037) is an investigational compound being
studied for the treatment of early Alzheimer’s disease. Biogen
licensed aducanumab from Neurimmune under a collaborative
development and license agreement. Aducanumab is a human monoclonal
antibody (mAb) derived from a de-identified library of B cells
collected from healthy elderly subjects with no signs of cognitive
impairment or cognitively impaired elderly subjects with unusually
slow cognitive decline using Neurimmune’s technology platform
called Reverse Translational Medicine (RTM). Since October 2017,
Biogen and Eisai have collaborated on the development and
commercialization of aducanumab globally. In addition, the U.S.
Food and Drug Administration (FDA) has granted Fast Track
designation for the development of aducanumab, a process allowing
priority reviews by the FDA for drugs deemed as having potential to
treat serious conditions and tackle key unmet medical needs.
About Biogen
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. 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 and only approved treatment for spinal muscular atrophy,
and is focused on advancing neuroscience research programs in
Alzheimer’s disease and dementia, MS and neuroimmunology, movement
disorders, neuromuscular disorders, acute neurology, neurocognitive
disorders, pain, and ophthalmology. Biogen also manufactures and
commercializes biosimilars of advanced biologics.
We routinely post information that may be important to investors
on our website at www.biogen.com. To learn more, please visit
www.biogen.com and follow us on social media – Twitter, LinkedIn,
Facebook, YouTube.
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 to
not only develop next generation treatments but also to develop
diagnosis methods and provide solutions.
For more information about Eisai Co., Ltd., please visit
www.eisai.com.
Biogen Safe Harbor
This press release contains forward-looking statements,
including statements made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995, the futility
analysis for the Phase 3 studies of aducanumab, the identification
and treatment of Alzheimer’s disease, the anticipated benefits and
potential of Biogen’s collaboration arrangements with Eisai and the
potential of Biogen’s commercial business and pipeline programs,
including aducanumab. These statements may be identified by words
such as “aim,” “anticipate,” “believe,” “could,” “estimate,”
“expect,” “forecast,” “intend,” “may,” “plan,” “possible,”
“potential,” “will” 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 our 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 aducanumab; 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 aducanumab and/or other Biogen drug
candidates; failure to protect and enforce our 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 our expectations in any forward-looking
statement. Investors should consider this cautionary statement, as
well as the risk factors identified in our most recent annual or
quarterly report and in other reports we have filed with the
Securities and Exchange Commission. These statements are based on
our current beliefs and expectations and speak only as
of the date of this press release. We do not undertake any
obligation to publicly update any forward-looking statements,
whether as a result of new information, future developments, or
otherwise.
Contacts |
MEDIA CONTACT:Biogen Inc.David
Caouette+1-617-679-4945public.affairs@biogen.com INVESTOR
CONTACT:Biogen Inc.Matt Calistri+1-781-464-2442IR@biogen.com |
MEDIA CONTACT:Eisai Co., Ltd.Public Relations DepartmentTEL:
+81-(0)3-3817-5120Eisai Inc.Public Relations DepartmentTEL:
+1-551-262-2686 INVESTOR CONTACT:Eisai Co., Ltd.Investor
Relations DepartmentTEL: +81-(0)3-3817-5327 |
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