TOKYO and CAMBRIDGE, Mass., July
5, 2018 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters:
Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (NASDAQ:
BIIB) (Headquarters: Cambridge,
Massachusetts, United
States, CEO: Michel
Vounatsos, "Biogen") announced positive topline results from
the Phase II study with BAN2401, an anti-amyloid beta protofibril
antibody, in 856 patients with early Alzheimer's disease. The study
achieved statistical significance on key predefined endpoints
evaluating efficacy at 18 months on slowing progression in
Alzheimer's Disease Composite Score (ADCOMS) and on reduction of
amyloid accumulated in the brain as measured using amyloid-PET
(positron emission tomography).
Study 201 (ClinicalTrials.gov identifier NCT01767311) is a
placebo-controlled, double-blind, parallel-group, randomized study
in 856 patients with mild cognitive impairment (MCI) due to
Alzheimer's disease (AD) or mild Alzheimer's dementia (collectively
known as early Alzheimer's disease) with confirmed amyloid
pathology in the brain. Efficacy was evaluated at 18 months by
predefined conventional statistics on ADCOMS, which combines items
from the Alzheimer's Disease Assessment Scale-cognitive subscale
(ADAS-Cog), the Clinical Dementia Rating Sum of Boxes (CDR-SB)
scale and the Mini-Mental State Examination (MMSE) to enable
sensitive detection of changes in early AD symptoms. Patients were
randomized to five dose regimens, 2.5 mg/kg biweekly, 5 mg/kg
monthly, 5 mg/kg biweekly, 10 mg/kg monthly and 10 mg/kg biweekly,
or placebo.
Topline results of the final analysis of the study demonstrated
a statistically significant slowing of disease progression on the
key clinical endpoint (ADCOMS) after 18 months of treatment in
patients receiving the highest treatment dose (10 mg/kg biweekly)
as compared to placebo. Results of amyloid PET analyses at 18
months, including reduction in amyloid PET standardized uptake
value ratio (SUVR) and amyloid PET image visual read of subjects
converting from positive to negative for amyloid in the brain, were
also statistically significant at this dose. Dose-dependent changes
from baseline were observed across the PET results and the clinical
endpoints. Further, the highest treatment dose of BAN2401 began to
show statistically significant clinical benefit as measured by
ADCOMS as early as 6 months including at 12 months.
BAN2401 demonstrated an acceptable tolerability profile through
18 months of study drug administration. The most common treatment
emergent adverse events were infusion-related reactions and Amyloid
Related Imaging Abnormalities (ARIA). Infusion related reactions
were mostly mild to moderate in severity. Incidence of ARIA-E
(edema) was not more than 10% in any of the treatment arms, and
less than 15% in patients with APOE4 at the highest dose per the
study protocol safety and reporting procedures.
Detailed results of the study will be presented at future
academic conferences.
"The 18-month results of the BAN2401 trial are impressive and
provide important support for the amyloid hypothesis," said
Jeff Cummings, M.D., founding
director, Cleveland Clinic Lou Ruvo Center for Brain Health. "I
look forward to seeing the full data set shared with the broader
Alzheimer's community as we advance against this devastating
disease."
"This is the first late-stage anti-amyloid antibody study to
successfully achieve statistically significant results at 18
months, further validating the amyloid hypothesis," said
Lynn Kramer, M.D., Chief Clinical
Officer and Chief Medical Officer, Neurology Business Group, Eisai.
"We will discuss these very encouraging results with regulatory
authorities to determine the best path forward. We continue to work
towards the goal of delivering BAN2401 to patients and healthcare
professionals as early as possible."
"The prospect of being able to offer meaningful
disease-modifying therapies to individuals suffering from this
terrible disease is both exciting and humbling," said Alfred Sandrock, M.D., Ph.D., executive vice
president and chief medical officer at Biogen. "These BAN2401
18-month data offer important insights in the investigation of
potential treatment options for patients with Alzheimer's disease
and underscores that neurodegenerative diseases may not be as
intractable as they once seemed."
As reported in December 2017, the
study did not achieve its primary outcome measure which was
designed to enable a potentially more rapid entry into Phase III
development based on Bayesian analysis at 12 months of treatment.
Upon the final analysis at 18 months using predefined conventional
statistical method, the study did demonstrate a statistically
significant slowing of disease progression on the key clinical
endpoint (ADCOMS) after 12 months of treatment in patients
receiving the highest treatment dose (10 mg/kg biweekly) as
compared to placebo.
This release discusses investigational uses of an agent in
development and is not intended to convey conclusions about
efficacy or safety. There is no guarantee that any investigational
uses of such product will successfully complete clinical
development or gain health authority approval.
Biogen Safe Harbor Statement
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 about results from
the Phase 2 study of BAN2401, the potential clinical effects of
BAN2401, risks and uncertainties associated with drug development
and commercialization, the potential benefits, safety and efficacy
of BAN2401, and therapies for other neurological diseases, the
timing and status of current and future regulatory filings, the
anticipated benefits and potential of Biogen's collaboration
arrangements with Eisai and the potential of Biogen's commercial
business and pipeline programs, including BAN2401, elenbecestat and
aducanumab. These forward-looking statements may be accompanied by
words such as "aim," "anticipate," "believe," "could," "estimate,"
"expect," "forecast," "intend," "may," "plan," "potential,"
"possible," "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 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, elenbecestat and/or aducanumab; the occurrence
of adverse safety events; risks of unexpected costs or delays; the
risks of other unexpected hurdles; uncertainty of success in the
development and potential commercialization of BAN2401,
elenbecestat and/or aducanumab, which may be impacted by, among
other things, unexpected concerns that may arise from additional
data or analysis, the occurrence of adverse safety events, failure
to obtain regulatory approvals in certain jurisdictions, failure to
protect and enforce Biogen's data, intellectual property and other
proprietary rights and uncertainties relating to intellectual
property claims and challenges; uncertainty as to whether the
anticipated benefits and potential of Biogen's collaboration
arrangement with Eisai can be achieved; 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 Securities and Exchange Commission. These
statements are based on Biogen's current beliefs and expectations
and speak only as of the date of this press 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
Inquiries
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Eisai Co.,
Ltd.
Public Relations
Department
TEL:
+81-(0)3-3817-5120
Eisai Inc.
Public Relations
Department
TEL:
+1-201-746-2139
|
Biogen
Inc.
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Affairs
TEL:
+1-781-464-3260
public.affairs@biogen.com
|
<Notes to
editors>
1. About
BAN2401
BAN2401 is a humanized monoclonal antibody for
Alzheimer's disease that is the result of a strategic research
alliance between Eisai and BioArctic. BAN2401 selectively binds to
neutralize and eliminate soluble, toxic Aβ aggregates that are
thought to contribute to the neurodegenerative process in
Alzheimer's disease. As such, BAN2401 may have the potential to
have an effect on disease pathology and to slow down the
progression of the disease. Eisai obtained the global rights to
study, develop, manufacture and market BAN2401 for the treatment of
Alzheimer's disease pursuant to an agreement concluded with
BioArctic in December 2007. In
March 2014, Eisai and Biogen entered
into a joint development and commercialization agreement for
BAN2401 and the parties amended that agreement in October 2017.
2. About
ADCOMS
Developed by Eisai, ADCOMS (AD Composite Score)
combines items from the ADAS-Cog (Alzheimer's Disease Assessment
Scale-cognitive subscale), CDR-SB (Clinical Dementia Rating Sum of
Boxes) and the MMSE (Mini-Mental State Examination) scales to
enable a sensitive detection of changes in clinical functions of
early AD symptoms and changes in memory. This Study 201 utilizes
ADCOMS as its key endpoint for assessing clinical symptoms.
3. About Amyloid PET
Imaging
Amyloid PET (Positron Emission Tomography) imaging
is a diagnostic method that enables the visualization of amyloid
plaque present in the brain as well as the quantitative evaluation
of amyloid plaque distribution and accumulation in the brain via
administration of a minute amount of PET tracer, which specifically
binds to amyloid plaque and marks it with positron. Amyloid PET
imaging enables the assessment of pathology change and assistance
of diagnosis of patients with Alzheimer's-disease including MCI,
and estimates the clinical effect of disease modifiers based on the
amyloid hypothesis.
4. About the Joint Development
Agreement between Eisai and Biogen for Alzheimer's
Disease
Eisai and Biogen are widely 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, while Biogen serves as the lead for
co-development of aducanumab, Biogen's investigational anti-amyloid
beta (Aβ) antibody for patients with Alzheimer's disease, and the
companies plan to pursue marketing authorizations for the three
compounds worldwide. If approved, the companies will also
co-promote the products in major markets, such as the United States, the European Union and
Japan.
As to BAN2401 and elenbecestat, both companies will equally
split overall costs, including research and development expenses.
Eisai will book all sales for elenbecestat and BAN2401 following
marketing approval and launch, and profits will be equally shared
between the companies.
5. 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.
6. 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 Weissman, 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, neuroimmunology,
movement disorders, neuromuscular disorders, pain, ophthalmology,
neuropsychiatry, and acute neurology. Biogen also manufactures and
commercializes biosimilars of advanced biologics.
Biogen 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.
7. About BioArctic
AB
BioArctic AB (publ) is a Swedish research-based biopharma
company focusing on disease modifying treatments and reliable
biomarkers and diagnostics for neurodegenerative diseases, such as
Alzheimer's disease and Parkinson's disease. The company also
develops a potential treatment for Complete Spinal Cord Injury.
BioArctic focuses on innovative treatments in areas with high unmet
medical needs. The company was founded in 2003 based on innovative
research from Uppsala University,
Sweden. Collaborations with
universities are of great importance to the company together with
our strategically important global partners in the Alzheimer
(Eisai) and Parkinson (AbbVie) projects. The project portfolio is a
combination of fully funded projects run in partnership with global
pharmaceutical companies and innovative in-house projects with
significant market- and out-licensing potential. BioArctic's
B-share is listed on Nasdaq Stockholm Mid Cap (STO:BIOA B).
www.bioarctic.com.
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