Biogen to Present Data from Alzheimer’s Disease Portfolio at the
2018 Clinical Trials on Alzheimer’s Disease (CTAD) Meeting
Biogen (Nasdaq: BIIB) announced it will present data from its
Alzheimer’s disease (AD) clinical development portfolio at the
upcoming Clinical Trials on Alzheimer’s Disease (CTAD) annual
meeting in Barcelona, Spain (October 24-27). The data being
presented are part of Biogen’s ongoing research programs targeting
possible causes of the disease through multiple modalities.
“We are excited to engage with the scientific community at CTAD,
to share learnings from our Alzheimer’s disease clinical research
and to learn from the work of our colleagues around the world. We
have hopes that our collective research will one day help the
millions of people living with Alzheimer’s disease,” said Samantha
Budd Haeberlein, Ph.D., vice president, Alzheimer’s disease,
dementia and movement disorders, late stage clinical development at
Biogen.
Biogen will share a late-breaking oral presentation and a
late-breaking poster on the efficacy of aducanumab and the
cumulative safety data from the Phase 1b PRIME long-term extension
study of patients with prodromal and mild Alzheimer’s disease.
Aducanumab is Biogen’s late-stage Alzheimer’s disease
investigational treatment, and is being co-developed with
Eisai.
In addition to presentations from our clinical research
programs, Dr. Budd Haeberlein will deliver a keynote titled “What
Have We Learned from Aducanumab?” that focuses on the lessons
learned from the aducanumab research.
Biogen presentations will highlight:
- Oral Presentation: Aducanumab Titration Dosing Regimen:
36-Month Analyses from PRIME, a Phase 1b Study in Patients with
Early Alzheimer’s Disease – Friday, October 26, 3:15-3:30 p.m.
CEST
- Keynote: What Have We Learned from Aducanumab? – Thursday,
October 25, 1:30-2:00 p.m. CEST
- Poster Presentation: Cumulative Aducanumab Safety Data from
PRIME: A Randomized, Double-blind, Placebo-controlled, Phase 1b
Study – Wednesday, October 24, through Saturday, October 27. The
poster will be available on Biogen.com
- Poster Presentation: Aducanumab 48-Month Analyses from PRIME, a
Phase 1b Study in Patients with Early Alzheimer’s Disease –
Wednesday, October 24, through Saturday, October 27. The poster
will be available on Biogen.com
Biogen will also host live webcasts of its oral presentation and
keynote address, as well as a Q&A session related to its
Alzheimer’s disease investigational therapies. To access the live
webcasts, please go to the Investors section of Biogen’s website at
investors.biogen.com. Following the live webcasts, archived
versions will be available on the website.
Biogen Webcast Details:
- Thursday, October 25, 7:30-8:00 a.m. ET / 1:30-2:00 p.m. CEST -
Keynote: What Have We Learned from Aducanumab?
- Thursday, October 25, 4:15 p.m. ET / 10:15 p.m. CEST - Investor
Q&A call with Alfred Sandrock, Jr., M.D., Ph.D., executive vice
president and chief medical officer at Biogen, and Samantha Budd
Haeberlein, Ph.D., vice president, Alzheimer’s disease, dementia
and movement disorders, late stage clinical development at
Biogen
- Friday, October 26, 9:15-9:30 a.m. ET / 3:15-3:30 p.m. CEST -
Oral Presentation: Aducanumab Titration Dosing Regimen: 36-Month
Analyses from PRIME, a Phase 1b Study in Patients with Early
Alzheimer’s Disease
Biogen’s collaborator Eisai will present safety and efficacy
data for the BACE inhibitor, elenbecestat, from the Phase 2 study
in MCI-to-moderate Alzheimer’s disease, along with clinical and
biomarker updates from the Phase 2 study of BAN2401, an
anti-amyloid beta antibody.
Eisai presentations will highlight:
- Oral Presentation: Elenbecestat in MCI-to-Moderate Alzheimer’s
Disease – Thursday, October 25, 9:30-9:45 a.m. CEST
- Symposium: Clinical and Biomarker Updates from BAN2401 Study
201 in Early AD – Thursday, October 25, 2:30-3:30 p.m. CEST
Eisai Webcast Details:
- Symposium: Clinical and Biomarker Updates from BAN2401 Study
201 in Early AD - Thursday, October 25, 2:30-3:30 p.m. CEST. To
access the live webcast, please visit
https://www.eisai.com/ir/index.html
About AducanumabAducanumab (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 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.
About ElenbecestatElenbecestat is an oral BACE
(beta amyloid cleaving enzyme) inhibitor currently being
investigated in Phase 3 clinical studies for Alzheimer’s disease
discovered by Eisai and in collaboration with Biogen. By inhibiting
BACE, a key enzyme in the production of Aβ peptides, elenbecestat
reduces Aβ production, which is thought to lead to a reduction in
amyloid plaque formations caused by the aggregation of toxic
oligomers and protofibrils in the brain. Currently, two global
Phase 3 clinical studies (MISSION AD1/2) of elenbecestat in early
Alzheimer’s disease including mild cognitive impairment (MCI) due
to AD/Prodromal AD and the early stages of mild AD are underway. In
addition, the U.S. Food and Drug Administration (FDA) has granted
Fast Track designation for the development of elenbecestat, a
process to facilitate development and expedite review by the FDA
for drugs deemed as having potential to treat serious conditions
and addressing unmet medical needs.
About BiogenAt 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, multiple sclerosis
and neuroimmunology, movement disorders, neuromuscular disorders,
pain, ophthalmology, neuropsychiatry and acute neurology. 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
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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, about the Phase 1b study of aducanumab and
results of certain subgroup analyses in the Phase 1b study, about
results from the Phase 2 study of BAN2401, about results from the
Phase 2 study of elenbecestat, the potential clinical effects of
aducanumab, BAN2401 and elenbecestat the potential benefits, safety
and efficacy of aducanumab, BAN2401 and elenbecestat, the
identification and treatment of Alzheimer’s disease, the
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