Biogen Inc. (Nasdaq: BIIB) today announced new data underscoring
the efficacy and safety of its broad, industry-leading portfolio of
multiple sclerosis (MS) therapies. These data will be presented
during MSVirtual2020, the eighth joint meeting of the Americas
Committee for Treatment and Research in Multiple Sclerosis and the
European Committee for Treatment and Research in Multiple Sclerosis
(ACTRIMS-ECTRIMS), which will be held virtually September 11-13,
2020.
“We at Biogen are proud of our commitment to addressing both the
urgent and long-term challenges facing people living with MS,” said
Maha Radhakrishnan, M.D., Chief Medical Officer at Biogen. “The
data we are presenting at ACTRIMS-ECTRIMS highlight the improved
outcomes that our broad MS portfolio has continued to provide for
people with relapsing forms of MS, regardless of where they are in
their treatment journey, as well as our ongoing investment in
research and development to identify potentially effective drug
candidates.”
New Phase 3 Data Further Characterize the Effectiveness
and Patient-Reported GI Tolerability of VUMERITY® (diroximel
fumarate)New data from the VUMERITY Phase 3 clinical
program further define the effectiveness and safety profile of
Biogen’s latest oral fumarate therapy. Findings from the five-week
EVOLVE-MS-2 study reinforce clinically meaningful improvements in
patient-assessed gastrointestinal (GI) tolerability associated with
VUMERITY treatment (n=253) compared to TECFIDERA® (dimethyl
fumarate) (n=251), and support its impact on quality of life for
people with relapsing MS. Study participants taking VUMERITY
reported a lower likelihood of experiencing GI symptoms that
interfered with daily activities or were associated with missed
work, as well as less concomitant medication use to treat GI
symptoms.
An exploratory analysis from the ongoing EVOLVE-MS-1 study
assessed the effects of VUMERITY on brain volume change and other
clinical measures in people with relapsing MS (n=365) treated for
up to two years. Separate studies have shown brain volume loss may
be associated with cognitive impairment, physical disability and
reduced quality of life in people with MS.1,2 Data from EVOLVE-MS-1
show:
- The annual rate of brain volume change in study participants
treated with VUMERITY for two years was similar to the rate
observed in healthy individuals; and
- Approximately 90 percent of people treated with VUMERITY
remained free from confirmed disability progression and around 84
percent were relapse-free at two years.
Also being presented at the meeting are final data from the
Phase 3 ENDORSE study, which further demonstrate the sustained
efficacy and well-characterized safety profile of TECFIDERA in
patients followed for up to 13 years.
Real-World Data From Separate Analyses in the Relapsing
MS Population Show Improved Outcomes With
TYSABRI® (natalizumab),
PLEGRIDY® (peginterferon
beta-1a) and
AVONEX® (interferon
beta-1a) Through MS PATHS (Partners Advancing Technology
and Health Solutions), Biogen is collaborating with leading MS
centers in Europe and the U.S. to generate standardized,
high-quality data from a diverse, real-world MS patient population.
To date, more than 17,000 patients have been enrolled in MS PATHS.
Data being presented from treatment in the real-world setting
support improved outcomes associated with TYSABRI, PLEGRIDY and
AVONEX. Results from separate analyses of MS PATHS data reveal the
following:
- In the first comparison of MS PATHS standardized magnetic
resonance imaging (MRI) protocols, analyses of changes in brain MRI
(occurring over a mean follow-up of 0.8 years) were compared during
natalizumab treatment with extended interval dosing (EID; n=85) to
the approved every-four-week (Q4W; n=569) dosing. The analysis
reported no significant differences in the rates of new T2 lesions,
T2 lesion volumes and brain atrophy. Differences in MRI scanners
and acquisition protocols in clinical practice have made
comparisons of brain MRI outcomes challenging. Multiple real-world
studies have suggested the effectiveness of natalizumab EID is
similar to the approved Q4W dosing.3-7 Biogen continues to evaluate
the efficacy, safety and tolerability of natalizumab EID through
the prospective NOVA trial (NCT03689972), and recently filed with
regulatory authorities for a subcutaneous dosing formulation which,
if approved, would allow for more options for TYSABRI
administration.
- Treatment with TYSABRI was associated with greater improvements
than Ocrevus® (ocrelizumab) in several quality of life domains
according to the Neuro-QoL (Quality of Life in Neurological
Disorders) assessment. In a subgroup analysis of matched patients
treated with TYSABRI or Ocrevus, significant improvement was
observed in nine of 12 Neuro-QoL domains in patients treated with
TYSABRI (n=144) and in four of 12 domains in patients treated with
Ocrevus (n=502). Overall, annualized rates of improvement were
higher with TYSABRI than with Ocrevus and significant differences
were observed in three domains: positive affect and well-being,
satisfaction with social roles and activities and sleep
disturbance.
- Clinical outcomes in people with MS aged 60 or older (n=286),
compared to those under 60 (n=729), indicate that PLEGRIDY and
AVONEX may provide real-world treatment benefits over two years in
both age groups. Data show functional improvements in processing
speed test (PST) and contrast sensitivity test (CST) over one year
in both age groups. Additionally, a majority of participants in
both age groups remained free from relapse over two years.
Data From a Phase 1 Study of BIIB091 Supports Continued
Development for the Treatment of MSBiogen also presented
data from a Phase 1 study of BIIB091, an orally active selective,
reversible (noncovalent), small molecule inhibitor of Bruton’s
Tyrosine Kinase (BTK). Data evaluated the safety, tolerability,
pharmacokinetics and pharmacodynamics of single and multiple
ascending oral doses in healthy adult participants. Selective BTK
inhibition may be beneficial for the treatment of MS by preventing
B-cell and myeloid cell activation without immune cell
depletion.
Data Presentations Featured at
ACTRIMS-ECTRIMS:Note: All poster presentations from
MSVirtual2020 will be made available online at 8 a.m. ET on Friday,
September 11, 2020.
- Improved GI Tolerability With Diroximel Fumarate is Associated
With Clinically Meaningful Benefits on Quality of Life Compared
With Dimethyl Fumarate in EVOLVE-MS-2 (Poster 0214)
- Effects of Diroximel Fumarate on Brain Volume Change and
Disability Progression in Adults With Relapsing-Remitting Multiple
Sclerosis From EVOLVE-MS-1 (Poster P0205)
- Safety and Efficacy in Patients Treated With Dimethyl Fumarate
and Followed for 13 Years: Final Results of ENDORSE (Platform
FC02.05 – Sunday, September 13, 1:48-2:00 p.m. ET)
- No Difference in Radiologic Outcomes for Natalizumab Patients
on Extended Interval Dosing Compared With Standard Interval Dosing
in MS PATHS (Poster P0360)
- Impact of Natalizumab on Quality of Life in a Real-World Cohort
of Patients With Multiple Sclerosis: Results from MS PATHS (Poster
P1036)
- Characteristics and Clinical Outcomes of Older Patients With MS
Treated With Peginterferon Beta-1a or Intramuscular Interferon
Beta-1a in MS PATHS (Poster P0843)
- A Phase 1 Study of BIIB091, a Bruton’s Tyrosine Kinase (BTK)
Inhibitor, in Healthy Adult Participants: Preliminary Results
(Poster P0186)
About VUMERITY® (diroximel fumarate)
VUMERITY is an oral fumarate with a distinct chemical structure
from TECFIDERA® (dimethyl fumarate), approved in the U.S. for the
treatment of relapsing forms of multiple sclerosis in adults, to
include clinically isolated syndrome, relapsing-remitting disease
and active secondary progressive disease. Once in the body,
VUMERITY rapidly converts to monomethyl fumarate, the same active
metabolite of dimethyl fumarate.
VUMERITY is contraindicated in patients with known
hypersensitivity to diroximel fumarate, dimethyl fumarate or any of
the excipients of VUMERITY; and in patients taking dimethyl
fumarate. Serious side effects for VUMERITY are based on data from
dimethyl fumarate (which has the same active metabolite as
VUMERITY) and include anaphylaxis and angioedema, progressive
multifocal leukoencephalopathy, which is a rare opportunistic viral
infection of the brain that has been associated with death or
severe disability, a decrease in mean lymphocyte counts during the
first year of treatment, herpes zoster and other serious
infections, liver injury and flushing. The most common adverse
events, obtained using data from dimethyl fumarate (which has the
same active metabolite as VUMERITY), were flushing, abdominal pain,
diarrhea and nausea.
Please click here for Important Safety Information and full
Prescribing Information, including Patient Information for VUMERITY
in the U.S.
About TECFIDERA® (dimethyl fumarate)
TECFIDERA, a treatment for relapsing forms of multiple sclerosis
(MS) in adults, is the most prescribed oral medication for
relapsing MS in the world and has been shown to reduce the rate of
MS relapses, slow the progression of disability and impact the
number of MS brain lesions, while demonstrating a
well-characterized safety profile in people with relapsing forms of
MS. TECFIDERA is approved in 69 countries, and more than 475,000
patients have been treated with it, representing more than 950,000
patient-years of exposure across clinical trial use and patients
prescribed TECFIDERA. Of these, 6,335 patients (14,241
patient-years) were from clinical trials.8
TECFIDERA is contraindicated in patients with a known
hypersensitivity to dimethyl fumarate or any of the excipients of
TECFIDERA. Serious side effects include anaphylaxis and angioedema,
and cases of progressive multifocal leukoencephalopathy, a rare
opportunistic viral infection of the brain which has been
associated with death or severe disability, have been seen with
TECFIDERA patients in the setting of prolonged lymphopenia although
the role of lymphopenia in these cases is uncertain. Other serious
side effects include a decrease in mean lymphocyte counts during
the first year of treatment, herpes zoster and other serious
infections, liver injury and flushing. In clinical trials, the most
common adverse events associated with TECFIDERA were flushing,
abdominal pain, diarrhea and nausea.
Please click here for Important Safety Information and full
Prescribing Information, including Patient Information for
TECFIDERA in the U.S., or visit your respective country’s product
website.
About TYSABRI® (natalizumab) TYSABRI
is a well-established relapsing multiple sclerosis (RMS) treatment
indicated for relapsing forms of MS in adults that has been proven
in clinical trials to slow physical disability progression, reduce
the formation of new brain lesions and cut relapses. TYSABRI is
approved in 80 countries, and over 213,000 people worldwide have
been treated with TYSABRI, with over 835,000 patient-years of
experience, based on clinical trials and prescription data.9
TYSABRI increases the risk of progressive multifocal
leukoencephalopathy (PML), a rare opportunistic viral infection of
the brain which has been associated with death or severe
disability. Risk factors that increase the risk of PML are the
presence of anti-JC virus antibodies, prior immunosuppressant use
and longer TYSABRI treatment duration. Patients who have all three
risk factors have the highest risk of developing PML. When
initiating and continuing treatment with TYSABRI, physicians should
consider whether the expected benefit of TYSABRI is sufficient to
offset this risk.
TYSABRI also increases the risk of developing encephalitis and
meningitis caused by herpes simplex and varicella zoster viruses,
and serious, life-threatening and sometimes fatal cases have been
reported in the post-marketing setting in MS patients receiving
TYSABRI. Clinically significant liver injury, including acute liver
failure requiring transplant, has also been reported in the
post-marketing setting. Other serious adverse events that have
occurred in TYSABRI-treated patients include hypersensitivity
reactions (e.g., anaphylaxis) and infections, including
opportunistic and other atypical infections.
Please click here for Important Safety Information, including
Boxed Warning, and full Prescribing Information, including
Medication Guide for TYSABRI in the U.S., or visit your respective
country’s product website.
About PLEGRIDY® (peginterferon beta-1a)
PLEGRIDY is a subcutaneous pegylated interferon dosed once every
two weeks for relapsing forms of multiple sclerosis (MS) in adults,
the most common form of MS. PLEGRIDY is currently approved in over
60 countries including the U.S., Canada, Australia and Switzerland
and across the European Union. Nearly 57,000 people worldwide have
been treated with PLEGRIDY, with over 107,000 patient-years of
experience, based on prescription data.10 Biogen continues to work
toward making PLEGRIDY available in additional countries across the
globe.
The efficacy and safety of PLEGRIDY are supported by one of the
largest pivotal studies with interferons conducted in people living
with relapsing-remitting MS. In clinical studies, PLEGRIDY has been
proven to significantly reduce the rate of MS relapses, slow the
progression of disability and reduce the number of MS brain lesions
while demonstrating a well-characterized safety profile for
patients with relapsing forms of MS. Side effects reported include
liver problems, including liver failure and increases in liver
enzymes; depression or suicidal thoughts; serious allergic
reactions; cardiac problems, including congestive heart failure;
autoimmune disorders; decreases in white blood cell or platelet
counts; and seizures. In clinical trials, the most common adverse
events associated with PLEGRIDY were injection site reactions and
flu-like symptoms. A list of adverse events can be found in the
full PLEGRIDY product labeling for each country where it is
approved.
Please click here for Important Safety Information and full
Prescribing Information, including Medication Guide for PLEGRIDY in
the U.S., or visit your respective country’s product website.
About AVONEX® (interferon beta-1a) AVONEX
is prescribed for relapsing forms of MS and is currently approved
in over 90 countries. Over 580,000 people worldwide have been
treated with AVONEX, with over 2.6 million patient-years
of experience, based on prescription data.11 AVONEX is indicated
for the treatment of relapsing forms of multiple sclerosis (MS), to
include clinically isolated syndrome, relapsing-remitting disease,
and active secondary progressive disease, in adults.
Symptoms of depression, suicidal ideation or psychosis, and
cases of suicide, have been reported with increased frequency with
patients receiving AVONEX. Severe hepatic injury, including cases
of hepatic failure has been reported rarely in patients. Rare cases
of anaphylaxis have been reported. While beta interferons do not
have any known direct cardiac toxicity, cases of congestive heart
failure, cardiomyopathy and cardiomyopathy with congestive heart
failure have been reported in patients without known
predisposition. Decreased peripheral blood counts have been
reported from postmarketing experience. Seizures have been reported
in patients using AVONEX, including patients with no prior history
of seizure. Autoimmune disorders of multiple target organs have
been reported. Routine periodic blood chemistry, hematology, liver
function and thyroid function tests are recommended.
Please click here for Important Safety Information and full
Prescribing Information, including Medication Guide for AVONEX in
the U.S., or visit your respective country’s product website.
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 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. Today Biogen 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, Alzheimer’s disease and dementia, neuromuscular
disorders, movement disorders, ophthalmology, immunology,
neurocognitive disorders, acute neurology and pain.
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.
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, relating to the potential benefits, safety and
efficacy of VUMERITY, TECFIDERA, TYSABRI, PLEGRIDY and BIIB091; the
results of certain real-world data; results from the EVOLVE-MS-2
study, Phase 3 ENDORSE study and the Phase 1 study of BIIB091; the
identification and treatment of MS; our research and development
program for the treatment of MS; potential regulatory discussions,
submissions and approvals and the timing thereof; the potential of
Biogen’s commercial business, including VUMERITY, TECFIDERA,
TYSABRI, PLEGRIDY and BIIB091; and risks and uncertainties
associated with drug development and commercialization. These
forward-looking 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 the occurrence of
adverse safety events and/or unexpected concerns that may arise
from additional data or analysis; risks of unexpected costs or
delays; unexpected concerns may arise from additional data,
analysis or results obtained during clinical trials; failure to
protect and enforce our data, intellectual property and other
proprietary rights and uncertainties relating to intellectual
property claims and challenges; regulatory authorities may require
additional information or further studies, or may fail to approve
or may delay approval of our drug candidates or expansion of
product labeling; failure to obtain regulatory approvals in other
jurisdictions; product liability claims; third party collaboration
risks; and the direct and indirect impacts of the ongoing COVID-19
pandemic on our 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 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 U.S. Securities and Exchange
Commission. These statements are based on our current beliefs and
expectations and speak only as of the date of this news 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.
References:
- Mowry EM, Beheshtian A, Waubant E, et al. Quality of life in
multiple sclerosis is associated with lesion burden and brain
volume measures. Neurology. 2009;72(20):1760-1765.
- Lanz M, Hahn HK, Hildebrandt H. Brain atrophy and cognitive
impairment in multiple sclerosis: a review [published correction
appears in J Neurol. 2008 Feb;255(2):309-10]. J Neurol.
2007;254 Suppl 2:II43-II48.
- Foley J, Xiong K, Hoyt T, et al. Serum neurofilament light
levels in patients with relapsing-remitting multiple sclerosis
switching from natalizumab every-4-week dosing to extended interval
dosing. AAN 2020; S10.009.
- Butzkueven, Kappos L, Spelman T, et al. No significant
difference in relapse outcomes in patients switching to natalizumab
extended interval dosing or remaining on standard interval dosing:
propensity score comparative effectiveness analysis of patients in
the TYSABRI Observational Program. ECTRIMS 2019; P1033.
- Yamout B, Sahraian MA, Ayoubi NE, et al. Efficacy and safety of
natalizumab extended interval dosing. Mult Scler Relat Disord.
2018;24:113-116.
- Zhovtis Ryerson L, Frohman TC, Foley J, et al. Extended
interval dosing of natalizumab in multiple sclerosis. J Neurol
Neurosurg Psychiatry. 2016;87:885-889.
- Bomprezzi R, Pawate S. Extended interval dosing of natalizumab:
a two-center, 7-year experience. Ther Adv Neurol Disord.
2014;7:227-231.
- Combined post-marketing data based on prescriptions and
clinical trials exposure to TECFIDERA as of June 30, 2020.
- Combined post-marketing data based on prescriptions and
clinical trials exposure to TYSABRI as of July 31, 2020.
- Combined post-marketing data based on prescriptions for
PLEGRIDY as of March 31, 2020.
- Combined post-marketing data based on prescriptions for AVONEX
as of March 31, 2020.
MEDIA CONTACT:David Caouette+ 1
617 679 4945public.affairs@biogen.com |
INVESTOR CONTACT:Joe Mara+1 781
464 2442IR@biogen.com |
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