New Data at ECTRIMS 2022 Highlight Biogen’s Commitment to Advancing
Individualized Disease Management for People Living with MS
Biogen Inc. (Nasdaq: BIIB) announced new data from its
industry-leading portfolio of multiple sclerosis (MS) therapies
being presented at the 38th Congress of the European Committee for
Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting
October 26-28, 2022. The presentations include the final safety and
efficacy results of the VUMERITY® (diroximel fumarate) EVOLVE-MS-1
study, as well as a matching analysis comparing treatment with
VUMERITY to Ponvory® (ponesimod) and Aubagio® (teriflunomide);
patient-reported outcomes and an analysis of the proprietary
StratifyJCV™ assay for TYSABRI® (natalizumab); a study evaluating
treatment with TECFIDERA® (dimethyl fumarate) to prevent first
clinical manifestation of MS for people with radiologically
isolated syndrome; and studies assessing the impact of PLEGRIDY®
(peginterferon beta-1a) and AVONEX® (interferon beta-1a) on
pregnancy, breastfeeding and child development.
“Presentations at this year’s ECTRIMS meeting highlight Biogen’s
commitment to pursuing research that has a meaningful impact on
patients,” said Maha Radhakrishnan, M.D., Chief Medical Officer at
Biogen. “These new data provide patients and healthcare
professionals with further insight on the safety and efficacy of
Biogen’s robust MS portfolio to help inform treatment decisions
throughout the lifelong MS journey, from the earliest phase of the
disease to important milestones such as pregnancy.”
Final Safety and Efficacy Results of VUMERITY
EVOLVE-MS-1 Study ReportedPresentations including data
from EVOLVE-MS-1 and OPTIMUM clinical studies further support the
safety and efficacy of VUMERITY:
- Final safety and efficacy results from EVOLVE-MS-1 demonstrate
decreases in disease activity and favorable tolerability for
VUMERITY in 1,057 patients over 96 weeks, in line with previous
assessments. The reduction in annualized relapse rate (ARR) was
81.6%, the estimated proportion of patients who were relapse-free
was 82.4%, and the estimated proportion with no evidence of disease
activity (NEDA-3) was 41.1%. While 24.3% of patients discontinued
treatment, discontinuation due to gastrointestinal adverse events
(0.7%) and flushing (0.5%) were low.
- A matching-adjusted indirect comparison was done between
VUMERITY (EVOLVE-MS-1) and Ponvory and Aubagio (OPTIMUM) clinical
studies for ARR, 12-week confirmed disability progression (CDP),
24-week CDP, absence of gadolinium-enhancing (Gd+) T1 lesions and
absence of new/enlarging T2 lesions. After weighting for
cross-trial differences, VUMERITY was associated with a higher
proportion of patients free of Gd+ T1 lesions and new/enlarging T2
lesions at the end of follow-up compared to Ponvory, with similar
efficacy for ARR and 12- and 24-week CDP. VUMERITY had greater
efficacy than Aubagio for all clinical and radiological outcome
measures, except for 24-week CDP, in which there was similar
efficacy.
Studies Highlight Patient-Reported Outcomes for TYSABRI;
Analysis Shows Impact of StratifyJCV AssayTwo
presentations highlight improvements in patient-reported outcomes
following treatment with TYSABRI along with preference and
satisfaction for the TYSABRI subcutaneous (SC) route of
administration:
- The results of recent survey analysis, which included TYSABRI
[n=52] and Ocrevus (ocrelizumab)-treated [n=92] relapsing-remitting
multiple sclerosis (RRMS) patients aged 21 and older who had taken
at least one prior disease modifying treatment (DMT), found more
patients treated with TYSABRI versus Ocrevus reported improvements
in disease activity (84.6% vs 59.8%), emotional symptoms (73.1% vs
35.9%), physical symptoms (69.2% vs 43.5%), cognitive symptoms
(61.5% vs 32.6%) and social roles/activities (71.2% vs 35.9%). In
addition, more patients treated with TYSABRI reported their DMT met
or exceeded treatment expectations in comparison to those treated
with Ocrevus (96.2% vs 72.8%).
- In the first interim analysis of 206 patients in the
observational, prospective, multi-center SISTER study in Germany,
the TYSABRI SC route of administration was preferred by individuals
(89.6%; 163 patients) compared with intravenous administration;
nearly all patients receiving SC treatment expressed satisfaction
with their choice (98.7%; 156 patients) and the most frequent
reasons for SC preference were shorter and more convenient
administration. The TYSABRI SC administration is available in 26
countries and over 16,000 patients have been treated with SC
therapy.1
“Given the recent introduction of natalizumab subcutaneous
administration in Europe, these findings validate clinical study
data with real-world insights,” said Prof. Ralf Gold,
Ruhr-University Bochum, Bochum, Germany. “In our study, we found
that nearly 90% of patients prefer subcutaneous administration
given its shorter duration and convenience of dosing.”
Separately, an analysis assessed utilization of Biogen’s
StratifyJCV™ -- a proprietary antibody assay used to detect the
presence of anti-JC virus (JCV) antibodies in serum and to quantify
antibody index values, which are correlated to progressive
multifocal leukoencephalopathy (PML) risk in patients treated with
TYSABRI. More than 2 million StratifyJCV tests have been conducted
worldwide. Aggregated data of the results of 845,498 StratifyJCV
tests conducted from January 2015 to December 2021 showed a
decrease in percentage of JCV-positive index results >1.5 in
retests, from 15% in 2015 to 8% in 2021, demonstrating that
healthcare professionals are using the assay to appropriately
identify, monitor and manage patients on TYSABRI.
Effect of TECFIDERA on Radiologically Isolated Syndrome
Reported for the First Time Results of the Assessment
of TECFIDERA in Radiologically Isolated Syndrome (ARISE) study, a
placebo-controlled, multi-center, double-blinded clinical trial,
will be presented in the late-breaking section. ARISE investigated
the impact of therapeutic intervention in preventing the first
clinical manifestation of MS for people with radiologically
isolated syndrome (RIS). ARISE enrolled 87 patients who were
randomized to TECFIDERA or placebo and treated for up to 96 weeks.
Researchers found treatment with TECFIDERA resulted in an 82% risk
reduction relative to placebo in the prevention of a first clinical
event related to CNS demyelination.
Impact of PLEGRIDY and AVONEX
on Pregnancy, Breastfeeding and Child Development
Two presentations assessed the impact of interferon exposure on
pregnancy, breastfeeding and child development. Data from the PRIMA
post-authorization safety study was consistent with results from
previous studies showing that exposure to PLEGRIDY or AVONEX during
pregnancy or lactation did not negatively impact child development
or intrauterine growth. Further, a preliminary analysis of the
German Multiple Sclerosis and Pregnancy Registry assessed child
development in infants born to mothers with AVONEX or PLEGRIDY
exposure during pregnancy, and treatment did not negatively impact
children’s development.
Title and Times of Data Presentations Featured at
ECTRIMS:
- Natalizumab-Treated RRMS Patients with Prior DMT Use Report
Better Outcomes, Treatment Satisfaction and Unique Benefits Than
Similar Patients Treated with Ocrelizumab – EP0851 – October 26, 8
a.m. CET / 2 a.m. ET
- Disease Activity and Pregnancy Outcomes After Long-Term
Exposure to Natalizumab During Pregnancy – 0039 – October 26, 2:56
p.m. CET / 8:56 a.m. ET
- SISTER – Subcutaneous: Non-Interventional, Observational,
Prospective, German Multicentre, Open Label Study Over 12-Months
for TYSABRI Patient Preference – Experience from Real-World –
Preliminary Results of the 1st Interim Analysis – P365 – October
26, 8 a.m. CET / 2 a.m. ET
- Long-Term Effectiveness of Natalizumab for RRMS: Dutch and
Global Interim Results from TYSABRI Observational Program – P373 –
October 26, 8 a.m. CET / 2 a.m. ET
- Exploratory Magnetic Resonance Imaging Endpoints from NOVA: A
Randomized Controlled Study of the Efficacy of 6-Week Dosing of
Natalizumab vs Continued 4-Week Treatment for Multiple Sclerosis –
P350 – October 26, 8 a.m. CET / 2 a.m. ET
- Interferon- or Peginterferon-Beta 1a Exposure During Pregnancy
in Women with Multiple Sclerosis: Outcomes on Child Development –
P075 – October 26, 8 a.m. CET / 2 a.m. ET and October 27, 1:05 p.m.
CET / 7:05 a.m. ET
- StratifyJCV™ Serum Anti-JCV Antibody Assay for Natalizumab
Patients: Unilabs Global Cohort Data Descriptive Analysis and
Unilabs Customer Satisfaction Survey Results – P750 – October 26, 8
a.m. CET / 2 a.m. ET
- Matching-Adjusted Indirect Comparisons of Diroximel Fumarate,
Ponesimod, and Teriflunomide for Relapsing Multiple Sclerosis –
P708 – October 26, 8 a.m. CET / 2 a.m. ET
- Diroximel Fumarate in Patients with Relapsing-Remitting
Multiple Sclerosis: Final Safety and Efficacy Results from the
Phase 3 EVOLVE-MS-1 Study – P712 – October 26, 8 a.m. CET / 2 a.m.
ET
- Interferon-Beta Exposure During Pregnancy and Breastfeeding:
Impact on Birth Outcome and Child Development – Results from the
Post-Authorisation Safety Study PRIMA – P478 – October 26, 8 a.m.
CET / 2 a.m. ET
- Multi-Center, Randomized, Double-Blinded Assessment of Dimethyl
Fumarate in Extending the Time to a First Clinical Demyelinating
Event in Radiologically Isolated Syndrome (ARISE) – 0179 – October
28, 3:49 p.m. CET / 9:49 a.m. ET
About
VUMERITY® (diroximel
fumarate)VUMERITY is an oral fumarate approved in the U.S.
for the treatment of relapsing forms of multiple sclerosis in
adults, including 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 (TECFIDERA). VUMERITY is available
in 15 countries, and more than 28,200 patients have been treated
with it, representing more than 24,200 patient-years of exposure
across clinical trial use and patients prescribed VUMERITY.2
VUMERITY is contraindicated in patients with a known
hypersensitivity to diroximel fumarate, dimethyl fumarate or any of
the excipients of VUMERITY and in patients taking dimethyl
fumarate. VUMERITY can cause anaphylaxis and angioedema after the
first dose or at any time during treatment. PML has occurred in
patients with MS treated with dimethyl fumarate (which has the same
active metabolite as VUMERITY). PML is an opportunistic viral
infection of the brain caused by the JC virus (JCV) that typically
only occurs in patients who are immunocompromised, and that usually
leads to death or severe disability. A fatal case of PML occurred
in a patient who received dimethyl fumarate for four years while
enrolled in a clinical trial. Serious cases of herpes zoster have
occurred with dimethyl fumarate, including disseminated herpes
zoster, herpes zoster ophthalmicus, herpes zoster
meningoencephalitis, and herpes zoster meningomyelitis. These
events may occur at any time during treatment. Other serious
opportunistic infections have occurred with dimethyl fumarate,
including cases of serious viral (herpes simplex virus, West Nile
virus, cytomegalovirus), fungal (Candida and Aspergillus), and
bacterial (Nocardia, Listeria monocytogenes, Mycobacterium
tuberculosis) infections. VUMERITY may decrease lymphocyte counts.
In the MS placebo-controlled trials, mean lymphocyte counts
decreased by approximately 30% during the first year of treatment
with dimethyl fumarate and then remained stable. Four weeks after
stopping dimethyl fumarate, mean lymphocyte counts increased but
did not return to baseline. Clinically significant cases of liver
injury have been reported in patients treated with dimethyl
fumarate in the post-marketing setting. The onset has ranged from a
few days to several months after initiation of treatment. Signs and
symptoms of liver injury, including elevation of serum
aminotransferases to greater than five-fold the upper limit of
normal and elevation of total bilirubin to greater than two-fold
the upper limit of normal have been observed. VUMERITY may cause
flushing (e.g., warmth, redness, itching, and/or burning
sensation). Forty percent of patients taking dimethyl fumarate
reported flushing, which was mostly mild to moderate in severity.
Three percent of patients discontinued dimethyl fumarate for
flushing and <1% had serious flushing events that led to
hospitalization. The most common adverse events associated with
dimethyl fumarate (incidence ≥10% and ≥2% more than placebo) were
flushing, abdominal pain, diarrhea and nausea. A list of adverse
events can be found in the full VUMERITY product labeling for each
country where it is approved.
Please click here for Important Safety
Information and full Prescribing Information,
including Patient Information for VUMERITY in the U.S.,
or visit your respective country’s product website.
About
TECFIDERA® (dimethyl
fumarate) TECFIDERA is approved for the treatment of
relapsing forms of multiple sclerosis (MS), including clinically
isolated syndrome, relapsing-remitting disease, and active
secondary progressive disease in adults. TECFIDERA 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 580,500 patients have been treated with it, representing
more than 1.2 million patient-years of exposure across clinical
trial use and patients prescribed TECFIDERA.3
TECFIDERA is contraindicated in patients with a known
hypersensitivity to dimethyl fumarate or any of the excipients of
TECFIDERA. TECFIDERA can cause anaphylaxis and angioedema after the
first dose or at any time during treatment. PML has occurred in
patients with MS treated with TECFIDERA. PML is an opportunistic
viral infection of the brain caused by the JC virus (JCV) that
typically only occurs in patients who are immunocompromised, and
that usually leads to death or severe disability. A fatal case of
PML occurred in a patient who received TECFIDERA for four years
while enrolled in a clinical trial. Serious cases of herpes zoster
have occurred with TECFIDERA, including disseminated herpes zoster,
herpes zoster ophthalmicus, herpes zoster meningoencephalitis, and
herpes zoster meningomyelitis. These events may occur at any time
during treatment. Other serious opportunistic infections have
occurred with TECFIDERA, including cases of serious viral (herpes
simplex virus, West Nile virus, cytomegalovirus), fungal (Candida
and Aspergillus), and bacterial (Nocardia, Listeria monocytogenes,
Mycobacterium tuberculosis) infections. TECFIDERA may decrease
lymphocyte counts. In the MS placebo-controlled trials, mean
lymphocyte counts decreased by approximately 30% during the first
year of treatment with TECFIDERA and then remained stable. Four
weeks after stopping TECFIDERA, mean lymphocyte counts increased
but did not return to baseline. Clinically significant cases of
liver injury have been reported in patients treated with TECFIDERA
in the post-marketing setting. The onset has ranged from a few days
to several months after initiation of treatment. Signs and symptoms
of liver injury, including elevation of serum aminotransferases to
greater than five-fold the upper limit of normal and elevation of
total bilirubin to greater than two-fold the upper limit of normal
have been observed. TECFIDERA may cause flushing (e.g. warmth,
redness, itching, and/or burning sensation). Forty percent of
patients taking TECFIDERA reported flushing, which was mostly mild
to moderate in severity. Three percent of patients discontinued
TECFIDERA for flushing and <1% had serious flushing events that
led to hospitalization. The most common adverse events associated
with TECFIDERA (incidence ≥10% and ≥2% more than placebo) were
flushing, abdominal pain, diarrhea and nausea. A list of adverse
events can be found in the full TECFIDERA product labeling for each
country where it is approved.
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 approved in the U.S. as
monotherapy for the treatment of relapsing forms of multiple
sclerosis, including clinically isolated syndrome,
relapsing-remitting disease, and active secondary progressive
disease in adults. TYSABRI increases the risk of progressive
multifocal leukoencephalopathy (PML). When initiating and
continuing treatment with TYSABRI, physicians should consider
whether the expected benefit of TYSABRI is sufficient to offset
this risk. TYSABRI is approved in more than 80 countries, and over
248,000 people worldwide have been treated with TYSABRI, with more
than 1 million patient-years of experience, based on clinical
trials and prescription data.1
TYSABRI increases the risk of 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. These
factors should be considered in the context of expected benefit
when initiating and continuing treatment with TYSABRI. Healthcare
professionals should monitor patients on TYSABRI for any new sign
or symptom that may be suggestive of PML. TYSABRI dosing should be
withheld immediately at the first sign or symptom suggestive of
PML. TYSABRI is contraindicated in patients who have or have had
PML and in patients who have had a hypersensitivity reaction to
TYSABRI.
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. Signs of liver injury, including markedly
elevated serum hepatic enzymes and elevated total bilirubin,
occurred as early as six days after the first dose; signs of liver
injury have also been reported for the first time after multiple
doses. Hypersensitivity reactions have occurred in patients
receiving TYSABRI, including serious systemic reactions (e.g.,
anaphylaxis) which occurred at an incidence of <1%. The immune
system effects of TYSABRI may increase the risk for infections. In
Study MS1, certain types of infections—including pneumonias and
urinary tract infections (including serious cases),
gastroenteritis, vaginal infections, tooth infections, tonsillitis,
and herpes infections—occurred more often in TYSABRI-treated
patients than in placebo-treated patients. In clinical trials,
TYSABRI was observed to induce increases in circulating
lymphocytes, monocytes, eosinophils, basophils, and nucleated red
blood cells. Observed changes persisted during TYSABRI exposure,
but were reversible, returning to baseline levels usually within 16
weeks after the last dose. Cases of thrombocytopenia, including
immune thrombocytopenic purpura, have been reported with the use of
TYSABRI in the post-marketing setting. Cases of neonatal
thrombocytopenia, at times associated with anemia, have been
reported in newborns with in utero exposure to TYSABRI. The most
common adverse reactions associated with TYSABRI (incidence ≥10%
and ≥2% more than placebo) were headache, fatigue, infusion
reactions, urinary tract infections, arthralgia, depression, pain
in extremity, rash, gastroenteritis, and vaginitis. A list of
adverse events can be found in the full TYSABRI product labeling
for each country where it is approved.
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 (peginterferon beta-1a) is indicated for
the treatment of relapsing forms of multiple sclerosis, including
clinically isolated syndrome, relapsing-remitting disease, and
active secondary progressive disease in adults. PLEGRIDY is
currently approved in over 60 countries including the U.S., Canada,
Australia and Switzerland and across the European Union. Over
81,000 people worldwide have been treated with PLEGRIDY, with
over 170,000 patient-years of experience, based on
prescription data.4 Biogen continues to work toward making
PLEGRIDY available in additional countries across the globe.
PLEGRIDY is contraindicated in patients with a history of
hypersensitivity to natural or recombinant interferon beta, or any
other component of the formulation. Rare cases of severe hepatic
injury, including cases of hepatic failure have been reported in
patients taking PLEGRIDY. Symptoms of depression, suicidal ideation
or psychosis, and cases of suicide, have been reported with
increased frequency with patients receiving PLEGRIDY. Serious
allergic reactions are rare complications of interferon beta;
anaphylaxis has been reported with use of PLEGRIDY. Injection site
reactions, including injection site necrosis, can occur with the
use of interferon beta, including PLEGRIDY; injection site
abscesses and cellulitis have been reported in the post-marketing
setting with use of PLEGRIDY. Some cases required treatment with
hospitalization for surgical drainage and intravenous antibiotics.
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 post-marketing experience; monitor
patients for infections, bleeding and anemia; monitor complete
blood cell counts, differential white cell counts, and platelet
counts. Cases of thrombotic microangiopathy, including thrombotic
thrombocytopenic purpura and hemolytic uremic syndrome, some fatal,
have been reported several weeks to years after starting interferon
beta products. Autoimmune disorders of multiple target organs
including idiopathic thrombocytopenia, hyper- and hypothyroidism,
and autoimmune hepatitis have been reported. Seizures have been
reported in patients using PLEGRIDY. The most common adverse
reactions in clinical trials of subcutaneous PLEGRIDY (incidence
≥10% and at least 2% more frequent on PLEGRIDY than on placebo)
were injection site erythema, influenza-like illness, pyrexia,
headache, myalgia, chills, injection site pain, asthenia, injection
site pruritus, and arthralgia. 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 indicated for the treatment of relapsing
forms of multiple sclerosis, including clinically isolated
syndrome, relapsing-remitting disease, and active secondary
progressive disease in adults. AVONEX is approved in over 90
countries and over 625,000 people worldwide have been treated with
AVONEX, with over 2.8 million patient-years of
experience, based on prescription data.5
Avonex is contraindicated in patients with a history of
hypersensitivity to natural or recombinant interferon beta, or any
other component of the formulation. Symptoms of depression,
suicidal ideation or psychosis, and cases of suicide, have been
reported with increased frequency with patients receiving AVONEX.
Rare cases of severe hepatic injury, including cases of hepatic
failure have been reported in patients taking AVONEX. Anaphylaxis
has been reported as a rare complication of AVONEX use; other
allergic reactions have included dyspnea, orolingual edema, skin
rash and urticaria. Injection site reactions, including injection
site necrosis, can occur with the use of interferon beta, including
AVONEX. Injection site abscesses and cellulitis and injection site
necrosis have been reported in the post-marketing setting with use
of AVONEX. Some cases required treatment with hospitalization for
surgical drainage and intravenous antibiotics. 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 post-marketing experience. Cases of thrombotic
microangiopathy (TMA), including thrombotic thrombocytopenic
purpura and hemolytic uremic syndrome, some fatal, have been
reported several weeks to years after starting interferon beta
products. Seizures have been temporally associated with the use of
beta interferons in clinical trials and post-marketing safety
surveillance. Post-marketing reports of autoimmune disorders of
multiple target organs in AVONEX-treated patients including
idiopathic thrombocytopenia, hyper- and hypothyroidism, and rare
cases of autoimmune hepatitis. Routine periodic blood chemistry,
hematology, liver function and thyroid function tests are
recommended. The most commonly reported adverse reactions (at least
5% more frequent on AVONEX than on placebo) were flu-like symptoms.
A list of adverse events can be found in the full AVONEX product
labeling for each country where it is approved.
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 BiogenAs pioneers in neuroscience, Biogen
discovers, develops, and delivers worldwide innovative therapies
for people living with serious neurological 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, Sir Kenneth Murray, and Nobel Prize
winners Walter Gilbert and Phillip Sharp. Today, Biogen has a
leading portfolio of medicines to treat multiple sclerosis, has
introduced the first approved treatment for spinal muscular
atrophy, and developed the first and only approved treatment to
address a defining pathology of Alzheimer’s disease. Biogen is also
commercializing biosimilars and focusing on advancing one of the
industry’s most diversified pipelines in neuroscience that will
transform the standard of care for patients in several areas of
high unmet need.
In 2020, Biogen launched a bold 20-year, $250 million initiative
to address the deeply interrelated issues of climate, health, and
equity. Healthy Climate, Healthy Lives™ aims to eliminate fossil
fuels across the company’s operations, build collaborations with
renowned institutions to advance the science to improve human
health outcomes, and support underserved communities.
We routinely post information that may be important to investors
on our website at www.biogen.com. Follow us on social
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Biogen Safe HarborThis 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 TYSABRI and VUMERITY; the results of certain real-world
data; clinical trials and data readouts and presentations; the
identification and treatment of MS; our research and development
program for the treatment of MS; and the potential of our
commercial business, including TYSABRI and VUMERITY. 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. 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; 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; 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:
- Combined post-marketing data based on prescriptions and
clinical trials exposure to TYSABRI as of July 31, 2022. TYSABRI
subcutaneous administration exposure as of September 30, 2022.
- Combined post-marketing data based on prescriptions and
clinical trials exposure to VUMERITY as of June 30, 2022.
- Combined post-marketing data based on prescriptions and
clinical trials exposure to TECFIDERA as of June 30, 2022.
- Post-marketing data based on PLEGRIDY prescriptions as of June
30, 2022.
- Post-marketing data based on AVONEX prescriptions as of June
30, 2022.
MEDIA CONTACT:Allison Parks+ 1 248 229
4461public.affairs@biogen.com |
INVESTOR CONTACT:Mike Hencke+1 781 464 2442IR@biogen.com |
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