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New Data at AAN 2021 from Across Biogen’s MS Portfolio Demonstrate Positive Impact of Treatment on People Living with Relapsing Multiple Sclerosis

Fri 16th April, 2021 12:30pm
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* New findings from MS PATHS show that treatment with
TYSABRI(®) (natalizumab) can lead to meaningful improvements in mental and
social health compared to Ocrevus(®) (ocrelizumab)

* Real-world data from VUMERITY(®) (diroximel fumarate) reinforce the
treatment’s positive gastrointestinal tolerability profile 
* Biogen advances leading research to help inform future patient management
including new information on the clinical profile of extended interval dosing
with natalizumab
CAMBRIDGE, Mass., April 16, 2021 (GLOBE NEWSWIRE) -- Biogen Inc.
(https://www.globenewswire.com/Tracker?data=rv8q6ROKQUcdprI1fTSPIgYCIID2ELoCTGzgDZZzRLSbG815fObUfP3aHMHpHu06KjLuL-Jl10QbgZnkbJ3cTg==) (Nasdaq:
BIIB) today announced new data from its industry-leading portfolio of multiple
sclerosis (MS) therapies to be presented at the American Academy of Neurology
(AAN) 2021 Virtual Annual Meeting, April 17-22. The presentations include data
on quality of life benefits and analyses of extended interval dosing (EID)
with TYSABRI(®) (natalizumab) as well as new real-world experience data from
VUMERITY(®) (diroximel fumarate). The research adds to the vast clinical
knowledge Biogen continues to advance as part of its commitment to the care of
people living with MS.

“With chronic conditions like MS, where every patient has a different
experience with the disease, it is critically important to understand how
treatment impacts their daily living and quality of life,” said Maha
Radhakrishnan, M.D., Chief Medical Officer at Biogen. “These data show that
the benefits TYSABRI provides in terms of a patient’s quality of life are
substantial and that the positive gastrointestinal tolerability profile of
VUMERITY can help people with relapsing MS continue with treatment, which is
essential to delay its progression.”

Analyses Demonstrate Improved Quality of Life Outcomes with TYSABRI and
Further Evaluate Extended Interval Dosing 
To better understand clinically meaningful quality of life benefits following
treatment with TYSABRI, MS PATHS (Partners Advancing Technology and Health
Solutions) researchers analyzed patient reported data on 12 different domains
on the Neuro-QoL (Quality of Life in Neurological Disorders) questionnaire
such as sleep disturbance, anxiety, fatigue, depression and participation in
daily activities. Results included:
* In people treated with TYSABRI or Ocrevus(®) (ocrelizumab) with baseline
impairment, statistically significant improvements were seen in 10 of 12 and 8
of 12 Neuro-QoL domains, respectively. In 11 of 12 domains on the Neuro-QoL
questionnaire, the adjusted annualized rate of improvement was greater with
TYSABRI as compared to Ocrevus.
* The difference between the two therapies was statistically significant in
favor of TYSABRI in three of the domains: satisfaction with social roles and
activities (p=0.02), participation in social roles and activities (p=0.0001)
and emotional and behavioral dyscontrol (p=0.01).
Neuro-QoL is an independently validated set of patient-reported outcome
measurements that assess the physical, mental and social effects of people
living with neurological conditions such as MS. Biogen established the MS
PATHS network to foster collaboration between leading MS centers in Europe and
the U.S. to help transform patient care by generating standardized data from a
diverse, real-world patient population.

Additionally, results from two new analyses investigating EID with natalizumab
may help further inform the drug’s benefit-risk profile. Biogen continues to
evaluate the efficacy, safety and tolerability of natalizumab EID through the
prospective NOVA trial (NCT03689972
(https://www.globenewswire.com/Tracker?data=Bgt7Q-iZVrv0G6H5XKZ3lmUFNIVx43HmC9rcchkK9_vsL0mQ8x3t5FY8JntO7xOXXR5oPWBZuAQfCPnWnIjm_lo4oFyNBXSht-SZUMCsPpk=))
with initial results expected in 2021.
* From an analysis of data in MS PATHS, natalizumab patients receiving either
EID or Standard Interval Dosing (SID) had comparable real-world effectiveness
on quantitative magnetic resonance imaging (MRI) outcomes (p>0.05 for all MRI
outcomes).
* An updated analysis of data from the TOUCH Prescribing Program demonstrated
in the primary analysis that EID is associated with a significant (P<0.0001)
88% reduction in the risk of progressive multifocal leukoencephalopathy (PML)
in comparison to the approved every four-week dose. The data, which included
more patients followed for a longer period and with slightly greater
exposures, reinforces results from earlier analyses of EID.
Data Confirm Positive Gastrointestinal Tolerability Profile With VUMERITY in
Real-World Setting
New findings on the use of VUMERITY in a real-world setting reinforce the
benefits of improved gastrointestinal (GI) tolerability and confirm that the
experience in clinical trials is consistent with clinical practice. In a
retrospective analysis of data from December 2019 to August 2020 of 160
patients with relapsing MS, the treatment discontinuation rate due to GI side
effects was low (3.8%) with 88.6% estimated to still be on therapy at the end
of analysis and a high rate of adherence (91.4%). In a subgroup of patients
who switched from TECFIDERA(®) (dimethyl fumarate) to VUMERITY, the majority
of patients switched as a result of gastrointestinal tolerability with most
remaining on therapy (92.3%).

Biogen Continues Leading Research in MS
The presentations at AAN are part of Biogen’s ongoing commitment to the MS
community, improving the understanding of the disease and advancing treatment
through innovation. The company recently launched a subcutaneous injection of
TYSABRI in Europe and an intramuscular administration of PLEGRIDY(®)
(peginterferon beta-1a) in the United States and Europe. Biogen currently has
more than 25 MS clinical trials underway including research on considerations
around COVID-19 vaccination for people with MS.

Data Presentations Featured at AAN:
* Impact of Natalizumab on Quality of Life in a Real-World Cohort of Patients
with Multiple Sclerosis: Results from MS Partners Advancing Technology and
Health Solutions (MS PATHS) – P15.023
* No Difference in Radiologic Outcomes for Natalizumab Patients on Extended
Interval Dosing Compared with Standard Interval Dosing in MS PATHS – P15.210
* Natalizumab Extended Interval Dosing (EID) is Associated with a Reduced Risk
of Progressive Multifocal Leukoencephalopathy (PML) Compared with Every-4-week
(Q4W) Dosing: Updated Analysis of the TOUCH(®) Prescribing Program Database
– P15.201
* Multiple Sclerosis Patients Treated with Diroximel Fumarate in the
Real-world Setting have High Rates of Persistence and Adherence – P15.227
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
220,000 people worldwide have been treated with TYSABRI, with over 880,000
patient-years of experience, based on clinical trials and prescription
data.(1)

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), a decrease in lymphocyte counts and infections,
including opportunistic and other atypical infections.

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TYSABRI in the U.S., or visit your respective country’s product website.

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 to 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.

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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 500,000 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.(2)

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
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TECFIDERA in the U.S., or visit your respective country’s product website.

About PLEGRIDY(®) (peginterferon beta-1a)
PLEGRIDY is a 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. Over 61,000
people worldwide have been treated with PLEGRIDY, with
over 120,000 patient-years of experience, based on prescription data.(3)
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; injection site reactions, cardiac problems, including congestive
heart failure; blood problems, such as decreases in white blood cell or
platelet counts; autoimmune disorders; 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. PLEGRIDY
can be considered for use in relapsing MS patients throughout the full course
of pregnancy and during breast-feeding, if clinically needed.

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PLEGRIDY in the U.S., or visit your respective country’s product website.

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 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, neuropsychiatry, immunology, acute
neurology and neuropathic pain.

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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 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:
1. Combined post-marketing data based on prescriptions and clinical trials
exposure to TYSABRI as of January 31, 2021.
2. Combined post-marketing data based on prescriptions and clinical trials
exposure to TECFIDERA as of December 31, 2020.
3. Combined post-marketing data based on prescriptions for PLEGRIDY as of
September 30, 2020.
 MEDIA CONTACT: David Caouette + 1 617 679 4945 public.affairs@biogen.com  INVESTOR CONTACT: Mike Hencke +1 781 464 2442 IR@biogen.com  

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