New Data Presented at ECTRIMS Reinforce Long-term Benefits of
TECFIDERA® (dimethyl fumarate) Over 10 Years
Biogen Inc. (Nasdaq: BIIB) announced new data to support the
consistent, long-term benefits of treatment with TECFIDERA®
(dimethyl fumarate) over 10 years, as well as additional diroximel
fumarate data that further characterize the tolerability profile of
this investigational oral fumarate for relapsing multiple sclerosis
(MS). These findings are being presented at the 35th Congress of
the European Committee for Treatment and Research in MS (ECTRIMS)
and 24th Annual Conference of Rehabilitation in MS in Stockholm
(September 11-13).
“Biogen’s new data underscore TECFIDERA’s role as a meaningful
long-term therapy option for relapsing MS, with many patients in
the study experiencing no relapses or progression in their
disability over a 10-year period,” said Alfred Sandrock, Jr., M.D.,
Ph.D., executive vice president and chief medical officer at
Biogen. “We are proud of the strong legacy TECFIDERA has achieved
over the years and are excited to continue building our franchise
of fumarate products with the potential addition of diroximel
fumarate. As a next-generation fumarate, diroximel fumarate offers
a differentiated gastrointestinal tolerability profile and, if
approved, will be a strong choice for physicians and patients with
relapsing MS to consider.”
TECFIDERA 10-Year Data Support Long-Term
BenefitsNew results from the ongoing Phase 3 ENDORSE
extension study reinforce the long-term effectiveness and safety of
continuous TECFIDERA treatment over a decade. In the analysis,
which included participants (n= 192) with at least 10 years of
follow up, TECFIDERA was associated with a low incidence of MS
relapses and disability progression over time. Results show that
approximately half (51 percent) of patients remained relapse-free
over the study period. In addition, 64 percent of patients had no
confirmed disability progression over the study period, and
patients generally maintained the ability to walk without
significant disability (79 percent). The well-characterized safety
profile of TECFIDERA was consistent over 10 years, with no
increased occurrence of serious infections.
Separately, a meta-analysis of real-world evidence to compare
the effectiveness of TECFIDERA versus other disease-modifying
therapies for relapsing MS is also being presented. The
meta-analysis analyzed data from 18 databases of large real-world
studies and found that TECFIDERA was significantly more effective
than interferon beta, glatiramer acetate and teriflunomide in
reducing annualized relapse rate and delaying time to first
relapse. TECFIDERA demonstrated comparable effectiveness to
fingolimod and was less effective than natalizumab and alemtuzumab.
These results are consistent with previously reported comparative
effectiveness data and reinforce the strong efficacy of TECFIDERA
over platform treatments across multiple data sets.
Data Support Diroximel Fumarate as a Potential New
Option for Relapsing MSUpdated interim data from the Phase
3 EVOLVE-MS-1 study support the potential of Biogen and Alkermes’
investigational treatment, diroximel fumarate, as a novel oral
fumarate. EVOLVE-MS-1 is an ongoing, single-arm, open-label,
two-year study evaluating the safety and exploring the efficacy of
diroximel fumarate in patients with relapsing-remitting MS and has
enrolled approximately 1,000 patients. The interim results, which
included data from 888 patients treated with diroximel fumarate for
a median of approximately 18 months, corroborate previous data
indicating diroximel fumarate is generally well-tolerated in people
with relapsing MS.
In the study, most adverse events were mild to moderate in
nature. The overall rate of treatment discontinuation due to
adverse events was low (7.1 percent), with less than 1 percent of
patients discontinuing diroximel fumarate treatment due to
gastrointestinal (GI) side effects. These data are further
supportive of recently reported topline results from the elective
Phase 3 EVOLVE-MS-2 study, in which diroximel fumarate demonstrated
statistically superior GI tolerability compared to TECFIDERA on the
study’s primary endpoint assessing self-reported GI events.
Exploratory efficacy results from EVOLVE-MS-1 suggest diroximel
fumarate significantly reduced annualized relapse rate by 79.4
percent and the mean number of gadolinium-enhancing lesions by 64.3
percent from baseline to 24 months, with similar results observed
in newly diagnosed patients.
Featured data presentation details:
- Overall Safety and Efficacy Through 10 Years of Treatment with
Delayed-release Dimethyl Fumarate in Patients with
Relapsing-remitting Multiple Sclerosis (P1397; Poster Session 3,
Friday, September 13, 12:15-2:15 pm CET)
- Comparative Effectiveness of Delayed-release Dimethyl Fumarate
vs. Other Disease-modifying Therapies in Patients with Multiple
Sclerosis: A Network Meta-analysis of Real-world Evidence (P1394;
Poster Session 3, Friday, September 13, 12:15-2:15 pm CET)
- Diroximel Fumarate (DRF) in Patients with Relapsing-remitting
Multiple Sclerosis: Interim Safety and Efficacy Results from the
Phase 3 EVOLVE-MS-1 Study (ePoster; available for duration of
congress)
About TECFIDERA® TECFIDERA is the most
prescribed oral medication for relapsing multiple sclerosis (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 415,000 patients have been
treated with it, representing more than 780,000 patient-years of
exposure across clinical trial use and patients prescribed
TECFIDERA. Of these, 6,335 patients (14,065 patient-years) were
from clinical trials.1
TECFIDERA is contraindicated in patients with a known
hypersensitivity to dimethyl fumarate or any of the excipients of
TECFIDERA. Rare 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, which then
plateaued, and liver function abnormalities, which resolved upon
treatment discontinuation. In clinical trials, the most common
adverse events associated with TECFIDERA were flushing and
gastrointestinal (GI) events.
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 Diroximel Fumarate Diroximel fumarate is
an investigational, novel oral fumarate candidate with a distinct
chemical structure in development for the treatment of relapsing
forms of MS. Diroximel fumarate is designed to rapidly convert to
monomethyl fumarate in the body and, based on bioequivalence data,
is referencing TECFIDERA® (dimethyl fumarate) as part of the
505(b)(2) regulatory pathway in the United States. Diroximel
fumarate is currently under review with the U.S. Food and Drug
Administration (FDA) with a PDUFA (Prescription Drug User Fee Act)
target action date in the fourth quarter of 2019. If approved by
the FDA, Biogen intends to market diroximel fumarate under the
conditionally approved brand name VUMERITY™. 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, and today 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, neuromuscular
disorders, movement disorders, Alzheimer’s disease and dementia,
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
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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 TECFIDERA and diroximel fumarate; potential clinical
effects of TECFIDERA and diroximel fumarate; potential regulatory
approval and the timing thereof; the results of certain real-world
data; the clinical development program for diroximel fumarate;
clinical trial results and plans; the potential of our commercial
business and pipeline programs, including diroximel fumarate; the
anticipated benefits and potential of our collaboration
arrangements with Alkermes; 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,” “except,” “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; regulatory authorities may require additional information
or further studies, or may fail to approve or may delay approval of
our drug candidates, including diroximel fumarate; actual timing
and content of submissions to and decisions made by the regulatory
authorities regarding our drug candidates, including diroximel
fumarate; regulatory submissions may take longer or be more
difficult to complete than expected; the risk that we may not fully
enroll our clinical trials or enrollment will take longer than
expected; unexpected concerns may arise from additional data,
analysis or results obtained during our clinical trials; failure to
protect and enforce our data, intellectual property and other
proprietary rights and uncertainties relating to intellectual
property claims and challenges; uncertainty of success in the
development and potential commercialization of VUMERITY; risks
relating to the potential launch of VUMERITY, including
preparedness of healthcare providers to treat patients, the ability
to obtain and maintain adequate reimbursement for VUMERITY and
other unexpected difficulties or hurdles; 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 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.
MEDIA
CONTACT:David Caouette +1 617 679
4945public.affairs@biogen.com |
INVESTOR
CONTACT:Joe Mara+1 781 464 2442IR@biogen.com |
_________________________1 Combined post-marketing data based on
prescriptions and clinical trials exposure to TECFIDERA as of June
30, 2019.
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