Alkermes and Biogen Announce Submission of a New Drug Application
to U.S. Food and Drug Administration for Diroximel Fumarate in
Multiple Sclerosis
Alkermes plc (Nasdaq: ALKS) and Biogen Inc. (Nasdaq: BIIB)
today announced that Alkermes has submitted a New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) for diroximel
fumarate (BIIB098), a novel oral fumarate in development for the
treatment of relapsing forms of multiple sclerosis (MS).
Alkermes is seeking approval of diroximel fumarate under the
505(b)(2) regulatory pathway, and the NDA submission includes data
from EVOLVE-1, a Phase 3 pivotal trial that evaluated long-term
safety in relapsing-remitting MS (RRMS) with approximately 700
patients dosed with diroximel fumarate. If approved, Biogen intends
to market diroximel fumarate under the brand name VUMERITY™. This
name has been conditionally accepted by the FDA and will be
confirmed upon approval.
“Diroximel fumarate was designed to provide patients with
relapsing forms of multiple sclerosis a novel oral fumarate with a
differentiated profile. The data encompassed in the regulatory
package underscore diroximel fumarate’s potential to be a
meaningful, new treatment option for the MS community,” stated
Craig Hopkinson, M.D., chief medical officer and senior vice
president, medicines development and medical affairs at
Alkermes. “This NDA submission is an important step in our
collaboration with Biogen for diroximel fumarate, and we look
forward to working together to bring this potential new medicine to
patients and healthcare providers.”
“The filing of diroximel fumarate by our partners at Alkermes
demonstrates our enduring commitment to people living with MS and
builds on our established track record as a leader in the
industry,” said Michael Ehlers, M.D., Ph.D., executive vice
president, research & development at Biogen. “MS is a
heterogeneous disease, and while there are a number of approved
therapies available today, continued treatment advances remain an
important priority.”
About the Diroximel Fumarate Clinical Development
ProgramThe key components of the clinical development
program of diroximel fumarate include the EVOLVE-MS-1 study, a
two-year safety study in relapsing-remitting MS (RRMS) patients,
along with pharmacokinetic bridging studies comparing diroximel
fumarate and dimethyl fumarate. In addition, Alkermes is conducting
the EVOLVE-MS-2 study, a five-week, head-to-head gastrointestinal
(GI) tolerability study versus dimethyl fumarate.
About Diroximel FumarateDiroximel fumarate
(BIIB098) is a novel oral fumarate candidate in development for the
treatment of relapsing forms of MS. Diroximel fumarate is designed
to rapidly convert to monomethyl fumarate in the body and may have
the potential to offer differentiated GI tolerability due to its
chemical structure as compared to dimethyl fumarate.
About Alkermes plcAlkermes plc is a fully
integrated, global biopharmaceutical company developing innovative
medicines for the treatment of central nervous system (CNS)
diseases. The company has a diversified commercial product
portfolio and a substantial clinical pipeline of product candidates
for chronic diseases that include schizophrenia, depression,
addiction and multiple sclerosis. Headquartered in Dublin, Ireland,
Alkermes plc has an R&D center in Waltham, Massachusetts; a
research and manufacturing facility in Athlone, Ireland; and a
manufacturing facility in Wilmington, Ohio. For more information,
please visit Alkermes’ website at www.alkermes.com.
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 www.biogen.com and follow us on social media
– Twitter, LinkedIn, Facebook, YouTube.
Alkermes Note Regarding Forward-Looking
Statements Certain statements set forth in this press
release constitute “forward-looking statements” within the meaning
of the Private Securities Litigation Reform Act of 1995, as
amended, including, but not limited to, statements concerning: the
potential therapeutic and commercial value of diroximel fumarate
for the treatment of relapsing forms of MS; the potential approval
by the FDA of an NDA for diroximel fumarate for the treatment of
relapsing forms of MS; the potential approval by the FDA of the
proposed brand name for diroximel fumarate and related marketing
plans; and the potential commercial and therapeutic benefits that
may be achieved through Alkermes’ collaboration with Biogen for
diroximel fumarate. Alkermes cautions that forward-looking
statements are inherently uncertain. Although Alkermes believes
that such statements are based on reasonable assumptions within the
bounds of its knowledge of its business and operations, the
forward-looking statements are neither promises nor guarantees and
they are necessarily subject to a high degree of uncertainty and
risk. Actual performance and results may differ materially from
those expressed or implied in the forward-looking statements due to
various risks and uncertainties. These risks and uncertainties
include, among others: whether the results from the head-to-head
study to evaluate the GI tolerability of diroximel fumarate
compared to dimethyl fumarate will show that diroximel fumarate has
a differentiated GI tolerability profile; whether preclinical and
clinical results for diroximel fumarate will be predictive of
future clinical study results or real-world results; changes in the
cost, scope and duration of the diroximel fumarate development and
regulatory program; whether diroximel fumarate could be shown
ineffective or unsafe during clinical studies, and whether, in such
instances, Alkermes may not be permitted by regulatory authorities
to undertake new or additional clinical studies of diroximel
fumarate; whether the NDA for diroximel fumarate, including the
proposed brand name for diroximel fumarate, will be approved by the
FDA; if approved, whether diroximel fumarate will be commercialized
successfully; whether the potential commercial and therapeutic
benefits of collaboration with Biogen under the license and
collaboration agreement between Alkermes and Biogen will be
achieved; and those risks described in the Alkermes Annual Report
on Form 10-K for the fiscal year ended Dec. 31, 2017 and in
subsequent filings made by Alkermes with the U.S. Securities and
Exchange Commission (SEC), which are available on the SEC’s website
at www.sec.gov. Existing and prospective investors are cautioned
not to place undue reliance on these forward-looking statements,
which speak only as of the date hereof. Except as required by law,
the company disclaims any intention or responsibility for updating
or revising any forward-looking statements contained in this press
release.
Biogen Safe HarborThis press release contains
forward-looking statements, including statements made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995, including statements about potential regulatory
approval and the timing thereof; the potential clinical effects of
diroximel fumarate; the potential benefits, safety and efficacy of
diroximel fumarate; clinical trial results and plans; the treatment
of MS; the potential of Biogen’s commercial business and pipeline
programs, including diroximel fumarate; the anticipated benefits
and potential of Biogen’s collaboration arrangements with Alkermes;
and risks and uncertainties associated with drug development and
commercialization. These forward-looking statements may be
accompanied by words such as “aim,” “anticipate,” “believe,”
“could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,”
“potential,” “possible,” “will” 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, actual timing and
content of submissions to and decisions made by the regulatory
authorities regarding diroximel fumarate; regulatory submissions
may take longer or be more difficult to complete than expected;
regulatory authorities may require additional information or
further studies, or may fail or refuse to approve or may delay
approval of Biogen’s drug candidates, including diroximel fumarate;
the risk that Biogen may not fully enroll its clinical trials or
enrollment will take longer than expected; the actual timing and
final results of the EVOLVE-MS-2 study; unexpected concerns may
arise from additional data, analysis or results obtained during
Biogen’s clinical trials; the occurrence of adverse safety events;
the risks of other unexpected hurdles, costs or delays; failure to
protect and enforce Biogen’s 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 Biogen’s expectations in any forward-looking statement.
Investors should consider this cautionary statement, as well as the
risk factors identified in Biogen’s most recent annual or quarterly
report and in other reports Biogen has filed with the Securities
and Exchange Commission. These statements are based on Biogen’s
current beliefs and expectations and speak only as of the date of
this press release. Biogen does not undertake any obligation to
publicly update any forward-looking statements, whether as a result
of new information, future developments or otherwise.
Alkermes Contacts: |
For Investors: |
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Sandy Coombs, +1 781 609 6377Eva Stroynowski, +1 781 609 6823 |
For Media: |
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Sherry Feldberg, +1 781 609 6276 |
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Biogen Contacts: |
For Investors: |
|
Matt Calistri, +1 781 464 2442 |
For Media: |
|
David Caouette, +1 617 679 4945 |