Biogen and Alkermes Announce FDA Approval of VUMERITY™ (diroximel
fumarate) for Multiple Sclerosis
Biogen Inc. (Nasdaq: BIIB) and Alkermes plc (Nasdaq: ALKS) today
announced that the U.S. Food and Drug Administration (FDA) approved
VUMERITY™ (diroximel fumarate), a novel oral fumarate with a
distinct chemical structure, for the treatment of relapsing forms
of multiple sclerosis (MS), to include clinically isolated
syndrome, relapsing-remitting disease and active secondary
progressive disease. Biogen holds the exclusive, worldwide license
to commercialize VUMERITY and intends to make it available in the
United States in the near future.
“The FDA’s approval of VUMERITY delivers on Biogen’s commitment
to pursue new therapies that may provide meaningful impact for
people living with relapsing MS, and we look forward to bringing it
to the MS community as an additional treatment option,” said Alfred
Sandrock, Jr., M.D., Ph.D., executive vice president, research and
development, and chief medical officer at Biogen. “VUMERITY is a
novel fumarate that offers the well-characterized efficacy of
TECFIDERA® (dimethyl fumarate) and has been studied for improved
patient-reported gastrointestinal tolerability.”
“The approval of VUMERITY for relapsing MS marks the culmination
of a multi-year development program and is the latest milestone in
our mission to develop new treatments for patients living with
chronic central nervous system disorders,” said Craig Hopkinson,
M.D., chief medical officer and senior vice president of medicines
development and medical affairs at Alkermes. “We are grateful to
the patients and study investigators who have participated in our
VUMERITY clinical trials and we look forward to working with our
collaboration partners at Biogen to make this new treatment
available to patients.”
The FDA approval of VUMERITY was based on a New Drug Application
(NDA) submitted under the 505(b)(2) filing pathway. It included
data from pharmacokinetic bridging studies comparing VUMERITY and
TECFIDERA to establish bioequivalence, and relied, in part, on the
FDA’s findings of safety and efficacy for TECFIDERA.The NDA
submission also included interim exposure and safety findings from
EVOLVE-MS-1, an ongoing, Phase 3, single-arm, open-label, two-year
safety study evaluating VUMERITY in patients with
relapsing-remitting MS. Interim results from EVOLVE-MS-1 at the
time of NDA submission included a low overall rate of VUMERITY
treatment discontinuation due to adverse
events (6.3 percent), and a rate of less than one percent
of patients who discontinued VUMERITY treatment due to
gastrointestinal (GI) adverse events. Additional exploratory
efficacy endpoints in the ongoing EVOLVE-MS-1 study showed changes
in clinical and radiological measures compared to baseline.
“MS is a heterogeneous disease, and real-world patient
circumstances can vary, reinforcing the benefits of having
therapeutic choices to support the diverse range of treatment
considerations,” said Robert Naismith, M.D., professor of
neurology, Washington University School of Medicine in St. Louis.
“Throughout its clinical development program, VUMERITY has
demonstrated a desirable therapeutic profile, making it a
compelling new option for patients.”
“MS is a lifelong disease that has a significant impact on the
people affected and their caregivers. We are encouraged by the
progress being made in the treatment of MS, and pleased that
another treatment option will soon be available,” said Bruce Bebo,
Ph.D., executive vice president, research, National MS Society.
“It’s important for people with MS to have treatments that are both
efficacious and tolerable to help manage their disease.”
Under the terms of the license and collaboration agreement
between Biogen and Alkermes, Biogen will pay Alkermes $150 million
in connection with the FDA’s approval of VUMERITY. Biogen plans to
account for this milestone payment as an asset that will be
amortized over the expected useful life of the product. Alkermes is
also entitled to receive a mid-teens percentage royalty on
worldwide net commercial sales of VUMERITY, subject, under certain
circumstances, to minimum annual payments for the first five years
following FDA approval and customary reductions as set forth in the
agreement.
Please see full Prescribing Information for
VUMERITY.
About VUMERITY™ (diroximel fumarate) VUMERITY
is a novel oral fumarate with a distinct chemical structure
approved in the U.S. for the treatment of relapsing forms of
multiple sclerosis, 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.
About the VUMERITY EVOLVE-MS Clinical Development
ProgramThe key components of the EVOLVE-MS
(Endeavoring to Advance Treatment
for Patients Living with
Multiple Sclerosis) clinical development program
of VUMERITY include the EVOLVE-MS-1 study, a Phase 3, open-label,
two-year safety study in relapsing-remitting multiple sclerosis
(MS) patients, along with pharmacokinetic bridging studies
comparing VUMERITY and TECFIDERA to demonstrate bioequivalence. The
EVOLVE-MS clinical development program also includes the
EVOLVE-MS-2 study, an elective Phase 3, five-week randomized,
prospective, double-blind, multi-center study that assessed the
gastrointestinal (GI) tolerability of VUMERITY and TECFIDERA using
self-administered GI questionnaires. INDICATION and
IMPORTANT SAFETY INFORMATION for VUMERITY™ (diroximel
fumarate)What is VUMERITYTM (diroximel
fumarate)?VUMERITY is a prescription medicine used to
treat people with relapsing forms of multiple sclerosis (MS), to
include clinically isolated syndrome, relapsing-remitting disease,
and active secondary progressive disease, in adults. It is not
known if VUMERITY is safe and effective in children.
Important Safety InformationWho should
not take VUMERITY?Patients should not use VUMERITY if they
have had an allergic reaction (such as welts, hives, swelling of
the face, lips, mouth or tongue, or difficulty breathing) to
diroximel fumarate, dimethyl fumarate, or any of the ingredients in
VUMERITY or if they are taking dimethyl
fumarate. Before
taking and while taking VUMERITY, patients should tell their
healthcare provider if they: have liver problems; kidney
problems; have or have had low white blood cell counts or an
infection; are pregnant or plan to become pregnant because it is
not known if VUMERITY will harm an unborn baby; are breastfeeding
or plan to breastfeed because it is not known if VUMERITY passes
into breast milk; are taking prescription or over-the-counter
medicines, vitamins, or herbal supplements.
What should patients avoid while taking
VUMERITY?Patients should not drink alcohol at the same
time they take a VUMERITY dose.
What are the possible side effects of
VUMERITY?VUMERITY may cause serious side effects
including:
- Allergic reaction (such as welts, hives,
swelling of the face, lips, mouth or tongue, or difficulty
breathing).
- PML (progressive multifocal
leukoencephalopathy), a rare brain infection that usually
leads to death or severe disability over a period of weeks or
months. Patients should tell their doctor right away if they get
any of these symptoms of PML: weakness on one side of the body that
gets worse, clumsiness in their arms or legs, vision problems,
changes in thinking and memory, confusion, or personality
changes.
- Decreases in your white blood cell count, the
patient’s healthcare provider should do a blood test to check their
white blood cell count before starting treatment with VUMERITY and
while on therapy. Patients should have bloods tests after 6 months
of treatment and every 6 to 12 months after that.
- Liver problems, the patient’s healthcare
provider should do blood tests to check liver function before
starting treatment with VUMERITY and during treatment if needed.
Patients should tell their healthcare provider right away if they
get any of these symptoms of a liver problem during treatment:
severe tiredness, loss of appetite, pain on the right side of the
stomach, have dark or brown (tea color) urine, or yellowing of the
skin or the white part of the eyes.
The most common side effects of VUMERITY
include: flushing, redness, itching, or rash; nausea,
vomiting, diarrhea, stomach pain, or indigestion. Flushing and
stomach problems are the most common reactions, especially at the
start of therapy, and may decrease over time. Taking VUMERITY with
food (avoid high-fat, high-calorie meal or snack) may help reduce
flushing. Patients should call their healthcare provider if they
have any of these symptoms, are bothered by them, or if they do not
go away.
These are not all the possible side effects of VUMERITY.
Patients should call their healthcare provider for medical advice
about side effects. Patients may report side effects to FDA at
1-800-FDA-1088. For more information go to
dailymed.nlm.nih.gov. Please
see the full Prescribing Information, including Patient Information
for VUMERITY.
INDICATION and IMPORTANT SAFETY INFORMATION for
TECFIDERA® (dimethyl fumarate)What is TECFIDERA®
(dimethyl fumarate)?TECFIDERA is a prescription medicine
used to treat relapsing forms of multiple sclerosis (MS), to
include clinically isolated syndrome, relapsing-remitting disease,
and active secondary progressive disease, in adults. It is not
known if TECFIDERA is safe and effective in children under 18 years
of age. Important
Safety Information
Who should not take TECFIDERA?Patients should
not use TECFIDERA if they have had an allergic reaction (such as
welts, hives, swelling of the face, lips, mouth or tongue, or
difficulty breathing) to TECFIDERA or any of its ingredients.
Before taking and while taking TECFIDERA, patients
should tell their healthcare provider if they have or have
had: low white blood cell counts, an infection, or any
other medical conditions.
Patients should tell their healthcare provider if
they: are pregnant or plan to become pregnant, because it
is not known if TECFIDERA will harm an unborn baby; patients should
talk to their healthcare provider about enrolling in the TECFIDERA
Pregnancy Registry if they become pregnant while taking TECFIDERA;
the purpose of this registry is to monitor the health of the
patient and baby and patients can enroll by calling 1-866-810-1462
or visiting www.tecfiderapregnancyregistry.com; are breastfeeding
or plan to breastfeed because it is not known if TECFIDERA passes
into breast milk; are taking prescription or over-the-counter
medicines, vitamins, or herbal
supplements. What
are the possible side effects of
TECFIDERA?TECFIDERA may cause serious side
effects, including:
- Allergic reaction (such as welts, hives,
swelling of the face, lips, mouth or tongue, or difficulty
breathing).
- PML, a rare brain infection that usually leads
to death or severe disability.
- Decreases in your white blood cell count, the
patient’s healthcare provider should do a blood test before
starting treatment with TECFIDERA and while on therapy.
- Liver problems, the patient’s healthcare
provider should do blood tests to check liver function before
starting treatment with TECFIDERA and during treatment if needed.
Patients should tell their healthcare provider right away if they
get any of these symptoms of a liver problem during treatment:
severe tiredness, loss of appetite, pain on the right side of your
stomach, have dark or brown (tea color) urine, yellowing of your
skin or the white part of your eyes.
The most common side effects of TECFIDERA
include: flushing, redness, itching, or rash; nausea,
vomiting, diarrhea, stomach pain, or indigestion. Flushing and
stomach problems are the most common reactions, especially at the
start of therapy, and may decrease over time. Taking TECFIDERA with
food may help reduce flushing. Patients should call their
healthcare provider if they have any of these symptoms, are
bothered by them, or if they do not go away. Ask your healthcare
provider if taking aspirin before taking TECFIDERA may reduce
flushing.
These are not all the possible side effects of TECFIDERA.
Patients should call their healthcare provider for medical advice
about side effects. Patients may report side effects to FDA at
1-800-FDA-1088. For more information go to
dailymed.nlm.nih.gov.
Please see full Prescribing Information,
including Patient
Information.
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, 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 visit
www.biogen.com and follow us on social media – Twitter,
LinkedIn, Facebook, YouTube.
About Alkermes plc Alkermes plc is a fully
integrated, global biopharmaceutical company developing innovative
medicines for the treatment of central nervous system (CNS)
diseases and oncology. The company has a diversified commercial
product portfolio and a substantial clinical pipeline of product
candidates for diseases that include schizophrenia, depression,
addiction, multiple sclerosis and cancer. 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.
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, relating to the potential benefits, safety and
efficacy of VUMERITY and TECFIDERA; potential clinical effects of
VUMERITY and TECFIDERA; results from the EVOLVE-MS-1 and
EVOLVE-MS-2 studies; the clinical development program for VUMERITY;
the launch of VUMERITY, including the timing of the launch;
Biogen’s research and development program for the treatment of MS;
the treatment of MS; the potential of Biogen’s commercial business
and pipeline programs, including VUMERITY and TECFIDERA; the
anticipated benefits and potential of Biogen’s collaboration
arrangements with Alkermes; risks and uncertainties associated with
drug development and commercialization; and Biogen’s future
financial and operating results. 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
Biogen’s drug candidates; unexpected concerns may arise from
additional data, analysis or results obtained during clinical
trials; 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 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 U.S. 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 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 VUMERITY for the
treatment of relapsing forms of MS; continued activities in the
EVOLVE-MS clinical development program for VUMERITY; plans and
expected timing for the commercial launch of VUMERITY by Biogen;
and the financial and commercial benefits that may be achieved
under the license and collaboration agreement between Alkermes and
Biogen in connection with the approval and commercialization of
VUMERITY. 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 clinical results for VUMERITY will
be predictive of real-world results; whether VUMERITY, in
real-world use, is shown to be unsafe or ineffective; whether
VUMERITY receives reimbursement from government and third-party
payers; whether there will be unexpected costs or delays in the
commercial launch of VUMERITY; whether physicians and patients
perceive VUMERITY as efficacious and well-tolerated; whether the
potential financial and commercial 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, 2018 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.
TECFIDERA® is a registered trademark of Biogen
Inc.VUMERITYTM is a trademark of Alkermes Pharma Ireland Limited
used by Biogen under an exclusive license.
Alkermes Contacts: For Investors: Sandy
Coombs, +1 781 609 6377For
Media: Gretchen Murphy, +1 781 609
6419
Biogen Contacts:For Media: David Caouette, + 617 679 4945,
public.affairs@biogen.comFor Investors: Joe Mara, +1 781 464 2442,
IR@biogen.com
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/1af51ae4-577d-4558-ad41-7abe5a1dae24
A video accompanying this announcement is available
at: https://www.globenewswire.com/NewsRoom/AttachmentNg/3191c160-3316-4e9c-bdd0-97ade134f441
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