– VUMERITY, a New Oral Treatment Option for Relapsing
Forms of MS, Offers a Combination of Well-Characterized Efficacy,
Safety and Tolerability –
CAMBRIDGE, Massachusetts and
DUBLIN, Oct. 30, 2019 /PRNewswire/ -- 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
Program
The 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 VUMERITY™
(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 Information
Who 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 Harbor
This 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.
VUMERITY™ is a trademark of Alkermes Pharma Ireland
Limited used by Biogen under an exclusive license.
Alkermes
Contacts:
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For
Investors:
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Sandy
Coombs,
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+1 781 609
6377
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For Media:
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Gretchen
Murphy,
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+1 781 609
6419
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Biogen
Contacts:
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For Media: David
Caouette, + 617 679 4945,
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public.affairs@biogen.com
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For Investors: Joe
Mara, +1 781 464 2442,
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IR@biogen.com
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