–– Novel, Oral, Fumarate Therapy Intended to Provide a Differentiated
Gastrointestinal Tolerability Profile ––
–– Biogen Brings Multiple Sclerosis Expertise to Commercialization of
ALKS 8700 ––
–– New Drug Application Anticipated for Submission in 2018 ––
CAMBRIDGE, Mass. & DUBLIN--(BUSINESS WIRE)--Nov. 27, 2017--
Biogen
(Nasdaq:BIIB) and Alkermes
plc (Nasdaq:ALKS) today announced that they have entered into a
global license and collaboration agreement to develop and commercialize
ALKS 8700, a novel, oral, monomethyl fumarate (MMF) small drug molecule
in Phase 3 development for the treatment of relapsing forms of multiple
sclerosis (MS).
“This partnership is further evidence of Biogen’s ongoing commitment to
multiple sclerosis and builds upon our deep experience in
neuroscience and particularly in MS,” stated Michel Vounatsos, Chief
Executive Officer at Biogen. “We aim to provide patients with a new oral
therapy which may bring differentiated benefits.”
“This collaboration has the potential to provide important benefits to
patients with multiple sclerosis and immediately increases the value of
ALKS 8700 to Alkermes,” said Richard Pops, Chief Executive Officer at
Alkermes. “Biogen has a broad product portfolio and a highly experienced
commercial team. In Biogen’s hands, we believe that patients will have
broader and more rapid access to this important medicine. Meanwhile, we
will focus our growing commercial capabilities on our expanding
portfolio of medicines in psychiatry, including addiction, schizophrenia
and depression.”
Under the terms of the agreement, Biogen will receive an exclusive,
worldwide license to commercialize ALKS 8700 and will pay Alkermes a
mid-teens royalty on worldwide net sales of ALKS 8700.
This collaboration aligns the interests of Alkermes and Biogen in the
successful development and commercialization of ALKS 8700 as an
important potential treatment option for patients suffering from MS.
Biogen will reimburse Alkermes for fifty percent (50%) of the 2017 ALKS
8700 development costs, with Alkermes receiving an upfront payment of
$28 million representing Biogen’s share of development expenses already
incurred in 2017. Beginning Jan. 1, 2018, Biogen will be responsible for
all development expenses related to ALKS 8700. Alkermes may also receive
milestone payments for ALKS 8700 with a maximum aggregate value of $200
million upon certain clinical and regulatory achievements. Biogen
anticipates the initial milestone payment of $50 million will be
recorded as an expense in 2017.
Alkermes will maintain responsibility for regulatory interactions with
the U.S. Food and Drug Administration (FDA) through the potential
approval of the New Drug Application (NDA) for ALKS 8700 for the
treatment of MS. Biogen shall be responsible for all commercialization
activities for ALKS 8700.
ALKS 8700 is currently in Phase 3 development for MS. Alkermes plans to
seek approval of ALKS 8700 under the 505(b)(2) regulatory pathway
referencing Biogen’s TECFIDERA® (dimethyl fumarate). The
registration package for ALKS 8700 will include pharmacokinetic bridging
studies that establish bioequivalence to TECFIDERA and data from a
two-year safety study known as EVOLVE-MS-1. Initial safety data from
EVOLVE-MS-1 were recently presented at MSParis2017, the 7th
Joint Meeting of the European Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS) and the Americas Committee for Treatment
and Research in Multiple Sclerosis (ACTRIMS) in October. Safety data
from the first month of the EVOLVE-MS-1 study (N=580) showed that
treatment with ALKS 8700 was associated with low rates of
gastrointestinal (GI) adverse events (AEs) leading to discontinuation
and no occurrence of serious GI AEs. The most common AEs during the
first month of treatment with ALKS 8700 were flushing, pruritus and
diarrhea.
Also, currently underway is a head-to-head study (EVOLVE-MS-2)
evaluating the GI tolerability of ALKS 8700 compared to TECFIDERA.
Initial data from EVOLVE-MS-2 are expected in the first half of 2018.
About the 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 ALKS 8700 include a two-year safety study and pharmacokinetic
bridging studies comparing ALKS 8700 and TECFIDERA. In addition, the
program includes an elective head-to-head study comparing the GI
tolerability of ALKS 8700 and TECFIDERA.
About ALKS 8700
ALKS 8700 is an oral, novel and proprietary monomethyl fumarate (MMF)
prodrug candidate in development for the treatment of relapsing forms of
multiple sclerosis (MS). ALKS 8700 is designed to rapidly and
efficiently convert to MMF in the body and to offer differentiated
features as compared to the currently marketed dimethyl fumarate,
TECFIDERA®.
About Multiple Sclerosis
Multiple sclerosis (MS) is an unpredictable, often disabling disease of
the central nervous system (CNS), which interrupts the flow of
information within the brain, and between the brain and body.1 MS
symptoms can vary over time and from person to person. Symptoms may
include extreme fatigue, impaired vision, problems with balance and
walking, numbness or pain and other sensory changes, bladder and bowel
symptoms, tremors, problems with memory and concentration and mood
changes, among others.1Approximately 400,000 individuals in
the U.S. and 2.5 million people worldwide have MS, and most are
diagnosed between the ages of 15 and 50.2
About Alkermes plc
Alkermes 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 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.
Founded in 1978 as one of the world’s first global biotechnology
companies by Charles Weissman, 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 and only approved treatment for spinal muscular
atrophy; and is focused on advancing neuroscience research programs in
Alzheimer’s disease and dementia, 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.
Biogen Safe Harbor
This press release contains forward-looking statements, made pursuant to
the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995, including statements relating to the potential benefits and
results, including financial and operating results, that may be achieved
through Biogen’s license agreement with Alkermes, risks and
uncertainties associated with drug development and commercialization,
the potential benefits, safety, efficacy and clinical effects of ALKS
8700, the timing and status of regulatory filings, and the potential of
Biogen’s commercial business and pipeline programs, including ALKS 8700.
These forward-looking statements may be accompanied by such words as
“aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,”
“forecast,” “intend,” “may,” “plan,” “potential,” “project,” “target,”
“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: uncertainty as to whether the anticipated
benefits and potential of Biogen’s license agreement with Alkermes can
be achieved; risks that Biogen and/or Alkermes may not fully enroll the
clinical trials for ALKS 8700 or will take longer than expected; risks
of unexpected costs or delays; uncertainty of success in the development
and potential commercialization of ALKS 8700, which may be impacted by,
among other things, unexpected concerns that may arise from additional
data or analysis, the occurrence of adverse safety events, failure to
obtain regulatory approvals in certain jurisdictions, failure to protect
and enforce Biogen’s data, intellectual property, and other proprietary
rights and uncertainties relating to intellectual property claims and
challenges; third party collaboration risks; and uncertainty of Biogen’s
success in developing, licensing, or acquiring other product candidates
or additional indications for existing products. 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 continued expansion of Alkermes’
portfolio of medicines in psychiatry, the continued clinical development
and the potential therapeutic and commercial value of ALKS 8700 for the
treatment of relapsing forms of MS, the number of patients enrolled in
the ALKS 8700 Phase 3 studies, the timing of expected initial data from
EVOLVE-MS-2, the regulatory strategy for filing of an NDA for ALKS 8700
and the adequacy of the EVOLVE-MS development program for ALKS 8700 to
serve as the basis for an NDA, the timing of the submission of an NDA to
the FDA for ALKS 8700 and the potential financial, commercial and
therapeutic benefits that may be achieved through collaboration with
Biogen under the license and collaboration agreement between Alkermes
and Biogen. 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 ALKS 8700 compared
to TECFIDERA will show that ALKS 8700 has more favorable GI
tolerability; whether preclinical and early clinical results for ALKS
8700 will be predictive of future clinical study results or real-world
results; whether clinical trials for ALKS 8700 will be completed on time
or at all; changes in the cost, scope and duration of the ALKS 8700
clinical trials; whether ALKS 8700 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 ALKS 8700; whether regulatory submissions
for ALKS 8700 will be submitted on time or at all; whether adverse
decisions by regulatory authorities will occur; whether the
pharmacokinetic, Phase 3 and other studies conducted for ALKS 8700 will
meet the FDA’s requirements for approval; whether the potential
financial, 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 December 31, 2016,
and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2017
and September 30, 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.
TECFIDERA® is a registered trademark of Biogen Inc.
1 National Multiple Sclerosis Society. Multiple
Sclerosis: Just the Facts. Accessed from http://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/Brochure-Just-the-Facts.pdf on Nov.
27, 2017.
2 Multiple Sclerosis Association of America. MS
Overview. Accessed from http://mymsaa.org/ms-information/overview/who-gets-ms/
on Nov. 27, 2017.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171127005263/en/
Source: Alkermes plc
Biogen:
For Investors:
Matt
Calistri, +1-781-464-2442
or
For Media:
Matt Fearer,
+1-781-464-3260
or
Alkermes:
For
Investors:
Sandy Coombs, +1-781-609-6377
or
Eva
Stroynowski +1-781-609-6823
or
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Snyder, +1-781-609-6166