–– Novel, Oral Fumarate Therapy Intended to Provide a
Differentiated Gastrointestinal Tolerability Profile ––
–– New Drug Application
Anticipated for Submission in Q4
2018 ––
DUBLIN, June 6, 2018 /PRNewswire/ -- Alkermes plc
(Nasdaq: ALKS) today announced it has received a $50 million payment from Biogen. This payment
follows Biogen's review of preliminary gastrointestinal
tolerability data from the ongoing clinical development program for
BIIB098 (diroximel fumarate). BIIB098 (formerly ALKS 8700) is a
novel, oral fumarate in phase 3 development for the treatment of
relapsing forms of multiple sclerosis (MS). Alkermes expects to
submit a New Drug Application (NDA) for BIIB098 to the U.S. Food
and Drug Administration (FDA) in the fourth quarter of 2018.
"The clinical data generated from this program underscore the
potential value of BIIB098 for patients with multiple sclerosis,"
said Richard Pops, Chief Executive Officer at Alkermes. "Our focus
remains on completing the registration requirements and preparing
the BIIB098 NDA for submission in the fourth quarter of 2018, as we
advance this important potential new therapeutic option for
patients with MS."
Substantially all of the payment will be recorded as License
Revenue in Alkermes' financial results for the quarter ending
June 30, 2018.
Under the terms of the license and collaboration agreement,
Biogen has an exclusive, worldwide license to commercialize BIIB098
and will pay Alkermes a mid-teens percentage royalty on worldwide
net sales. Alkermes may also receive a $150
million milestone payment from Biogen upon FDA approval, on
or before Dec. 31, 2021, of the NDA
for BIIB098.
BIIB098 is currently in phase 3 development for relapsing forms
of MS. Alkermes plans to seek approval of BIIB098 under the
505(b)(2) regulatory pathway referencing Biogen's
TECFIDERA® (dimethyl fumarate). Alkermes' registration
package for BIIB098 will include pharmacokinetic bridging studies
to establish bioequivalence to dimethyl fumarate and data from a
two-year safety study known as EVOLVE-MS-1.
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
BIIB098 include a two-year safety study and pharmacokinetic
bridging studies comparing BIIB098 and dimethyl fumarate.
About BIIB098
BIIB098 (diroximel fumarate) is an oral,
novel fumarate candidate in development for the treatment of
relapsing forms of multiple sclerosis (MS). BIIB098 is designed to
rapidly and efficiently convert to monomethyl fumarate in the body
and to potentially offer differentiated features as compared to
dimethyl fumarate.
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.
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 clinical
development and the potential therapeutic and commercial value of
BIIB098 for the treatment of relapsing forms of MS, the regulatory
strategy for filing of an NDA for BIIB098 and the adequacy of the
EVOLVE-MS development program for BIIB098 to serve as the basis for
an NDA, the timing of the submission of an NDA to the FDA for
BIIB098 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 BIIB098 compared to
dimethyl fumarate will show that BIIB098 has more favorable GI
tolerability; whether preclinical and early clinical results for
BIIB098 will be predictive of future clinical study results or
real-world results; whether clinical trials for BIIB098 will be
completed on time or at all; changes in the cost, scope and
duration of the BIIB098 clinical trials; whether BIIB098 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
BIIB098; whether regulatory submissions for BIIB098 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 BIIB098 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 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.
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 June
5, 2018.
2 Multiple Sclerosis Association of
America. MS Overview. Accessed
from http://mymsaa.org/ms-information/overview/who-gets-ms/on June
5, 2018.
Alkermes
Contacts:
|
|
For
Investors:
|
Sandy
Coombs +1 781 609 6377
|
|
Eva Stroynowski +1
781 609 6823
|
For Media:
|
Jennifer
Snyder +1 781 609 6166
|
Logo -
https://mma.prnewswire.com/media/616416/Alkermes_plc_Logo.jpg