–– Company on Track to Initiate Registration
Program for Novel Twice-Daily Oral Candidate by End of 2015 and
File New Drug Application in 2018 ––
Alkermes plc (NASDAQ: ALKS) today provided an update on its
regulatory strategy and positive clinical trial results for ALKS
8700, a novel, oral monomethyl fumarate (MMF) molecule in
development for the treatment of multiple sclerosis (MS). ALKS 8700
is designed to rapidly and efficiently convert to MMF in the body
and offer differentiated features as compared to the currently
marketed dimethyl fumarate, TECFIDERA®.
Regulatory update: Based on a
meeting with the U.S. Food and Drug Administration (FDA), Alkermes
plans to file a 505(b)(2) New Drug Application (NDA) using
pharmacokinetic bridging data from studies comparing ALKS 8700 and
TECFIDERA, as well as a two-year phase 3 safety study of ALKS 8700
in approximately 600 patients with MS. Importantly, this means that
Alkermes will not be required to conduct a separate phase 3
efficacy study in patients with MS. In addition, Alkermes intends
to initiate a randomized, head-to-head study comparing the
gastrointestinal (GI) tolerability of ALKS 8700 and TECFIDERA in
approximately 420 patients with MS in mid-2016. Alkermes expects to
complete these studies and file the NDA in 2018.
Clinical update: Alkermes recently
completed a randomized, double-blind phase 1 comparative
pharmacokinetic study evaluating plasma MMF levels achieved by
administration of single doses of ALKS 8700 and TECFIDERA. Initial
data from this study showed that ALKS 8700 met the pharmacokinetic
criteria for bioequivalence to TECFIDERA. The most common adverse
events (AEs) in the study were flushing, dizziness and constipation
for ALKS 8700, and flushing, nausea and diarrhea for TECFIDERA.
Based on these results, Alkermes has selected the ALKS 8700 dose to
be used in the registration program. Alkermes will need to conduct
additional preclinical studies and pharmacokinetic studies to
further support pharmacokinetic comparability to TECFIDERA.
“With these positive pharmacokinetic bridging results and
agreement with the FDA on our regulatory strategy in hand, our path
to approval for ALKS 8700 has been clarified. A key component of
the program is the comparison of GI tolerability, as we see this as
an opportunity to potentially provide new benefits to MS patients,”
said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “We
remain on track to advance ALKS 8700 twice-daily into phase 3
development with the initiation of the two-year safety study later
this year, and we plan to file the NDA in 2018.”
Recent Phase 1 Study Design and
Results
This phase 1, randomized, double-blind clinical study evaluated
the safety, tolerability and single-dose pharmacokinetics (PK) of
ALKS 8700 compared to active control in 35 healthy volunteers. In
this two-treatment, two-period crossover design, subjects received
a single dose of either ALKS 8700 or TECFIDERA, followed by the
other agent in the subsequent treatment period, thereby enabling a
crossover comparison of PK and tolerability within the same
subjects. Initial data from this study showed that ALKS 8700 met
the pharmacokinetic criteria for bioequivalence to TECFIDERA.
The most common AEs in the study were flushing, dizziness and
constipation for ALKS 8700, and flushing, nausea and diarrhea for
TECFIDERA. No serious AEs or discontinuations due to AEs were
observed in the study. Alkermes will present safety and PK data
from the phase 1 study at an upcoming medical meeting and submit
the results for publication in a peer-reviewed journal.
About ALKS 8700
ALKS 8700 is an oral, novel and proprietary monomethyl fumarate
(MMF) molecule in development for the treatment 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.1 Approximately
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
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 of ALKS 8700 for the treatment of MS, the timing of the
commencement of the phase 3 studies of ALKS 8700, the number of
patients enrolled in the phase 3 studies, if a separate phase 3
efficacy study of ALKS 8700 in patients with MS will be required,
and the timing of the submission of the NDA to the FDA for ALKS
8700. You are cautioned that forward-looking statements are
inherently uncertain. Although the company 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 preclinical and early clinical
results for ALKS 8700 will be predictive of future clinical study
results; whether future clinical trials for ALKS 8700 will be
initiated or 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 occur; whether the pharmacokinetic, phase 3
and other studies conducted for ALKS 8700 will meet FDA’s
requirements; and those risks described in the Alkermes plc
Quarterly Report on Form 10-Q for the period ended Sept. 30, 2015
and Annual Report on Form 10-K for the fiscal year ended Dec. 31,
2014, and in any other subsequent filings made by the company with
the U.S. Securities and Exchange Commission (SEC), which are
available on the SEC’s website at www.sec.gov. The information
contained in this press release is provided by the company as of
the date hereof, and, except as required by law, the company
disclaims any intention or responsibility for updating or revising
any forward-looking information contained in this press
release.
TECFIDERA® is a registered trademark of Biogen MA 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 Oct. 28, 2015.
2 Multiple Sclerosis Association of America. MS Overview.
Accessed from http://mymsaa.org/about-ms/overview/ on Oct. 28,
2015.
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Alkermes:For Investors:Sandy Coombs, +1 781-609-6377orFor
Media:Jennifer Snyder, +1 781-609-6166
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