–– Company on Track to Initiate Registration Program for Novel
Twice-Daily Oral Candidate by End of 2015 and File New Drug Application
in 2018 ––
DUBLIN--(BUSINESS WIRE)--Oct. 29, 2015--
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151029005132/en/
Source: Alkermes plc
Alkermes:
For Investors:
Sandy Coombs, +1 781-609-6377
or
For
Media:
Jennifer Snyder, +1 781-609-6166