Alkermes to Present New Clinical Data on ALKS 8700 at MSParis2017, the 7th Joint ECTRIMS-ACTRIMS Meeting
October 16 2017 - 7:00AM
Business Wire
–– Safety and Gastrointestinal Tolerability
Profile During Initial Three Months of ALKS 8700 Treatment in
Ongoing Long-Term Safety Study to be Highlighted ––
Alkermes plc (NASDAQ: ALKS) today announced that two posters on
ALKS 8700, a novel, oral monomethyl fumarate (MMF) prodrug
candidate in development for the treatment of relapsing forms of
multiple sclerosis (MS), will be 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), being held
Oct. 25-28, 2017 in Paris, France. Interim safety and
gastrointestinal (GI) tolerability data during the first three
months of treatment with ALKS 8700 from the ongoing two-year,
open-label, phase 3 safety study will be presented. A poster
detailing the study design for the ongoing phase 3 GI tolerability
study comparing ALKS 8700 to TECFIDERA® will also be presented.
“We designed ALKS 8700, a MMF prodrug with distinct
physical-chemical properties, to harness the efficacy of monomethyl
fumarate with a differentiated safety and tolerability profile,”
said Elliot Ehrich, M.D., Executive Vice President of Research and
Development at Alkermes. “The presentations at MSParis2017 will
provide additional insight into the emerging safety and
tolerability profile of ALKS 8700 and the potential of ALKS 8700 to
provide patients suffering from MS with an important treatment
alternative.”
Alkermes presentations at MSParis2017 will include:
- Poster #708, “EVOLVE-MS-2: A
Randomized, Double-Blind, Phase 3 Study of the Gastrointestinal
Tolerability of ALKS 8700 Versus Dimethyl Fumarate in
Relapsing-Remitting Multiple Sclerosis,” will describe the study
design, preliminary patient demographics and baseline
characteristics of an ongoing, elective head-to-head study
evaluating ALKS 8700 vs. TECFIDERA during Poster Session I,
Thursday, Oct. 26, 2017, 3:30 – 5:00 p.m. CEST.
- Poster #1170, “EVOLVE-MS-1: A Phase 3,
Open-Label, Long-Term Safety Study of ALKS 8700 in
Relapsing-Remitting Multiple Sclerosis,” will describe patient
demographics, baseline characteristics, and safety and GI
tolerability data from the ongoing two-year, open-label safety
study of ALKS 8700 during Poster Session II, Friday, Oct. 27, 2017,
3:30 – 5:00 p.m. CEST.
For more information, please visit the conference website
at https://www.ectrims-congress.eu/2017.html.
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.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 and therapeutic value of ALKS 8700 and the commercial
potential of ALKS 8700. The company cautions 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 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 favorable GI tolerability;
whether preclinical and early clinical results for ALKS 8700 will
be predictive of future clinical study 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 occur; whether
the pharmacokinetic, phase 3 and other studies conducted for ALKS
8700 will meet the U.S. Food and Drug Administration’s
requirements; and those risks described in the Alkermes plc Annual
Report on Form 10-K for the fiscal year ended Dec. 31, 2016, and
Quarterly Reports on Form 10-Q for the quarters ended March 31,
2017 and June 30, 2017 and in 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. 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 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.
13, 2017.2 Multiple Sclerosis Association of America. MS
Overview. Accessed
from http://mymsaa.org/ms-information/overview/who-gets-ms/
on Oct. 13, 2017.
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version on businesswire.com: http://www.businesswire.com/news/home/20171016005166/en/
Alkermes Contacts:For Investors:Eva
Stroynowski, +1 781-609 6823Sandy Coombs, +1 781-609-6377orFor
Media:Jennifer Snyder, +1 781-609-6166
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