Alkermes to Present Clinical Data on ALKS 8700 at Annual Meeting of the Consortium of Multiple Sclerosis Centers
May 29 2015 - 7:00AM
Business Wire
– Data Showed Novel, Oral Product Candidate
Provided Monomethyl Fumarate Exposures Comparable to TECFIDERA®,
With Favorable Gastrointestinal Tolerability –
Alkermes plc (NASDAQ: ALKS) today announced that data from its
phase 1, randomized, double-blind clinical study of ALKS 8700, a
novel monomethyl fumarate (MMF) molecule in development for the
treatment of multiple sclerosis (MS), is scheduled to be presented
at the 2015 Annual Meeting of the Consortium of Multiple Sclerosis
Centers (CMSC) being held in Indianapolis, Ind., May 27-30, 2015.
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®.
The study evaluated the safety, tolerability and single-dose
pharmacokinetics (PK) of oral formulations of ALKS 8700 compared to
both placebo and active control groups in healthy volunteers. Data
from the study showed that ALKS 8700 was generally well tolerated
and provided MMF exposures comparable to TECFIDERA, with less
variability and favorable gastrointestinal (GI) tolerability. The
most common adverse events (AEs) were flushing and GI-related.
Based on the positive results from the study, Alkermes plans to
advance ALKS 8700 with twice-daily dosing into pivotal development
in 2015.
“The data being presented during the CMSC annual meeting
demonstrated that ALKS 8700 efficiently converts to MMF following
oral administration with the potential to offer favorable GI
tolerability for patients with MS,” said Elliot Ehrich, M.D., Chief
Medical Officer of Alkermes. “We are committed to bringing this
innovative potential new treatment option to patients and remain on
track to initiate pivotal development of ALKS 8700 later this
year.”
A poster on the phase 1 data, titled “Safety, Tolerability and
Pharmacokinetics of ALKS 8700, a Novel Oral Therapy for
Relapsing-Remitting Multiple Sclerosis in Healthy Subjects” (P#
DX37) will be presented on Friday, May 29, 2015, 12:00 – 2:00 p.m.
EDT. For more information including a complete list of abstract
titles, please visit the CMSC website at
http://annualmeeting.mscare.org.
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 therapeutic value,
development plans and commercial potential of 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,
the company may not be permitted by regulatory authorities to
undertake new or additional clinical studies of ALKS 8700; and
those risks and uncertainties described under the heading “Risk
Factors” in the company’s 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. Existing and prospective investors are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date they are made. 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.
1National Multiple Sclerosis Society. Multiple Sclerosis: Just
the Facts. Accessed from
http://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/Brochure-Just-the-Facts.pdf
on May 28, 2015.2Multiple Sclerosis Association of America. MS
Overview. Accessed from http://mymsaa.org/about-ms/overview/ on May
28, 2015.
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version on businesswire.com: http://www.businesswire.com/news/home/20150529005045/en/
Alkermes Contacts:For
Investors:Rebecca Peterson, +1 781-609-6378orFor Media:Jennifer
Snyder, +1 781-609-6166
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