─ Head-to-Head Study to Assess
Tolerability Profile of ALKS 8700 Compared to TECFIDERA®
─
─ Novel, Oral, Twice-Daily Drug
Candidate Designed to Provide MMF Exposures Equivalent to TECFIDERA
With Differentiated Profile ─
Alkermes plc (NASDAQ: ALKS) today announced the initiation of a
new phase 3 study of ALKS 8700, a novel, oral 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 offer
differentiated features as compared to the currently marketed
dimethyl fumarate, TECFIDERA®. The five-week, head-to-head study
will evaluate the gastrointestinal (GI) tolerability of ALKS 8700
compared to TECFIDERA in approximately 420 patients with
relapsing-remitting MS (RRMS). This elective study is part of the
ongoing clinical development program for ALKS 8700, named EVOLVE-MS
(Endeavoring to Advance Treatment for Patients
Living with Multiple Sclerosis). The company plans to submit a
New Drug Application (NDA) for ALKS 8700 for the treatment of RRMS
to the U.S. Food and Drug Administration (FDA) in 2018.
“ALKS 8700, a MMF prodrug with distinct physical-chemical
properties, is designed to provide therapeutic concentrations of
MMF in the body and offer differentiated features as compared to
the market leader dimethyl fumarate, TECFIDERA, which is associated
with gastrointestinal side effects. These adverse events can lead
to treatment interruption or discontinuation for patients with MS,”
stated Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “We
believe ALKS 8700 may represent a valuable new option for patients
suffering from MS who want the efficacy of fumarate therapy with
more favorable gastrointestinal tolerability. We look forward to
conducting this study and submitting the planned NDA for ALKS 8700
in 2018.”
“This elective study for ALKS 8700 demonstrates Alkermes’ unique
approach to fully characterize the potential value of new
medicines, reflecting our commitment to integrating inputs from
patients, physicians and payers into our development programs in
response to an increasingly complex healthcare system,” stated
Richard Pops, Chief Executive Officer of Alkermes. “The data from
this study will help determine ALKS 8700’s potential advantages for
patients and its future positioning in the fumarate market, which
represents a $3 billion opportunity in the U.S.”
The phase 3, multicenter, double-blind, active-controlled,
five-week study is designed to evaluate the GI tolerability of ALKS
8700 462 mg twice daily compared to TECFIDERA 240 mg twice daily in
approximately 420 patients with RRMS. Both treatment groups will
include an initial one-week dose titration period. Key GI symptoms,
including nausea, vomiting, upper and lower abdominal pain and
diarrhea, will be assessed using two patient-reported symptom
rating scales: the Individual Gastrointestinal Symptom and Impact
Scale (IGISIS) and the Global Gastrointestinal Symptom and Impact
Scale (GGISIS). Intensity, frequency and duration of symptoms, as
well as effect on daily activities will also be assessed.
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 for the treatment of
relapsing forms of MS, the number of patients enrolled in the ALKS
8700 phase 3 studies, the adequacy of the EVOLVE-MS development
program for ALKS 8700 to serve as the basis for an NDA, the
commercial potential of ALKS 8700, and the timing of the submission
of the NDA to the FDA for 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 more 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 FDA’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 in 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 March 15, 2017.
2 Multiple Sclerosis Association of America. MS Overview.
Accessed from
http://mymsaa.org/ms-information/overview/who-gets-ms/ on March 15,
2017.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170316005073/en/
Alkermes Contacts:For Investors:Eva
Stroynowski, +1 781-609-6823orSandy Coombs, +1 781-609-6377orFor
Media:Jennifer Snyder +1 781-609-6166
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