─ 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 ─
DUBLIN--(BUSINESS WIRE)--Mar. 16, 2017--
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/
Source: Alkermes plc
Alkermes Contacts:
For Investors:
Eva
Stroynowski, +1 781-609-6823
or
Sandy Coombs, +1 781-609-6377
or
For
Media:
Jennifer Snyder +1 781-609-6166