— Company Plans to File IND and Advance MMF Prodrug Formulations Into
the Clinic in Mid 2014 —
DUBLIN--(BUSINESS WIRE)--Jan. 6, 2014--
Alkermes
plc (NASDAQ:ALKS) today announced that the United States Patent and
Trademark Office (USPTO) has issued a Notice of Allowance for U.S.
Patent Application 14/032,736, entitled “Prodrugs of fumarates and their
use in treating various diseases.” The allowed composition of matter
claims will cover Alkermes’ MMF prodrug, ALKS 8700, a proprietary,
small-molecule prodrug of monomethyl fumarate (MMF) for the treatment of
multiple sclerosis. The Notice of Allowance resulted from a prioritized
examination granted by the USPTO, and the allowed claims are directed
toward a novel MMF prodrug that is designed to rapidly and efficiently
convert to MMF in the body. Alkermes expects to file an Investigational
New Drug (IND) application with the U.S. Food and Drug Administration
(FDA) and initiate a phase 1 study of ALKS 8700 in mid 2014.
“This patent allowance is a critical step in solidifying our
intellectual property protection for our MMF prodrug program and our
lead MMF prodrug candidate, ALKS 8700, which we continue to advance
toward an IND filing and phase 1 study initiation in mid 2014,” stated
Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “Our world-class
formulation expertise and prodrug capabilities put Alkermes in a unique
position to create and develop prodrug formulations that rapidly and
efficiently convert to MMF in the body and that are designed to offer
differentiated dosing and tolerability, as compared to the currently
marketed dimethyl fumarate prodrug, TECFIDERA®.”
Alkermes expects this patent to issue within the next few months and to
expire no earlier than 2033. A Notice of Allowance is issued after the
USPTO makes a determination that a patent can be granted from an
application.
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, often disabling, disease that
attacks the central nervous system (CNS), which is made up of the brain,
spinal cord and optic nerves. Symptoms may be mild or severe, ranging
from numbness in the limbs to paralysis or loss of vision. The
progression, severity and specific symptoms of MS are unpredictable and
vary from one person to another. MS affects more than 2.3 million people
worldwide.1 Best current estimates indicate that there are at
least 400,000 people with MS in the United States. 2
About Alkermes plc
Alkermes plc is a fully integrated, global biopharmaceutical company
that applies its scientific expertise and proprietary technologies to
develop innovative medicines that improve patient outcomes. The company
has a diversified portfolio of more than 20 commercial drug products and
a substantial clinical pipeline of product candidates that address
central nervous system (CNS) disorders such as addiction, schizophrenia
and depression. Headquartered in Dublin, Ireland, Alkermes plc has an
R&D center in Waltham, Massachusetts; a research and manufacturing
facility in Athlone, Ireland; and manufacturing facilities in
Gainesville, Georgia and 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, including, but not limited to,
whether Patent Application 14/032,736 will issue; whether such issued
patent will adequately protect the company’s MMF prodrugs, including
ALKS 8700, against competition; the expiration date and strength of such
patent; and the therapeutic value, development plans and commercial
potential of the company’s prodrug program, including ALKS 8700 for the
treatment of multiple sclerosis. 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 projected or suggested in the forward-looking
statements due to various risks and uncertainties. These risks and
uncertainties include, among others: whether the validity and
enforceability of Patent Application 14/032,736, if issued, will be
challenged by one or more third parties and upheld; whether preclinical
and early clinical results for the company’s MMF prodrug program,
including ALKS 8700, will be predictive of future clinical study
results; whether the company’s MMF prodrugs, including ALKS 8700, will
be shown to be ineffective or unsafe during clinical studies; decisions
by the FDA or foreign regulatory authorities regarding the company’s MMF
prodrug program, including ALKS 8700, for the treatment of multiple
sclerosis; potential changes in cost, scope and duration of clinical
trials of the company’s MMF prodrug program, including those for ALKS
8700, for the treatment of multiple sclerosis; and those risks described
in the Alkermes plc Annual Report for the year ended March 31, 2013, and
in other 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 any
forward-looking information contained in this press release.
TECFIDERA® is a registered trademark of Biogen Idec.
1 National Multiple Sclerosis Society (NMSS). FAQs about MS.
Date accessed: January 3, 2014. http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-about-ms/faqs-about-ms/index.aspx
2 National Multiple Sclerosis Society (NMSS). MS Prevalence.
Date accessed: January 3, 2014. http://www.nationalmssociety.org/about-the-society/ms-prevalence/index.aspx
Source: Alkermes plc
Alkermes Contacts:
For Investors:
Rebecca Peterson, +1 781-609-6378
For Media: Jennifer Snyder, +1
781-609-6166
