– New Molecular Entities Advancing for the Treatment of Multiple Sclerosis, Pain and Cancer –
– Company Also Highlights Late-Stage CNS Clinical Candidates, Including Aripiprazole Lauroxil, ALKS 5461 and ALKS 3831 –
In addition to the three newly unveiled drug candidates, the company will provide details on its later-stage pipeline candidates, specifically: commercial plans for aripiprazole lauroxil, a once-monthly, long-acting atypical antipsychotic currently in phase 3 development for the treatment of schizophrenia; review of the phase 2 data for ALKS 5461, a proprietary opioid modulator with a novel mechanism for the treatment of major depressive disorder (MDD); and the clinical rationale and development plan, including initiation of a phase 2 clinical study, for ALKS 3831, a proprietary oral compound designed as a broad spectrum antipsychotic treatment for schizophrenia.
“During this R&D Day, a more complete picture of our growth strategy
will emerge,” commented Richard Pops, Chief Executive Officer of
“The three new drug candidates that we are unveiling today exemplify the
productivity of R&D at
R&D Highlights
-
MMF Prodrug Program for the Treatment of Multiple Sclerosis:
The company’s MMF prodrug program has resulted in novel,
small-molecule prodrugs of monomethyl fumarate for the treatment of
multiple sclerosis. Alkermes’ MMF prodrugs are designed to rapidly and
efficiently convert to MMF in the body and to offer advantages over
the currently marketed dimethyl fumarate prodrug, TECFIDERA®.
Alkermes expects to file an Investigational New Drug (IND) application and initiate a phase 1 study in mid calendar 2014. -
ALKS 7106 for the Treatment of Pain: ALKS 7106 is Alkermes’
novel, small-molecule drug candidate derived from the company’s opioid
modulator platform. ALKS 7106 is a potent, oral opioid analgesic
designed for the treatment of pain with intrinsically low potential
for abuse and overdose death, two liabilities associated with other
opioid medicines.
Alkermes will present preclinical data showing that ALKS 7106 had more potent analgesic properties than morphine and was well tolerated at doses far in excess of those required for analgesic action. Additional preclinical data for ALKS 7106 demonstrated a ceiling effect on neurotransmitter release over a broad concentration range, suggesting low potential for abuse and overdose death.Alkermes expects to file an IND and initiate a phase 1 study of ALKS 7106 in mid calendar 2014. -
RDB 1419, a Cancer Immunotherapy Based on IL-2 and its Receptors:
Alkermes will present preclinical data showing that RDB 1419, a novel biologic based on IL-2 and its receptors, preferentially expanded the number of tumor-killing cells involved in immunotherapeutic effects on cancer. Additional preclinical data demonstrated that RDB 1419 inhibited lung metastases in a model of lung cancer. The company will describe how RDB 1419 was engineered using its proprietary fusion protein technology platform to modulate the natural mechanism of action of a biologic and to provide safety and tolerability advantages over existing therapies.Alkermes expects to conduct IND-enabling activities for RDB 1419 in calendar 2014.
Webcast
A live webcast of the company's R&D Day will begin today at
About
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,
statements concerning: the therapeutic value, development plans, and
commercial potential of the company’s products, including aripiprazole
lauroxil, ALKS 5461, ALKS 3831, ALKS 7106, RDB 1419 and the MMF prodrug
program. 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 projected or suggested in the
forward-looking statements due to various risks and uncertainties. These
risks and uncertainties include, among others: clinical trials of our
products may be unsuccessful or not initiated or conducted in a timely
manner; regulatory submissions, including INDs, may not occur or be
submitted in a timely manner; our products may not show sufficient
therapeutic effects or acceptable safety profiles; adverse decisions by
regulatory authorities; existing clinical and preclinical data with
respect to our products may not be indicative of future clinical or
commercial results; and our inability to manufacture successfully our
products; and those risks described in the
TECFIDERA® is a registered trademark of
Source:
Alkermes:
For Investors:
Rebecca
Peterson, +1 781-609-6378
or
For Media:
Jennifer Snyder,
+1 781-609-6166