Alkermes Plc : Alkermes Announces Results from Phase 2 Study of ALKS 37 for Treatment of Opioid-Induced Constipation
05/30/2012| 04:05pm US/Eastern
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Alkermes
plc (NASDAQ: ALKS)
today announced topline results from a phase 2b dose-ranging clinical
study of ALKS 37 in the treatment of opioid-induced constipation. The
multicenter, randomized, double-blind, placebo-controlled, repeat-dose
study was designed to assess the safety, tolerability, pharmacokinetic
profile and efficacy of ALKS 37 in approximately 150 patients. ALKS 37
was generally well tolerated at all dose levels, and while subjects
taking ALKS 37 demonstrated an increase in bowel movements compared to
baseline, the product profile did not satisfy our pre-specified criteria
for advancing into phase 3 clinical trials. Based on this evaluation,
Alkermes has decided not to advance ALKS 37 and will consider
out-licensing opportunities.
"We had predetermined the product profile we needed to observe in order
to continue to advance ALKS 37 into phase 3 clinical studies. Based on
the results of this study, we will focus our future clinical development
efforts on our other development programs, including ALKS 9070 for
schizophrenia and ALKS 5461 for major depressive disorder," said Dr.
Elliot Ehrich, Chief Medical Officer of Alkermes. "We will continue to
maintain a disciplined approach to R&D and focus our resources on
clinical candidates that show the most promise."
A second phase 2b study of ALKS 37 for the treatment of opioid-induced
constipation is concluding, and no additional clinical studies for ALKS
37 are planned.
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 and manufacturing facilities in
Athlone, Ireland; 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 above may constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, including, but not limited to, statements concerning
the future development and potential out-licensing of ALKS 37; the focus
and nature of the company's future clinical development efforts,
including the development of ALKS 9070 for schizophrenia and ALKS 5461
for major depressive disorder; and the potential promise shown by ALKS
9070 and ALKS 5461. 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. The company's business is subject to
significant risk and uncertainties and there can be no assurance that
its actual results will not differ materially from its expectations.
These risks and uncertainties include, among others: whether preclinical
and early clinical results for ALKS 9070 and ALKS 5461 will be
predictive of future clinical study results; whether clinical trials for
ALKS 37, ALKS 9070 and ALKS 5461 will be completed on time or at all;
changes in the cost, scope and duration of clinical trials; whether ALKS
37, ALKS 9070 and ALKS 5461 could be ineffective or unsafe during
clinical studies; whether a development partner for ALKS 37 will be
found; and those risks described in the Alkermes plc Annual Report on
Form 10-K for the year ended March 31, 2012 and in other filings made by
the company with the Securities and Exchange Commission ("SEC"), which
are available at 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.
Alkermes plc
For Investors:
Rebecca Peterson, +1 781-609-6378
or
For
Media:
Jennifer Snyder, +1 781-609-6166
© Business Wire 2012
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