DUBLIN--(BUSINESS WIRE)--Feb. 24, 2015--
Alkermes
plc (NASDAQ: ALKS) today announced topline results from a phase 1
clinical study of ALKS 7106, a new molecule intended for the treatment
of pain. The randomized, double-blind, placebo-controlled study was
designed to evaluate the safety, tolerability and pharmacokinetics of
single escalating doses of ALKS 7106 in 64 healthy adults. Data from the
study showed that ALKS 7106 did not meet the company’s pre-specified
criteria for advancing into phase 2 clinical trials. Based on this
evaluation, Alkermes will not pursue further development of ALKS 7106.
The company will continue its efforts in developing novel compounds for
the treatment of pain with intrinsically low potential for overdose
toxicity and abuse, and it will now concentrate its efforts on the
development of back-up compounds.
“The development of new medicines for the treatment of pain with
differentiated profiles from conventional pain medicines is a dedicated
focus area for Alkermes, as we leverage our deep understanding of opioid
chemistry and pharmacology to enable the modulation of key brain
receptors. ALKS 7106 does not have the properties necessary to warrant
testing of our pharmacologic hypothesis in further studies in patients
with pain, so we will shift our efforts to the identification and
development of other pain candidates from our R&D initiatives,” said Dr.
Elliot Ehrich, Chief Medical Officer of Alkermes. “Our decision with
ALKS 7106 exemplifies Alkermes’ approach to drug development in which we
conduct highly informative studies and set pre-specified criteria that
drive our disciplined decisions for whether to proceed or halt
investment in candidates early in the development process.”
About Alkermes
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,
depression 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 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, as amended, including, but not
limited to statements concerning the focus and nature of the company’s
future clinical development efforts. 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 expressed or implied in the forward-looking
statements due to various risks and uncertainties. These risks and
uncertainties include those risks described in the Alkermes plc
Transition Report on Form 10-K for the fiscal period ended Dec. 31,
2013, and in any 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.
Source: Alkermes plc
Alkermes plc
For Investors:
Rebecca Peterson, +1 781-609-6378
or
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Media:
Jennifer Snyder, +1 781-609-6166