Alkermes Expands CNS Pipeline and Announces Positive Results from Phase 1 Study of ALKS 3831, a Novel Antipsychotic Therapy for the Treatment of Schizophrenia

Thu Jan 3, 2013 7:00am EST

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- Data Showed ALKS 3831 Significantly Attenuated Antipsychotic-Related Weight
Gain -

- Alkermes Plans to Initiate Phase 2 Study in Mid Calendar 2013 -
DUBLIN--(Business Wire)--
Alkermes plc (NASDAQ: ALKS) today announced positive topline results from a
phase 1 study of its new antipsychotic candidate, ALKS 3831, a combination of a
proprietary drug molecule, ALKS 33, and olanzapine, a molecule that is
commercially available under the name ZYPREXA®. ALKS 3831 is in development for
the treatment of schizophrenia, a central nervous system (CNS) disease, and is
designed to attenuate the antipsychotic-related metabolic side effect of weight
gain. 

The multicenter, randomized, double-blind, placebo- and active-controlled study
was designed to compare the mean change from baseline in body weight in 106
healthy volunteers following three weeks of once-daily, oral administration of
ALKS 3831, compared to olanzapine alone or placebo. Data from the study showed
that patients administered ALKS 3831 demonstrated significantly less weight gain
compared to patients taking olanzapine. Weight gain is a common and clinically
relevant side effect of atypical antipsychotic medications, and olanzapine has
one of the highest incidences and greatest amounts of weight gain among the
widely prescribed products in this class of drugs.1

Based on the positive results of the phase 1 study, Alkermes plans to meet with
the U.S. Food and Drug Administration (FDA) and initiate a phase 2 study of ALKS
3831 in mid calendar 2013. The company expects to present comprehensive data
from the phase 1 study at an upcoming medical meeting. 

"Based on these encouraging results, we are very excited to advance ALKS 3831 as
one of our proprietary clinical candidates as we continue to expand Alkermes`
strength as a developer of novel CNS medications for unmet patient needs," said
Richard Pops, Chief Executive Officer of Alkermes. "ALKS 3831 is a prime example
of the productivity of our R&D efforts that leverage Alkermes` scientific
expertise in opioid biology and pharmacology as well as the company`s clinical
and commercial knowledge in the field of CNS disorders." 

"Antipsychotic-induced weight gain is a common side effect and area of medical
concern in the treatment of patients with schizophrenia. We believe a
combination therapy that could reduce the metabolic side effects of olanzapine,
without inhibiting olanzapine`s antipsychotic activity, would provide
significant value to physicians and patients," stated Elliot Ehrich, M.D., Chief
Medical Officer of Alkermes. "We are encouraged by these data showing
statistically significant results with ALKS 3831 during a three-week study, and
since weight gain continues to increase with ongoing use of antipsychotics, we
look forward to evaluating ALKS 3831 in our longer-duration phase 2 clinical
study, which we plan to initiate in mid calendar 2013." 

The phase 1, randomized, double-blind, placebo- and active-controlled study was
designed to compare the mean change from baseline in body weight following three
weeks of oral administration of ALKS 3831 in a study that included 106 healthy,
normal-weight male volunteers. ALKS 3831 was generally well tolerated in the
study, and the safety and tolerability results for ALKS 3831 were similar to
those observed with olanzapine alone. Healthy volunteers who received ALKS 3831
gained an average of 2.5 kg (5.5 lbs), while subjects who received olanzapine
alone gained an average of 3.4 kg (7.5 lbs). The difference between the ALKS
3831 treatment group and the control group receiving olanzapine alone was
statistically significant over the three-week study period (p=0.014), with a
trend indicating the potential for even greater differentiation over longer
study periods. 

About ALKS 3831

ALKS 3831, a proprietary drug compound for the treatment of schizophrenia, is
the combination of ALKS 33, a potent opioid modulator, and the established
antipsychotic agent, olanzapine. Weight gain is a common and clinically relevant
side effect of atypical antipsychotic medications, and olanzapine has one of the
highest incidences and greatest amounts of weight gain among the widely
prescribed products in this class of drugs.1 The weight gain side effect from
atypical antipsychotics may be associated with the onset or exacerbation of
diabetes and dyslipidemia, which are known risk factors for cardiovascular
disease and mortality.2

In preclinical models, an ALKS 3831 regimen was shown to mitigate
olanzapine-induced weight gain without affecting olanzapine`s ability to
demonstrate efficacy in a standard preclinical model used to assess
antipsychotic activity. In another preclinical study, ALKS 3831 was shown to
attenuate olanzapine-induced weight gain and abdominal adipose accretion. 

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 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 planned future
development of ALKS 3831, including the expected timing of the phase 2 study;
and the therapeutic value of ALKS 3831 and ALKS 33. 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 3831 and ALKS 33 will be predictive of future
clinical study results; whether future clinical trials for ALKS 3831 will be
completed on time or at all; whether there will occur potential changes in cost,
scope and duration of the ALKS 3831 clinical development program; whether ALKS
3831 or ALKS 33 could be shown ineffective or unsafe during clinical studies,
and the company may not be permitted by regulatory authorities to undertake new
or additional clinical studies for ALKS 3831 or ALKS 33; and those risks
described in the company`s 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") and 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. 

ZYPREXA® is a registered trademark of Eli Lilly & Company. 

1Komossa K, Rummel-Kluge C, Hunger H, Schmid F, Schwarz S, Duggan L, Kissling W,
Leucht S. Olanzapine versus other atypical antipsychotics for schizophrenia.
Cochrane Database of Systematic Reviews. 2010, Issue 3. Art. No.: CD006654.
2American Diabetes Association; American Psychiatric Association; American
Association of Clinical Endocrinologists; North American Association for the
Study of Obesity. Consensus development conference on antipsychotic drugs and
obesity and diabetes. Diabetes Care. 2004;27:596-601.

Alkermes Contacts:
For Investors:
Rebecca Peterson, +1 781 609 6378
or
For Media:
Jennifer Snyder, +1 781 609 6166 



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