plc (NASDAQ: ALKS) today announced that data on three of the
company’s clinical programs are scheduled to be presented at two
upcoming major medical meetings this week. At the Annual Meeting of the
American College of Neuropsychopharmacology (ACNP) in Hollywood, Fla.,
Dec. 2-6, 2012, Alkermes will present pharmacokinetic data on ALKS 9070,
a new chemical entity currently in phase 3 development for the treatment
of schizophrenia. Results will be shown from a clinical trial supporting
the once-monthly dosing regimen for this novel injectable agent. Also at
that meeting, positive results will be presented from a phase 1/2 study
of ALKS 5461, Alkermes’ novel drug candidate for major depressive
disorder (MDD), in patients who have an inadequate response to standard
therapies for clinical depression. Data relating to the potential use of
ALKS 5461 in the treatment of cocaine dependence will also be presented.
At the American Academy of Addiction Psychiatry (AAAP) Annual Meeting in
Aventura, Fla., Dec. 6-9, 2012, new data on the clinical and
pharmacoeconomic benefits of naltrexone for extended-release injectable
suspension (XR-NTX) will be presented. XR-NTX is marketed by Alkermes as
VIVITROL® and is approved in the U.S. for the treatment of
alcohol dependence and the prevention of relapse to opioid dependence
following opioid detoxification.
Key presentations for these two medical meetings include:
Dec. 3, 2012, at 3:00 p.m. EST The oral presentation, “New
Clinical Research in Opioid Modulation Indicates Novel Utility in
Treating Resistant Depression” will be given by Elliot Ehrich, M.D.,
Alkermes, Inc., during a mini-panel session entitled, “Renaissance in
Opioid Biology: From Preclinical Concepts to Clinical Practice.”
Wednesday, Dec. 5, 2012, at 5:30 p.m. EST Poster
18: “ALKS 5461, a Novel Opioid Receptor Modulator, Reduces the
Subjective Effects of Cocaine and was Safe and Well Tolerated During
Concurrent Cocaine Administration” will be presented by Ryan Turncliff,
Ph.D., Alkermes, Inc.
Poster 173: “ALKS 5461, a Novel Opioid Receptor Modulator, Normalizes
Human EEG Responses in an Auditory Oddball Task After Cocaine
Administration as Indicated by a Novel Brain Network Activation
Analysis” will be presented by Edward Sellers, M.D., Ph.D., President
and Principal, DL Global Partners Inc.
Poster 174: “Pharmacokinetic Modeling of ALKS 9070 (ALKS 9072), a Novel
Once-Monthly Prodrug of Aripiprazole” will be presented by Ryan
Turncliff, Ph.D., Alkermes, Inc.
Dec. 8, 2012, at 5:00 p.m. EST “Medication and
Non-Medication Treatment of Alcohol Dependence: A NNT (Number Needed to
Treat) Analysis” will be presented by David Gastfriend, M.D., Alkermes,
“Extended-Release Naltrexone (XR-NTX) in Inpatient Rehab Post-Detox:
Retention, Readmission, Clinical Experience and Impact on Managed Care”
will be presented by Kathleen Brady, M.D., Ph.D., Professor and
Director, Clinical Neuroscience Division at the Medical University of
“Cost-Effectiveness of Treatment with Extended-Release Naltrexone: A
Meta-Analysis Across Five Studies” will be presented by David
Gastfriend, M.D., Alkermes, Inc.
“Extended-Release Injectable Naltrexone (XR-NTX) for Opioid Dependence:
Efficacy in Depressed Patients and Other Clinically Relevant
Subpopulations” will be presented by Edward Nunes, M.D., Professor of
Clinical Psychiatry at Columbia University Medical Center.
About ALKS 9070 and LinkeRx® LinkeRx
is a novel, proprietary technology platform developed by Alkermes that
enables the creation of injectable extended-release atypical
antipsychotics and other central nervous system (CNS) therapies. ALKS
9070, which leverages the LinkeRx technology, is a once-monthly,
injectable atypical antipsychotic in development for the treatment of
schizophrenia. Once in the body, ALKS 9070 converts to aripiprazole.
Aripiprazole is commercially available under the name ABILIFY® for
the treatment of a number of CNS disorders.
About ALKS 5461 ALKS 5461 is
the combination of ALKS 33 and buprenorphine and is designed to be a
non-addictive opioid modulator. ALKS 33 is an oral opioid modulator that
builds on Alkermes’ scientific expertise in opioid biology and
pharmacology, as well as the company’s clinical and commercial knowledge
in the field of addiction and CNS disorders. ALKS 5461 is in clinical
development for the treatment of MDD in patients who have an inadequate
response to standard therapies for clinical depression, as well as for
the treatment of cocaine dependence, which is being funded through a
grant from the National Institute on Drug Abuse (NIDA).
About VIVITROL VIVITROL
(naltrexone for extended-release injectable suspension) 380 mg/vial is
the first and only once-monthly, extended-release injectable medication
for the treatment of alcohol dependence and opioid dependence. The
proprietary Medisorb® drug delivery technology in VIVITROL
enables the medication to be gradually released into the body at a
controlled rate over a one-month time period. Treatment with VIVITROL
should be part of a comprehensive treatment program that includes
psychosocial support. VIVITROL has been studied in more than 1,000
patients and has been used to treat more than 45,000 people for alcohol
and opioid dependence in the U.S. The VIVITROL clinical development
program was funded in part with a Small Business Innovation Research
Program grant from NIDA. For a copy of the VIVITROL full prescribing
information, please visit www.vivitrol.com
or call 1-800-VIVITROL (1-800-848-4876). Please see below for important
safety information, including boxed warning.
Important Safety Information for VIVITROL®
(naltrexone for extended-release injectable suspension) 380 mg/vial.
Naltrexone has the capacity to cause hepatocellular injury when given
in excessive doses.
Naltrexone is contraindicated in acute hepatitis or liver failure,
and its use in patients with active liver disease must be carefully
considered in light of its hepatotoxic effects.
The margin of separation between the apparently safe dose of
naltrexone and the dose causing hepatic injury appears to be only
five-fold or less. VIVITROL does not appear to be a hepatotoxin at the
Patients should be warned of the risk of hepatic injury and advised
to seek medical attention if they experience symptoms of acute
hepatitis. Use of VIVITROL should be discontinued in the event of
symptoms and/or signs of acute hepatitis.
VIVITROL is contraindicated in patients with acute hepatitis or liver
failure, patients receiving opioid analgesics, patients with current
physiologic opioid dependence, patients in acute opioid withdrawal, any
individual who has failed the naloxone challenge test or has a positive
urine screen for opioids, and in patients who have previously exhibited
hypersensitivity to naltrexone, polylactide-co-glycolide (PLG),
carboxymethylcellulose or any other components of the diluent.
• Injection Site Reactions: VIVITROL is administered as an
intramuscular (IM) gluteal injection. Inadvertent subcutaneous injection
of VIVITROL may increase the likelihood of severe injection site
reactions. VIVITROL must be injected using one of the customized needles
provided in the carton. Because needle length may not be adequate due to
body habitus, each patient should be assessed prior to each injection to
assure that needle length is adequate for IM administration. VIVITROL
injections may be followed by pain, tenderness, induration, swelling,
erythema, bruising or pruritus; however, in some cases injection site
reactions may be very severe. Injection site reactions not improving may
require prompt medical attention, including in some cases surgical
• Eosinophilic Pneumonia: VIVITROL patients should be warned of
the risk of eosinophilic pneumonia, and advised to seek medical
attention should they develop symptoms of pneumonia.
• Hypersensitivity Reactions Including Anaphylaxis: Patients
should be warned of the risk of hypersensitivity reactions, including
• Unintended Precipitation of Opioid Withdrawal: Opioid-dependent
and opioid-using patients, including those being treated for alcohol
dependence, must be opioid-free for a minimum of 7-10 days before
starting VIVITROL treatment.
• Opioid Overdose at the End of a Dosing Interval, After Missing a
Dose and Following an Attempt to Overcome Opioid Blockade: Use of
lower doses of opioids after VIVITROL treatment is discontinued, at the
end of a dosing interval, or after missing a dose could result in
life-threatening opioid intoxication. Any attempt by a patient to
overcome the blockade produced by VIVITROL by taking opioids is very
dangerous and may lead to fatal overdose.
• Depression and Suicidality: VIVITROL patients should be
monitored for the development of depression or suicidal thinking.
• Intramuscular Injections: VIVITROL should be administered with
caution to patients with thrombocytopenia or any coagulation disorder.
• When Reversal of VIVITROL Blockade is Required for Pain Management: In
an emergency situation in patients receiving VIVITROL, suggestions for
pain management include regional analgesia or use of non-opioid
The adverse events seen most frequently in association with VIVITROL
therapy for alcohol dependence include nausea, vomiting, injection site
reactions (including induration, pruritus, nodules and swelling), muscle
cramps, dizziness or syncope, somnolence or sedation, anorexia,
decreased appetite or other appetite disorders. The adverse events seen
most frequently in association with VIVITROL in opioid-dependent
patients include hepatic enzyme abnormalities, injection site pain,
nasopharyngitis, insomnia, and toothache.
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. These statements are neither promises nor guarantees
and are subject to a variety of risks and uncertainties, many of which
are beyond the company’s control, which could cause actual results to
differ materially from those contemplated in these forward-looking
These risks and uncertainties include the 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
Existing and prospective investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the
date they are made. 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.
VIVITROL® and Medisorb® are registered trademarks
of Alkermes, Inc. LinkeRx® is a registered trademark of
Alkermes Pharma Ireland Limited. ABILIFY® is a registered
trademark of Otsuka Pharmaceutical Co., Ltd.
Alkermes Contacts: For Investors: Rebecca
Peterson, +1 781 609 6378 or For Media: Jennifer Snyder,
+1 781 609 6166