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02/26/14 - €39.32
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alkermes plc (8AK) Details

Alkermes Public Limited Company, an integrated biopharmaceutical company, develops medicines that enhance patient outcomes. The company offers RISPERDAL CONSTA for schizophrenia and bipolar I disorder; INVEGA SUSTENNA to treat schizophrenia; AMPYRA/FAMPYRA to treat multiple sclerosis; BYDUREON to treat type II diabetes; VIVITROL for alcohol and opioid dependence; TRICOR, LIPANTHYL, LIPIDIL, and SUPRALIP to lower cholesterol; ZANAFLEX for muscle spasticity; AVINZA for moderate to severe pain; EMEND to treat nausea associated with chemotherapy and surgery; and FOCALIN XR and RITALIN LA for attention deficit and hyperactivity disorder. Its products also include MEGACE ES to treat cachexia associated with AIDS; LUVOX CR for obsessive-compulsive disorder; RAPAMUNE to prevent renal transplant rejection; NAPRELAN for mild to moderate pain indications; VERAPAMIL SR, VERELAN, VERELAN PM, VERAPAMIL PM, VERECAPS, UNIVER, and AFEDlTAB CR for hypertension; DILZEM SR, DILZEM XL, DILTELAN, and CARDIZEM CD for hypertension and/or angina; and ZOHYDRO ER for severe pain. In addition, it is developing Aripiprazole Lauroxil for the treatment of schizophrenia; ALKS 33, which has completed Phase II study for modulation of brain opioid receptors; ALKS 5461 that is under Phase III study for the treatment of depressive disorder; ALKS 3831, a phase II study medicine to treat schizophrenia; ALKS 8700, a prodrug of monomethyl fumarate to treat multiple sclerosis; ALKS 7106, a small-molecule product candidate to treat pain with intrinsically low potential for abuse and overdose death; and RDB 1419, a proprietary biologic cancer immunotherapy candidate. The company serves pharmaceutical wholesalers, specialty pharmacies, and specialty distributors directly through its sales force. It has collaboration agreements with Janssen Pharmaceutica, NV; AstraZeneca plc; Acorda Therapeutics, Inc.; and other collaboration partners. The company was founded in 1987 and is headquartered in Dublin, Ireland.

1,250 Employees
Last Reported Date: 02/27/14
Founded in 1987

alkermes plc (8AK) Top Compensated Officers

Chairman of the Board and Chief Executive Off...
Total Annual Compensation: $810.2K
Total Annual Compensation: $579.9K
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $444.1K
Chief Operating Officer, Chief Risk Officer a...
Total Annual Compensation: $437.5K
Chief Legal Officer, Chief Compliance Officer...
Total Annual Compensation: $435.5K
Compensation as of Fiscal Year 2013.

alkermes plc (8AK) Key Developments

Alkermes Announces Initiation of Phase 1 Clinical Study of ALKS 8700 for Treatment of Multiple Sclerosis

Alkermes plc announced the initiation of a phase 1 clinical study of ALKS 8700, a novel monomethyl fumarate (MMF) molecule in development for the treatment of multiple sclerosis (MS). The randomized, double-blind study will evaluate the safety, tolerability and pharmacokinetics of several oral formulations of ALKS 8700 compared to both placebo and active control groups in approximately 125 healthy volunteers. ALKS 8700 is designed to rapidly and efficiently convert to MMF in the body and offer differentiated features as compared to the currently marketed dimethyl fumarate, TECFIDERA(R). This phase 1 study will investigate the pharmacokinetics and pharmacodynamics of multiple formulations and doses of ALKS 8700, and is designed to determine those suitable to progress into advanced clinical testing. The initiation of the phase 1 study follows Alkermes' filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA), and the issuance of a composition of matter patent for ALKS 8700 from the United States Patent and Trademark Office (USPTO) in March 2014, which is expected to provide patent protection into 2033.

Alkermes plc Presents Phase 3 Data from Successful Pivotal Study of Aripiprazole Lauroxil for Treatment of Schizophrenia at ASCP Annual Meeting

Alkermes plc announced the presentation of data from its phase 3 clinical trial of aripiprazole lauroxil, an investigational drug candidate in development for schizophrenia, at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Hollywood, Fla. In the pivotal study, both doses of aripiprazole lauroxil tested, 441 mg and 882 mg administered once-monthly, met the primary endpoint with statistically and clinically significant reductions in Positive and Negative Syndrome Scale (PANSS) scores, met all secondary endpoints and demonstrated significant improvements in schizophrenia symptoms versus placebo. This is the first demonstration of the efficacy of a range of doses of a long-acting injectable form of aripiprazole in a randomized clinical trial. The company remains on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2014. Data from the full analysis set of the phase 3 study showed: During the 12-week, double-blind treatment period, patients treated once-monthly with either 441 mg or 882 mg of aripiprazole lauroxil demonstrated statistically and clinically significant placebo-adjusted mean reductions from baseline in PANSS total scores (-10.9 points, p<0.001 for aripiprazole lauroxil 441 mg; and -11.9 points, p<0.001 for aripiprazole lauroxil 882 mg). In addition to meeting the prespecified primary efficacy endpoint of PANSS total score reduction, the study also met the prespecified key secondary endpoint of improvement on the Clinical Global Impression -- Improvement (CGI-I) scale for each aripiprazole lauroxil group versus placebo at Week 12 (p<0.001). Both of the aripiprazole lauroxil dosing groups demonstrated significant improvement at all post-baseline visits. Additionally, all other secondary endpoints were found to be statistically significant across both doses. Overall, 64% of patients who received aripiprazole lauroxil completed the study, compared to 46% of patients who received placebo. Aripiprazole lauroxil was generally well tolerated in the study, and the observed safety profile of aripiprazole lauroxil was similar to that reported with oral aripiprazole. The most common adverse events in the study were insomnia, akathisia and headache. Study Design: The phase 3, randomized, multicenter, double-blind, placebo-controlled study was designed to assess the efficacy, safety and tolerability of aripiprazole lauroxil in patients experiencing acute exacerbation of schizophrenia. The trial included adult patients who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR(R)) criteria for schizophrenia and had a PANSS total score of 70 or higher at study baseline. A total of 623 patients were randomized to receive once-monthly intramuscular injections of aripiprazole lauroxil 441 mg, aripiprazole lauroxil 882 mg or a matching placebo injection of either high volume or low volume for 12 weeks. Following randomization, patients received their first injection along with daily oral study drug for the first three weeks. Patients randomized to the two aripiprazole lauroxil treatment groups received oral aripiprazole for those initial three weeks, while patients randomized to the placebo group received matching oral placebo for three weeks. A total of 596 patients were included in the full analysis set, as defined by those who received at least one dose of study drug and had at least one primary efficacy assessment following administration of study drug. The primary efficacy endpoint of the study was the mean change from baseline at Week 12 in PANSS total score, using an analysis of covariance (ANCOVA) with a last observation carried forward (LOCF) approach. The Hommel procedure was used for multiple hypothesis testing. Efficacy was also analyzed using a mixed model for repeated measures (MMRM) as a sensitivity analysis. All participants in the double-blind portion of the study were eligible to continue in an open-label phase and receive aripiprazole lauroxil for an additional 12 months. The objective of the extension phase of the study is to assess the safety and long-term durability of effect of once-monthly aripiprazole lauroxil.

Alkermes Announces Initiation of FORWARD-3 and FORWARD-4 Efficacy Studies in Pivotal Program for ALKS 5461 for Treatment of Major Depressive Disorder

Alkermes plc announced the initiation of FORWARD-3 and FORWARD-4, two of the three planned phase 3 core efficacy studies in the pivotal clinical program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD). These studies will evaluate the efficacy and safety of ALKS 5461 in patients suffering from MDD who have had an inadequate response to commonly prescribed drugs, including selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). Approximately two-thirds of patients who are diagnosed with MDD do not adequately respond to initial antidepressant therapy. FORWARD-3 and FORWARD-4 are both phase 3, multinational, randomized, double-blind, placebo-controlled studies designed to evaluate the efficacy and safety of ALKS 5461 as adjunctive treatment in patients with MDD. The two studies combined are expected to randomize approximately 1,000 patients and incorporate sophisticated design features to ensure rigorous patient selection, monitoring and evaluation. Data from these two core efficacy studies are expected in 2016. FORWARD-5, the third core efficacy trial, is expected to initiate in mid 2014. The FORWARD (Focused On Results With A Rethinking of Depression) pivotal program for ALKS 5461 includes three core phase 3 efficacy studies, as well as nine supportive studies to evaluate the long-term safety, dosing, pharmacokinetic profile and human abuse liability of ALKS 5461. The three core efficacy studies will utilize methodologies to reduce the impact of clinically meaningful placebo response and are expected to randomize a total of approximately 1,500 patients with MDD who have had an inadequate response to standard therapies. The primary efficacy endpoint for the three core efficacy studies will be the change from baseline in Montgomery--Åsberg Depression Rating Scale (MADRS) scores. Alkermes expects to use safety and efficacy data from the FORWARD program as the basis for a New Drug Application (NDA) to be submitted to the U.S. Food and Drug Administration (FDA), pending study results.


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