Last €33.68 EUR
Change Today -0.421 / -1.23%
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As of 12:59 PM 10/20/14 All times are local (Market data is delayed by at least 15 minutes).

alkermes plc (8AK) Snapshot

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02/26/14 - €39.32
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10/24/13 - €24.83
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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 plc Announces Completion of Patient Enrollment in Phase 2 Study of ALKS 3831

Alkermes plc announced completion of patient enrollment in a phase 2 study of ALKS 3831, an investigational, novel, oral, broad-spectrum atypical antipsychotic medicine in development for the treatment of schizophrenia. ALKS 3831 is composed of samidorphan, a novel, potent mu-opioid antagonist, in combination with the established antipsychotic drug, olanzapine. The double-blind, active-controlled, dose-ranging study will assess ALKS 3831's efficacy, safety and tolerability in the treatment of schizophrenia and its attenuation of weight gain, compared with olanzapine. Weight gain is a common and clinically relevant metabolic side effect of atypical antipsychotic medications. This double-blind, olanzapine-controlled phase 2 study randomized 309 patients at multiple centers in the U.S. and Europe. Alkermes expects topline results from the 12-week, double-blind treatment period of this phase 2 study in early 2015. The double-blind treatment period will be followed by an additional 12-week period in which all patients will receive ALKS 3831.

Alkermes Announces Initiation of Phase 1 Clinical Study of ALKS 7106 for Treatment of Pain

Alkermes plc announced the initiation of a phase 1 clinical study of ALKS 7106, a proprietary, novel, oral, small-molecule drug candidate for the treatment of pain. The randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics of ALKS 7106 in approximately 80 healthy, male adults. ALKS 7106 represents a new class of analgesic agents in development at Alkermes: potent opioid modulators designed for the treatment of pain with intrinsically low potential for abuse and overdose death -- two liabilities associated with opioid analgesics. ALKS 7106's potential attributes derive from its intrinsic mechanism of action in the brain rather than through the use of abuse-deterrent technologies or formulations. This phase 1, randomized, double-blind, placebo-controlled, single-ascending-dose, multi-cohort, four-week study will evaluate the safety, tolerability and pharmacokinetics of ALKS 7106 administered orally in approximately 80 healthy, male adults. Results from this phase 1 study are expected in the first half of 2015.

Alkermes plc Submits New Drug Application to FDA for Aripiprazole Lauroxil for Treatment of Schizophrenia

Alkermes plc announced that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of aripiprazole lauroxil, the company's investigational, novel, once-monthly, long-acting injectable atypical antipsychotic for the treatment of schizophrenia. The data submitted as part of this NDA include the positive results from the pivotal phase 3 study assessing the efficacy and safety of aripiprazole lauroxil, in which aripiprazole lauroxil demonstrated significant improvements in schizophrenia symptoms, compared to placebo. The NDA submission follows the completion of the randomized, multicenter, double-blind, placebo-controlled, phase 3 study, in which both doses of aripiprazole lauroxil tested, 441 mg and 882 mg administered once monthly, met the primary endpoint with statistically significant and clinically meaningful reductions in Positive and Negative Syndrome Scale (PANSS) scores, met all secondary endpoints and demonstrated significant improvements in schizophrenia symptoms versus 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.


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