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Profile: Alkermes Plc (ALKS.O)

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Alkermes plc, incorporated on May 4, 2011, is a biopharmaceutical company. The Company is engaged in the researching, developing and commercializing pharmaceutical products that are designed to address medical needs of patients in therapeutic areas. The Company has a portfolio of marketed drug products and a clinical pipeline of products that address central nervous system (CNS) disorders, such as schizophrenia, depression, addiction and multiple sclerosis (MS). Its products include ARISTADA, VIVITROL, INVEGA SUSTENNA, XEPLION, INVEGA TRINZA, TREVICTA, RISPERDAL CONSTA, AMPYRA, FAMPYRA, BYDUREON, Aripiprazole lauroxil, ALKS 5461, ALKS 3831, ALKS 8700, ALKS 6428, ALKS 4230 and ALKS 7119.

The Company's product platforms include injectable extended release microsphere technology, LinkeRx technology, NanoCrystal technology and oral controlled release (OCR) technology. The Company's subsidiaries include Alkermes Ireland Holdings Limited, Daravita Pharma Ireland Limited, Daravita Limited, Alkermes Science Four Limited, Alkermes Science Five Limited, Alkermes Science Six Limited, Alkermes Pharma Ireland Limited, Alkermes U.S. Holdings, Inc., Alkermes, Inc., Alkermes Controlled Therapeutics, Inc., Alkermes Europe, Ltd., Alkermes Finance Ireland Limited, Alkermes Finance Ireland (No. 2) Limited, Alkermes Finance Ireland (No. 3) Limited and Alkermes Finance S.a r.l.

ARISTADA is an extended-release intramuscular injectable suspension for the treatment of schizophrenia. It utilizes its LinkeRx technology. It is a prodrug; once in the body, it is converted by enzyme-mediated hydrolysis to N-hydroxymethyl aripiprazole, which is then hydrolyzed to aripiprazole. It is the antipsychotic with once-monthly and six-week dosing options to deliver and maintain therapeutic levels of medication in the body. It has three dosing options: 441 milligrams (mg), 662 mg and 882 mg and is packaged in a pre-filled product format. It develops, manufactures and commercializes it in the United States.

VIVITROL is a once monthly, non-addictive and injectable medication for the treatment of alcohol dependence and for the prevention of relapse to opioid dependence, following opioid detoxification. It uses its polymer based microsphere injectable extended release technology to deliver and maintain therapeutic medication levels in the body through one intramuscular injection every four weeks. It develops, manufactures and commercializes VIVITROL in the United States, Russia and other countries.

INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and RISPERDAL CONSTA are antipsychotics. INVEGA SUSTENNA is for the treatment of schizophrenia and for the treatment of schizoaffective disorder as either a monotherapy or adjunctive therapy. INVEGA SUSTENNA/XEPLION extended-release injectable suspension is for the treatment of schizophrenia and is marketed and sold under the trade name, XEPLION. INVEGA SUSTENNA/XEPLION uses its nanoparticle injectable extended-release technology to increase the rate of dissolution and enable the formulation of an aqueous suspension for once-monthly intramuscular administration.

INVEGA TRINZA is an antipsychotic injection for the treatment of schizophrenia used in people treated with INVEGA SUSTENNA. INVEGA TRINZA is the schizophrenia treatment to be taken once every three months. TREVICTA is used for the maintenance treatment of schizophrenia in adult patients clinically stable on XEPLION. RISPERDAL CONSTA is approved for the treatment of schizophrenia and as both monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment of bipolar I disorder. It uses its polymer-based microsphere injectable extended-release technology to deliver and maintain therapeutic medication levels in the body through just one intramuscular injection every two weeks.

AMPYRA (dalfampridine)/FAMPYRA (fampridine) is the treatment approved across Europe, Asia and the Americas to develop walking in adults with MS having walking disability. Extended-release dalfampridine tablets are marketed and sold by Acorda in the United States under the trade name AMPYRA and by Biogen MA Inc. outside the United States under the trade name FAMPYRA. BYDUREON (exenatide extended-release for injectable suspension) is approved for the treatment of type 2 diabetes. BYDUREON, a once-weekly formulation of exenatide, uses its polymer-based microsphere injectable extended-release technology. BYDUREON Pen 2 mg, a pre-filled, single use pen injector that contains the same formulation and dose as the original BYDUREON single dose tray, is available in the United States, certain countries in the European Union and Japan.

Aripiprazole lauroxil, which is an intramuscular injectable antipsychotic available as ARISTADA, with once monthly and six-week dosing options, for the treatment of schizophrenia, is in development with a two-month dosing interval. ALKS 5461 is a once-daily, oral sublingual investigational medicine, with a mechanism of action, in development for the adjunctive treatment of major depressive disorder (MDD) in patients with a response to standard antidepressant therapies. ALKS 5461 consists of samidorphan in combination with buprenorphine.

ALKS 3831 is an oral investigational medicine designed as an antipsychotic for the treatment of schizophrenia. ALKS 3831 consists of samidorphan in combination with the established antipsychotic drug olanzapine, which is available under the name ZYPREXA. ALKS 3831 is designed to provide the ability of olanzapine and a differentiated safety profile from olanzapine with weight and metabolic properties and to have utility in the treatment of schizophrenia in patients with co-occurring alcohol use disorder. ALKS 8700 is an oral investigational monomethyl fumarate (MMF) molecule in development for the treatment of MS.

ALKS 6428 is designed to enable healthcare providers' transition patients from physical dependence on opioids to initiation with VIVITROL. ALKS 6428 is an investigational regimen of ascending doses of oral naltrexone administered in conjunction with ancillary medications during a seven-day treatment period, prior to first VIVITROL injection. ALKS 4230 is its selective effector cell activator (SECA) that is designed to harness a patient's immune system to activate and increase the number of tumor killing immune cells. SECA proteins target immune cells to avoid expansion of immune regulatory cells, which interfere with the anti-tumor response. SECA molecules are engineered using its fusion protein technology platform to modulate the natural mechanism of action of a biologic product. ALKS 7119 is an oral investigational medicine that has a multivalent mechanism of action that acts on receptors in the brain involved in several CNS diseases, including agitation in Alzheimer's disease, MDD and others.

The injectable extended release microsphere technology allows to encapsulate small molecule pharmaceuticals, peptides and proteins in microspheres made of common medical polymers. The technology is designed to enable formulations of pharmaceuticals by providing controlled, extended release of drugs over time. The LinkeRx technology platform is designed to enable the creation of extended release injectable versions of antipsychotic therapies and are also useful in other disease areas in, which extended duration of action provides therapeutic benefits. The technology uses linker tail chemistry to create new molecular entities derived from known agents.

The NanoCrystal technology is applicable to water soluble compounds and involves formulating and stabilizing drugs into particles that are nanometers in size. A drug in NanoCrystal form can be incorporated into a range of common dosage forms and administration routes, including tablets, capsules, inhalation devices and sterile forms for injection. Its OCR technologies are used to formulate, develop and manufacture oral dosage forms of pharmaceutical products that control the release characteristics of standard dosage forms. Its OCR platform includes technologies for pharmacokinetic profiles, including Spheroidal Oral Drug Absorption System (SODAS) technology, Chronotherapeutic Oral Drug Absorption System (CODAS) technology, Intestinal Protective Drug Absorption System (IPDAS) technology and the Matrix Drug Absorption System (MXDAS) drug absorption system.

SODAS technology involves producing spherical beads of 1 millimeter (mm) to 2 mm in diameter containing drug plus excipients and coated with product specific modified release polymers. CODAS technology enables the delayed onset of drug release incorporating the use of specific polymers, resulting in a drug release profile that complements circadian patterns. IPDAS technology conveys gastrointestinal protection by a dispersion of drug in a manner, through the use of controlled release beads compressed into a tablet form. MXDAS technology formulates the drug in a hydrophilic matrix and incorporates one or more hydrophilic matrix forming polymers into a solid oral dosage form, which controls the release of drug through a process of diffusion and erosion in the gastrointestinal tract.

The Company competes with Eli Lilly & Company, Otsuka Pharmaceutical Co., Ltd., Indivior plc, BioDelivery Sciences, Braeburn Pharmaceuticals, Orexo US, Inc., Novo Nordisk A/S, Biogen MA Inc., Bayer HealthCare Pharmaceuticals, Teva Pharmaceutical Industries Ltd, EMD Serono, Inc., Novartis AG, and Sanofi Aventis.

Company Address

Alkermes Plc

Connaught HSE, 1 Burlington Road
DUBLIN     00000
P: +3531.7728000

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