Profile: Alkermes Plc (ALKS.O)
Alkermes Public Limited Company, incorporated on May 4, 2011, is an integrated, global biopharmaceutical company. The Company has a portfolio of more than 20 commercial drug products and a clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. The Company manufactures RISPERDAL CONSTA, VIVITROL and polymer for BYDUREON in its Wilmington, Ohio facility. The Company operates PERDAL CONSTA lines and one VIVITROL line at commercial scale. The Company manufactures AMPYRA/FAMPYRA, RAPAMUNE and other products in its Athlone, Ireland facility. It manufactures FOCALIN XR, RITALIN LA, AVINZA, VERAPAMIL and other products in its Gainesville, Georgia facility.
RISPERDAL CONSTA and INVEGA SUSTENNA/XEPLION
The Company’s RISPERDAL CONSTA (risperidone long-acting injection) and INVEGA SUSTENNA/XEPLION (paliperidone palmitate extended-release injectable suspension) are long-acting atypical antipsychotics that incorporate its technologies. RISPERDAL CONSTA uses its polymer-based microsphere injectable extended-release technology to deliver and maintain therapeutic medication levels in the body through just one injection every two weeks. RISPERDAL CONSTA is manufactured by the Company and is marketed and sold by Ortho-McNeil-Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica International, a division of Cilag International AG (Janssen) around the globe. INVEGA SUSTENNA 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.
The product incorporates the Company’s OCR technology. AMPYRA and FAMPYRA are manufactured by the Company.
The Company collaborated with Amylin Pharmaceuticals, Inc on the development of BYDUREON. BYDUREON, a once-weekly formulation of exenatide, the active ingredient in BYETTA (exenatide), uses its polymer-based microsphere injectable extended-release technology.
The medication uses the Company’s polymer-based microsphere injectable extended-release technology to deliver and maintain therapeutic medication levels in the body through just one injection every four weeks. The Company markets and sells VIVITROL in the United States Cilag sells VIVITROL in Russia.
The Company is studying aripiprazole lauroxil for the treatment of schizophrenia. Aripiprazole lauroxil is designed to provide once-monthly dosing of a medication that converts in vivo into aripiprazole, a molecule that is commercially available under the name ABILIFY.
ALKS 33 is an oral opioid modulator characterized by limited hepatic metabolism and durable pharmacologic activity in modulating brain opioid receptors. ALKS 33 has completed a phase 2 study in alcohol dependence and is being evaluated as a component of ALKS 5461 and ALKS 3831.
ALKS 5461 is an investigational medicine with a mechanism for the treatment of depressive disorder. ALKS 5461 consists of buprenorphine, a partial agonist, and ALKS 33, a potent mu-opioid antagonist, and is designed to be a once-daily, non-addictive medicine.
ZOHYDRO ER (hydrocodone bitartrate extended-release capsules) is an oral, single-entity (without acetaminophen), controlled-release formulation of hydrocodone in development by Zogenix, Inc. ZOHYDRO ER utilizes its oral controlled-release technology, which nables longer-lasting and more consistent pain relief with fewer daily doses.
ALKS 3831 is a medicine designed as a spectrum treatment for schizophrenia. ALKS 3831consist of ALKS 33, an opioid modulator that acts as a potent mu-opioid antagonist, in combination with the antipsychotic drug olanzapine. ALKS 3831 is designed to attenuate olanzapine-induced metabolic side effects, including weight gain, and offer the therapeutic benefits of olanzapine to a range of patients with schizophrenia.
The Company Lilly, Otsuka Pharmaceutical Co., Ltd., Forest Laboratories, Odyssey Pharmaceuticals, Benckiser Pharmaceuticals, Inc., Novo Nordisk A/S, Biogen Idec, Bayer HealthCare Pharmaceuticals, Teva Pharmaceutical Industries Ltd, Merck Serono, Novartis AG, and Sanofi-Aventis.
1 Burlington Road, Dublin 4