Full Description

Alkermes, Inc. (Alkermes) is an integrated biotechnology company. The Company has developed, manufactured and commercialized VIVITROL for alcohol dependence and manufactured RISPERDAL CONSTA for schizophrenia and bipolar disorder. Its pipeline includes injectable, pulmonary and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. It has research facilities in Massachusetts and a commercial manufacturing facility in Ohio.

RISPERDAL CONSTA

Alkermes is a long-acting formulation of risperidone, a product of Janssen Pharmaceutica, Inc., a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica International, a division of Cilag International (together, Janssen). RISPERDAL CONSTA is the long-acting, atypical antipsychotic to be approved by the United States Food and Drug Administration (FDA). The medication uses its Medisorb technology to deliver and maintain therapeutic medication levels in the body through just one injection every two weeks. RISPERDAL CONSTA is approved for the treatment of schizophrenia in approximately 85 countries and marketed in approximately 60 countries, and Janssen continues to launch the product around the world. In the United States, RISPERDAL CONSTA is also approved for the treatment of bipolar I disorder.

In October 2008, the FDA approved the deltoid muscle of the arm as a new injection site for RISPERDAL CONSTA. In January 2009, the Company announced that its partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), initiated a phase I, single-dose, open-label study of a four-week, long-acting injectable formulation of risperidone for the treatment of schizophrenia. The study is designed to assess the pharmacokinetics, safety and tolerability of a gluteal injection of this risperidone formulation in approximately 26 patients diagnosed with chronic, stable schizophrenia. In April 2009, it announced that Janssen received approval from the Pharmaceuticals and Medical Devices Agency in Japan to market RISPERDAL CONSTA for the treatment of schizophrenia. In May 2009, the FDA approved RISPERDAL CONSTA for use as both a monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment of bipolar I disorder.

VIVITROL

VIVITROL is an extended-release Medisorb formulation of naltrexone developed by Alkermes. VIVITROL is the once-monthly injectable medication for the treatment of alcohol dependence. Each injection of VIVITROL provides medication for one month and alleviates the need for patients to make daily medication dosing decisions. VIVITROL was approved by the FDA. In August 2008, the Russian regulatory authorities approved VIVITROL for the treatment of alcohol dependence. The Company’s collaborator, Cilag GmbH International (Cilag), a subsidiary of Johnson & Johnson, launched VIVITROL in Russia in March 2009.

The Company is also developing VIVITROL for the treatment of opioid dependence, a serious and chronic brain disease characterized by compulsive, prolonged-self administration of opioid substances that are not used for a medical purpose. In June 2008, it initiated a randomized, multi-center registration study of VIVITROL in Russia for the treatment of opioid dependence. The study is designed to assess the efficacy and safety of VIVITROL in more than 250 opioid dependent patients.

Exenatide Once Weekly

The Company is collaborating with Amylin Pharmaceuticals, Inc. (Amylin) on the development of exenatide once weekly for the treatment of type 2 diabetes. Exenatide once weekly is an injectable formulation of Amylin’s BYETTA (exenatide), which is an injection administered twice daily. BYETTA was approved by the FDA, as adjunctive therapy to improve blood sugar control in patients with type 2 diabetes who have not achieved adequate control on metformin and/or sulfonylurea, which are commonly used oral diabetes medications. Amylin has an agreement with Eli Lilly and Company (Lilly) for the development and commercialization of exenatide, including exenatide once weekly.

In June 2008, the Company, Amylin and Lilly announced positive results from a 52-week, open-label clinical study (DURATION-1 study) that showed the durable efficacy of exenatide once weekly. In March 2009, the Company, Amylin and Lilly reported positive results from a 26-week, double-blind superiority study that compared exenatide once weekly to sitagliptin or pioglitazone (DURATION-2 study). In May 2009, Amylin submitted a new drug application (NDA) to the FDA for the treatment of type 2 diabetes.

ALKS 33

ALKS 33 is an opioid modulator, identified from the library of compounds in-licensed from Rensselaer Polytechnic Institute (RPI). In July 2008, the Company announced positive preclinical results for ALKS 33. In April 2009, it reported positive results from a phase I randomized, double-blind, placebo-controlled study for ALKS 33 in healthy volunteers.

ALKS 29

The Company is developing ALKS 29, an oral combination therapy for the treatment of alcohol dependence. ALKS 29 is a co-formulation of ALKS 33, an opioid modulator, and baclofen, an FDA-approved muscle relaxant and antispasmodic therapeutic. In April 2009, the Company reported positive data from a phase I, open-label crossover study of an extended-release formulation of baclofen.

ALKS 27

Using the Company’s AIR pulmonary technology, it is developing an inhaled trospium product for the treatment of chronic obstructive pulmonary disease (COPD). COPD is a serious, chronic disease characterized by a gradual loss of lung function. In February 2009, it initiated a phase IIa study of ALKS 27 designed to assess the efficacy, safety, tolerability and pharmacokinetics of ALKS 27 in patients with COPD. In this randomized, double-blind, cross-over, placebo-controlled study, patients are focused to receive single administrations of three doses of ALKS 27 and placebo, each separated by a wash out period.

ALKS 36

The Company is developing ALKS 36, a co-formulation of an opioid analgesic and RDC-1036, an oral, peripherally-acting opioid antagonist, for the treatment of pain. In November 2008, it announced positive preclinical data demonstrating that RDC-1036 was effective in reversing opioid effects on gastrointestinal motility.

The Company competes with Forest Laboratories, Inc., Odyssey Pharmaceuticals, Inc., Duramed Pharmaceuticals, Inc., Bristol-Myers Squibb Pharmaceuticals Ltd. and Mallinckrodt, Inc.