Schizophrenia and Bipolar Disorder

At any given time, an estimated one percent of the world’s population suffers from schizophrenia and approximately 2.6 percent of American adults are affected by bipolar disorder. To aid them, our partner, Janssen is marketing RISPERDAL® CONSTA®, a long-acting injection of the oral medicine RISPERDAL® (risperidone).

 

• Market Size: In 2008, worldwide sales of RISPERDAL CONSTA were approximately $1.3 billion. RISPERDAL CONSTA is currently commercialized for the treatment of schizophrenia in over 60 countries. In the U.S., RISPERDAL CONSTA is also approved for as both a monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment of bipolar I disorder.  
• Long-acting formulation: RISPERDAL CONSTA uses Alkermes’ proprietary Medisorb® technology to deliver and maintain therapeutic medication levels in the body through just one injection every two weeks.
• Pipeline update: In June 2009, J&JPRD launched RISPERDAL CONSTA in Japan for the treatment of schizophrenia.

For more information, please visit www.risperdalconsta.com.

RISPERDAL CONSTA Full U.S. Prescribing Information
 

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Alcohol Dependence

Approximately 18 million people in the U.S. abuse alcohol; half of them are alcohol dependent. VIVITROL®, the first and only once-monthly injectable medication for alcohol dependence, is intended to be used in combination with psychosocial support, such as counseling or group therapy.

 

• Long-acting formulation: VIVITROL uses Alkermes’ proprietary Medisorb® technology to deliver and maintain therapeutic medication levels in the body through just one injection every month.
• Market opportunity: Over the past several years, medication has become increasingly recognized as an effective treatment for alcohol dependence. In the U.S., an estimated 2.6 million people receive treatment for alcohol dependence or abuse each year.(1) In addition, VIVITROL is approved in Russia, where the growing market includes approximately 10 million alcohol dependent people.(2)

For more information, please visit www.vivitrol.com.

VIVITROL Full U.S. Prescribing Information

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Opioid Dependence

Opioid dependence is a serious disease affecting approximately two million people in the U.S.(1) In addition to the use of heroin, an illegal opioid, opioid dependence includes the non-medical use of opioid analgesics approved by the U.S. Food and Drug Administration (FDA). We are developing VIVITROL® as a potential new treatment option for people who are dependent upon or abuse opioids.

 

• New treatment paradigm: There are few approved medications available for treating opioid dependence and no approved long-acting antagonist therapies. If approved, VIVITROL would be the first and only non-narcotic, non-addictive, long-acting medication for the treatment of opioid dependence.
• Pipeline progress: In November 2009, Alkermes announced positive preliminary results from a phase 3 clinical trial of VIVITROL for the treatment of opioid dependence.  The six-month phase 3 study met its primary efficacy endpoint and data showed that patients treated once-monthly with VIVITROL demonstrated statistically significant higher rates of clean (opioid-free) urine screens, compared to patients treated with placebo. Based on the positive results of this phase 3 study, Alkermes plans to file a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) in the first half of calendar 2010.

VIVITROL is not currently approved for the treatment of opioid dependence.




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Alcohol Dependence

Approximately 18 million people in the U.S. abuse alcohol; half of them are alcohol dependent. We are developing ALKS 29, an oral compound for the treatment of alcohol dependence, which could offer a new treatment option for people suffering from this disease.

 

• Potential for an effective, oral therapy: Addiction is an underserved disease area where a variety of treatments are needed that can improve outcomes for patients. ALKS 29, a co-formulation of baclofen and ALKS 33, is designed to provide enhanced medical benefits over current oral medications for the treatment of alcohol dependence.
• Pipeline progress: Alkermes is currently evaluating the components of ALKS 29 separately. In April 2009, Alkermes announced positive topline data from a clinical study of a proprietary, extended-release formulation of baclofen. In the open-label, crossover study involving 16 healthy volunteers, Alkermes’ extended-release baclofen formulation demonstrated a favorable pharmacokinetic profile compared to the currently marketed, immediate-release formulation and was generally well tolerated.

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Addiction

ALKS 33 is an investigational oral opioid modulator in development for the treatment of addiction. Opioid modulators are thought to have a number of clinical applications, including the treatment of central nervous system disorders and impulse-control disorders. ALKS 33 builds on Alkermes’ unique understanding of biological pathways as well as the company’s clinical and commercial knowledge of opioid pharmacology.

 

• Potential for an effective oral therapy: Clinical data has shown that ALKS 33 is generally well tolerated and demonstrated rapid oral absorption, high plasma concentrations and duration of action that supports once daily dosing. Furthermore, data has shown that ALKS 33 is not readily metabolized by the liver, a unique advantage over certain oral therapies for addiction.
• Pipeline progress: In November 2009, Alkermes initiated a phase 2 study of ALKS 33 in alcohol dependent patients. The study will assess the safety and efficacy of multiple doses of ALKS 33 and is designed to further define the clinical profile of ALKS 33.

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Type 2 Diabetes

Ninety to 95 percent of the estimated 246 million adults worldwide who suffer from diabetes have type 2 diabetes.(1) Despite the introduction of new medications over the last decade, many people with diabetes are unable to control their blood sugar.(2) An extended-release formulation of exenatide may provide a new treatment option for patients with type 2 diabetes.

 

• New treatment paradigm: Exenatide once weekly is an extended-release formulation that contains the same active ingredient in BYETTA® injection. BYETTA is a first-in-class injectable medication for the treatment of type 2 diabetes, and is administered twice daily. In clinical studies, exenatide once weekly has demonstrated superior blood sugar control compared to sitagliptin, pioglitazone and insulin glargine, common diabetes medications with combined 2008 sales exceeding $8 billion.
• Pipeline progress: In May 2009, Alkermes, Amylin Pharmaceuticals, Inc. and Eli Lilly and Company submitted a New Drug Application (NDA) for exenatide once weekly to the U.S. Food and Drug Administration (FDA). The NDA was accepted for review by the FDA in July 2009. If approved, exenatide once weekly would be the first once-a-week therapy for the treatment of type 2 diabetes.

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Chronic Obstructive Pulmonary Disease

Chronic Obstructive pulmonary disease (COPD) is a chronic disease of the airways that is characterized by a gradual loss of lung function. The fourth leading cause of death in the U.S., it is estimated that over 12 million adults have been diagnosed with COPD.

 

• Potential for once-daily dosing: ALKS 27 leverages Alkermes’ proprietary AIR® technology and is being developed as an inhaled formulation with the potential for once-daily dosing through a simple inhaler.
• Pipeline progress: In August 2009, Alkermes reported positive topline data from a clinical study of ALKS 27 in 24 patients with COPD.  In the randomized, double-blind, crossover study, ALKS 27 was generally well tolerated, had a rapid onset of action, and led to statistically significant improvements in lung function compared to placebo.

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Pain

ALKS 36 is an oral co-formulation of an opioid analgesic and ALKS 37, a peripherally-restricted opioid antagonist with potential to block the opioid agonist effects on gastrointestinal motility. A pain medication that does not inhibit gastrointestinal motility, such as ALKS 36, may provide a unique advantage over current therapies.

 

• Unmet medical need:  Opioids are a common and effective treatment for managing chronic pain, with over 200 million prescriptions written for opioids in the U.S. in 2007. Many studies indicate that a high percentage of patients receiving opioids are likely to experience side effects affecting gastrointestinal motility, which can be debilitating and may diminish patient adherence to pain medication.
• Pipeline progress: In October 2009, Alkermes initiated a phase 1 clinical study of ALKS 37, a component of ALKS 36. The randomized, double-blind, placebo-controlled study will assess the safety, tolerability and pharmacokinetic effects of a single oral administration of five doses of ALKS 37 in approximately 40 healthy volunteers. The company expects to report top-line results from the study in the first half of calendar 2010.

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Opioid-Induced Constipation

ALKS 37 is an orally active, peripherally-restricted opioid antagonist with potential to block the opioid agonist effects on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC). ALKS 37 is a component of ALKS 36, a co-formulation of an opioid analgesic and ALKS 37.

 

• Unmet medical need:  IMS Health shows over 200 million prescriptions were written for opioids in 2007 in the U.S., yet a high percentage of patients receiving opioids are likely to experience side effects affecting gastrointestinal motility. There are currently no available oral therapies for OIC, which has severe quality of life implications.
• Pipeline progress: Preclinical studies have shown ALKS 37 targets the gastrointestinal tract following oral administration, with limited systemic exposure. Based on these results, in October 2009, Alkermes initiated a phase 1 clinical study of ALKS 37. The randomized, double-blind, placebo-controlled study will assess the safety, tolerability and pharmacokinetic effects of a single oral administration of five doses of ALKS 37 in approximately 40 healthy volunteers. The company expects to report top-line results from the study in the first half of calendar 2010.

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Rheumatoid Arthritis 

ALKS 6931 is a long-acting form of a TNF receptor-Fc fusion protein for the treatment of rheumatoid arthritis (RA) and related autoimmune diseases. The TNF receptor-Fc fusion protein, which utilizes Alkermes’ proprietary Medifusion™ technology, is structurally similar to etanercept. In vivo studies have shown an extended half-life for ALKS 6931 beyond the half-life of etanercept. ALKS 6931 builds on Alkermes’ unique expertise and insight in developing effective long-acting medications in areas of unmet medical need.

• Unmet medical need:  Of the estimated 1.8 million Americans suffering from RA, only 6% are treated with TNF inhibitors, suggesting that there is room for market growth. In addition, research has shown that the long and successful clinical history of etanercept could make the long-acting version a particularly helpful therapeutic candidate for patients and their physicians.
• Pipeline progress: In December 2009, Alkermes announced that Accleron Pharma, Inc. is conducting preclinical studies of ALKS 6931 and Alkermes expects to file an Investigational New Drug Application (IND) for ALKS 6931 with the U.S. Food and Drug Administration (FDA) in calendar 2010.

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Schizophrenia 

ALKS 9070 is a once-monthly, injectable, extended-release version of aripiprazole for the treatment of schizophrenia. ALKS 9070, which utilizes the company’s proprietary LinkeRx™ technology, builds on Alkermes’ unique expertise and insight in developing effective long-acting medications in areas of unmet medical need.

• Unmet medical need:  Approximately 1% of the world’s population suffers from schizophrenia. Studies have shown that use of long-acting medications for the treatment of schizophrenia can improve patient outcomes and reduce costs. An additional extended-release injectable medication such as ALKS 9070 could provide another valuable option for patients and physicians to manage this serious, chronic disease.
• Pipeline progress: Alkermes expects to initiate a phase 1 clinical trial for ALKS 9070 in the second half of calendar 2010.

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