FDA Approves ARISTADA INITIO™ for the Initiation of ARISTADA® for Schizophrenia

-- Novel Regimen Enables Physicians to Fully Dose Up to Two Months of ARISTADA Treatment on Day One --

DUBLIN, Ireland I July 2, 2018 I Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved ARISTADA INITIO (aripiprazole lauroxil) for the initiation of ARISTADA® (aripiprazole lauroxil), a long-acting injectable atypical antipsychotic for the treatment of schizophrenia in adults. For the first time, ARISTADA INITIO, in combination with a single 30 mg dose of oral aripiprazole, provides physicians with an alternative regimen to initiate patients onto any dose of ARISTADA on day one. ARISTADA INITIO is expected to be available in mid-July.

For people living with schizophrenia, medication compliance and continuity of care can be challenging and the transition from inpatient care to outpatient settings can be an especially vulnerable time.1 Previously, the standard initiation regimen for ARISTADA included 21 consecutive days of oral aripiprazole starting with the first ARISTADA dose. The ARISTADA INITIO regimen provides patients with relevant levels of aripiprazole within four days of initiation. The result is an alternative initiation regimen that gives healthcare providers an additional tool to support patients during this critical time in their treatment journey.

"The approval of ARISTADA INITIO makes ARISTADA the first and only long-acting atypical antipsychotic that can be initiated on day one, representing an important addition to the treatment paradigm for the complex illness of schizophrenia," said David Walling, Ph.D., Chief Executive Officer and Principal Investigator of the Collaborative Neuroscience Network. "For physicians and caregivers alike, the ARISTADA INITIO regimen provides a level of confidence that patients can walk out the door with up to two months of coverage with a proven medication in their system. This supports continuity of care for patients and allows the care team to focus their efforts on other aspects of the treatment paradigm that contribute to long-term positive outcomes."

ARISTADA and ARISTADA INITIO both contain aripiprazole lauroxil; however, the two medications are not interchangeable because of differing pharmacokinetic profiles. ARISTADA INITIO leverages the company's proprietary NanoCrystal® technology and is designed to provide an extended-release formulation using a smaller particle size of aripiprazole lauroxil compared to ARISTADA, thereby enabling faster dissolution and leading to more rapid achievement of relevant levels of aripiprazole.

ARISTADA INITIO can be used for initiation onto any dose of ARISTADA (441 mg, 662 mg or 882 mg monthly, 882 mg once every six weeks and 1064 mg once every two months), offering a wide range of flexible dosing options for patients and healthcare providers. The first ARISTADA dose may be administered on the same day as ARISTADA INITIO or up to 10 days thereafter.

"Long-acting injectable atypical antipsychotics have an increasingly recognized role in the treatment of schizophrenia. The ability to initiate ARISTADA on day one may be particularly useful in the hospital setting, where more than one-third of patients initiate onto long-acting therapies," said Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. "The approval of ARISTADA INITIO adds an important new option to our growing schizophrenia portfolio and reaffirms Alkermes' commitment to developing innovative treatments that address the real-world needs of people living with schizophrenia."

About Schizophrenia 
Schizophrenia is a chronic, severe and disabling brain disorder. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal), as well as by disorganized thinking. An estimated 2.4 million American adults live with schizophrenia,2 with men and women affected equally.

About ARISTADA INITIO
ARISTADA INITIO, in combination with a single 30 mg dose of oral aripiprazole, can be used to initiate onto any dose of ARISTADA. The first ARISTADA dose may be administered on the same day as ARISTADA INITIO or up to 10 days thereafter.

About ARISTADA®
ARISTADA is an injectable atypical antipsychotic approved in four doses and three dosing durations for the treatment of schizophrenia (441 mg, 662 mg or 882 mg monthly, 882 mg once every six weeks and 1064 mg once every two months). Once in the body, ARISTADA converts to aripiprazole.

INDICATION and IMPORTANT SAFETY INFORMATION for ARISTADA INITIO(aripiprazole lauroxil) and ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension, for intramuscular use

INDICATION

ARISTADA INITIO, in combination with oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults.

ARISTADA is indicated for the treatment of schizophrenia.

About Alkermes plc
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

1 Markowitz, M., et al. (2013). "Antipsychotic adherence patterns and health care utilization and costs among patients discharged after a schizophrenia-related hospitalization." BMC Psychiatry 13(1): 246.
2 National Institutes of Health. Schizophrenia. Accessed on June 30, 2018 from https://report.nih.gov/nihfactsheets/ViewFactSheet.aspx?csid=67.

SOURCE: Alkermes

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