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FDA Approves Two-Month Aristada for Treatment of Schizophrenia

DUBLIN--(BUSINESS WIRE)--Jun. 6, 2017-- Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved two-month Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. Aristada is now FDA-approved in four doses and three dosing duration options (441 mg, 662 mg or 882 mg once monthly, 882 mg once every six weeks and 1064 mg once every two months) and can be initiated at any dose or interval, offering an unprecedented range of flexibility to patients and healthcare providers. The new two-month dose is expected to be available in mid-June.

“We designed Aristada to offer flexibility to meet the real-world needs of patients suffering from schizophrenia and the healthcare professionals providing their care. As the first and only long-acting atypical antipsychotic approved in three dosing durations and with the ability to initiate treatment at any dose or duration, Aristada provides a range of options to help clinicians tailor treatment to the individual needs of their patients,” said Elliot Ehrich, M.D., Executive Vice President, Research and Development of Alkermes. “Building on nearly two decades of experience developing innovative medicines for chronic and serious CNS diseases, we are dedicated to helping improve the lives of patients with treatment options that are well-suited for use in today’s complex treatment system.”

Treatment adherence for patients on daily therapy for chronic diseases is a known challenge for patients, and schizophrenia may make this challenge even greater. Long-acting injectable medications, like Aristada, eliminate the burden of taking an oral antipsychotic medicine on a daily basis. The newly approved two-month Aristada gives people living with schizophrenia an option to treat their symptoms with only six injections per year.

“Transitioning patients with schizophrenia from inpatient care to outpatient settings can be challenging. The availability of an antipsychotic that can be initiated prior to hospital discharge and provide therapeutic levels of medication for two months will be a welcome new treatment option for healthcare providers, caregivers and patients,” said Joseph McEvoy, M.D., I. Clark Case Distinguished Chair in Psychotic Disorders at Augusta University and Professor Emeritus of Psychiatry and Behavioral Health at Duke University Medical Center. “The clinical community is increasingly using long-acting atypical antipsychotic medications earlier in the treatment paradigm as recognition grows of the benefits of less frequent dosing and the resulting ability to focus on other important treatment goals for patients.”

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 have schizophrenia,1 with men and women affected equally.

About Aristada

Aristada is an injectable atypical antipsychotic with one-month, six-week and two-month dosing options for the treatment of schizophrenia. Aristada is administered by a healthcare professional. Once in the body, Aristada converts to aripiprazole. Aristada was originally approved by the FDA in October 2015.

About Alkermes

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.

Forward-Looking Statements

Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning the timing of the launch of two-month Aristada in the U.S., the commercialization of two-month Aristada and the potential therapeutic and commercial value of two-month Aristada for the treatment of schizophrenia. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: when two-month Aristada will become commercially available; whether the safety results demonstrated in our open-label pharmacokinetic, safety and tolerability study of two-month Aristada for the treatment of schizophrenia will be predictive of results when commercialized; whether two-month Aristada will be commercialized successfully; whether third party payers will cover or reimburse the two-month dosing option of Aristada for the treatment of schizophrenia; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended Dec. 31, 2016 and Quarterly Report on Form 10-Q for the quarter ended Mar. 31, 2017 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

Aristada® is a registered trademark of Alkermes Pharma Ireland Limited.

1 National Institutes of Health. Schizophrenia. Accessed on June 5, 2017 from https://report.nih.gov/nihfactsheets/ViewFactSheet.aspx?csid=67.

Source: Alkermes plc

Posted: June 2017

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