DUBLIN, December 29, 2020 / PRNewswire / – Alkermes plc (Nasdaq: ALKS) announced today that the United States Food and Drug Administration (FDA) has acknowledged receipt of the Company’s New Drug Request (NDA) for ALKS 3831 (olanzapine / samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder and assigned the application a new target action date under the Prescription Drug User Fees Act (PDUFA) of June 1, 2021.

The FDA classified the resubmission as a Class 2 Complete Response to the Complete Response Letter (CRL) issued in november 2020, following a remote review of records requested under Section 704 (a) (4) of the Federal Food, Drug and Cosmetic Act (the “FDCA”) regarding the manufacture of ALKS 3831 on company premises. Wilmington, Ohio establishment. Following the resubmission of the NDA by Alkermes, the FDA issued a new application for registration under section 704 (a) (4) of the FDCA to supplement the information previously provided by the company. Neither the LCR nor this subsequent registration request identified or raised concerns regarding clinical or non-clinical data in the NDA and the FDA did not ask Alkermes to complete new clinical trials to support the approval of Requirement.

Alkermes will continue to work closely with the FDA as it completes its review of ALKS 3831 NDA and remains committed to making ALKS 3831 available to patients as quickly as possible.

About schizophrenia
Schizophrenia is a serious brain disorder characterized by positive symptoms (hallucinations and delusions, disorganized speech and thoughts, and agitated or repeated movements) and negative symptoms (depression, blunted emotions, and social withdrawal).1 It is estimated that 2.4 million American adults suffer from schizophrenia,2 with men and women affected alike.

About Bipolar I Disorder
Bipolar disorder is a brain disorder that causes changes in a person’s mood, energy, and ability to function. People with this brain disorder can experience debilitating mood swings, ranging from extreme highs (mania) to extreme lows (depression). Bipolar I disorder is characterized by the occurrence of at least one manic episode, with or without the occurrence of a major depressive episode, and affects approximately one percent of the adult population in the United States in any given year. .3

About ALKS 3831 (olanzapine / samidorphan)
ALKS 3831 is a new atypical once-daily oral antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. ALKS 3831 is composed of samidorphan, a novel, co-formulated entity. with the established antipsychotic agent, olanzapine, in a single bilayer tablet.

About Alkermes plc
Alkermes plc is a fully integrated global biopharmaceutical company developing innovative drugs in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, as well as a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. 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 plant in Wilmington, Ohio. For more information, visit the Alkermes website website at www.alkermes.com.

Note regarding forward-looking statements
Certain statements made 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 regarding: therapeutic and commercial value potential of ALKS 3831 for the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder; the company’s expectations regarding the NDA’s next steps for ALKS 3831, including the FDA’s PDUFA target action date for the NDA and the company’s plans to work with the FDA as it completes its review of the NDA; and the company’s commitment to making the ALKS 3831 available to patients as quickly as possible. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that these statements are based on reasonable assumptions within the limits of its knowledge of its activities and operations, 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 forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, but are not limited to: whether data from the company’s manufacturing processes may be interpreted by the FDA in ways that are different from what the company interprets; potential changes in the cost, scope and duration of the ALKS 3831 development and regulatory program following receipt of the CRL from the FDA and subsequent registration application; whether the FDA will approve the NDA for ALKS 3831 in a timely manner or not at all; if approved, whether the FDA will impose conditions on the commercialization of ALKS 3831, such as a risk assessment and a mitigation strategy; whether future clinical trials for ALKS 3831, if any, will be completed on time or not at all; unanticipated impacts of the COVID-19 pandemic on company operations and on the operations of regulatory bodies involved in the review and potential approval of ALKS 3831; whether ALKS 3831 could prove to be ineffective or dangerous during clinical studies; and the risks and uncertainties described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the United States Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec .gov. Existing and potential 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 to update or revise any forward-looking statements contained in this press release.

1American Psychiatric Association. Spectrum of schizophrenia and other psychiatric disorders. Diagnostic and Statistical Manual of Mental Disorders. 5e ed. Washington, DC: American Psychiatric Publishing; 2013.

2 National Institutes of Health. Schizophrenia. Accessed December 28, 2020 from https://archives.nih.gov/asites/report/09-09-2019/report.nih.gov/nihfactsheets/Pdfs/Schizophrenia(NIMH).pdf.

3 Merikangas et al. Lifetime and 12-month prevalence of bipolar spectrum disorder in the National Comorbidity Survey Replication. Arch Gen Psychiatry, May 2007; 64 (5): 543-552. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1931566/

Contacts in Alkermès:

For investors:

Combes of sand

+1 781 609 6377

For the media:

Marisa Borgasano

+1 781 609 6659

SOURCE Alkermes plc

Related links

http://www.alkermes.com


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