Aristada Initio (aripiprazole lauroxil nanocrystal dispersion) / Alkermes - LARVOL DELTA

Initiating Aripiprazole Lauroxil: Post Hoc Analysis of Safety and Tolerability of 1-Day and 21-Day Regimens. (PubMed, J Clin Psychiatry) - P3, P3b | "Objective: Aripiprazole lauroxil (AL), a long-acting injectable antipsychotic, has 2 initiation options: 1-day (AL NanoCrystal Dispersion [ALNCD] injection plus 30 mg oral aripiprazole on day 1 only) and 21-day (15 mg oral aripiprazole for 21 days)...Engaging patients in discussions regarding options for initiating AL may help facilitate shared decision-making and personalization of treatment for patients with schizophrenia. Trial Registration: ClinicalTrials.gov identifiers: NCT03345979 and NCT01469039."

Clinical • Journal • Retrospective data • CNS Disorders • Psychiatry • Schizophrenia

Treatment Patterns and Healthcare Resource Utilization Following Initiation of Aripiprazole Lauroxil Using a 1-Day Initiation Regimen (ASCP 2024) - "Findings from this first real-world study suggest that initiating AL using ALNCD may result in clinically meaningful reductions in patient burden and healthcare costs, as evidenced by significant declines in HCRU. Learning Objectives 1) At the conclusion of this presentation, attendees will understand the treatment patterns observed over up to 6 months after initiation of aripiprazole lauroxil (AL) initiated using a one-time injection of a Nanocrystal Dispersion formulation of AL (ALNCD). 2) At the conclusion of this presentation, attendees will be able to describe the changes in 1 healthcare resource utilization observed from 6-month baseline to 6-month follow-up after initiating AL using ALNCD"

HEOR • CNS Disorders • Psychiatry • Schizophrenia

Safety and Tolerability of Starting Aripiprazole Lauroxil With Aripiprazole Lauroxil NanoCrystal Dispersion in 1 Day Followed by Aripiprazole Lauroxil Every 2 Months Using Paliperidone Palmitate Monthly as an Active Control in Patients With Schizophrenia: A Post Hoc Analysis of a Randomized Controlled Trial. (PubMed, J Clin Psychiatry) - P3b | "Results were consistent with known safety profiles of AL and PP and support the safety of AL 1064 mg every 2 months initiated using ALNCD plus 30-mg oral aripiprazole. Trial Registration: ClinicalTrials.gov identifier: NCT03345979."

Clinical • Journal • Retrospective data • Anesthesia • CNS Disorders • Hypotension • Psychiatry • Schizophrenia • Suicidal Ideation

"@GlobalNCDs @ChadHoc @EPNolley @ShakirHossen777 @SarinaKS @HopkinsPCCM @DavidNHager @JHUPCCMFellows" (@KathrynLee27)

APPRAISE: Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode (clinicaltrials.gov) - P4 | N=20 | Terminated | Sponsor: University of California, Los Angeles | N=128 ➔ 20 | Trial completion date: Jun 2025 ➔ Oct 2022 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2025 ➔ Oct 2022; Withdraw of financial support by industry collaborator

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Depression • Psychiatry • Schizophrenia • Schizophreniform Disorder

"Fruitful discussions at #ATS2022 today on best ways to measure personal exposures in air pollution studies @GlobalNCDs" (@laura_nicolaou)

"cc. @beatNCDs @GlobalNCDsUK @un_ncd @ncdalliance @gacd_media @worldheartfed @WUF_UNHabitat @ISHBP @alta_schutte @LSHTM_CGCC @MikkelsenBente_ @ahyder1 @sandrogalea @NammiKan @fortunafort @SIAC_cardio See ☝🏽" (@jjaimemiranda)

DERL1

Observational Study of Long Acting Injectable Medications (LAIs) in Schizophrenia (OASIS) (clinicaltrials.gov) - P=N/A | N=338 | Active, not recruiting | Sponsor: Alkermes, Inc. | Recruiting ➔ Active, not recruiting | N=1000 ➔ 338

Enrollment change • Enrollment closed • CNS Disorders • Psychiatry • Schizophrenia

"@NICEComms @HelmsleyTrust @pahowho @C3health @PIH @nmcnews @ESPCH_UK @G2H2_Geneva @un_ncd @NCDFREE @NCDChild @uicc @WomenAndNCDs @DefeatNCD @GlobalNCDsUK @NCDAccess @NCDSynergies @NCDIpoverty @VicHealth @wcrfint @RwandaNCDA @PhilipsFDN @novonordisk @WomenAndNCDs @DefeatNCD" (@RESPONDncd)

"@doctorsoumya @amibanerjee1 @FahmiJFarah @AnastasiaSMihai @mmamas1973 @CMichaelGibson @Dr_AshokSeth @DrMariaNeira @DrRkumar92 @duyeonkim @manishgautamDr @BhramarBioStat @CMO_England @SDGS4GOOD @UniOslo_GH @FCDOGovUK @orfonline @GlobalNCDsUK @BBCHughPym @PrinSciAdvGoI" (@RajayNarain)

Clinical

"Milk lactoferrin; A nutraceutical supplement against bacterial infections https://t.co/zIuqGqKabw #MILK #camel @GlobalNCDsUK #globalnewbornsociety @XHNews @USAID @SanofiUS @UNDP" (@DiabetesAsiaOrg)

Clinical • Infectious Disease

Alkermes plc Reports Second Quarter 2021 Financial Results (PRNewswire) - "Net sales of ARISTADA were $72.4 million, compared to $58.8 million for the same period in the prior year, representing an increase of approximately 23%. Manufacturing and royalty revenues for the quarter were $142.3 million, compared to $116.5 million for the same period in the prior year. Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $95.5 million, compared to $83.1 million for the same period in the prior year."

Commercial • Sales • CNS Disorders • Schizophrenia

"@ASTMH @RSTMH @PeruPulm @GlobalNCDs @Emerge_UPCH @NCBarengo @Medscape @MedscapeES @CDC_AR @pahowho @WHO @wellcometrust @pablotsukayama" (@rodrigoc_90)

Alkermes to Showcase Data From Psychiatry Portfolio at Upcoming Scientific Conferences Throughout Mental Health Awareness Month (PRNewswire) - "Alkermes plc...today announced plans to present clinical data and outcomes research from its psychiatry portfolio at three scientific conferences during Mental Health Awareness Month in May. The meetings, all held virtually, include: American Psychiatric Association (APA) Annual Meeting, May 1-3; International Society for Bipolar Disorders (ISBD) Annual Conference, May 13-15; International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual Meeting, May 17-20."

Retrospective data • Review • CNS Disorders • Schizophrenia

Alkermes plc Reports First Quarter 2021 Financial Results (PRNewswire) - "Total revenues for the quarter were $251.4 million....Net sales of ARISTADA were $55.4 million, compared to $51.0 million for the same period in the prior year, representing an increase of approximately 9%....'Coupled with expected growth of our commercial portfolio, including the potential launch of LYBALVI™ and growth of VUMERITY®, and a focus on efficiency, cost management and strong governance, we have the potential to drive significant growth and value creation in 2021 and beyond.'"

Launch US • Sales • CNS Disorders • Schizophrenia

Alkermes Presents New Data From Psychiatry Portfolio at Virtual 2021 Congress of the Schizophrenia International Research Society (PRNewswire) - P3, N=561; ENLIGHTEN-2 (NCT02694328); P3, N=200; ALPINE (NCT03345979); Sponsor: Alkermes; "The company's presentations included new exploratory analyses from the phase 3 ENLIGHTEN-2 study...including...results from prespecified subgroup analyses evaluating olanzapine/samidorphan's effect on weight gain across several patient subgroups, including those known to be at higher risk for weight gain with olanzapine, based on sex, race, age and baseline body mass index (BMI)...Data from an exploratory analysis within the phase 3b ALPINE...study...suggest that handwriting kinematic measures may serve as a biomarker for anticipating response to antipsychotic treatment."

P3 data • CNS Disorders • Schizophrenia

Aristada Initio: Expiry of patents in US in 2030 and 2035 (Alkermes) - Annual Report 2020

Patent • Schizophrenia

Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2020 and Provides Financial Expectations for 2021 (PRNewswire) - "Net sales of ARISTADA® were $241.0 million, compared to $189.1 million in the prior year, representing an increase of approximately 27%. Manufacturing and royalty revenues for the year were $484.0 million, compared to $447.9 million in the prior year. Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $345.6 million, compared to $323.3 million in the prior year."

Commercial • Sales • CNS Disorders • Schizophrenia

Alkermes plc Reports Third Quarter 2020 Financial Results and Raises 2020 Financial Expectations (PRNewswire) - "Net sales of VIVITROL were $80.3 million, compared to $85.2 million for the same period in the prior year, representing a decrease of 6%,...Net sales of ARISTADA were $62.4 million, compared to $53.6 million for the same period in the prior year, representing an increase of 16%, driven primarily by continued growth of the ARISTADA provider base and growth of the ARISTADA two-month dose. Manufacturing and royalty revenues were $120.4 million, compared to $103.8 million for the same period in the prior year. Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $87.9 million, compared to $76.7 million for the same period in the prior year, primarily driven by an increase in royalty revenue from INVEGA SUSTENNA and the timing of manufacturing shipments of RISPERDAL CONSTA."

Commercial • Sales • CNS Disorders • Schizophrenia

Alkermes Presents New Psychiatry Data at Psych Congress 2020 Virtual Experience (PRNewswire) - "Alkermes plc...today announced the presentation of new real-world outcomes research and clinical data related to its psychiatry portfolio at the Psych Congress 2020 Virtual Experience, held Sept. 10-13, 2020. The company presented six posters, one of which focused on new outcomes research that analyzed treatment challenges of second-generation antipsychotics, such as weight gain and treatment interruptions, in patients living with schizophrenia or bipolar I disorder....In addition to the outcomes data, Alkermes presented several posters related to the company's psychiatry products and development candidates, ARISTADA® (aripiprazole lauroxil), ARISTADA INITIO® (aripiprazole lauroxil) and ALKS 3831 (olanzapine/samidorphan)."

Clinical data • P3 data • Retrospective data • CNS Disorders • Schizophrenia

Efficacy and Safety of a 2-Month Formulation of Aripiprazole Lauroxil With 1-Day Initiation in Patients Hospitalized for Acute Schizophrenia Transitioned to Outpatient Care: Phase 3, Randomized, Double-Blind, Active-Control ALPINE Study. (PubMed, J Clin Psychiatry) - P3b | "AL and PP were efficacious and well-tolerated for initiating treatment of schizophrenia in the hospital and continuing outpatient treatment."

Clinical • Journal • P3 data • CNS Disorders • Pain • Schizophrenia

Keeping up with the therapeutic advances in schizophrenia: a review of novel and emerging pharmacological entities. (PubMed, CNS Spectr) - "Therapies targeting total symptoms include cannabidiol, D3 antagonist/5-HT1A partial agonist F17464, lumateperone (ITI-007), phosphodiesterase 10A (PDE10A) inhibitors MK-8189 and TAK-063, sodium nitroprusside, and trace amine-associated receptor-1 (TAAR1) agonist RO5263397 and SEP-363856. Treatments targeting negative symptoms include the PDE10A inhibitor LuAF-11167, 5-HT2A inverse agonist pimavanserin, sigma-2/5-HT2A antagonist roluperidone (MIN-101), and d-amino acid oxidase (DAAO) inhibitor TAK-831. Agents targeting primarily cognitive dysfunction are the glycine transporter-1 inhibitor BI-425809 and cannabidiol. Therapies targeting residual positive symptoms/treatment-resistant schizophrenia include pimavanserin, dopamine D1/D2 antagonist LuAF-35700, and DAAO inhibitor sodium benzoate. Two new long-acting injectable antipsychotic formulations, Aripiprazole Lauroxil NanoCrystal® and the first subcutaneous injectable LAI Perseris (RBP-7000), were recently approved..."

Journal • CNS Disorders • Schizophrenia

Alkermes plc Reports Second Quarter 2020 Financial Results and Issues 2020 Financial Expectations (PRNewswire) - "Net sales of ARISTADA were $58.8 million, compared to $48.4 million for the same period in the prior year, representing an increase of approximately 21%...Manufacturing and royalty revenues were $116.5 million, compared to $127.9 million for the same period in the prior year. Manufacturing and royalty revenues from RISPERDAL CONSTA®, INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA® were $83.1 million, compared to $91.9 million for the same period in the prior year, primarily driven by a decrease in manufacturing and royalty revenues related to RISPERDAL CONSTA."

Commercial • Sales • CNS Disorders • Schizophrenia

Aristada Initio Kit: Newly added patent in Orange Book (Orange Book) - Expiry on August 17, 2035

Patent • Schizophrenia

Long-Acting Injections in Schizophrenia: a 3-Year Update on Randomized Controlled Trials Published January 2016-March 2019. (PubMed, Curr Psychiatry Rep) - "LAIs included two new formulations, aripiprazole lauroxil nanocrystal dispersion and subcutaneously injectable risperidone Perseris, as well as aripiprazole lauroxil, aripiprazole once-monthly, paliperidone once-monthly, paliperidone 3-monthly, and risperidone-LAI...In RCTs, LAIs are superior to placebo, but only in some aspects, superior to OAPs. Comparative effectiveness of LAIs vs. OAPs requires further study, ideally in generalizable/real-world samples."

Clinical • Journal • Review • CNS Disorders • Schizophrenia