ALKS Alkermes plc

19.59
-0.17  -1%
Previous Close 19.76
Open 20.02
52 Week Low 11.98
52 Week High 25.35
Market Cap $3,109,697,382
Shares 158,739,019
Float 111,422,728
Enterprise Value $3,034,884,015
Volume 938,137
Av. Daily Volume 1,544,747
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Upcoming Catalysts

Drug Stage Catalyst Date
ALKS 3831
Schizophrenia, bipolar
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
ALKS 4230 + Keytruda - ARTISTRY-2
Solid tumors
Phase 1
Phase 1
Phase 1 data presented at SITC November 8, 2019.
ALKS 4230 ARTISTRY-1
Solid tumors
Phase 1
Phase 1
Phase 1/2 data at SITC November 2019 - 8/14 SD for monotherapy, 12/18 for combo (incl. 2 PRs).
Diroximel fumarate (BIIB098)
Multiple sclerosis (MS)
Approved
Approved
FDA Approval announced October 30, 2019.
ALKS 4230 + Keytruda (ION-01)
Head and neck squamous cell cancer
Phase 2
Phase 2
Phase 2 trial to be initiated 4Q 2019.
Diroximel fumarate (BIIB098) - Head-to-head trial versus Tecfidera -
Relapsing Remitting Multiple Sclerosis (RRMS)
Phase 3
Phase 3
Phase 3 top-line data met primary endpoint - July 30, 2019.
Aristada and Invega Sustenna
Schizophrenia
Phase 3
Phase 3
Phase 3 data released April 9, 2019 - primary endpoint met.
ALKS 5461
Major depressive disorder
CRL
CRL
CRL announced February 1, 2019.
Aripiprazole Lauroxil NanoCrystal Dispersion (ALNCD)
Schizophrenia
Approved
Approved
FDA approval announced July 2, 2018.
ALKS 6428
Opioid dependence
Phase 3
Phase 3
Phase 3 trial did not meet endpoint - February 2017. Second trial is ongoing.
ALKS 3831 - ENLIGHTEN-1
Schizophrenia
Phase 3
Phase 3
Phase 3 preliminary data released June 30, 2017. Primary endpoint met - adverse events included weight gain.
Aristada
Schizophrenia
Approved
Approved
Approved October 5 2015. sNDA filed for 2-month option with approval announced June 6, 2017.
BYDUREON
Type 2 diabetes
Approved
Approved
CRL received March 15, 2010.

Latest News

  1. DUBLIN, June 29, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that it will begin accepting applications for its annual Alkermes Pathways Research Awards® program on July 1, 2020. This competitive grant program is designed to support the next generation of researchers working on the front lines to advance understanding and awareness of disease states in the field of neuroscience. In its third year, the program will offer grants to early-career investigators who have demonstrated their commitment to helping people living with substance use disorders (SUDs), schizophrenia, and/or bipolar disorder. The application period will open July 1, 2020 and will run through October 30, 2020.

    "With millions of people in the U.S. impacted…

    DUBLIN, June 29, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that it will begin accepting applications for its annual Alkermes Pathways Research Awards® program on July 1, 2020. This competitive grant program is designed to support the next generation of researchers working on the front lines to advance understanding and awareness of disease states in the field of neuroscience. In its third year, the program will offer grants to early-career investigators who have demonstrated their commitment to helping people living with substance use disorders (SUDs), schizophrenia, and/or bipolar disorder. The application period will open July 1, 2020 and will run through October 30, 2020.

    "With millions of people in the U.S. impacted by serious mental illness or substance use disorders, the need for advancements remains critical," said Craig Hopkinson, M.D., Executive Vice President, Research & Development and Chief Medical Officer at Alkermes. "At Alkermes, we envision a world where diverse communities come together, and through cutting-edge science, innovative medicine, and strident advocacy, help address critical public health challenges and pave the way for meaningful change for people living with serious chronic diseases. The Pathways program is designed to contribute to this important effort by supporting a variety of projects across the U.S. that are focused on advancing research in the field of neuroscience."

    The 3rd annual Alkermes Research Pathways Awards program offers individual grant amounts of up to $100,000 per project. To qualify, early-career investigators must be M.D.s, Ph.D.s, or equivalent, who are within five years of their initial academic appointment or are current post-doctoral fellows, and who are affiliated with a medical or research institution within the U.S. Applicants will be evaluated by an independent review committee comprised of specialists in psychiatry, neurobiology, pharmacology, and behavioral science from academic research centers.

    The Pathways program began in 2018 and has since provided funding to researchers across the U.S. Award recipients have undertaken important, mentor-supported research to help progress the study of neuroscience. For more information on the Alkermes Research Pathways Awards program, including the 3rd annual edition of the program  and full eligibility criteria, visit www.PathwaysResearchAwards.com.

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and 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 facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Alkermes Pathways Research Awards® is a registered service mark of Alkermes, Inc.

    Alkermes Contacts:

    For Investors:  Sandy Coombs,   +1 781 609 6377

    For Media:      Katie Joyce,         +1 781 249-8927

     

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    SOURCE Alkermes plc

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  2. DUBLIN, June 24, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that 10 nonprofit organizations have been awarded grants from the company's COVID-19 Relief Fund, a special edition of the company's signature Alkermes Inspiration Grants® program, that was established to assist nonprofit organizations in their work to rapidly address pandemic-related needs for people living with addiction, serious mental illness, or cancer. More than 350 applications were submitted in May 2020 for this highly competitive program.

    Collectively, the programs receiving grants reach across Alkermes' therapeutic focus areas and seek to serve populations that span ethnic, socio-economic, gender, and age spectrums, utilizing…

    DUBLIN, June 24, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that 10 nonprofit organizations have been awarded grants from the company's COVID-19 Relief Fund, a special edition of the company's signature Alkermes Inspiration Grants® program, that was established to assist nonprofit organizations in their work to rapidly address pandemic-related needs for people living with addiction, serious mental illness, or cancer. More than 350 applications were submitted in May 2020 for this highly competitive program.

    Collectively, the programs receiving grants reach across Alkermes' therapeutic focus areas and seek to serve populations that span ethnic, socio-economic, gender, and age spectrums, utilizing a variety of approaches targeted to the acute challenges presented by COVID-19, including: peer-support programs; innovative technologies, formats and channels to expand access to and reach of essential nonprofit programming; creative approaches to bolster crisis response; and provision of essentials such as food, housing, and career support.

    "As stay-at-home orders took effect across the U.S., we reached out to understand how efforts to stem the spread of COVID-19 were impacting people living with addiction, serious mental illness, or cancer," said Richard Pops, Chief Executive Officer of Alkermes. "We learned that the fear, social isolation, and economic hardship impacting so many has led to even greater challenges for these communities. We remain steadfast in our commitment to help address their unique and complex needs and will continue to evolve our longstanding efforts to provide meaningful and lasting support for these patient populations."

    2020 Grant Recipient Organizations and Programs:

    10,000 Beds is launching a new podcast to give people in recovery access to accurate information, a safe place to be heard and to listen, and a source for guidance on how to navigate a socially distanced world as they attempt to socially reintegrate.

    Clubhouse International's Online Communities project is a comprehensive digital response to establish new channels of communication and virtual resources for Clubhouses and their members to address social and economic isolation for people living with mental illness.

    Community Servings is increasing kitchen/delivery capacity and providing 75,000 medically-tailored meals to 340 clients and their families affected by cancer throughout Massachusetts.

    Faces & Voices of Recovery is working to ensure recovery community organizations across the nation can sustain and adapt peer recovery support services through and beyond the current COVID-19 pandemic, with tools and resources to build organizational knowledge, capacity, and resilience in response to emergencies and risks.

    Imerman Angels provides COVID-19 related information and will increase online capacity, video programming and other digital vehicles to partner cancer fighters, survivors, and caregivers with someone just like them – a "Mentor Angel" – a cancer survivor, previvor, or caregiver who has faced the same type of cancer.

    National Alliance on Mental Illness of New York City, through its NAMI-NYC Helpline, provides materials, information, resources, and referrals on current and ever-changing COVID-19 issues relating to mental health in New York City, connecting callers with vital services including housing, employment, healthcare, public services/benefits, and legal services.

    Ohio Recovery Housing provides recovery housing operators with best-practice guidance, along with training and technical assistance, so that they may continue to offer quality environments during and after the pandemic, looking beyond immediate needs, bringing back lost capacity, being more sustainable, and growing to meet increasing demand.

    Sound Mind Live's Artist Ambassadors Crisis Response Program will feature well-known musical artists speaking out on mental health effects of COVID-19 and ways to address them, including a COVID-19 Mental Health Resource Toolkit and a series of online interviews, virtual panels, and podcasts.

    This Is My Brave is building upon BraveTV, a Facebook Live series, to urgently address COVID-19 related needs for people living with addiction and serious mental illness to continually increase the number of individuals putting a name, face, and story to mental illness through storytelling, and with a focus on highlighting and partnering with mental health organizations that are led by, and serve, members of the Black community.

    Young People in Recovery serves youth and young adults who are no longer able to access in-person services with virtual peer recovery support services such as peer recovery support meetings, pro-social activities, and life skills trainings to help them maintain long-term recovery from drugs and alcohol.

    Grant recipients were selected based on pre-determined decision criteria including: a focus on people living with mental illness, substance use disorders, or cancer; clearly defined needs, objectives, activity format, mode of delivery, and intended audience; relevance to the COVID-19 pandemic; ability to implement in a rapid time frame and sustainability of the impact beyond the immediate crisis; the organization's ability to execute the proposed program; and uniqueness and creativity of the proposed program/solution.

    Since 2016, the Alkermes Inspiration Grants program has awarded more than $3 million in funding to innovative programs that support the comprehensive needs of those most impacted by serious diseases in our areas of focus. Due to the urgent and unexpected needs created by the COVID-19 pandemic, the company revamped its Alkermes Inspiration Grants program for 2020 to provide grants to assist nonprofit organizations in their work to urgently address pandemic-related needs for people living with addiction, serious mental illness, or cancer. For more information on the Alkermes COVID-19 Relief Fund, including additional details about the grant recipients and awarded programs, please visit https://www.alkermes.com/responsibility.

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and 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 facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    ALKERMES INSPIRATION GRANTS is a registered service mark of Alkermes, Inc.

    Alkermes Contacts:

    For Investors: Sandy Coombs, +1 781 609 6377

    For Media:      Katie Joyce, +1 781 609 6806

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  3. DUBLIN and BOULDER, Colo., June 22, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) and Clovis Oncology, Inc. (NASDAQ:CLVS) today announced positive preclinical data from a study designed to evaluate the combination potential of ALKS 4230, Alkermes' investigational engineered interleukin-2 (IL-2) variant immunotherapy, with lucitanib, Clovis' investigational angiogenesis inhibitor. The data will be presented during a poster session at the American Association for Cancer Research (AACR) Virtual Annual Meeting II, taking place June 22-24, 2020.

    The study evaluated the antitumor efficacy and mechanism of action of mALKS 4230, a mouse ortholog of ALKS 4230, and lucitanib as monotherapies and in combination in a preclinical syngeneic mouse model…

    DUBLIN and BOULDER, Colo., June 22, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) and Clovis Oncology, Inc. (NASDAQ:CLVS) today announced positive preclinical data from a study designed to evaluate the combination potential of ALKS 4230, Alkermes' investigational engineered interleukin-2 (IL-2) variant immunotherapy, with lucitanib, Clovis' investigational angiogenesis inhibitor. The data will be presented during a poster session at the American Association for Cancer Research (AACR) Virtual Annual Meeting II, taking place June 22-24, 2020.

    The study evaluated the antitumor efficacy and mechanism of action of mALKS 4230, a mouse ortholog of ALKS 4230, and lucitanib as monotherapies and in combination in a preclinical syngeneic mouse model of colon cancer. The combination of mALKS 4230 with lucitanib resulted in dose-dependent, durable complete responses (absence of any detectable tumor) and enhanced survival compared with monotherapy treatment with mALKS 4230 and lucitanib.

    "Combining treatments with complementary mechanisms may offer synergistic clinical benefit and expand treatment options for a broader set of patient populations," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "These compelling preclinical data provide a foundational rationale to further explore novel combination options, such as an angiogenesis inhibitor, for ALKS 4230, with the goal of bringing improved therapeutic outcomes to patients across multiple tumor types."

    Key findings presented in the poster include the following:

    • In the group that received the higher dose of mALKS 4230 (out of two doses tested) combined with lucitanib, 100 percent of the treated mice exhibited complete tumor regression and protection from new tumor growth upon re-challenge, an indication of the development of immunological memory.

    • The combination of mALKS 4230 with lucitanib resulted in an increase in intratumoral immune cells, including CD8+ T cells and dendritic cells, compared to monotherapy treatment, changes that are associated with anti-tumor immune responses.
    • The combination of mALKS 4230 with lucitanib elicited a distinct gene expression profile associated with anti-tumor activity, including increased immune cytolytic gene expression with decreased expression of genes with pro-angiogenic functions.



    A virtual poster titled, "The Combination of a Mouse Ortholog of ALKS 4230, a Selective Agonist of the Intermediate-Affinity IL-2 Receptor, and the Angiogenesis Inhibitor Lucitanib Enhances Antitumor Activity," along with a pre-recorded audio presentation by Dr. Jared Lopes, Principal Scientist, Alkermes will be available on the AACR website at https://www.aacr.org/meeting/aacr-annual-meeting-2020/

    About ALKS 4230 

    ALKS 4230 is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

    About Lucitanib 

    Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDFGRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs reverses this immunosuppression and can augment response to immunotherapy.

    Lucitanib is an unlicensed medical product.

    About Alkermes 

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and 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 facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    About Clovis Oncology 

    Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado; please visit www.clovisoncology.com for more information, including additional office locations in the U.S. and Europe.

    Alkermes Note Regarding 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 potential therapeutic value of ALKS 4230, as a monotherapy or in combination. You are cautioned 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 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, whether preclinical and preliminary, interim or final clinical results for ALKS 4230—whether as a monotherapy or in combination—will be predictive of future data from the same studies, results of future clinical studies or real-world results; whether ALKS 4230, as a monotherapy or in combination, could be shown to be unsafe or ineffective; whether future clinical trials or future stages of ongoing clinical trials for ALKS 4230, as a monotherapy or in combination, will be initiated or completed on time or at all; changes in the cost, scope and duration of, and clinical trial operations for, development activities for ALKS 4230, including changes relating to the novel coronavirus (COVID-19); 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, 2019, the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 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.

    Clovis Oncology Note Regarding Forward-Looking Statements

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding the potential benefit of our drug candidate lucitanib in combination with ALKS 4230 and expanding treatment options for a broader set of patient populations. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, whether future pre-clinical or clinical study results will support continued development or regulatory approval, whether our clinical development programs for our drug candidates and those of our partners can be completed on time or at all, whether future study results will be consistent with study findings to date, and actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to accept or approve drug applications that may be filed, as well as their decisions regarding drug labeling, reimbursement and pricing, and other matters that could affect the development, approval, availability or commercial potential of our drug candidates. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

    Alkermes Contacts:





    For Investors:

    Sandy Coombs

    +1 781 609 6377

    For Media:

    Sourojit Bhowmick, Ph.D.

    +1 781 609 6397







    Clovis Contacts:





    For Investors:

    Breanna Burkart

    +1 303 625 5023



    Anna Sussman

    +1 303 625 5022

    For Media:

    Lisa Guiterman

    +1 301 217 9353

     

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

     

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    SOURCE Alkermes plc

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  4. DUBLIN, June 4, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) announced today that management will participate in a fireside chat at the 41st Annual Goldman Sachs Global Healthcare Conference on Thursday, June 11, 2020 at 9:40 a.m. ET (2:40 p.m. BST). The webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer…

    DUBLIN, June 4, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) announced today that management will participate in a fireside chat at the 41st Annual Goldman Sachs Global Healthcare Conference on Thursday, June 11, 2020 at 9:40 a.m. ET (2:40 p.m. BST). The webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

    About Alkermes plc

    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and 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 facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Contact:
    Alex Braun
    Investor Relations
    +1 781 296 8493

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

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    SOURCE Alkermes plc

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  5. DUBLIN, May 20, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that data from its phase 3b ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness) study were published in the Journal of Clinical Psychiatry. ALPINE was a six-month study evaluating the efficacy and safety of the ARISTADA INITIO® (aripiprazole lauroxil) one-day initiation regimen, consisting of ARISTADA INITIO and one single dose of 30 mg of oral aripiprazole, together with the ARISTADA® (aripiprazole lauroxil) two-month dose in patients experiencing an acute exacerbation of schizophrenia. Positive topline data were first reported in April 2019. Results from the study provide evidence to support the use of the ARISTADA INITIO one-day…

    DUBLIN, May 20, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that data from its phase 3b ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness) study were published in the Journal of Clinical Psychiatry. ALPINE was a six-month study evaluating the efficacy and safety of the ARISTADA INITIO® (aripiprazole lauroxil) one-day initiation regimen, consisting of ARISTADA INITIO and one single dose of 30 mg of oral aripiprazole, together with the ARISTADA® (aripiprazole lauroxil) two-month dose in patients experiencing an acute exacerbation of schizophrenia. Positive topline data were first reported in April 2019. Results from the study provide evidence to support the use of the ARISTADA INITIO one-day regimen together with ARISTADA for treatment of an acute exacerbation of schizophrenia, started in the hospital setting and continued through the critical transition to outpatient care.

    "Schizophrenia is a complex illness that benefits from a rapid response when people are experiencing an acute exacerbation of their symptoms. Results from the ALPINE study demonstrate the role that LAIs may play in the treatment of schizophrenia and underscore the potential clinical utility of using these medications to initiate patients onto treatment during an acute exacerbation of schizophrenia in an inpatient setting and through their transition back to the community," said Craig Hopkinson, M.D., Executive Vice President, Research & Development and Chief Medical Officer at Alkermes. "The ALPINE study illustrates our commitment to developing important medicines to address challenges in the treatment of schizophrenia."

    ALPINE was a multi-center, randomized, double-blind, phase 3b study designed to examine the efficacy and safety of using either ARISTADA (aripiprazole lauroxil) or INVEGA SUSTENNA® (paliperidone palmitate) to start treatment in hospitalized patients experiencing an acute exacerbation of schizophrenia and continue them on treatment during the transition to outpatient care for ongoing continuation phase therapy. Positive and Negative Syndrome Scale (PANSS) total scores at Week 4, Week 9 and Week 25 were prespecified outcomes. Patients randomized to the ARISTADA treatment group were initiated using the ARISTADA INITIO regimen* on day 1, followed by ARISTADA (1064 mg) on day 8 and every two months thereafter. Patients randomized to the INVEGA SUSTENNA treatment group were initiated using a loading dose of INVEGA SUSTENNA (234 mg) on day 1, followed by INVEGA SUSTENNA (156 mg) on day 8 and every month thereafter. The inclusion of the INVEGA SUSTENNA arm provided an active control for ARISTADA while avoiding the use of a placebo in patients with schizophrenia.  

    About Schizophrenia 
    Schizophrenia is a serious brain disorder marked 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 An estimated 2.4 million American adults have schizophrenia,2 with men and women affected equally.

    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.

    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 the ARISTADA INITIO regimen or up to 10 days thereafter.

    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 in adults.

    IMPORTANT SAFETY INFORMATION

     

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ARISTADA INITIO and ARISTADA are not approved for the treatment of patients with dementia-related psychosis. 

     

    Contraindication: Known hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis.

    Cerebrovascular Adverse Reactions, Including Stroke: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities, have been reported in placebo-controlled trials of elderly patients with dementia-related psychosis treated with risperidone, aripiprazole, and olanzapine. ARISTADA INITIO and ARISTADA are not approved for the treatment of patients with dementia-related psychosis. 

    Potential for Dosing and Medication Errors: Medication errors, including substitution and dispensing errors, between ARISTADA INITIO and ARISTADA could occur.  ARISTADA INITIO is intended for single administration in contrast to ARISTADA which is administered monthly, every 6 weeks, or every 8 weeks. Do not substitute ARISTADA INITIO for ARISTADA because of differing pharmacokinetic profiles.

    Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex may occur with administration of antipsychotic drugs, including ARISTADA INITIO and ARISTADA. Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant serious medical problems for which specific treatments are available. 

    Tardive Dyskinesia (TD): The risk of developing TD (a syndrome of abnormal, involuntary movements) and the potential for it to become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic increase. The syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Prescribing antipsychotics should be consistent with the need to minimize TD. Discontinue ARISTADA if clinically appropriate. TD may remit, partially or completely, if antipsychotic treatment is withdrawn.

    Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include: 

    • Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics. There have been reports of hyperglycemia in patients treated with oral aripiprazole. Patients with diabetes should be regularly monitored for worsening of glucose control; those with risk factors for diabetes should undergo baseline and periodic fasting blood glucose testing. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia, including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients require continuation of antidiabetic treatment despite discontinuation of the suspect drug.
    • Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.
    • Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

    Pathological Gambling and Other Compulsive Behaviors:  Compulsive or uncontrollable urges to gamble have been reported with use of aripiprazole. Other compulsive urges less frequently reported include sexual urges, shopping, binge eating and other impulsive or compulsive behaviors which may result in harm for the patient and others if not recognized. Closely monitor patients and consider dose reduction or stopping aripiprazole if a patient develops such urges.

    Orthostatic Hypotension: Aripiprazole may cause orthostatic hypotension which can be associated with dizziness, lightheadedness, and tachycardia. Monitor heart rate and blood pressure, and warn patients with known cardiovascular or cerebrovascular disease and risk of dehydration and syncope.

    Falls: Antipsychotics including ARISTADA INITIO and ARISTADA may cause somnolence, postural hypotension or motor and sensory instability which may lead to falls and subsequent injury.  Upon initiating treatment and recurrently, complete fall risk assessments as appropriate.

    Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics. Monitor complete blood count in patients with pre-existing low white blood cell count (WBC)/absolute neutrophil count or history of drug-induced leukopenia/neutropenia. Discontinue ARISTADA INITIO and/or ARISTADA at the first sign of a clinically significant decline in WBC and in severely neutropenic patients.

    Seizures: Use with caution in patients with a history of seizures or with conditions that lower the seizure threshold. 

    Potential for Cognitive and Motor Impairment: ARISTADA INITIO and ARISTADA may impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are certain therapy with ARISTADA INITIO and/or ARISTADA does not affect them adversely.

    Body Temperature Regulation: Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents. Advise patients regarding appropriate care in avoiding overheating and dehydration. Appropriate care is advised for patients who may exercise strenuously, may be exposed to extreme heat, receive concomitant medication with anticholinergic activity, or are subject to dehydration.

    Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use; use caution in patients at risk for aspiration pneumonia.

    Concomitant Medication: ARISTADA INITIO is only available at a single strength as a single-dose pre-filled syringe, so dosage adjustments are not possible. Avoid use in patients who are known CYP2D6 poor metabolizers or taking strong CYP3A4 inhibitors, strong CYP2D6 inhibitors, or strong CYP3A4 inducers, antihypertensive drugs or benzodiazepines.   

    Depending on the ARISTADA dose, adjustments may be recommended if patients are 1) known as CYP2D6 poor metabolizers and/or 2) taking strong CYP3A4 inhibitors, strong CYP2D6 inhibitors, or strong CYP3A4 inducers for greater than 2 weeks.   Avoid use of ARISTADA 662mg, 882mg, or 1064 mg for patients taking both strong CYP3A4 inhibitors and strong CYP2D6 Inhibitors. (See Table 4 in the ARISTADA full Prescribing Information)

    Commonly Observed Adverse Reactions: In pharmacokinetic studies the safety profile of ARISTADA INITIO was generally consistent with that observed for ARISTADA. The most common adverse reaction (≥5% incidence and at least twice the rate of placebo reported by patients treated with ARISTADA 441mg and 882 mg monthly) was akathisia. 

    Injection-Site Reactions: In pharmacokinetic studies evaluating ARISTADA INITIO, the incidences of injection site reactions with ARISTADA INITIO were similar to the incidence observed with ARISTADA.  Injection-site reactions were reported by 4%, 5%, and 2% of patients treated with 441 mg ARISTADA (monthly), 882 mg ARISTADA (monthly), and placebo, respectively. Most of these were injection-site pain and associated with the first injection and decreased with each subsequent injection. Other injection-site reactions (induration, swelling, and redness) occurred at less than 1%.

    Dystonia: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first days of treatment and at low doses.

    Pregnancy/Nursing: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients to notify their healthcare provider of a known or suspected pregnancy. Inform patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ARISTADA INITIO and/or ARISTADA during pregnancy. Aripiprazole is present in human breast milk. The benefits of breastfeeding should be considered along with the mother's clinical need for ARISTADA INITIO and/or ARISTADA and any potential adverse effects on the infant from ARISTADA INITIO and/or ARISTADA or from the underlying maternal condition.

    Please see full Prescribing Information, including Boxed Warning for ARISTADA INITIO and ARISTADA.

    About Alkermes plc
    Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and 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 facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

    Note Regarding 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 potential therapeutic and commercial value of LAIs, of ARISTADA, and of the ARISTADA INITIO regimen* for initiation onto ARISTADA, in the treatment of schizophrenia, including during an acute exacerbation of symptoms and during the transition from hospitalization to outpatient care. 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: whether results from the ALPINE study are predictive of real-world results 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, 2019, the company's Quarterly Report on Form 10-Q for the period ended March 31, 2020 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. 

    *The ARISTADA INITIO regimen is comprised of ARISTADA INITIO (675 mg) + a single 30 mg oral dose of aripiprazole, and provides an alternative to the concomitant three weeks of oral aripiprazole for initiation onto ARISTADA.

    ARISTADA® and ARISTADA INITIO® are registered trademarks of Alkermes Pharma Ireland Limited.

    INVEGA SUSTENNA® is a registered trademark of Johnson & Johnson.

    1American Psychiatric Association. Schizophrenia Spectrum and Other Psychiatric Disorders. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington, DC: American Psychiatric Publishing; 2013.

    2 National Institutes of Health. Schizophrenia. Accessed on May 19, 2020 from https://archives.nih.gov/asites/report/09-09-2019/report.nih.gov/nihfactsheets/Pdfs/Schizophrenia(NIMH).pdf.

    Alkermes Contacts:
    For Investors:  Sandy Coombs, +1 781 609 6377
    For Media:  Marisa Borgasano, +1 781 609 6659

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