ALKS Alkermes plc

16.57
+0.04  (+0%)
Previous Close 16.53
Open 16.41
52 Week Low 11.98
52 Week High 21.88
Market Cap $2,635,353,960
Shares 159,043,691
Float 111,727,400
Enterprise Value $2,544,466,940
Volume 932,832
Av. Daily Volume 1,246,175
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
ALKS 3831
Schizophrenia, bipolar
PDUFA
PDUFA
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Drug Pipeline

Drug Stage Notes
ALKS 4230 ARTISTRY-1
Solid tumors
Phase 1
Phase 1
Phase 1/2 data presented at ESMO September 18, 2020. 1/5 partial responses in melanoma cohort (monotherapy).
ALKS 4230 (ARTISTRY-3)
Solid Tumors
Phase 3
Phase 3
Phase 2 trial initiation announced August 18, 2020.
ALKS 4230 + Keytruda - ARTISTRY-2
Solid tumors
Phase 1
Phase 1
Phase 1 data presented at SITC November 8, 2019.
Diroximel fumarate (BIIB098)
Multiple sclerosis (MS)
Approved
Approved
FDA Approval announced October 30, 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 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, Sept. 18, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today presented new clinical data from ARTISTRY-1, an ongoing phase 1/2 study evaluating Alkermes' investigational engineered interleukin-2 (IL-2) variant immunotherapy, ALKS 4230, administered intravenously as monotherapy and in combination with the PD-1 inhibitor pembrolizumab (KEYTRUDA®) in patients with refractory solid tumors. Data from the ongoing ARTISTRY-1 study showed encouraging single-agent activity of ALKS 4230 in melanoma and durable responses in multiple tumor types in combination with pembrolizumab. The most frequently observed treatment-emergent adverse events (AEs) in both the monotherapy and combination cohorts were transient fever and chills, consistent with…

    DUBLIN, Sept. 18, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today presented new clinical data from ARTISTRY-1, an ongoing phase 1/2 study evaluating Alkermes' investigational engineered interleukin-2 (IL-2) variant immunotherapy, ALKS 4230, administered intravenously as monotherapy and in combination with the PD-1 inhibitor pembrolizumab (KEYTRUDA®) in patients with refractory solid tumors. Data from the ongoing ARTISTRY-1 study showed encouraging single-agent activity of ALKS 4230 in melanoma and durable responses in multiple tumor types in combination with pembrolizumab. The most frequently observed treatment-emergent adverse events (AEs) in both the monotherapy and combination cohorts were transient fever and chills, consistent with anticipated effects of immunotherapy. These data are being presented in a mini oral presentation at the 2020 European Society for Medical Oncology (ESMO) Virtual Congress, held Sept. 18-21. The company also announced today the expansion of the ARTISTRY-1 monotherapy melanoma cohort based on achievement of protocol-defined efficacy response criteria.

    "New treatment options are needed to improve clinical outcomes in many cancer types. Current immunotherapies are not an option for all cancer types and only a portion of eligible patients respond to them," said Ulka N. Vaishampayan, M.D., Lead Investigator and Professor, Internal Medicine, Division of Hematology/Oncology, University of Michigan. "The monotherapy anti-tumor efficacy and the durable responses in the combination cohorts in multiple tumor types, including heavily pretreated platinum-resistant ovarian cancer, triple-negative breast cancer and esophageal cancer, provide additional insights into ALKS 4230's potential as a treatment option for patients with advanced tumors that may not respond to the current standard of care."

    Data highlights include:

    ALKS 4230 Monotherapy

    The monotherapy expansion stage of ARTISTRY-1 is evaluating the recommended phase 2 dose of ALKS 4230 (6 µg/kg/day) administered intravenously in patients with refractory melanoma or refractory renal cell carcinoma (RCC). A total of 15 patients across both monotherapy cohorts were treated, with responses observed in melanoma. (Data as of July 24, 2020 unless otherwise noted.)

    • Melanoma cohort
      • Of the 5 evaluable melanoma patients (>1 scan), one had a confirmed partial response (PR) and two had stable disease on at least two consecutive scans.
      • The PR was achieved in a patient with metastatic urethral melanoma by week 20 of treatment, and a deepening of response was observed through week 39 of treatment. This patient's serum lactate dehydrogenase (LDH) levels, a known marker for treatment response in melanoma, normalized at week 5 of treatment and remained within the normal range throughout the treatment period. As of July 27, 2020, the patient had experienced a total tumor shrinkage of 39% and was continuing monotherapy treatment.
      • Since the July 24, 2020 data cut, one additional melanoma patient achieved a PR, awaiting a confirmatory scan. As of Sept. 1, 2020, this additional patient had experienced a total tumor shrinkage of 39% and was continuing monotherapy treatment.
      • With the observance of two PRs among the first 6 evaluable patients in the monotherapy melanoma cohort, the protocol-defined response criteria for expansion of this cohort was achieved, and the cohort will now enroll up to 20 additional patients for a total of up to 41 patients.

    ALKS 4230 in Combination with Pembrolizumab

    Data presented at ESMO from the combination stage of ARTISTRY-1 included data from patients in the PD-1/L1-approved, PD-1/L1-unapproved and monotherapy rollover cohorts (n=67 total). Patients representing more than 10 tumor types received ALKS 4230 3 µg/kg/day in combination with pembrolizumab. Responses were observed across multiple tumor types. (Data as of Aug. 7, 2020.)

    • Refractory ovarian cancer
      • Of the 13 evaluable patients (≥1 scan) with progressive, refractory ovarian cancer, 9 demonstrated stable disease on their first scan. Six of these 9 patients received a second scan by the data cutoff date, and 5 had stable disease or better. All 5 of these ovarian cancer patients were heavily pretreated and platinum-resistant, and each experienced tumor burden reduction with the combination of ALKS 4230 and pembrolizumab. Of these 5 patients:
        • One patient with platinum-resistant ovarian cancer achieved a complete response (CR) by week 45 of treatment, and a deepening of response was observed through week 81 of treatment. As of the data cut, this patient had a durable, confirmed CR and had remained on treatment for more than 18 months.
        • Two other patients with platinum-resistant ovarian cancer achieved PRs, one confirmed and one unconfirmed. As of the data cut, the patient with the confirmed PR demonstrated a deepening of response and had remained on treatment for more than 5 months.
    • Other tumor types
      • Additional PRs were achieved in multiple other tumor types across the PD-1/L1 approved and unapproved cohorts, including one patient with triple-negative breast cancer and two patients with esophageal cancer (one of which is awaiting confirmation). As of the data cut, these three patients had sustained PRs and continued on treatment.

    Safety and Tolerability

    (Data as of July 24, 2020 unless otherwise noted.)

    • The safety profile of ALKS 4230 in combination with pembrolizumab was generally consistent with the monotherapy profile. Based on the data available, ALKS 4230 in combination with pembrolizumab did not demonstrate any additive toxicity to that already established with pembrolizumab alone.
    • The most frequently observed treatment-emergent AEs in both the monotherapy and combination groups were transient fever and chills, all grade 1 or 2 in severity, which are consistent with anticipated effects of cytokine therapy. One patient in the monotherapy cohort had a grade 3 transient hypotension that was managed with fluids. There were no reports of vascular leak syndrome, which is a known AE associated with high-dose IL-2 treatment.
    • There were no deaths due to treatment-related AEs in the monotherapy cohorts. One death of a pancreatic cancer patient in the combination cohort, which occurred after the data cutoff, was due to inanition (starvation) and assessed as related to both study drugs.

    "The data presented at ESMO include early evidence of ALKS 4230's single-agent activity and its potential to deliver clinical benefit in multiple tumor types as a combination therapy," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "We're seeing increased momentum in enrollment trends across the broader ARTISTRY clinical development program, and we look forward to presenting our accumulating data for ALKS 4230 at future medical meetings."

    The mini oral presentation (#1027) titled, "ALKS 4230 Monotherapy and in Combination With Pembrolizumab in Patients With Refractory Solid Tumors (ARTISTRY-1)," is available on the ESMO website at www.esmo.org/meetings/esmo-virtual-congress-2020.

    Conference Call and Webcast

    Alkermes will host a webcast presentation and conference call with accompanying slides for analysts and investors on Friday, Sept. 18, 2020, at 8:30 a.m. ET (1:30 p.m. BST) to discuss the latest data from the ARTISTRY-1 clinical trial. The webcast will feature the lead study investigator, Dr. Ulka N. Vaishampayan, Professor of Internal Medicine, Division of Hematology/Oncology, at the University of Michigan, and members of Alkermes' management team. The webcast player may be accessed on the Investors section of Alkermes' website at www.alkermes.com. To participate in the question and answer session, please also dial in to the conference call, which may be accessed by dialing +1 877-407-2988 for U.S. callers and +1 201-389-0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes' website or by dialing +1 877-660-6853 for U.S. callers and +1 201-612-7415 for international callers, using replay access code 13708824. The conference call replay will be available from 11:30 a.m. ET (4:30 p.m. BST) on Friday, Sept. 18, 2020 through Friday, Sept. 25, 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 the ARTISTRY Clinical Development Program 

    ARTISTRY is an Alkermes-sponsored clinical development program evaluating ALKS 4230 in patients with advanced solid tumors.

    ARTISTRY-1 and ARTISTRY-2 are phase 1/2 studies evaluating the safety, tolerability, efficacy and pharmacokinetic and pharmacodynamic effects of ALKS 4230 in patients with refractory advanced solid tumors, in both monotherapy and combination settings with the PD-1 inhibitor pembrolizumab (KEYTRUDA®). In ARTISTRY-1, ALKS 4230 is administered as an intravenous infusion daily for five consecutive days.  In ARTISTRY-2, ALKS 4230 is administered subcutaneously and is being evaluated with once-weekly and once-every-three-week dosing schedules.

    ARTISTRY-3 is a phase 2 study evaluating the clinical and immunologic effects of ALKS 4230 monotherapy administered intravenously on the tumor microenvironment of a variety of advanced, malignant solid tumors.

    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.

    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 cancer immunotherapy when used as monotherapy or in combination across multiple tumor types; and the status of and plans for the clinical development of ALKS 4230, including enrollment trends across the ARTISTRY clinical development program, details of the ongoing ARTISTRY studies and the company's plans for presentation of data relating to the ARTISTRY development program. 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 ALKS 4230, as a monotherapy or in combination, could be shown to be unsafe or ineffective; whether preclinical results and data from ongoing clinical studies for ALKS 4230—whether as a monotherapy or in combination—will be predictive of future or final results from such studies, results of future clinical studies or real-world results; 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 impact of the novel coronavirus (COVID-19) pandemic; 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 June 30, 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.

    KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp.

    Alkermes Contacts:

    For Investors: Sandy Coombs, +1 781 609 6377

    For Media: Sourojit Bhowmick, Ph.D.+1 781 609 6397

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/alkermes-presents-new-clinical-data-on-alks-4230-in-mini-oral-presentation-at-2020-european-society-for-medical-oncology-esmo-virtual-congress-301133701.html

    SOURCE Alkermes plc

    View Full Article Hide Full Article
  2. DUBLIN, Sept. 14, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) 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.

    The recent outcomes research used data from the OM1 Real-World Data Cloud1 to assess patterns of antipsychotic-associated weight gain and treatment interruptions (i.e., switching or discontinuation) among patients with schizophrenia…

    DUBLIN, Sept. 14, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) 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.

    The recent outcomes research used data from the OM1 Real-World Data Cloud1 to assess patterns of antipsychotic-associated weight gain and treatment interruptions (i.e., switching or discontinuation) among patients with schizophrenia or bipolar I disorder who initiated oral second-generation antipsychotics of moderate-to-high weight gain risk.2 A total of 8,174 patients with schizophrenia and 9,142 patients with bipolar I disorder were included in this retrospective analysis, with an average age of 57 years and 48 years, respectively.

    "Real-world data is important in understanding the impact that certain treatment side effects may have on a patient," said Linda Stalters, MSN, APRN(ret), Founder and Director of Health Affairs at Schizophrenia and Related Disorders Alliance of America (SARDAA). "Schizophrenia and bipolar I disorder are lifelong diseases that may require long-term treatment, so it is important to take a holistic approach when considering a patient's treatment journey."

    "We were pleased to share new research at this year's virtual Psych Congress, underscoring Alkermes' commitment to addressing the challenges faced by those living with serious mental illness," said Amy O'Sullivan, Vice President, Health Economics and Outcomes Research at Alkermes. "The outcomes research findings offer insight into the weight gain and treatment interruption patterns that may occur in patients with schizophrenia and bipolar I disorder, providing us with a broader understanding of the potential needs of these patient communities."

    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). The full list of Alkermes' presentations at Psych Congress is as follows:

    • Poster #101: "A Combination of Olanzapine and Samidorphan in Adults With Schizophrenia and Bipolar I Disorder: Overview of Clinical Data"
    • Poster #135: "Disease Prevalence, Comorbid Conditions, and Medication Utilization Among Patients with Schizophrenia in the United States"
    • Poster #185: "Phase 3 Safety and Tolerability Results of the Combination of Olanzapine and Samidorphan in Patients With Schizophrenia: The 1-Year ENLIGHTEN-2-Extension"
    • Poster #192: "Qualitative Clinical Trial Exit Interviews Evaluating Treatment Benefit, Burden, and Satisfaction in Patients With Schizophrenia"
    • Poster #200: "Safety and Tolerability of Aripiprazole Lauroxil 2-Month Formulation With 1-Day Initiation for Treatment of Schizophrenia in the ALPINE Study"
    • Poster #214: "Weight Gain and Treatment Interruptions with Second-Generation Oral Antipsychotics: Analysis of Real-World Data Among Patients with Schizophrenia or Bipolar I Disorder"

    For more information, please visit the Psych Congress website at https://national.psychcongress.com.

    About ALKS 3831

    ALKS 3831 is an investigational, novel, once-daily, oral atypical 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, new molecular entity, co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.

    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

    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.

     

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

    1 The OM1 Real-World Data Cloud (OM1, Inc.; Boston, MA) includes de-identified patient-level health care claims and electronic medical records (EMRs) linked for >50 million patients using a proprietary method with patient-specific identifiers.

    2 Oral second-generation antipsychotics of moderate-to-high weight gain risk included in the retrospective analysis were: Olanzapine, Clozapine (SZ only), Iloperidone (SZ only), Paliperidone (SZ only), Risperidone, Quetiapine, Olanzapine/fluoxetine combination (BD-1 only)

     

    Alkermes Contacts:

    For Investors: Sandy Coombs,    +1 781 609 6377

    For Media:      Marisa Borgasano,  +1 781 609 6659

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/alkermes-presents-new-psychiatry-data-at-psych-congress-2020-virtual-experience-301129673.html

    SOURCE Alkermes plc

    View Full Article Hide Full Article
  3. DUBLIN, Sept. 9, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) announced today that that its Chief Executive Officer, Richard Pops, will participate in a fireside chat at the Cantor Virtual Global Healthcare Conference on Wednesday, Sept. 16, 2020 at 10:40 a.m. ET (3:40 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…

    DUBLIN, Sept. 9, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) announced today that that its Chief Executive Officer, Richard Pops, will participate in a fireside chat at the Cantor Virtual Global Healthcare Conference on Wednesday, Sept. 16, 2020 at 10:40 a.m. ET (3:40 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)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/alkermes-to-take-part-in-cantor-virtual-global-healthcare-conference-301126833.html

    SOURCE Alkermes plc

    View Full Article Hide Full Article
  4. DUBLIN, Sept. 8, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that it will present new clinical data related to ALKS 4230, its investigational engineered interleukin-2 (IL-2) variant immunotherapy, at the European Society for Medical Oncology (ESMO) Virtual Congress, taking place Sept. 18-21, 2020. Safety and anti-tumor efficacy data from the ongoing phase 1/2 ARTISTRY-1 study, evaluating ALKS 4230 as monotherapy and in combination with pembrolizumab in patients with refractory solid tumors, will be shared in a mini oral presentation. The company will host an accompanying webcast and conference call at 8:30 a.m. ET on Friday, Sept. 18, 2020.

    "The ESMO Virtual Congress serves as an important forum to share the latest data on…

    DUBLIN, Sept. 8, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that it will present new clinical data related to ALKS 4230, its investigational engineered interleukin-2 (IL-2) variant immunotherapy, at the European Society for Medical Oncology (ESMO) Virtual Congress, taking place Sept. 18-21, 2020. Safety and anti-tumor efficacy data from the ongoing phase 1/2 ARTISTRY-1 study, evaluating ALKS 4230 as monotherapy and in combination with pembrolizumab in patients with refractory solid tumors, will be shared in a mini oral presentation. The company will host an accompanying webcast and conference call at 8:30 a.m. ET on Friday, Sept. 18, 2020.

    "The ESMO Virtual Congress serves as an important forum to share the latest data on our immunotherapy candidate, ALKS 4230, with the global oncology community," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "We look forward to sharing new safety and efficacy data from our ARTISTRY-1 clinical trial, where we are evaluating ALKS 4230 as a monotherapy and combination therapy to treat a variety of tumor types in patients with tumors that are refractory to currently established treatments."

    A mini oral presentation (#1027) titled, "ALKS 4230 Monotherapy and in Combination With Pembrolizumab in Patients With Refractory Solid Tumors (ARTISTRY-1)," to be presented by Ulka N. Vaishampayan, M.D., Professor, Internal Medicine, Division of Hematology/Oncology, University of Michigan, will be available on the ESMO website at https://www.esmo.org/meetings/esmo-virtual-congress-2020.

    Conference Call and Webcast

    Alkermes will host a webcast presentation and conference call with accompanying slides for analysts and investors on Friday, Sept. 18, 2020, at 8:30 a.m. ET (1:30 p.m. BST) to discuss the latest data from the ARTISTRY-1 clinical trial. The webcast will feature the lead study investigator, Dr. Ulka N. Vaishampayan, Professor of Internal Medicine, Division of Hematology/Oncology, at the University of Michigan, and members of Alkermes' management team. The webcast player may be accessed on the Investors section of Alkermes' website at www.alkermes.com. To participate in the question and answer session, please also dial in to the conference call, which may be accessed by dialing +1 877-407-2988 for U.S. callers and +1 201-389-0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes' website or by dialing +1 877-660-6853 for U.S. callers and +1 201-612-7415 for international callers, using replay access code 13708824. The conference call replay will be available from 11:30 a.m. ET (4:30 p.m. BST) on Friday, Sept. 18, 2020 through Friday, Sept. 25, 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 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.

    Alkermes Contacts:

    For Investors: Sandy Coombs +1 781 609 6377

    For Media: Sourojit Bhowmick, Ph.D. +1 781 609 6397

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/alkermes-to-present-new-data-on-investigational-immuno-oncology-candidate-alks-4230-at-the-2020-european-society-for-medical-oncology-esmo-virtual-congress-301124669.html

    SOURCE Alkermes plc

    View Full Article Hide Full Article
  5. DUBLIN, Aug. 21, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that a joint meeting of the U.S. Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to review the New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan) has been tentatively scheduled for Oct. 9, 2020. ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. The Prescription Drug User Fee Act (PDUFA) action date for the ALKS 3831 NDA is Nov. 15, 2020.

    It is expected that the advisory committee panel will review the efficacy…

    DUBLIN, Aug. 21, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that a joint meeting of the U.S. Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to review the New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan) has been tentatively scheduled for Oct. 9, 2020. ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. The Prescription Drug User Fee Act (PDUFA) action date for the ALKS 3831 NDA is Nov. 15, 2020.

    It is expected that the advisory committee panel will review the efficacy, safety, and benefit-risk profile of ALKS 3831 for the proposed indications of schizophrenia and bipolar I disorder. As announced previously, the company expects the advisory panel to focus on the clinical meaningfulness of ALKS 3831's attenuation of olanzapine-associated weight gain, including the magnitude of weight effect and the impact of ALKS 3831 on laboratory-based metabolic parameters. Since that time, the company has learned that the panel will also discuss certain potential clinical risks related to the interaction of ALKS 3831, which includes samidorphan, an opioid receptor antagonist, and opioids in the intended patient populations.

    "We look forward to engaging with members of the joint advisory committee panel in a robust discussion of the clinical evidence for ALKS 3831," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "For adults living with schizophrenia or bipolar I disorder, populations already prone to shortened life expectancy and cardiovascular comorbidities, the significant weight gain often associated with olanzapine can represent a major clinical liability. Patients and healthcare providers may benefit from additional treatment options that help manage disease symptoms while mitigating weight gain. We are committed to bringing this potential new medicine to adults living with schizophrenia or bipolar I disorder."  

    The NDA submission and clinical development program for ALKS 3831 are supported by data from 27 clinical studies, including 18 studies evaluating ALKS 3831 and nine studies evaluating samidorphan alone. Throughout the clinical development program, ALKS 3831 showed evidence of antipsychotic efficacy, safety and tolerability, including attenuation of olanzapine-associated weight gain.

    About ALKS 3831

    ALKS 3831 is an investigational, novel, once-daily, oral atypical 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, new molecular entity, co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.

    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 Bipolar I Disorder

    Bipolar disorder is a brain disorder that causes shifts in a person's mood, energy and ability to function. Patients with this brain disorder may experience debilitating mood shifts 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 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 ALKS 3831 for the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder; the company's current expectations regarding the timing and substance of the FDA's joint advisory committee meeting to review the ALKS 3831 NDA, including the joint advisory committees' consideration of the clinical meaningfulness of ALKS 3831's attenuation of olanzapine-associated weight gain, including the magnitude of weight effect and the impact of ALKS 3831 on laboratory-based metabolic parameters, and potential clinical risks related to the interaction of ALKS 3831 with opioids in the intended patient populations; and the company's additional expectations regarding the ALKS 3831 NDA, including the FDA's PDUFA target action date for the NDA and the adequacy of the data contained in the NDA to serve as the basis for approval of ALKS 3831 for the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder. 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: unanticipated impacts of the COVID-19 pandemic on the company's operations, plans and prospects and on the operations of the regulatory agencies involved in the review and potential approval of ALKS 3831; potential changes in the cost, scope and duration of the ALKS 3831 development and regulatory program; whether ALKS 3831 could be shown ineffective or unsafe during clinical studies; data from the ALKS 3831 clinical development program may be interpreted by the FDA in different ways than the company interprets it; the FDA may not agree with the company's regulatory approval strategies or components of its NDA filing for ALKS 3831, including the company's clinical trial designs, conduct and methodologies, manufacturing processes and facilities; the FDA's determination as to the clinical meaningfulness of the ALKS 3831 weight data, including the effects of ALKS 3831 on metabolic parameters; the joint advisory committees' or FDA's views of impact on the risk/benefit profile of ALKS 3831 of the interaction of ALKS 3831 with opioids in the intended patient populations; and the adequacy of the preclinical and clinical results of the ALKS 3831 studies and the PK bridging data and other information included in the ALKS 3831 NDA to meet the FDA's requirements for approval for the proposed schizophrenia and bipolar I disorder indications; if approved, whether ALKS 3831 will be commercialized successfully; 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 June 30, 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.

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

    National Institutes of Health. Schizophrenia. Accessed on Aug. 20, 2020 from https://archives.nih.gov/asites/report/09-09-2019/report.nih.gov/nihfactsheets/Pdfs/Schizophrenia(NIMH).pdf.

    Merikangas et al. Lifetime and 12-Month Prevalence of Bipolar Spectrum Disorder in the National Comorbidity Survey Replication. Arch Gen Psychiatry, 2007 May; 64(5): 543–552. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1931566/

    Alkermes Contacts:

    For Investors:

    Sandy Coombs

    +1 781 609 6377

    For Media:

    Eva Stroynowski

    +1 781 609 6823

     

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/virtual-fda-advisory-committee-meeting-to-review-new-drug-application-for-alks-3831-for-treatment-of-schizophrenia-and-bipolar-i-disorder-tentatively-scheduled-for-oct-9-2020-301116109.html

    SOURCE Alkermes plc

    View Full Article Hide Full Article
View All Alkermes plc News