ALKS Alkermes plc

21.47
-0.82  -4%
Previous Close 22.29
Open 22.22
52 Week Low 11.98
52 Week High 23.02
Market Cap $3,416,945,884
Shares 159,149,785
Float 111,833,494
Enterprise Value $3,363,664,707
Volume 1,234,655
Av. Daily Volume 1,331,799
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Upcoming Catalysts

Drug Stage Catalyst Date
ALKS 3831 (olanzapine/samidorphan)
Schizophrenia, bipolar
PDUFA priority review
PDUFA priority review
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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, Jan. 14, 2021 /PRNewswire/ -- Results from a National Institute on Drug Abuse (NIDA)-funded study evaluating the efficacy and safety of naltrexone for extended-release injectable suspension (XR-NTX) administered once every three weeks plus oral extended-release bupropion administered daily as a combination treatment for adults with moderate or severe methamphetamine use disorder (MUD) were published today by Dr. Madhukar H. Trivedi et al. in the New England Journal of Medicine (NEJM).1 This is the second published study evaluating this combination regimen for the treatment of MUD.2 

    The number of adults living with MUD has risen in recent years. In 2019, approximately 1 million adults in the U.S. reported having a methamphetamine use…

    DUBLIN, Jan. 14, 2021 /PRNewswire/ -- Results from a National Institute on Drug Abuse (NIDA)-funded study evaluating the efficacy and safety of naltrexone for extended-release injectable suspension (XR-NTX) administered once every three weeks plus oral extended-release bupropion administered daily as a combination treatment for adults with moderate or severe methamphetamine use disorder (MUD) were published today by Dr. Madhukar H. Trivedi et al. in the New England Journal of Medicine (NEJM).1 This is the second published study evaluating this combination regimen for the treatment of MUD.2 

    The number of adults living with MUD has risen in recent years. In 2019, approximately 1 million adults in the U.S. reported having a methamphetamine use disorder—an increase of more than 50 percent since 2016.3 Currently, there are no FDA-approved medicines for the treatment of MUD. 

    "Given the scale and severity of the methamphetamine epidemic in the U.S., we applaud the clinical community's efforts and commitment to advancing research focused on treatment options for this critically underserved patient population," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "We're encouraged by the publication of this NIDA-funded study in the New England Journal of Medicine, and plan to engage with the FDA to better understand what options may exist for VIVITROL with regards to these data."

    VIVITROL® (naltrexone for extended-release injectable suspension) is not approved for the treatment of MUD. VIVITROL, developed by Alkermes (NASDAQ:ALKS), was approved by the U.S. Food and Drug Administration (FDA) for the treatment of alcohol dependence in 2006 and for the prevention of relapse to opioid dependence, following opioid detoxification, in 2010. VIVITROL is to be administered once every four weeks as part of a comprehensive management program that includes psychosocial support.

    About the ADAPT-2 Study

    The "Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder" study was a multi-site, double-blind, 12-week trial to evaluate the efficacy and safety of XR-NTX (380 mg every three weeks) plus oral extended-release bupropion (450 mg/day) in adults with moderate or severe MUD. Participants (N=403) with moderate or severe MUD (defined as reported use on at least 18 of the 30 days prior to randomization) were randomized to combination therapy (XR-NTX, 380 mg IM every three weeks, plus bupropion XL, up to 450 mg/d) versus placebo in a two-stage study. Placebo non-responders from stage 1 (6 weeks) were re-randomized in stage 2 for another 6 weeks. The primary outcome was the proportion of "responders," defined as having at least three methamphetamine-negative urine samples out of four samples obtained during weeks 5-6 (for stage 1) or weeks 11-12 (for stage 2). Response rates were higher with XR-NTX plus bupropion than with placebo across both stages (overall weighted treatment effect of 11.1 percentage points; Wald z-test statistic = 4.53; p < 0.001; NNT =9), as well as in each stage [stage 1: (16.5% COMB vs. 3.4% PBO); stage 2: (11.4% COMB vs. 1.8% PBO)]. Secondary outcomes also favored treatment with XR-NTX plus bupropion XL as compared to placebo. Adverse events in the combination treatment group included gastrointestinal disorders, tremor, malaise, hyperhidrosis, and anorexia. Serious adverse events occurred in 8 of 223 participants (3.6%) who received XR-NTX plus bupropion in the study. Alkermes provided XR-NTX and matched placebo free of charge for use in this trial under a written agreement with NIDA.

    About VIVITROL

    VIVITROL® (naltrexone for extended-release injectable suspension) is a once-monthly medication for the treatment of alcohol dependence and for the prevention of relapse to opioid dependence, following opioid detoxification. Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support. For more information, visit www.vivitrol.com.

    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.

    IMPORTANT SAFETY INFORMATION

    INDICATIONS

    VIVITROL is indicated for:

    • Treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Patients should not be actively drinking at the time of initial VIVITROL administration.
    • Prevention of relapse to opioid dependence, following opioid detoxification.
    • VIVITROL should be part of a comprehensive management program that includes psychosocial support.

    CONTRAINDICATIONS

    VIVITROL is contraindicated in patients:

    • Receiving opioid analgesics
    • With current physiologic opioid dependence
    • In acute opioid withdrawal
    • Who have failed the naloxone challenge test or have a positive urine screen for opioids
    • Who have exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent

    IMPORTANT SAFETY INFORMATION

    WARNINGS AND PRECAUTIONS

    Vulnerability to Opioid Overdose:

    • After opioid detoxification, patients are likely to have a reduced tolerance to opioids. VIVITROL blocks the effects of exogenous opioids for approximately 28 days after administration. As the blockade wanes and eventually dissipates completely, use of previously tolerated doses of opioids could result in potentially life-threatening opioid intoxication (respiratory compromise or arrest, circulatory collapse, etc.).
    • Cases of opioid overdose with fatal outcomes have been reported in patients who used opioids at the end of a dosing interval, after missing a scheduled dose, or after discontinuing treatment. Patients and caregivers should be told of this increased sensitivity to opioids and the risk of overdose.
    • Although VIVITROL is a potent antagonist with a prolonged pharmacological effect, the blockade produced by VIVITROL is surmountable. The plasma concentration of exogenous opioids attained immediately following their acute administration may be sufficient to overcome the competitive receptor blockade. This poses a potential risk to individuals who attempt, on their own, to overcome the blockade by administering large amounts of exogenous opioids.
    • Any attempt by a patient to overcome the VIVITROL blockade by taking opioids may lead to fatal overdose. Patients should be told of the serious consequences of trying to overcome the opioid blockade.

    Injection Site Reactions:

    • VIVITROL must be prepared and administered by a healthcare provider.
    • VIVITROL injections may be followed by pain, tenderness, induration, swelling, erythema, bruising, or pruritus; however, in some cases injection site reactions may be very severe.
    • In the clinical trials, one patient developed an area of induration that continued to enlarge after 4 weeks, with subsequent development of necrotic tissue that required surgical excision.
    • Injection site reactions not improving may require prompt medical attention, including, in some cases, surgical intervention.
    • Inadvertent subcutaneous/adipose layer injection of VIVITROL may increase the likelihood of severe injection site reactions.
    • Select proper needle size for patient body habitus, and use only the needles provided in the carton.
    • Patients should be informed that any concerning injection site reactions should be brought to the attention of their healthcare provider.

    Precipitation of Opioid Withdrawal:

    • When withdrawal is precipitated abruptly by administration of an opioid antagonist to an opioid-dependent patient, the resulting withdrawal syndrome can be severe. Some cases of withdrawal symptoms have been severe enough to require hospitalization, and in some cases, management in the ICU.
    • To prevent occurrence of precipitated withdrawal, opioid-dependent patients, including those being treated for alcohol dependence, should be opioid-free (including tramadol) before starting VIVITROL treatment:
      • An opioid-free interval of a minimum of 7–10 days is recommended for patients previously dependent on short-acting opioids.
      • Patients transitioning from buprenorphine or methadone may be vulnerable to precipitated withdrawal for as long as two weeks.
    • If a more rapid transition from agonist to antagonist therapy is deemed necessary and appropriate by the healthcare provider, monitor the patient closely in an appropriate medical setting where precipitated withdrawal can be managed.
    • Patients should be made aware of the risk associated with precipitated withdrawal and be encouraged to give an accurate account of last opioid use.
    • Precipitated opioid withdrawal has been observed in alcohol-dependent patients in circumstances where the prescriber had been unaware of the additional use of opioids or co-dependence on opioids.

    Hepatotoxicity:

    • Cases of hepatitis and clinically significant liver dysfunction have been observed in association with VIVITROL. Warn patients of the risk of hepatic injury; advise them to seek help if experiencing symptoms of acute hepatitis. Discontinue use of VIVITROL in patients who exhibit acute hepatitis symptoms.

    Depression and Suicidality:

    • Alcohol- and opioid-dependent patients taking VIVITROL should be monitored for depression or suicidal thoughts. Alert families and caregivers to monitor and report the emergence of symptoms of depression or suicidality.

    When Reversal of VIVITROL Blockade Is Required for Pain Management:

    • For VIVITROL patients in emergency situations, suggestions for pain management include regional analgesia or use of non-opioid analgesics. If opioid therapy is required to reverse the VIVITROL blockade, patients should be closely monitored by trained personnel in a setting staffed and equipped for CPR.

    Eosinophilic Pneumonia:

    • Cases of eosinophilic pneumonia requiring hospitalization have been reported. Warn patients of the risk of eosinophilic pneumonia and to seek medical attention if they develop symptoms of pneumonia.

    Hypersensitivity Reactions including Anaphylaxis:

    • Cases of urticaria, angioedema, and anaphylaxis have been observed with use of VIVITROL in the clinical trial setting and in postmarketing use.
    • Patients should be warned of the risk of hypersensitivity reactions, including anaphylaxis.
    • In the event of a hypersensitivity reaction, patients should be advised to seek immediate medical attention in a healthcare setting prepared to treat anaphylaxis. The patient should not receive any further treatment with VIVITROL.

    Intramuscular Injections:

    • As with any intramuscular injection, VIVITROL should be administered with caution to patients with thrombocytopenia or any coagulation disorder.

    Alcohol Withdrawal:

    • Use of VIVITROL does not eliminate nor diminish alcohol withdrawal symptoms.

    Interference with Laboratory Tests

    • VIVITROL may be cross-reactive with certain immunoassay methods for the detection of drugs of abuse (specifically opioids) in urine.
    • For further information, reference to the specific immunoassay instructions is recommended.

    ADVERSE REACTIONS

    • The adverse events seen most frequently in association with VIVITROL therapy for alcohol dependence (ie, those occurring in ≥5% and at least twice as frequently with VIVITROL than placebo) include nausea, vomiting, injection site reactions (including induration, pruritus, nodules, and swelling), arthralgia, arthritis, or joint stiffness, muscle cramps, dizziness or syncope, somnolence or sedation, anorexia, decreased appetite or other appetite disorders.
    • The adverse events seen most frequently in association with VIVITROL in opioid-dependent patients (ie, those occurring in ≥2% and at least twice as frequently with VIVITROL than placebo) were hepatic enzyme abnormalities, injection site pain, nasopharyngitis, insomnia, and toothache.

    You are encouraged to report side effects to the FDA.

    Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    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 XR-NTX plus bupropion as a combination treatment for MUD; and the company's plans to engage with the FDA regarding potential options for VIVITROL relating to the ADAPT-2 data. 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 the combination treatment of XR-NTX plus bupropion could be shown to be unsafe or ineffective; whether clinical results for this combination treatment will be predictive of results of future clinical studies or real-world results; the outcome of interactions with the FDA related to VIVITROL and the ADAPT-2 data; 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.

    VIVITROL® is a registered trademark of Alkermes, Inc.

     

    1 Trivedi MH, Walker R, Ling, W, et al. Bupropion and Naltrexone in Methamphetamine Use Disorder. New England Journal of Medicine, 2021;384:140-53. DOI: 10.1056/NEJMoa2020214

    2 Mooney LJ, Hillhouse MP, Thomas C, et al. Utilizing a Two-stage Design to Investigate the Safety and Potential Efficacy of Monthly Naltrexone Plus Once-daily Bupropion as a Treatment for Methamphetamine Use Disorder. Journal of Addiction Medicine, 2016;10(4), 236–243. https://doi.org/10.1097/ADM.0000000000000218 

    3 SAMHSA. Behavioral Health Trends in the United States: Results from the 2016 and 2019 National Surveys on Drug Use and Health. Accessed on Jan. 12, 2021 from: https://www.samhsa.gov/data/data-we-collect/nsduh-national-survey-drug-use-and-health.

     

    Alkermes Contacts:

    For Investors: Sandy Coombs, +1 781 609 6377

    For Media: Marisa Borgasano, +1 781 609 6659

     

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  2. DUBLIN, Jan. 6, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) announced today that its Chief Executive Officer, Richard Pops, will provide a corporate overview and update at the 39th Annual J.P. Morgan Healthcare Conference. The presentation will take place virtually on Wednesday, Jan. 13, 2021 at 10:00 a.m. EST (3:00 p.m. GMT), followed by a question and answer session. The live 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…

    DUBLIN, Jan. 6, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) announced today that its Chief Executive Officer, Richard Pops, will provide a corporate overview and update at the 39th Annual J.P. Morgan Healthcare Conference. The presentation will take place virtually on Wednesday, Jan. 13, 2021 at 10:00 a.m. EST (3:00 p.m. GMT), followed by a question and answer session. The live 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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  3. DUBLIN, Jan. 6, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS), a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology, today announced a series of changes to its executive leadership team. Blair C. Jackson has been appointed chief operating officer (COO) and Iain M. Brown will assume the role of chief financial officer (CFO), replacing James M. Frates. Mr. Frates will leave the company following a 20-year career at Alkermes to pursue another opportunity.  

    "Alkermes is focused on executing on our business strategy, including the implementation of our recently-announced Value Enhancement Plan. I am pleased to have Blair and Iain assume these key leadership roles at this…

    DUBLIN, Jan. 6, 2021 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS), a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology, today announced a series of changes to its executive leadership team. Blair C. Jackson has been appointed chief operating officer (COO) and Iain M. Brown will assume the role of chief financial officer (CFO), replacing James M. Frates. Mr. Frates will leave the company following a 20-year career at Alkermes to pursue another opportunity.  

    "Alkermes is focused on executing on our business strategy, including the implementation of our recently-announced Value Enhancement Plan. I am pleased to have Blair and Iain assume these key leadership roles at this pivotal time as we position the company for our next stage of growth and advance our commitment to delivering value to all of our stakeholders," said Richard Pops, chairman and chief executive officer of Alkermes. "On behalf of the entire Alkermes team, I want to thank Jim for his countless contributions to the organization. Jim's dedication and commitment to Alkermes and the disease areas we serve has been an inspiration to us all. We are grateful for his leadership during his tenure and wish him the best in his future endeavors."

    Mr. Jackson will expand his current role as senior vice president of corporate planning to become executive vice president and COO, a newly created role which will oversee global operations, quality, finance, information technology, and corporate planning. Mr. Jackson has more than 20 years of experience in the biopharmaceutical industry and has served in various positions in both a scientific and corporate capacity at Alkermes. Mr. Jackson received a Bachelor of Arts degree in Biochemistry from the University of Calgary, a Bachelor of Arts in Chemical Engineering and a Master of Business Administration from the University of Alberta, and a Master of Science in Chemical Engineering from the Massachusetts Institute of Technology.

    Mr. Brown, currently senior vice president and chief accounting officer, will assume full responsibility for the finance organization in his new role as CFO with additional oversight of the business planning, procurement and strategic sourcing functions. Mr. Brown is a highly-accomplished finance professional and Chartered Accountant with more than 24 years of experience in the biopharmaceutical industry, with a strong track record in operational finance and financial compliance. Mr. Brown received a Bachelor of Science degree in Business Studies from the University of Bradford, England. 

    "It has been a great privilege to be part of the Alkermes team and I am incredibly proud of all that the organization has accomplished," said Mr. Frates. "I depart with confidence knowing that the organization is strong and well positioned to support its fundamental mission of making a meaningful difference in the lives of people living with serious mental illness, addiction and cancer."

    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.

    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 company's expectations concerning future financial and operating performance, business plans or prospects, including the company's ability to execute on its business strategy, position itself for growth and deliver value to its stakeholders; and the potential therapeutic and commercial value of the company's marketed and development products focused on serious mental illness, addiction and cancer. 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: the cost structure review and optimization activities being undertaken by the company may not yield the intended results; the company may not be able to achieve its targeted financial metrics, profitability or long-term value creation in a timely manner or at all; the unfavorable outcome of litigation, including so-called "Paragraph IV" litigation and other patent litigation, related to any of the company's products or products using the company's proprietary technologies, which may lead to competition from generic drug manufacturers; clinical development activities may not be completed on time or at all; the results of the company's clinical development activities may not be positive, or predictive of real-world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products, such as decisions not to approve the company's NDAs, including the NDA for ALKS 3831; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; the impacts of the ongoing COVID-19 pandemic and continued efforts to mitigate its spread on the company's business, results of operations or financial condition; 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.

    Alkermes Contacts:





    For Investors: 

    Sandy Coombs

    +1 781 609 6377

    For Media:     

    Katie Joyce

    +1 781 609 6806

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  4. DUBLIN, Dec. 29, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the company's New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder, and has assigned the application a new Prescription Drug User Fee Act (PDUFA) target action date of June 1, 2021.

    The FDA classified the resubmission as a complete, Class 2 response to the Complete Response Letter (CRL) issued in November 2020, following a remote review of records requested under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (the "FDCA") relating to the manufacture of ALKS 3831 at…

    DUBLIN, Dec. 29, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the company's New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder, and has assigned the application a new Prescription Drug User Fee Act (PDUFA) target action date of June 1, 2021.

    The FDA classified the resubmission as a complete, Class 2 response to the Complete Response Letter (CRL) issued in November 2020, following a remote review of records requested under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (the "FDCA") relating to the manufacture of ALKS 3831 at the company's Wilmington, OH facility. Subsequent to Alkermes' resubmission of the NDA, the FDA issued a new request for records under Section 704(a)(4) of the FDCA to supplement the information previously provided by the company. Neither the CRL nor this subsequent records request identified or raised any concerns about the clinical or non-clinical data in the NDA and the FDA has not asked Alkermes to complete any new clinical trials to support approval of the application.

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

    About Schizophrenia 

    Schizophrenia is a serious brain disorder 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. Individuals 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 ALKS 3831 (olanzapine/samidorphan)

    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 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 expectations regarding next steps for the NDA for ALKS 3831, including the FDA's PDUFA target action date for the NDA and the company's plans to work with the FDA as it completes its review of the NDA; and the company's commitment to making ALKS 3831 available to patients as quickly as possible. 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 data from the company's manufacturing processes may be interpreted by the FDA in different ways than the company interprets it; potential changes in the cost, scope and duration of the ALKS 3831 development and regulatory program following receipt of the FDA's CRL and subsequent records request; whether the FDA will approve the NDA for ALKS 3831 in a timely manner or at all; if approved, whether the FDA will impose conditions on the marketing of ALKS 3831, such as a risk evaluation and mitigation strategy; whether future clinical trials for ALKS 3831, if any, will be completed on time or at all; unanticipated impacts of the COVID-19 pandemic on the operations of the company and on the operations of the regulatory agencies involved in the review and potential approval of ALKS 3831; whether ALKS 3831 could be shown ineffective or unsafe during clinical studies; 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 Dec. 28, 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:

    Marisa Borgasano

    +1 781 609 6659

     

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

     

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  5. DUBLIN, Dec. 10, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced a Value Enhancement Plan, or the Plan, designed to drive growth, improve operational and financial performance and enhance shareholder value, as the company continues to advance its mission of developing new medicines designed to have a real-world impact in the treatment of serious mental illness, addiction and cancer. The Plan includes a commitment to multi-year profitability targets, a review and optimization of the company's cost structure, potential monetization of non-core assets, and continued governance enhancements, including the addition of two new independent directors with substantial financial and operational expertise to the company's board of directors…

    DUBLIN, Dec. 10, 2020 /PRNewswire/ -- Alkermes plc (NASDAQ:ALKS) today announced a Value Enhancement Plan, or the Plan, designed to drive growth, improve operational and financial performance and enhance shareholder value, as the company continues to advance its mission of developing new medicines designed to have a real-world impact in the treatment of serious mental illness, addiction and cancer. The Plan includes a commitment to multi-year profitability targets, a review and optimization of the company's cost structure, potential monetization of non-core assets, and continued governance enhancements, including the addition of two new independent directors with substantial financial and operational expertise to the company's board of directors (the "Board").

    The Value Enhancement Plan is the result of an intensive process initiated over the last several months and is intended to position the company to efficiently execute on its business strategy, support the continued growth of its commercial products, including the potential approval and launch of ALKS 3831, and further the advancement of its pipeline of development programs. The Plan builds upon the company's implementation of a restructuring and addition of two new independent directors to the Board in the fall of 2019 and the company's board refreshment efforts announced in July 2020. These initiatives also follow constructive dialogue with the company's shareholders, including funds advised by Elliott Advisors (UK) Limited ("Elliott"), and entry into an associated cooperation agreement between Alkermes and affiliates of Elliott.

    "Alkermes' Board and management are committed to engaging with shareholders and understanding their perspective and have been working on initiatives to drive greater operational efficiency, with a focus on shareholder value creation. These new initiatives also support our strong growth trajectory, which has come more clearly into focus over the past few months, with the positive advisory committee meeting and constructive regulatory interactions for ALKS 3831 for schizophrenia and bipolar I disorder, and with new clinical data emerging in our ALKS 4230 immuno-oncology program," said Richard Pops, Chairman and Chief Executive Officer of Alkermes. "We believe these actions, alongside our focus on commercial execution, the potential approval and commercial launch of ALKS 3831, and the continued development of our pipeline candidates, position the company well for long-term value creation."

    A spokesperson for Elliott said, "Elliott is highly supportive of the initiatives announced today and commends the Board and management of Alkermes on taking these steps. From our dialogue with management we are confident that the Company is committed to creating shareholder value. Further, both David Daglio and Brian McKeon will add significant value to Alkermes' Board and the newly formed board committee. Alkermes is significantly undervalued given its attractive assets and growth potential, and we are confident that these new initiatives will yield meaningful share price upside. We thank Richard and the rest of the team for their constructive dialogue and look forward to an ongoing engagement with the Company."

    Profitability Targets & Cost Structure Optimization Efforts

    As part of the Value Enhancement Plan, the company today announced its commitment to achieving:

    • FY 2023 non-GAAP net income equal to 25% of the company's total revenues and EBITDA margin1 of 20% of total revenues
    • FY 2024 non-GAAP net income equal to 30% of the company's total revenues and EBITDA margin of 25% of total revenues

    The company plans to achieve these margins through disciplined management of the company's cost structure combined with revenue growth, and is committed to meeting these targets in a range of scenarios. To underline Alkermes' commitment to strong profitability, the compensation committee of the Board will consider these targets in its design of this year's long-term incentive plan for senior management.

    Alkermes has already undertaken several important initiatives to support these targets, including a reorganization of the company's commercial infrastructure, which was implemented in November 2020. As part of the reorganization, several functional areas within the company's commercial organization were consolidated to improve efficiencies and approximately 80 full-time positions were reallocated to support the anticipated launch of ALKS 3831, reducing the need for previously planned new hires. Additionally, the company has commenced an extensive review of its operations and structure both internally and with external advisors to identify potential areas for improved efficiencies. This review is ongoing, and the company plans to provide an update on the findings and planned initiatives resulting from the review following its conclusion, expected in the first quarter of 2021.

    Evaluation of Strategic Opportunities

    A newly set-up committee of the board will evaluate a broad range of potential strategic options related to Alkermes' non-core assets, including monetization and divestiture opportunities.

    In addition, the company underscored its prior commitment to exploring a strategic collaboration for ALKS 4230, the company's immuno-oncology pipeline candidate, as an important element of the company's focus on realizing the full potential of ALKS 4230 across a broad spectrum of possible treatment combinations, tumor types and lines of therapy. Alkermes believes that accumulating objective response data and subcutaneous administration data from its ARTISTRY development program for ALKS 4230 will serve as the basis for potential collaboration discussions.     

    Board Refreshment and Governance Update

    The company today announced that it is taking a series of actions as part of its ongoing commitment to strong corporate governance and regular Board refreshment. These efforts build upon the refreshment process that began in 2019 with the engagement of a leading recruitment firm and the subsequent appointment of two highly-qualified independent directors: Andy Wilson and Richard Gaynor, M.D. 

    • Following the company's July 2020 announcement of its continuing Board refreshment efforts, the Alkermes Board has appointed two new independent directors – David Daglio and Brian McKeon – who bring investor perspectives and strong financial and operational expertise to the Board.
    • Two long-serving directors, Robert Breyer and Paul Mitchell, plan to retire and step down from the Board at the close of the company's 2021 Annual General Meeting of Shareholders.
    • The Board plans to identify at least one additional independent director to be appointed in the first half of 2021.

    "Our board refreshment efforts during the past two years reflect our continued commitment to a strong, independent board with expertise that aligns with and directly supports Alkermes' strategic priorities," said Lead Independent Director David W. Anstice. "I am pleased to welcome David and Brian to the Board and believe that Alkermes will benefit greatly from their distinct combination of financial and operational expertise. We are confident that the Board is well positioned to provide robust guidance and oversight as the company continues its efforts to positively impact the lives of patients living with serious mental illness, addiction and cancer, while driving shareholder value creation."

    "On behalf of the Board, I would also like to express our most sincere appreciation to Paul Mitchell and Bob Breyer for their long and distinguished tenure on the Board and their invaluable contributions to Alkermes," Mr. Anstice added.

    In addition to the appointment of new directors, the company will also undertake the following corporate governance actions:

    • The Board plans to form a committee to oversee achievement of the Profitability Targets and the potential monetization of the company's non-core assets. The committee will initially be comprised of the Chief Executive Officer and three independent directors, including two of the newly appointed directors.
    • The Board also intends to recommend that the company's shareholders approve, at the company's 2021 Annual General Meeting of Shareholders, an amendment to the company's Articles of Association to declassify the Board.

    Investor Day

    The company plans to host an investor day in the first quarter of 2021 to provide an update on the implementation of the Value Enhancement Plan and highlight some of the new research and development programs in the company's portfolio.

    New Director Biographies

    About David Daglio

    As former Executive Vice President and Chief Investment Officer of Mellon Investments, Mr. Daglio brings a seasoned institutional investment management perspective to the Board. Over his 21-year career at Mellon, Mr. Daglio oversaw active equity portfolio management teams, served as the head of Opportunistic Value strategies and on Mellon's board of directors, and helped architect and manage the merger of three unique companies to create the 12th largest U.S. asset manager. In his roles at Mellon, Mr. Daglio worked with institutional clients and boards around the world and grew portfolio assets by more than five-fold. Mr. Daglio currently serves as a director of Total Brain Ltd.

    About Brian McKeon

    Mr. McKeon brings strong financial and management expertise as well as public company executive and director experience to the Board. He has served as Executive Vice President and Chief Financial Officer of IDEXX Laboratories since 2014, leading its finance, corporate development and strategy, and investor relations functions, and, since June 2019, has overseen IDEXX's livestock, water and human diagnostics businesses. Mr. McKeon previously served as a director of IDEXX from 2003 through 2013, and as a director of athenahealth, Inc. from September 2017 to February 2019. Prior to IDEXX, Mr. McKeon held executive leadership roles at Iron Mountain, The Timberland Company and PepsiCo.

    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 Elliott

    Elliott Management Corporation manages approximately $41 billion of assets. Its flagship fund, Elliott Associates, L.P., was founded in 1977, making it one of the oldest funds of its kind under continuous management. The Elliott funds' investors include pension plans, sovereign wealth funds, endowments, foundations, funds-of-funds, and employees of the firm. Elliott Advisors (UK) Limited is an affiliate of Elliott Management Corporation.

    Non-GAAP Financial Measures

    Non-GAAP net income (loss) adjusts for one-time and non-cash charges by excluding from U.S. generally accepted accounting principles ("GAAP") results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; changes in the fair value of the contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items.

    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 company's expectations concerning future financial and operating performance, business plans or prospects, including expected revenue growth, the company's commitment to, and ability to achieve, specified profitability targets, including non-GAAP net income and EBITDA margin targets as a percentage of total revenues, oversight of the achievement of such targets by a newly formed Board committee, and the company's ability to create share price upside and long-term value for shareholders through expense management, cost structure optimization and potential monetization or divestiture of non-core assets; the company's expectations regarding the timing and results of the review of the company's operations and cost structure; the potential therapeutic and commercial value of the company's marketed and development products; the company's expectations concerning future development activities for the company's development products, including expectations regarding the potential for future ALKS 4230 data to serve as a basis for a potential collaboration; expectations concerning the company's regulatory interactions and commercial activities, including those relating to the potential approval and commercial launch of ALKS 3831; and the company's plans for additional Board-related changes, including the expected appointment of at least one additional director and its plans to recommend declassification of the Board. The company cautions that forward-looking statements are inherently uncertain. 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: the cost structure review and optimization activities being undertaken by the company may not yield the intended results; the company may not be able to achieve its targeted profitability metrics, including non-GAAP net income and EBITDA margin targets as a percentage of total revenues, in a timely manner or at all; the unfavorable outcome of litigation, including so-called "Paragraph IV" litigation and other patent litigation, related to any of the company's products or products using the company's proprietary technologies, which may lead to competition from generic drug manufacturers; clinical development activities may not be completed on time or at all; the results of the company's clinical development activities may not be positive, or predictive of real-world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products, such as decisions not to approve the company's NDAs, including the NDA for ALKS 3831; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and the impacts of the ongoing COVID-19 pandemic and continued efforts to mitigate its spread on the company's business, results of operations or financial condition; 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.

    Alkermes Contacts:



    For Investors:

    Sandy Coombs +1 781 609 6377

    For Media:

    Katie Joyce +1 781 609 6806

     

    Alkermes plc Logo (PRNewsfoto/Alkermes plc)

    1Calculated as earnings before interest, taxation, depreciation, amortization and one-time items, includes share-based compensation expenses

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