HZNP Horizon Therapeutics Public Limited Company

91.48
+0.48  (+1%)
Previous Close 91
Open 90.6
52 Week Low 30
52 Week High 96.54
Market Cap $20,503,237,765
Shares 224,128,091
Float 217,174,543
Enterprise Value $19,300,706,281
Volume 1,046,060
Av. Daily Volume 1,987,583
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Upcoming Catalysts

Drug Stage Catalyst Date
VIB7734
COVID-19-Related Acute Lung Injury
Phase 1b
Phase 1b
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.
Krystexxa with Methotrexate - MIRROR RCT
Gout
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
VIB7734
Cutaneous lupus erythematosus
Phase 2
Phase 2
Phase 2 trial to commence 1H 2021.
VIB4920
Sjögren’s syndrome
Phase 2b
Phase 2b
Phase 2b enrollment resumed following pause due to COVID-19.
Inebilizumab
IgG4-related disease
Phase 2b
Phase 2b
Phase 2b trial initiated 4Q 2020.
Inebilizumab
Myasthenia gravis
Phase 3
Phase 3
Phase 3 trial initiated 4Q 2020.
VIB4920
Kidney transplant rejection
Phase 2
Phase 2
Phase 2a trial has resumed enrollment following pause due to COVID-19.
Inebilizumab
Kidney transplant desensitization
Phase 2
Phase 2
Phase 2 enrolment paused due to COVID-19.
Inebilizumab
Neuromyelitis Optica Spectrum Disorder
Approved
Approved
FDA Approval announced June 11, 2020.
Teprotumumab
Thyroid Eye Disease (TED) - chronic
Phase 3
Phase 3
Phase 3 trial to commence 2Q 2021.
HZN-825
Idiopathic pulmonary fibrosis (IPF)
Phase 2b
Phase 2b
Phase 2b trial to be initiated 1H 2021.
Teprotumumab
Thyroid Eye Disease (TED)
Approved
Approved
FDA Approval announced January 21, 2020.
ACTIMMUNE
Friedreich's Ataxia (FA)
Phase 3
Phase 3
Phase 3 data released December 8, 2016 - primary endpoint not met.

Latest News

  1. Horizon Therapeutics plc (NASDAQ:HZNP) announced today that its first-quarter 2021 financial results will be released on Wednesday, May 5, 2021. Following the announcement, Horizon's management will host a live webcast at 8 a.m. Eastern Time to review the Company's financial and operating results.

    The live webcast and a replay may be accessed at http://ir.horizontherapeutics.com. Please connect to the Company's website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. A replay of the webcast will be available approximately two hours after the live webcast.

    About Horizon

    Horizon is focused on the discovery, development and commercialization of medicines…

    Horizon Therapeutics plc (NASDAQ:HZNP) announced today that its first-quarter 2021 financial results will be released on Wednesday, May 5, 2021. Following the announcement, Horizon's management will host a live webcast at 8 a.m. Eastern Time to review the Company's financial and operating results.

    The live webcast and a replay may be accessed at http://ir.horizontherapeutics.com. Please connect to the Company's website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. A replay of the webcast will be available approximately two hours after the live webcast.

    About Horizon

    Horizon is focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

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  2. -- Primary study endpoint demonstrates 86 percent response rate for patients receiving co-therapy of KRYSTEXXA and mycophenolate mofetil --

    Horizon Therapeutics plc (NASDAQ:HZNP) announced the publication of data from the first randomized controlled clinical trial (RCT) of KRYSTEXXA (pegloticase injection) concomitantly used with an immunomodulator, mycophenolate mofetil, in Arthritis & Rheumatology [doi.org/10.1002/art.41731].

    The Reducing Immunogenicity of Pegloticase (RECIPE) trial demonstrated that 86 percent of patients (19 of 22) receiving co-therapy of KRYSTEXXA with the immunomodulator mycophenolate mofetil achieved serum uric acid (sUA) ≤ 6 mg/dL at 12 weeks, the primary study endpoint, compared to 40 percent of patients (4 of 10…

    -- Primary study endpoint demonstrates 86 percent response rate for patients receiving co-therapy of KRYSTEXXA and mycophenolate mofetil --

    Horizon Therapeutics plc (NASDAQ:HZNP) announced the publication of data from the first randomized controlled clinical trial (RCT) of KRYSTEXXA (pegloticase injection) concomitantly used with an immunomodulator, mycophenolate mofetil, in Arthritis & Rheumatology [doi.org/10.1002/art.41731].

    The Reducing Immunogenicity of Pegloticase (RECIPE) trial demonstrated that 86 percent of patients (19 of 22) receiving co-therapy of KRYSTEXXA with the immunomodulator mycophenolate mofetil achieved serum uric acid (sUA) ≤ 6 mg/dL at 12 weeks, the primary study endpoint, compared to 40 percent of patients (4 of 10) receiving KRYSTEXXA monotherapy. The safety and efficacy of KRYSTEXXA co-prescribed with mycophenolate mofetil has not been established by any health authorities.

    "Our focus on urgently reducing the buildup of uric acid crystals and addressing the impact of uncontrolled gout on patients led us to explore how to curtail the development of anti-drug antibodies with pegloticase through the RECIPE trial," said Puja Khanna, M.D., M.P.H., associate professor and rheumatologist at the University of Michigan, and co-primary investigator for the RECIPE trial. "This trial adds major insight to the evolving body of data – that co-treatment with immunomodulatory medications can mitigate antibody production, and thereby improve the response rates of pegloticase. We believe that this novel approach has the potential of meaningfully improving the patient's response to urate lowering therapy and long-term outcomes as a result."

    Data from this investigator-initiated Phase 2, double-blind, placebo-controlled proof-of-concept trial led by the University of Alabama at Birmingham and University of Michigan funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and Horizon illustrate the effect of a concomitant regimen of KRYSTEXXA with mycophenolate mofetil. In the study, 35 adult patients with uncontrolled gout were randomized (3:1) to receive either mycophenolate mofetil or placebo for two weeks prior to starting KRYSTEXXA (12 infusions of 8 mg every two weeks). Thirty-two patients received at least one dose of KRYSTEXXA and were included in the analysis, with three patients discontinuing prior to the first KRYSTEXXA infusion. During the trial, patients continued to receive either mycophenolate mofetil (1g) twice daily or placebo with KRYSTEXXA for 12 weeks. After Week 12, all patients received only KRYSTEXXA 8 mg IV every two weeks for 12 weeks, providing six months of KRYSTEXXA therapy. The primary endpoint was the proportion of patients who reached and maintained response to therapy (defined as sUA levels ≤6 mg/dL at 12 weeks).1

    In total, 86 percent (19 of 22) of patients receiving co-therapy of KRYSTEXXA and mycophenolate mofetil achieved serum uric acid ≤ 6 mg/dL at Week 12 versus 40 percent (4 of 10) of patients in the KRYSTEXXA and placebo arm, with a sustained response at Week 24 in 68 percent (15 of 22) of patients versus 30 percent (3 of 10) of patients, respectively. In the KRYSTEXXA with mycophenolate mofetil arm, no (0 of 22 patients) infusion reactions were reported compared to 30 percent (3 of 10) of patients reporting infusion reactions in the KRYSTEXXA with placebo arm. The most commonly reported adverse events for the KRYSTEXXA with mycophenolate mofetil arm versus the KRYSTEXXA with placebo arm included musculoskeletal (41 percent versus 10 percent), gastrointestinal disorders (18 percent versus 10 percent), respiratory (18 percent versus 0 percent) and infections (9 percent versus 0 percent).1

    "This publication reflects a fundamental aspect of our collaborative research efforts with leading voices in the rheumatology community," said Paul M. Peloso, M.D., M.Sc., vice president and therapeutic area head, rheumatology, Horizon. "As we listen to and learn from studies outside of Horizon, along with our clinical colleagues, we can refine strategies to best improve the utility of our medicines and optimize benefits to patients."

    About KRYSTEXXA

    INDICATIONS AND USAGE

    KRYSTEXXA® (pegloticase injection) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.

    Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

    Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

    IMPORTANT SAFETY INFORMATION

    WARNING: ANAPHYLAXIS AND INFUSION REACTIONS

    Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion. However, delayed-type hypersensitivity reactions have also been reported. KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be premedicated with antihistamines and corticosteroids. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA. Serum uric acid levels should be monitored prior to infusions, and healthcare providers should consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

    The risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response.

    Concomitant use of KRYSTEXXA and oral urate-lowering agents may blunt the rise of sUA levels. Patients should discontinue oral urate-lowering agents and not institute therapy with oral urate-lowering agents while taking KRYSTEXXA.

    In the event of anaphylaxis or infusion reaction, the infusion should be slowed, or stopped and restarted at a slower rate.

    Patients should be informed of the symptoms and signs of anaphylaxis and instructed to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting.

    CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND METHEMOGLOBINEMIA

    Patients should be screened for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. KRYSTEXXA should not be administered to these patients.

    GOUT FLARES

    An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, including treatment with KRYSTEXXA. If a gout flare occurs during treatment, KRYSTEXXA need not be discontinued. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA therapy and lasting at least 6 months, unless medically contraindicated or not tolerated.

    CONGESTIVE HEART FAILURE

    KRYSTEXXA has not been studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. Caution should be exercised when using KRYSTEXXA in patients who have congestive heart failure, and patients should be monitored closely following infusion.

    ADVERSE REACTIONS

    The most commonly reported adverse reactions in clinical trials with KRYSTEXXA were gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting.

    Please see Full Prescribing Information and Medication Guide for more information.

    About Horizon

    Horizon is focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements regarding the potential benefits of combining immunomodulator (including mycophenolate mofetil) treatment with KRYSTEXXA. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include, but are not limited to, risks regarding whether results of additional clinical trials will be consistent with results of prior trials or other data or Horizon's expectations, the risks associated with clinical development of drug candidates and risks related to competition or other factors that may change physician treatment strategies. For a further description of these and other risks facing Horizon, please see the risk factors described in Horizon's filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in those filings. Forward-looking statements speak only as of the date of this press release and Horizon undertakes no obligation to update or revise these statements, except as may be required by law.

    References

    1. Khanna, P, et al. Reducing Immunogenicity of Pegloticase (RECIPE) with Concomitant Use of Mycophenolate Mofetil in Patients with Refractory Gout — a Phase II Double Blind Placebo Controlled Randomized Trial. Arthritis & Rheumatology. 2021. doi:10.1002/art.41731

     

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  3. -- Data from the pivotal N-MOmentum trial will highlight UPLIZNA long-term safety and efficacy, as well as its impact on pain in NMOSD patients --

    -- New survey results demonstrate NMOSD patient attitudes towards diagnosis and treatment --

    Horizon Therapeutics plc (NASDAQ:HZNP) today announced new UPLIZNA (inebilizumab-cdon) data will be presented at the American Academy of Neurology's 73rd Annual Meeting, which will be held virtually April 17-22, 2021. UPLIZNA is the first and only FDA-approved B-cell depleter for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody positive NMOSD.

    UPLIZNA data being presented at AAN 2021 include:

    • Inebilizumab Treatment Reduces the Occurrence of Pain in NMOSD Patients

    -- Data from the pivotal N-MOmentum trial will highlight UPLIZNA long-term safety and efficacy, as well as its impact on pain in NMOSD patients --

    -- New survey results demonstrate NMOSD patient attitudes towards diagnosis and treatment --

    Horizon Therapeutics plc (NASDAQ:HZNP) today announced new UPLIZNA (inebilizumab-cdon) data will be presented at the American Academy of Neurology's 73rd Annual Meeting, which will be held virtually April 17-22, 2021. UPLIZNA is the first and only FDA-approved B-cell depleter for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody positive NMOSD.

    UPLIZNA data being presented at AAN 2021 include:

    • Inebilizumab Treatment Reduces the Occurrence of Pain in NMOSD Patients
      • Session: P2.017, H. Kim
      • Date: On Demand (scientific poster)
    • Long-Term Efficacy Outcomes with Inebilizumab Treatment in NMOSD: the N-MOmentum Trial
      • Session: P15.076, B. Cree
      • Date: On Demand (scientific poster)
    • Long-Term Safety Outcomes with Inebilizumab Treatment in NMOSD: the N-MOmentum Trial
      • Session: P15.100, B. Cree
      • Date: On Demand (scientific poster)
    • Evaluation of Infusion Reactions and Infusion Times in the N-MOmentum Study of Inebilizumab for NMOSD
      • Session: P15.211, M. Tullman
      • Date: On Demand (scientific poster)
    • Pharmacodynamic Modeling and Exposure-Response Assessment of Inebilizumab in Subjects With Neuromyelitis Optica Spectrum Disorder
      • Session: S29.003, L. Yan
      • Date: Wednesday, April 21, 2021, 4:24 p.m. ET (live broadcast)

    Additional data highlighting NMOSD patient perspectives being presented at AAN 2021 include:

    • Patient Attitudes Towards NMOSD Diagnosis and Treatment: Final Survey Results
      • Session: P2.106, G. Garcia
      • Date: On Demand (scientific poster)

    In addition, Horizon will host two Industry Therapeutic Updates. The first is on Tuesday, April 20, 2021 at 1 p.m. ET called "Advances in NMOSD Treatment: Inebilizumab-cdon," featuring Adil Javed, M.D. Ph.D., associate professor of neurology, University of Chicago. The second is on Wednesday, April 21, 2021 at 9 a.m. ET called "B Cell Biology in Myasthenia Gravis: From Pathogenesis to Targeted Therapies."

    About Neuromyelitis Optica Spectrum Disorder (NMOSD)

    NMOSD is a unifying term for neuromyelitis optica (NMO) and related syndromes. NMOSD is a rare, severe, relapsing, neuroinflammatory autoimmune disease that attacks the optic nerve, spinal cord and brain stem.1,2 Approximately 80% of all patients with NMOSD test positive for anti-AQP4 antibodies.3 These AQP4 autoantibodies are produced by CD19+ B cells and bind primarily to astrocytes in the central nervous system.4 Binding of AQP4 antibodies to central and peripheral nervous system cells is believed to trigger attacks, which can damage the optic nerve, spinal cord and brain.4,5 Loss of vision, paralysis, loss of sensation, bladder and bowel dysfunction, nerve pain and respiratory failure can all be manifestations of the disease.6 Each NMOSD attack can lead to further damage and disability.2,7,8 NMOSD occurs more commonly in women and may be more common in individuals of African and Asian descent.9,10

    About UPLIZNA

    INDICATION

    UPLIZNA is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

    IMPORTANT SAFETY INFORMATION

    UPLIZNA is contraindicated in patients with:

    • A history of life-threatening infusion reaction to UPLIZNA
    • Active hepatitis B infection
    • Active or untreated latent tuberculosis

    WARNINGS AND PRECAUTIONS

    Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine and an anti-pyretic.

    Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%) and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

    Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

    The risk of hepatitis B virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

    Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation. Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

    Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion. Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

    Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.

    Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

    For additional information on UPLIZNA, please see Prescribing Information at www.UPLIZNA.com.

    About Horizon

    Horizon is focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

    References

    1. Ajmera MR, Boscoe A, Mauskopf J, Candrilli SD, Levy M. Evaluation of comorbidities and health care resource use among patients with highly active neuromyelitis optica. J Neurol Sci. 2018; 384:96-103.
    2. What is NMO? Guthyjacksonfoundation.org. www.guthyjacksonfoundation.org/neuromyelitis-optica-nmo/ Accessed March 9, 2020.
    3. Layman's Guide to NMO. Sumairafoundation.org. https://www.sumairafoundation.org/laymans-guide-to-nmo/ Accessed March 9, 2020.
    4. Liu Y, et al. A tract-based diffusion study of cerebral white matter in neuromyelitis optica reveals widespread pathological alterations. Mult Scler. 2011;18(7);1013-1021.
    5. Duan T, Smith AJ, Verkamn AS. Complement-independent bystander injury in AQP4-IgG seropositive neuromyelitis optica produced by antibody-dependent cellular cytotoxity. Acta Neuropathologica Comm. 2019;7(112)
    6. Beekman J, et al. Neuromyelitis optica spectrum disorder: patient experience and quality of life. Neural Neuroimmunol Neuroinflamm. 2019;6(4):e580
    7. Kimbrough DJ, et al. Treatment of neuromyelitis optica: review and recommendations. Mult Scler Relat Disord. 2012;1(4):180-187.
    8. Baranello RJ, Avasarala, JR. Neuromyelitis optica spectrum disorders with and without aquaporin 4 antibody: Characterization, differential diagnosis, and recent advances. J Neuro Ther. 2015;1(1):9-14.
    9. Wingerchuk DM. Neuromyelitis optica: effect of gender. J Neurol Sci. 2009;286(1-2):18-23
    10. Flanagan EP, et al. Epidemiology of aquaporin-4 autoimmunity and neuromyelitis optica spectrum. Ann Neurol. 2016;79(5):775-783.

     

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  4. Horizon Therapeutics plc (NASDAQ:HZNP) today announced that the U.S. Food and Drug Administration (FDA) has approved a prior approval supplement (PAS) to the previously approved Biologics Licensing Application (BLA) giving Horizon authorization to manufacture more TEPEZZA drug product resulting in an increased number of vials with each manufacturing slot. The company plans to resupply the market beginning in April, which will end the supply disruption that began in December 2020 following U.S. government orders prioritizing the manufacturing of a COVID-19 vaccine.

    "We commend the efforts of the FDA and the Biden Administration to accelerate COVID-19 vaccine production while working together with our team so that people living with Thyroid…

    Horizon Therapeutics plc (NASDAQ:HZNP) today announced that the U.S. Food and Drug Administration (FDA) has approved a prior approval supplement (PAS) to the previously approved Biologics Licensing Application (BLA) giving Horizon authorization to manufacture more TEPEZZA drug product resulting in an increased number of vials with each manufacturing slot. The company plans to resupply the market beginning in April, which will end the supply disruption that began in December 2020 following U.S. government orders prioritizing the manufacturing of a COVID-19 vaccine.

    "We commend the efforts of the FDA and the Biden Administration to accelerate COVID-19 vaccine production while working together with our team so that people living with Thyroid Eye Disease are able to resume or start treatment with TEPEZZA," said Tim Walbert, chairman, president and chief executive officer, Horizon. "We are pleased that patients who have had to struggle with the debilitating effects of Thyroid Eye Disease will soon have access again to TEPEZZA, the only FDA-approved medicine to treat this rare disease, and we appreciate their patience and understanding during this unfortunate disruption. We understand the ongoing need for vaccine production and hope that the Biden Administration continues to prioritize all patients who need access to medically necessary treatments."

    Information for Patients

    TED patients who have been affected by the TEPEZZA supply disruption should talk with their doctor about their plan for starting or resuming treatment and share the plan with their infusion center. Patients can contact their infusion center directly to schedule their infusions or call their Horizon Patient Access Liaison (PAL) if they have questions about the process of starting or resuming treatment. To enroll in Horizon Patient Services, please call 1‐833‐583‐7399 Monday to Friday, 8 a.m. through 8 p.m. ET. Additional information for patients is available on Horizon's website.

    Information for Health Care Professionals

    Physicians with questions should call or email Horizon Medical Information at 1-866-479-6742 or .

    Additional TEPEZZA Information

    The Company continues to expect full-year 2021 TEPEZZA net sales of more than $1.275 billion, which assumes the successful completion of future committed manufacturing slots for TEPEZZA at its third-party manufacturer, Catalent. The company expects its TEPEZZA clinical trial in chronic TED and exploratory trial in diffuse cutaneous systemic sclerosis to start mid-year 2021 and anticipates data from the chronic TED trial mid-year 2022. In addition, Horizon is making progress with its second drug product manufacturer and is on track to begin shipping TEPEZZA supply from this manufacturer, following U.S. FDA approval, by year end.

    About TEPEZZA

    INDICATION

    TEPEZZA is indicated for the treatment of Thyroid Eye Disease.

    IMPORTANT SAFETY INFORMATION

    Warnings and Precautions

    Infusion Reactions: TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. Reported infusion reactions have usually been mild or moderate in severity. Signs and symptoms may include transient increases in blood pressure, feeling hot, tachycardia, dyspnea, headache and muscular pain. Infusion reactions may occur during an infusion or within 1.5 hours after an infusion. In patients who experience an infusion reaction, consideration should be given to premedicating with an antihistamine, antipyretic or corticosteroid and/or administering all subsequent infusions at a slower infusion rate.

    Preexisting Inflammatory Bowel Disease: TEPEZZA may cause an exacerbation of preexisting inflammatory bowel disease (IBD). Monitor patients with IBD for flare of disease. If IBD exacerbation is suspected, consider discontinuation of TEPEZZA.

    Hyperglycemia: Increased blood glucose or hyperglycemia may occur in patients treated with TEPEZZA. In clinical trials, 10% of patients (two-thirds of whom had preexisting diabetes or impaired glucose tolerance) experienced hyperglycemia. Hyperglycemic events should be managed with medications for glycemic control, if necessary. Monitor patients for elevated blood glucose and symptoms of hyperglycemia while on treatment with TEPEZZA. Patients with preexisting diabetes should be under appropriate glycemic control before receiving TEPEZZA.

    Adverse Reactions

    The most common adverse reactions (incidence ≥5% and greater than placebo) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache and dry skin.

    For additional information on TEPEZZA, please see Full Prescribing Information at TEPEZZAhcp.com.

    About Horizon

    Horizon is focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to the anticipated end of the TEPEZZA supply disruption; the timing of availability of TEPEZZA to patients; and business and other statements that are not historical facts. These forward-looking statements are based on Horizon's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risk of future supply disruptions, whether as a result of additional government orders or other issues at Horizon's third party manufacturers; impacts of the COVID-19 pandemic and actions taken to slow its spread; regulatory obligations and oversight, including any changes in the legal and regulatory environment in which Horizon operates and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Horizon's filings and reports with the SEC. Horizon undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information.

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  5. - Partnership Includes Robust Science, Technology, Engineering, Arts and Math (STEAM) and Rare Disease Awareness Programming -

    Horizon Therapeutics (NASDAQ:HZNP) and the Cubs today announced a Legacy Partnership that includes a Cubs STEAM Program, presented by Horizon, which will include an innovative, citywide science camp and fair that allows Chicagoland-area middle and high school students to explore the connection between science and baseball as well as showcase their STEAM talents. Horizon is a biotechnology company that addresses critical needs for people impacted by rare, autoimmune and severe inflammatory diseases.

    On Oct. 2, the Cubs STEAM Program, presented by Horizon in partnership with Science of Sport, will launch with an event…

    - Partnership Includes Robust Science, Technology, Engineering, Arts and Math (STEAM) and Rare Disease Awareness Programming -

    Horizon Therapeutics (NASDAQ:HZNP) and the Cubs today announced a Legacy Partnership that includes a Cubs STEAM Program, presented by Horizon, which will include an innovative, citywide science camp and fair that allows Chicagoland-area middle and high school students to explore the connection between science and baseball as well as showcase their STEAM talents. Horizon is a biotechnology company that addresses critical needs for people impacted by rare, autoimmune and severe inflammatory diseases.

    On Oct. 2, the Cubs STEAM Program, presented by Horizon in partnership with Science of Sport, will launch with an event designed to provide an opportunity for middle and high school students to increase their awareness of the STEAM field as a future education and career option. Through interactive learning opportunities, the program curriculum will showcase the connection between science and baseball-related actions such as launch angles, curveballs and fastballs, by bringing real-world concepts and experiments to life.

    As part of the Program, in the spring of 2022, Horizon and the Cubs will also host a public, citywide science fair and STEAM Family Day where participating students will have an opportunity to exhibit their science projects to both attendees and judges from Horizon and the Cubs. In addition to the showcase, attendees will get to experience several interactive exhibits on the science of baseball. At the conclusion of the fair, judges will select winners in each grade level. Winners will have an exclusive opportunity to participate in the Program's two-week summer camp.

    In addition, Horizon and the Cubs will host an event during Spring Training 2022 to raise awareness about the more than 7,000 known rare diseases, of which only five percent have U.S. FDA-approved treatment options. The event will recognize global Rare Disease Day and bring together people living with rare disease to elevate their unique stories, challenges and triumphs.

    "Horizon started from humble roots in the Chicago-area in 2008 and as we continue to grow, we look for partners like the Cubs to help us continue to make a meaningful impact in the community," said Tim Walbert, chairman, president and chief executive officer, Horizon. "Together with the Cubs, we have the opportunity to harness the ingenuity of these students, nurture the next generation of science leaders through this unique programming, as well as raise awareness about the significant impact of rare diseases."

    "We're excited to welcome Horizon to the Cubs family as our newest Legacy Partner," said Crane Kenney, president of business operations, Cubs. "Horizon shares our commitment to being a good neighbor in the communities where we work and live, so we are thrilled to launch the Cubs STEAM Program to expose Chicagoland youth to future education and career options. By focusing this effort in Chicago, we hope students across this great city take full advantage of this innovative, citywide science camp and fair."

    Horizon becomes the 11th Legacy Partner of the Cubs, joining Advocate Health Care, American Airlines, Anheuser-Busch, Beam Suntory, Gallagher, Marriott, Nuveen, Sloan Valve Company, Toyota and Wintrust.

    About Horizon

    Horizon is focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

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