HZNP Horizon Therapeutics Public Limited Company

55.24
+0.01  (+0%)
Previous Close 55.23
Open 55.26
52 Week Low 22.69
52 Week High 57.34
Market Cap $10,824,961,595
Shares 195,962,375
Float 193,096,669
Enterprise Value $11,414,070,971
Volume 2,088,921
Av. Daily Volume 2,780,289
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Upcoming Catalysts

Drug Stage Catalyst Date
Krystexxa with Methotrexate - MIRROR RCT
Gout
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
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. -- Each share of the FOCUS graphic on social media will generate a donation from Horizon to the patient advocacy organization, Prevent Blindness --

    Today, in support of Graves' Disease Awareness Month, Horizon Therapeutics plc (NASDAQ:HZNP) and Prevent Blindness, the nation's oldest volunteer eye health organization, launched an initiative encouraging people who are living with Graves' disease to FOCUS on their eye health by recognizing the symptoms of a separate, but related disease called Thyroid Eye Disease (TED). Up to half of people with Graves' disease will develop TED – a serious, progressive and vision-threatening rare autoimmune disease that causes painful symptoms like eye bulging, double vision and facial disfigurement.1,2

    This press…

    -- Each share of the FOCUS graphic on social media will generate a donation from Horizon to the patient advocacy organization, Prevent Blindness --

    Today, in support of Graves' Disease Awareness Month, Horizon Therapeutics plc (NASDAQ:HZNP) and Prevent Blindness, the nation's oldest volunteer eye health organization, launched an initiative encouraging people who are living with Graves' disease to FOCUS on their eye health by recognizing the symptoms of a separate, but related disease called Thyroid Eye Disease (TED). Up to half of people with Graves' disease will develop TED – a serious, progressive and vision-threatening rare autoimmune disease that causes painful symptoms like eye bulging, double vision and facial disfigurement.1,2

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200701005301/en/

    The initiative, which was developed with input from the Graves' disease and TED community, features a memory device that uses the word FOCUS to help people take steps to recognize and manage TED. Now through July 31, 2020, Horizon will donate $1 (up to $25,000) to Prevent Blindness each time the FOCUS graphic is shared on social media.

    "When first diagnosed with Graves' disease, I thought the eye symptoms were just one facet of this rare autoimmune disease," said Christine G., who has been living with TED for 10 years. "Similar to others with TED, I had light sensitivity, grittiness, pain, swelling and bulging of my eyes. After years of struggling to find answers, I learned that TED needed to be managed separately from Graves'. With this knowledge, an entirely new world of hope opened before me. I am confident that this initiative will help others get an accurate diagnosis and will provide them with the vital resources and support now available to them."

    The FOCUS memory device includes the following steps:

    • Figure out your risk for TED
    • Observe your symptoms
    • Contact an eye specialist, such as an ophthalmologist, neuro-ophthalmologist or oculoplastic surgeon (visit TEDdoctors.com)
    • Use resources to educate yourself and take action
    • Speak up for the care you deserve

    "Prevent Blindness is committed to helping people who live with low vision, vision impairment and vision-related eye diseases feel empowered to speak up and get the care they deserve," said Jeff Todd, president and chief executive officer, Prevent Blindness. "People living with TED don't have to struggle in silence. There are resources, like this initiative, that can help. We are proud to be a part of bringing much-needed attention to this often overlooked eye disease."

    People who are living with Graves' disease are encouraged to pay attention to changes in their eyes and visit an eye specialist, such as an ophthalmologist, neuro-ophthalmologist or oculoplastic surgeon, to get an eye exam. Spotting the signs and symptoms of TED early can help decrease the chances of serious and potentially permanent eye damage.3 All FOCUS resources will be posted throughout the month of July to the Listen to Your Eyes Facebook community. Additional information about TED can be found at ThyroidEyes.com, including what symptoms to watch for, a tool for tracking symptoms and a specialist finder; and on the Prevent Blindness website.

    "Over the past few years, we have been fortunate to listen and learn from the TED community about their experiences with this truly life changing disease, and how we can provide education and support," said Matt Flesch, vice president, communications and patient advocacy, Horizon. "We often hear from people living with TED that not only is it difficult to distinguish the eye symptoms caused by TED from all of the other symptoms caused by Graves' disease, but that it is also incredibly difficult to know where to go for support. This initiative was created to clear up the confusion and direct people to useful resources that will help them along their journey."

    About Graves' Disease

    Graves' disease is an autoimmune disease that causes the thyroid gland to produce excess thyroid hormones.2 These hormones control a variety of bodily functions, from metabolism and breathing to heart rate, body temperature and cognitive emotions.4 Common symptoms of Graves' disease include anxiety, tremors, heat sensitivity, weight loss, hair loss, change in menstrual cycle and irregular heartbeat; many of which are present in other diseases, leading to misdiagnosis or delayed diagnosis.5

    About Thyroid Eye Disease

    TED is most often seen in patients with Graves' disease – affecting up to half of people with Graves' – but it is a distinct disease that requires separate treatment.1,2,6 A diagnosis of TED may even precede a finding of Graves' and can serve as an early warning sign of future thyroid dysfunction.7 TED can also occur in Hashimoto's hypothyroidism or even in patients with neither diagnosis.6 Common symptoms of TED include light sensitivity, eye grittiness, bulging eyes and double vision, among others – all of which can reduce a person's independence, ability to work and self-confidence.3,8 In fact, people living with TED often experience long-term functional, psychosocial and economic burdens, including inability to work and perform activities of daily living.8,9

    About Prevent Blindness

    Founded in 1908, Prevent Blindness is the nation's leading volunteer eye health and safety organization dedicated to fighting blindness and saving sight. Focused on promoting a continuum of vision care, Prevent Blindness touches the lives of millions of people each year through public and professional education, advocacy, certified vision screening and training, community and patient service programs and research. These services are made possible through the generous support of the American public. Together with a network of affiliates, Prevent Blindness is committed to eliminating preventable blindness in America. For more information, or to make a contribution to the sight-saving fund, call 1-800-331-2020. Or, visit us on the Web at preventblindness.org or facebook.com/preventblindness.

    About Horizon

    Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic 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. Lazarus JH. Epidemiology of Graves' orbitopathy (GO) and relationship with thyroid disease. Best Pract Res Clin Endocrinol Metab. 2012;26(3):273-279.
    2. Smith TJ, Hegedüs L. Graves' disease. N Engl J Med. 2016;375(16):1552-1565.
    3. Barrio-Barrio J, Sabater AL, Bonet-Farriol E, Velazquez-Villoria A, Galofre JC. Graves' Ophthalmopathy: VISA versus EUGOGO Classification, Assessment, and Management. Journal of Ophthalmology. 2015:1-16.
    4. About Graves' Disease. Graves' Disease & Thyroid Foundation. https://www.gdatf.org/about/about-graves-disease/. Accessed June 17, 2020.
    5. Graves' Disease. National Institute of Diabetes and Digestive and Kidney Diseases. https://www.niddk.nih.gov/health-information/endocrine-diseases/graves-disease. Accessed June 17, 2020.
    6. Eckstein AK, Losch C, Glowacka D, et al. Euthyroid and primarily hypothyroid patients develop milder and significantly more asymmetrical Graves' ophthalmopathy. Br J Ophthalmol. 2009;93(8):1052-1056.
    7. McAlinden C. An overview of thyroid eye disease. Eye Vis (Lond). 2014;1:9. Published 2014 Dec 10. doi:10.1186/s40662-014-0009-8
    8. Ponto KA, Pitz S, Pfeiffer N, Hommel G, Weber MM, Kahaly GJ. Quality of life and occupational disability in endocrine orbitopathy. Dtsch Arztebl Int. 2009;106:283-299.
    9. Ponto KA, Merkesdal S, Hommel G, Pitz S, Pfeiffer N, Kahaly GJ. Public health relevance of Graves' orbitopathy. Journal of Clinical Endocrinology & Metabolism. 2013;98:145-152.

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  2. Horizon Therapeutics plc (NASDAQ:HZNP) today announced that it issued a notice of redemption for all $400 million of its 2.50% exchangeable senior notes due 2022. The redemption date is August 3, 2020. The exchangeable senior notes may be exchanged by holders at any time before 5 p.m. (Eastern time) on July 30, 2020. Each $1,000 principal amount of the notes is exchangeable into 34.8979 ordinary shares of the Company, plus cash in lieu of fractional shares.

    "The redemption of our $400 million in exchangeable senior notes is an additional step in successfully executing our strategy to improve our capital structure to be in line with that of our biopharma peers," said Paul Hoelscher, executive vice president, chief financial officer, Horizon…

    Horizon Therapeutics plc (NASDAQ:HZNP) today announced that it issued a notice of redemption for all $400 million of its 2.50% exchangeable senior notes due 2022. The redemption date is August 3, 2020. The exchangeable senior notes may be exchanged by holders at any time before 5 p.m. (Eastern time) on July 30, 2020. Each $1,000 principal amount of the notes is exchangeable into 34.8979 ordinary shares of the Company, plus cash in lieu of fractional shares.

    "The redemption of our $400 million in exchangeable senior notes is an additional step in successfully executing our strategy to improve our capital structure to be in line with that of our biopharma peers," said Paul Hoelscher, executive vice president, chief financial officer, Horizon. "We began to execute on this strategy about a year ago, and inclusive of this redemption, we will have reduced our gross debt by about $1 billion, while maintaining a strong cash balance. In addition, through our refinancing and debt reduction initiatives, we have lowered our annualized cash interest expense by more than 40 percent versus a year ago and extended the maturity of our senior secured term loans and senior notes out to 2026 and 2027, respectively."

    As of March 31, 2020, the Company had cash and cash equivalents of $754.6 million. In addition, the total principal amount of debt outstanding was $1.418 billion, consisting of $418 million in senior secured term loans due 2026, $600 million of senior notes due 2027 and $400 million of exchangeable senior notes due 2022. Following the exchange or redemption of the exchangeable senior notes, the total principal amount of debt outstanding will be $1.018 billion. The Company has no maintenance covenants on its debt.

    About Horizon

    Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic 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 planned redemption of the exchangeable senior notes and the impact on Horizon's debt levels. 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, risks associated with executing the redemption of the senior notes and events that could impact the terms of the redemption, as well as those 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 does not undertake any obligation to update or revise these statements, except as may be required by law.

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  3. -- MIRROR open-label trial demonstrates 79 percent of patients achieved a complete response using KRYSTEXXA with methotrexate --

    -- Additional data presentations highlight the effect of co-therapy for KRYSTEXXA with two other commonly used immunomodulators, supporting flexible options for patients and physicians --

    -- Oral presentation provides insights on real-world use of KRYSTEXXA with immunomodulators --

    -- Horizon will host an investor webcast on June 4, 2020, at 3 p.m. ET --

    Horizon Therapeutics plc (NASDAQ:HZNP) announced today a series of data presentations that demonstrate KRYSTEXXA® (pegloticase injection) can be co-prescribed with three commonly used immunomodulators in rheumatology to potentially help more people with chronic…

    -- MIRROR open-label trial demonstrates 79 percent of patients achieved a complete response using KRYSTEXXA with methotrexate --

    -- Additional data presentations highlight the effect of co-therapy for KRYSTEXXA with two other commonly used immunomodulators, supporting flexible options for patients and physicians --

    -- Oral presentation provides insights on real-world use of KRYSTEXXA with immunomodulators --

    -- Horizon will host an investor webcast on June 4, 2020, at 3 p.m. ET --

    Horizon Therapeutics plc (NASDAQ:HZNP) announced today a series of data presentations that demonstrate KRYSTEXXA® (pegloticase injection) can be co-prescribed with three commonly used immunomodulators in rheumatology to potentially help more people with chronic gout refractory to conventional therapies – also known as uncontrolled gout – achieve complete and durable response to therapy. Presentations during the European League Against Rheumatism (EULAR) European E-Congress of Rheumatology 2020 (EULAR E-Congress 2020) include new data from the MIRROR open-label trial of KRYSTEXXA with methotrexate, as well as in-practice cases and an investigator-initiated trial for two other immunomodulators with KRYSTEXXA, all of which show high response rates. An analysis of real-world use of KRYSTEXXA with immunomodulators will also be discussed in an oral presentation on June 4, 2020.

    "Uncontrolled gout has been increasingly linked to a range of complications, including cardiovascular and renal risks, making it crucially important that we continue to gather more insight on how physicians can best treat this disease," said Jeffrey D. Kent, M.D., FACG, FACP, executive vice president, medical affairs and outcomes research, Horizon. "It is encouraging to see the rheumatology community embracing opportunities to further improve outcomes for patients with trusted immunomodulators like methotrexate, as ongoing data generation continues to support KRYSTEXXA as an important tool for treating uncontrolled gout."

    While KRYSTEXXA has been traditionally used as a biologic monotherapy with a clinically demonstrated impact on uncontrolled gout, recent literature suggests that using an immunomodulator such as methotrexate has the potential to increase the durability of response to KRYSTEXXA.1 Reducing the burden of urate is critical to improving overall outcomes and quality of life.

    "Multiple studies presented at EULAR show that we may be on the cusp of a paradigm shift toward immunomodulatory co-therapy with KRYSTEXXA and further support the 80 to 100 percent response rates shown using KRYSTEXXA with methotrexate in previously presented data," said John K. Botson, M.D., R.Ph., C.C.D., president, Alaska Rheumatology Alliance and rheumatologist, Orthopedic Physicians Alaska. "I am also encouraged by data on KRYSTEXXA with other commonly used immunomodulators showing high percentages of people who were able to complete a full course of therapy. Given individual patient comorbidities, it is imperative that physicians have the flexibility to select from a range of immunomodulators that could be co-prescribed with KRYSTEXXA and have the potential to provide similar efficacy for the overall response and durability of response to therapy."

    New data from the Methotrexate to Increase Response Rates in Patients With Uncontrolled GOut Receiving KRYSTEXXA (MIRROR OL, NCT03635957) open-label trial showed that when treated with oral methotrexate (15 mg/week) prior to and throughout the KRYSTEXXA treatment period, 78.6 percent of patients (11 of 14 patients) achieved a complete response, defined as the proportion of serum uric acid (sUA) responders (sUA < 6 mg/dL) during Month 6. All patients tolerated methotrexate and no new safety concerns were identified. [Pegloticase response improvement by co-treatment with methotrexate: results from the MIRROR open-label clinical trial in patients with uncontrolled gout]

    Additional data presented during the EULAR E-Congress 2020 indicate the benefit of this enhanced therapeutic approach may extend to other commonly used immunomodulators, helping to prevent the development of anti-drug antibodies with biologics:

    • Methotrexate addition to KRYSTEXXA allowed most patients to complete therapy and achieve a full therapeutic response. Based on experience in a community rheumatology practice between 2017 and 2019, this chart review included 10 patients treated with a combination of KRYSTEXXA and methotrexate. Most were treated with subcutaneous methotrexate. All 10 patients experienced a rapid decrease in serum uric acid and 80.0 percent (8 of 10 patients) were complete responders. Two patients discontinued treatment before infusion 12; one due to a mild infusion reaction and one lost to follow-up. A gout flare was reported in one patient and no new safety concerns were identified. [Pegloticase response rate in uncontrolled gout patients co-treated with methotrexate: experience in a community rheumatology practice]
    • Leflunomide as an immunomodulator showed high response rates with KRYSTEXXA. This in-practice case series shows 70.0 percent (7 of 10 patients) achieved a complete response when co-treated with KRYSTEXXA and leflunomide. Three patients discontinued or were lost to follow-up. The findings indicated that low-to-moderate immunomodulation could minimize or prevent the formation of anti-drug antibodies and increase the number of patients who gain the full benefit of a course of treatment, with no new safety concerns. [Leflunomide co-therapy with pegloticase in uncontrolled gout]
    • Azathioprine with KRYSTEXXA could increase the frequency of patients experiencing long-term lowering of serum urate. The interim data for this investigator-initiated open-label trial of 12 uncontrolled gout patients showed that at the time of data publication 60.0 percent (6 of 10 patients) achieved a complete response; two patients were still receiving treatment with persistent urate-lowering. No adverse events related to azathioprine were reported and gout flares were noted in six patients. [Companion Immunosuppression with Azathioprine Increases the frequency of Persistent Responsiveness to pegloticase in patients with chronic refractory gout]

    In addition to the above, an oral presentation on real-world use of KRYSTEXXA with immunomodulators will be held on June 4, 2020 at 10:35 a.m. CET. This analysis uses claims data to understand the portion of patients prescribed an immunomodulator (methotrexate or azathioprine) with KRYSTEXXA. [Immunomodulation co-therapy with pegloticase: database trends 2014-2019]

    On June 4, 2020, at 3 p.m. ET, Horizon will host an investor webcast to discuss data presented at the EULAR E-Congress 2020 on the range of immunomodulators used to increase the durability of response to KRYSTEXXA, as well as provide an overview of immunomodulation and the Company's immunomodulation strategy for KRYSTEXXA.

    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 researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic 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 KRYSTEXXA in treating uncontrolled gout and the potential benefits of using immunomodulators 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 Horizon's expectations, and the risks associated with clinical development. 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. Botson J and Peterson J. Ann Rheum Dis. 2019; 78: A1289 and Bessen SY, et al. Semin Arthritis Rheum. 2019;49:56-61.

     

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  4. Horizon Therapeutics plc (NASDAQ:HZNP) today announced that it has been named No. 1 on the Great Place to Work® "Best Workplaces in Chicago 2020" list in the small and medium category. The list includes 39 other top small-to-medium sized companies, as well as 40 best large workplaces in the Chicago area.

    "We are proud of this top workplace award and the commitment it demonstrates, especially in the challenging environment we face today," said Irina Konstantinovsky, executive vice president, chief human resources officer, Horizon. "Our passion for patients, their families and communities fuels every decision we make, including the decision to provide employees with support that helps our team improve lives each day."

    Horizon's No. 1 ranking…

    Horizon Therapeutics plc (NASDAQ:HZNP) today announced that it has been named No. 1 on the Great Place to Work® "Best Workplaces in Chicago 2020" list in the small and medium category. The list includes 39 other top small-to-medium sized companies, as well as 40 best large workplaces in the Chicago area.

    "We are proud of this top workplace award and the commitment it demonstrates, especially in the challenging environment we face today," said Irina Konstantinovsky, executive vice president, chief human resources officer, Horizon. "Our passion for patients, their families and communities fuels every decision we make, including the decision to provide employees with support that helps our team improve lives each day."

    Horizon's No. 1 ranking was based on employees' anonymous responses to an extensive survey about their experiences at work. Great Place to Work® reviewed the survey results of more than 27,000 employees from companies across Chicago. Horizon was also recently selected as one of the 2020 Best Workplaces in Health Care and Biopharma by Great Place to Work® and Fortune.

    About Horizon

    Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic 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.

    About the Best Workplaces in Chicago

    Great Place to Work based its ranking on a data-driven methodology applied to anonymous Trust Index™ survey responses from over 27,000 employees at Great Place to Work-Certified organizations in the Chicago Metropolitan Statistical Area. This ranking was finalized prior to the COVID-19 pandemic and does not reflect companies' roles or responses to their people or communities in addressing the impact of the coronavirus. To learn more about Great Place to Work Certification and recognition on Best Workplaces lists, visit Greatplacetowork.com.

    About Great Place to Work®

    Great Place to Work® is the global authority on workplace culture. They help organizations quantify their culture and produce better business results by creating a high-trust work experience for all employees. Emprising®, their culture management platform, empowers leaders with the surveys, real-time reporting, and insights they need to make data-driven people decisions. They use their unparalleled benchmark data to recognize Great Place to Work-Certified™ companies and the Best Workplaces™ in the United States and more than 60 countries, including the 100 Best Companies to Work For® list published annually in Fortune.

    To learn more, visit greatplacetowork.com, listen to the podcast Better by Great Place to Work, and read "A Great Place to Work for All." Join the community on LinkedIn, Twitter, and Instagram.

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  5. -- Additional data presented will highlight the effect of urate deposition and link between gout and serious comorbidities --

    -- Two oral presentations will be given on Thursday, June 4, 2020 --

    Horizon Therapeutics plc (NASDAQ:HZNP) announced today that multiple case series and studies will be presented at the Annual European Congress of Rheumatology (EULAR 2020), being held virtually June 3 - 6, 2020. Several presentations of clinical trial data and in-practice cases will provide results on KRYSTEXXA® (pegloticase injection) with commonly used immunomodulators to help more people with chronic gout refractory to conventional therapies – also known as uncontrolled gout – potentially achieve complete and durable response to treatment.

    Additional…

    -- Additional data presented will highlight the effect of urate deposition and link between gout and serious comorbidities --

    -- Two oral presentations will be given on Thursday, June 4, 2020 --

    Horizon Therapeutics plc (NASDAQ:HZNP) announced today that multiple case series and studies will be presented at the Annual European Congress of Rheumatology (EULAR 2020), being held virtually June 3 - 6, 2020. Several presentations of clinical trial data and in-practice cases will provide results on KRYSTEXXA® (pegloticase injection) with commonly used immunomodulators to help more people with chronic gout refractory to conventional therapies – also known as uncontrolled gout – potentially achieve complete and durable response to treatment.

    Additional data to be featured during EULAR 2020 demonstrate the systemic impact of gout and potential kidney, cardiovascular and other risks associated with the disease.

    "We look forward to presenting these data, which add to the to the growing body of evidence regarding the use of KRYSTEXXA with immunomodulators," said Jeffrey D. Kent, M.D., FACG, FACP, executive vice president, medical affairs and outcomes research, Horizon. "Along with additional data linking uncontrolled gout to serious risks and complications, these presentations reflect the growing body of evidence and evolving approach to aggressively manage this disease and address its systemic impact."

    Presentation Details:

    Immunomodulation approaches combining KRYSTEXXA with commonly used immunomodulators to prevent the development of anti-drug antibodies with biologics:

    • Title: Pegloticase response improvement by co-treatment with methotrexate: results from the MIRROR open-label clinical trial in patients with uncontrolled gout

      Abstract: THU0416
    • Title: Leflunomide co-therapy with pegloticase in uncontrolled gout

      Abstract: THU0434
    • Title: Companion Immunosuppression with Azathioprine Increases the frequency of Persistent Responsiveness to pegloticase in patients with chronic refractory gout

      Abstract: THU0410

      *Investigator-initiated trial
    • Title: Pegloticase response rate in uncontrolled gout patients co-treated with methotrexate: experience in a community rheumatology practice

      Abstract: THU0431
    • Title: Immunomodulation co-therapy with pegloticase: database trends 2014-2019

      Oral presentation: OP0173, 10:55 a.m. CET, June 4, 2020

    Data on the link between hyperuricemia and non-alcoholic fatty liver disease (NAFLD):

    • Title: Treatment with Pegloticase Improves Hepatic Fibrosis Estimated by Fibrosis-4 Index in Subjects with Chronic Refractory Gout

      Abstract: THU0433

    Please see important safety information for KRYSTEXXA below.

    Additional data showing associated complications for people living gout, furthering understanding of the disease:

    • Title: Amputation procedures in patients with gout compared to patients with diabetes

      Oral presentation: OP0169, 10:25 a.m. CET, June 4, 2020
    • Title: Effect of new-onset gout on kidney transplant outcomes: a retrospective cohort analysis of the United States Renal Data System

      Abstract: THU0408
    • Title: Renal Urate Deposition: Summary of Published Evidence

      Abstract: THU0430
    • Title: Gout and Heart Failure in the US: A National Perspective

      Abstract: THU0442

      **Independent study, Horizon support and funding provided

    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 researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic 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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