MNKKQ Mallinckrodt plc

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Latest News

  1. DUBLIN, May 3, 2021 /PRNewswire/ -- Mallinckrodt plc (OTC:MNKKQ), a global biopharmaceutical company, today announced data from its Phase 4, multi-center, open-label study to assess the efficacy and safety of Acthar® Gel (repository corticotropin injection) in adult patients with treatment-resistant, severe non-infectious keratitis, a disease which involves painful inflammation of the cornea.1 The full results were presented in a poster at The Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, and further data will be shared at the upcoming virtual International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual Meeting. The poster can be accessed here on the company's website.

    DUBLIN, May 3, 2021 /PRNewswire/ -- Mallinckrodt plc (OTC:MNKKQ), a global biopharmaceutical company, today announced data from its Phase 4, multi-center, open-label study to assess the efficacy and safety of Acthar® Gel (repository corticotropin injection) in adult patients with treatment-resistant, severe non-infectious keratitis, a disease which involves painful inflammation of the cornea.1 The full results were presented in a poster at The Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, and further data will be shared at the upcoming virtual International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual Meeting. The poster can be accessed here on the company's website.

    Acthar Gel is approved by the U.S. Food and Drug Administration (FDA) for the treatment of severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation.2 Please see Important Safety Information for Acthar Gel below.

    The primary efficacy endpoint of the study was the proportion of patients who improved by 12 points or more in the symptom bother module of the Impact of Dry Eye on Everyday Life (IDEEL) score at week 12. The IDEEL is a patient-reported outcome assessment with three modules—impact on daily life, treatment satisfaction and symptom bother—and six dimensions. After 12 weeks of treatment with Acthar Gel, 50.0 percent (n=17) of patients experienced improvements in their symptom bother score by at least 12 points, a clinically important change3 (95% CI 33.2, 66.8).4

    "As ophthalmologists, we rely heavily on patient-reported symptoms when evaluating severe keratitis, especially for those who require alternative treatments," said one of the study authors David Wirta, M.D., Ophthalmologist, Eye Research Foundation, Newport Beach. "The clinically important improvement in the symptom bother module is very encouraging and helps us better understand the potential impact for Acthar Gel to effectively treat appropriate patients with severe keratitis who are in need of additional treatment options."

    Exploratory endpoints included the change from baseline to week 12 in each item of the Visual Analog Scale (VAS), and corneal fluorescein staining and conjunctival lissamine green staining as measured by Ora Calibra™ scales. After 12 weeks of treatment with Acthar Gel, all symptoms assessed by the VAS had improved from baseline, with the most pronounced improvements observed for eye dryness and discomfort. Additionally, improvements from baseline in corneal fluorescein staining and conjunctival lissamine green staining were observed as early as week four and were sustained through week 12. Additionally, the proportions of patients who experienced greater than or equal to 20, 30 or 50 percent improvement in the IDEEL symptom bother score at week 12 were 50.0 percent (95% CI 33.2, 66.8), 44.1 percent (95% CI 27.4, 60.8) and 14.7 percent (95% CI 2.8, 26.6), respectively.

    Safety was assessed regarding treatment-emergent adverse events (TEAEs) and serious TEAEs collected throughout the study. Of patients in the safety population (n=36), 33.3 percent experienced ≥1 TEAE after initiation of Acthar Gel treatment; most TEAEs were single incidences. In the study, the most commonly reported TEAE was hypertension (n=2). No serious TEAEs were related to the study drug.4 

    "These data provide meaningful evidence to support Acthar Gel's potential role in improving outcomes for patients with severe keratitis that persists after the use of one or more standard treatments," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "We are pleased to be able to share these important data broadly with the healthcare community with the hopes of helping physicians better understand which individuals may benefit from the drug as a treatment alternative." 

    About the Study4:

    • The study was designed to evaluate the efficacy and safety of Acthar Gel in adult patients with treatment-resistant, severe non-infectious keratitis.
    • In the 16-week study period, 36 patients were enrolled at eight sites across the United States.
    • To ensure inclusion of moderate to severe dry eye patients, eligibility criteria included all of the following in at least one eye (the same eye) at screening and baseline:
      • Inferior corneal fluorescein staining score of at least two points in any field in at least one eye.
      • Sum corneal fluorescein staining score ≥4.
      • Sum lissamine green conjunctival score of ≥2.
      • Conjunctival redness score ≥1 (0-4 scale).
      • Schirmer score ≥1 mm and ≤10 mm/5 min in at least one eye.
      • Ocular Discomfort Score of ≥2.
    • After a 28-day screening, subjects who met entry criteria were treated with Acthar Gel 1 mL (80 units) subcutaneously twice per week for 12 weeks, followed by a tapering period of four weeks.
    • The mean age of the study population was 63.3 years, and most patients were female (71.4 percent), White (80.0 percent) and not of Hispanic or Latino ethnicity (94.3 percent).

    Find out more information about the study here on the ClinicalTrials.gov website.

    About Severe Keratitis

    Keratitis is a painful inflammation of the cornea and is a significant cause of ocular morbidity around the world.1 It can result from infectious agents (e.g., microbes including bacteria, fungi, amebae and viruses) or from noninfectious causes (e.g., eye trauma, chemical exposure and ultraviolet exposure).5 Non-infectious severe keratitis may be associated with various collagen vascular or other autoimmune diseases, sometimes as the presenting sign of the disease.6

    IMPORTANT SAFETY INFORMATION

    Contraindications

    Acthar is contraindicated:

    • For intravenous administration
    • In infants under 2 years of age who have suspected congenital infections
    • With concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar
    • In patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, or sensitivity to proteins of porcine origin

    Warnings and Precautions

    • The adverse effects of Acthar are related primarily to its steroidogenic effects
    • Acthar may increase susceptibility to new infection or reactivation of latent infections
    • Suppression of the hypothalamic-pituitary-adrenal (HPA) axis may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g., trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA axis suppression after stopping treatment
    • Cushing's syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms
    • Acthar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Monitor blood pressure and sodium and potassium levels
    • Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy
    • Acthar can cause gastrointestinal (GI) bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain GI disorders. Monitor for signs of perforation and bleeding
    • Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression to psychosis. Existing conditions may be aggravated
    • Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravis
    • Prolonged use of Acthar may produce cataracts, glaucoma, and secondary ocular infections. Monitor for signs and symptoms
    • Acthar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Acthar activity
    • There may be an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver
    • Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients
    • Decrease in bone density may occur. Bone density should be monitored in patients on long-term therapy
    • Pregnancy Class C: Acthar has been shown to have an embryocidal effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

    Adverse Reactions

    • Commonly reported postmarketing adverse reactions for Acthar include injection site reaction, asthenic conditions (including fatigue, malaise, asthenia, and lethargy), fluid retention (including peripheral swelling), insomnia, headache, and blood glucose increased
    • The most common adverse reactions for the treatment of infantile spasms (IS) are increased risk of infections, convulsions, hypertension, irritability, and pyrexia. Some patients with IS progress to other forms of seizures; IS sometimes masks these seizures, which may become visible once the clinical spasms from IS resolve

    Other adverse events reported are included in the full Prescribing Information.

    Please see full Prescribing Information for additional Important Safety Information.

    ABOUT MALLINCKRODT 

    Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

    Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

    CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS

    This release includes forward-looking statements concerning Acthar Gel including its potential impact on patients and anticipated benefits associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

    CONTACT

    Media Inquiries

    Caren Begun

    Green Room Communications

    201-396-8551

    Investor Relations

    Daniel J. Speciale

    Vice President, Finance and Investor Relations Officer

    314-654-3638

    Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2021 Mallinckrodt. US-2001768 04/21

    References

    1 Sharma S. Keratitis. Bioscience Reports. 2001;21:419-444.

    2 Acthar® Gel (repository corticotropin injection) [prescribing information]. Mallinckrodt ARD LLC.

    Fairchild CJ, et al. Optom Vis Sci. 2008;85(8):699-707.

    Grieco J, McLaurin E, Ousler G, Liu J, Kacmaz O, Wirta D. Results from a multicenter, open-label, Phase 4 study of repository corticotropin injection in patients with treatment-resistant severe non-infectious keratitis. Presented at: Association for Research in Vision and Ophthalmology Annual Meeting; May 1, 2021; San Francisco, CA.

    5 Collier SA, Gronostaj MP, MacGurn, AK, Cope JR, Awsumb KL, Yoder JS, et al. Estimated burden of keratitis--United States, 2010. MMWR Morb Mortal Wkly Rep. 2014;63(45):1027–1030.

    6 Donzis PB, Mondino BJ. Management of noninfectious corneal ulcers. Surv Ophthalmol. 1987;32:94–110.

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    SOURCE Mallinckrodt plc

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  2. DUBLIN, April 30, 2021 /PRNewswire/ -- Mallinckrodt plc (OTC:MNKKQ), a global biopharmaceutical company, today announced that data from its Phase 4 observational registry comparing the safety and effectiveness of INOmax® (nitric oxide) gas, for inhalation, in term and near-term (TNT) neonates to that in preterm (PT) neonates with pulmonary hypertension (PH) will be presented in a poster at The Pediatric Academic Societies (PAS) 2021 Virtual Meeting. The poster can be accessed here on the company's website. The safety and efficacy of INOmax in premature neonates has not been evaluated by the U.S. Food and Drug Administration.

    INOmax has been on the market in the U.S. since 2000 and is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. Please see Important Safety Information below.  

    The primary outcome measure of the registry was the number of PT neonates and TNT neonates with a significant response to INOmax, which was defined as at least a 25 percent improvement (decrease) from baseline in oxygenation index or surrogate oxygenation index (OI/SOI) during INOmax treatment. A total of 50 (90.9 percent) PT and 75 (88.2 percent) TNT neonates achieved a ≥25 percent decrease in OI/SOI during treatment with INOmax. Efficacy in the PT group demonstrated non-inferiority (95 percent confidence interval: 0.0267 [-0.0333, 0.0868], with a pre-defined margin of -0.1452). In addition, the proportion of neonates with ≥25 percent decrease in OI/SOI was similar across severity groups with no significant difference in time to improvement between groups.1

    "These registry findings help expand our understanding of a potential role of inhaled nitric oxide therapy in preterm infants with hypoxic respiratory failure with pulmonary hypertension," said study author Leif D. Nelin, M.D., Division Chief of Neonatology at Nationwide Children's Hospital.

    Persistent pulmonary hypertension of the newborn (PPHN) is a serious and sometimes fatal cardiorespiratory complication of the transition to extra-uterine life.2,3 The registry trial was conducted to examine the utility of INOmax in pre-term neonates. Due to the seriousness of the condition, a randomized controlled trial cannot be conducted in the pre-term neonate population.

    Overall, 21 adverse events of special interest were reported in 17 patients, all of which were classified as serious events, and no serious adverse events were attributed to the study drug.

    "After ending this registry much earlier than anticipated last year based on positive findings, Mallinckrodt is extremely pleased to be able to share these important data with the healthcare community and add to the body of research and real-world data for this vulnerable patient population," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt.

    About the Observational Registry

    • The Registry Evaluating Premature and Term and Near-Term Neonates with Pulmonary Hypertension Receiving Inhaled Nitric Oxide (PaTTerN) was a multicenter, prospectively defined, observational registry study that evaluated the use of INOmax to treat pulmonary PH in premature neonates (27 to less than 34 weeks gestational age) and term and near-term neonates (34 to 40 weeks gestational age).
    • In the 11-day study period, a total of 140 neonates (PT, n=55; TNT, n=85) were enrolled across 30 sites in the United States.
    • The primary outcome measure compared the incidence of subjects with at least a 25 percent improvement (decrease) from baseline in OI or SOI during the INOmax treatment period in pre-term versus term and near-term neonates with PH.
    • Secondary efficacy endpoints included:
      • The incidence of subjects with at least a 25 percent improvement in OI/SOI in each severity group of mild, moderate and severe
      • The time to response to INOmax up to 96 hours for each severity and age group
      • Evaluation of 25 percent improvement in OI/SOI with univariate and multivariate logistic regressions for baseline factors: age and severity group, disease subtype, weight, race, gender
      • The incidence of partial responders (<25 percent improvement in OI/SOI) and non-responders (<5 percent improvement in OI/SOI) summarized by age group and by each severity group within each age group
    • Patients were classified as mild, moderate or severe based on a primary measure of OI or a secondary measure of SOI for hypoxic respiratory failure (HRF) severity:
      • Mild: OI <16 or SOI <10
      • Moderate: OI value 16 to 25 or SOI value 10 to 15
      • Severe: OI >25 or SOI >15
    • Patients were evaluated for response to INOmax and safety during a treatment period of up to 96 hours ± 12 hours and a safety follow-up through 7 days (for a total of up to 11 days) or to hospital discharge, whichever came first

    More information about the trial can be found here.

    Study Limitations

    The study was a prospective observational registry that collected real world data that described INOmax nitric oxide gas use in clinical practice. As an observational study it did not utilize placebo. Hence, some of the improvement observed in the study could be due to factors other than treatment with INOmax. Similarly, without placebo control it is not possible to understand the magnitude to which patients who experienced limited response to inhaled nitric oxide would have otherwise decompensated without this treatment.

    About Persistent Pulmonary Hypertension of the Newborn (PPHN)

    PPHN is a serious and sometimes fatal cardiorespiratory complication of the transition to extra-uterine life.2,3 PPHN is a clinical syndrome associated with various neonatal cardiorespiratory diseases, including meconium aspiration, respiratory distress syndrome (hyaline membrane disease), congenital heart disease and congenital hernia.2 Despite the diversity of causes, marked pulmonary vasoconstriction is the central pathophysiologic feature of PPHN.4 The most significant hemodynamic feature in neonates with severe hypoxia is a pulmonary-to-systemic pressure imbalance.5 Treatment in these neonates is directed toward lowering the pulmonary vascular pressure and supporting the systemic circulation.2,4

    IMPORTANT SAFETY INFORMATION

    • INOmax is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.
    • Abrupt discontinuation of INOmax may lead to increasing pulmonary artery pressure and worsening oxygenation.
    • Methemoglobinemia and NO2 levels are dose dependent. Nitric oxide donor compounds may have an additive effect with INOmax on the risk of developing methemoglobinemia. Nitrogen dioxide may cause airway inflammation and damage to lung tissues.
    • In patients with pre-existing left ventricular dysfunction, INOmax may increase pulmonary capillary wedge pressure leading to pulmonary edema.
    • Monitor for PaO2, inspired NO2, and methemoglobin during INOmax administration.
    • INOmax must be administered using a calibrated FDA-cleared Nitric Oxide Delivery System.

    Please see Full Prescribing Information.

    ABOUT MALLINCKRODT

    Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

    Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

    CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS

    This release includes forward-looking statements concerning inhaled nitric oxide ("iNO") and the Company's iNO product, including statements with regard to the clinical data generated in the study described above. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

    CONTACTS

    For Trade Media Inquiries

    Caren Begun

    Green Room Communications

    201-396-8551

    Investor Relations

    Daniel J. Speciale, CPA

    Vice President, Finance and Investor Relations Officer

    314-654-3638

    Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2021 Mallinckrodt. US-2000338 04/21

    References

    1 Nelin L, Kinsella J, Courtney S, Pallotto E, Tarau E, Potenziano J. Use of Inhaled Nitric Oxide in Preterm vs Term/Near-Term Neonates With Pulmonary Hypertension: Results of the PaTTerN Registry Study. Presented at: Pediatric Academic Societies Annual Meeting; May 1, 2021.

    2 Nair J, Lakshminrusimha S. Update on PPHM: Mechanisms and treatment. Semin Perinatol. 2014;38(2):78-91.

    3 Clark RH. The epidemiology of respiratory failure in neonates born at an estimated gestational age of 34 weeks or more. J Perinatol. 2005;25(4):251-257.

    Wedgwood S, Steinhorn RH, Lakshminrushimha S. Optimal oxygenation and role of free radicals in PPHN. Free Radical Biology and Medicine. 2019;142:97-106.

    5 Lakshminrusimha S. The pulmonary circulation in neonatal respiratory failure. Clin Perinatol. 2012;39(3):655-683.

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  3. ST. LOUIS, March 29, 2021 /PRNewswire/ -- Mallinckrodt plc (OTC:MNKKQ), a global biopharmaceutical company, today announced that its Specialty Generics division has been recognized as Manufacturing Leadership Award winners for outstanding achievement in two categories – Collaborative Innovation Leadership and Operational Excellence Leadership – by the National Association of Manufacturers (NAM).

    Mallinckrodt Specialty Generics COVID-19 Response Team was selected as a Collaborative Innovation Leadership Award winner for its cross-functional response to the pandemic. To protect the health and safety of its over1600 employees and ensure patients have access to critical medicines throughout the pandemic, the COVID-19 Response Team's multifaceted program included: implementation of strict safety protocols at its five US-based manufacturing sites; deployment of non-essential employees to work from home; specialized training in accordance with guidance from the Centers for Disease Control and Prevention (CDC); provisions for COVID-19 in-home testing; governance of strict return-to-site and contingency plans; and ongoing employee communications from site-level management and executive leadership. As a result of these measures, Mallinckrodt Specialty Generics experienced zero pandemic-related delays in the manufacturing and distribution of its finished dose and advanced pharmaceutical ingredient (API) products. This included the company's successful response to an increased demand for acetaminophen – an important pain reliever for COVID-related symptoms – and other essential medicines during the pandemic. Additionally, amidst PPE shortages at the onset of the pandemic, the organization began manufacturing hand sanitizer for donation to emergency management operations located in regions in which it operates and to all Opioid Treatment Programs across the US in support of their uninterrupted care of opioid use disorder patients.

    Winner in the Operational Excellence Leadership category, Mallinckrodt Specialty Generics' Hobart, NY manufacturing facility was recognized for its Packaging Process Improvement Project. The multi-functional team assembled at the Hobart site sought to make significant improvements to the efficiencies and reliability of its carton-sealing process for all packaging lines. Upon completing the initiative, the process improvements successfully realized a reduction in maintenance time and waste, enhanced safety and reliability of packaging shipped to customers, and improved operator productivity and morale, which resulted in significant cost savings.

    "We are extremely honored to receive the NAM's manufacturing leadership awards which come at a pivotal time when the pandemic has exposed the vital need for our country to maintain a domestic, reliable and safe medical supply chain — particularly for low-cost, generic drugs and APIs," said Spiro Gavaris, President, Mallinckrodt Specialty Generics. "I am incredibly proud of our COVID-19 Response Team's collaborative efforts this past year and our Hobart team's ongoing pursuit of innovative manufacturing solutions. Both award recognitions demonstrate Mallinckrodt Specialty Generics' commitment to providing patients with access to quality generic medicines and our focus on being a US-based supplier of choice to help protect the national security and health of our nation."

    David Hollingshead, Senior Director of Manufacturing and Site Leader at Hobart said, "We are thrilled that the Hobart site has been honored for the fourth year in a row and, in 2021, has earned the prestigious Manufacturing Leadership Award in the Operational Excellence category. Our packaging process improvement project was a total team effort and testament to the passion, mindsets, and behaviors of all Hobart employees for continuous improvement in the manufacturing and delivery of essential products that our customers — and patients — rely on."

    Mallinckrodt will be recognized at the Manufacturing Leadership Awards Gala, which will take place as a virtual event on Wednesday, May 19, 2021. Details on attending the virtual gala are available at https://mlawards.manufacturingleadershipcouncil.com.

    About Mallinckrodt

    Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market, and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

    About the Manufacturing Leadership Awards

    The Manufacturing Leadership Awards honor manufacturing companies and individual manufacturing leaders that are shaping the future of global manufacturing. Winning projects and individual manufacturing leaders have demonstrated achievement in one of a wide range of categories, and are chosen by a panel of expert judges for results that have delivered clear and compelling value, return on investment, and other tangible outcomes. There will be several winners in each category, including one High Achiever's Award in each project category, as well as a 2021 Manufacturer of the Year for both small and large enterprises. Also unveiled at the gala will be the ML Awards Manufacturing Leader of the Year and Lifetime Achievement Award winners.

    About the National Association of Manufacturers

    The National Association of Manufacturers (NAM) is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states. Manufacturing employs more than 12 million men and women, contributes $2.25 trillion to the U.S. economy annually, has the largest economic impact of any major sector and accounts for more than three-quarters of all private-sector research and development in the nation. The NAM is the powerful voice of the manufacturing community and the leading advocate for a policy agenda that helps manufacturers compete in the global economy and create jobs across the United States.

    The NAM's world-class staff of policy experts provide unmatched access and information on the key issues affecting your business and bottom line. We are on the front lines of a wide range of policy battles, from immigration reform and labor relations, to energy and the environment, to trade policy and taxes. At every turn, we are working on behalf of manufacturers in America to advance policies that help manufacturers do what they do best: create economic strength and jobs.

    www.nam.org 

    CONTACTS

    For Financial/Dailies Media Inquiries

    Ron Bartlett

    H+K Strategies

    Senior Vice President

    M: +1 813 545 2399

      

    Investor Relations

    Daniel J. Speciale

    Vice President, Finance and Investor Relations Officer

    314-654-3638

    Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners.

    ©2021 Mallinckrodt. US-2001742 02/21.

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  4. DUBLIN, March 10, 2021 /PRNewswire/ -- Mallinckrodt plc (OTC:MNKKQ) ("Mallinckrodt" or the "Company") today announced that it has reached agreement with an ad hoc group of first lien term lenders holding approximately $1.3 billion of its outstanding First Lien Term Loans (the "First Lien Term Loan Lenders") to support the Company's previously announced restructuring support agreement ("RSA"). The agreement, which is based on providing new term loans financing to replace the First Lien Term Loans, resolves the open dispute between the Company and the First Lien Term Loan Lenders as to how such Lenders are to be treated under the restructuring plan and serves to extend near-term debt maturities.

    DUBLIN, March 10, 2021 /PRNewswire/ -- Mallinckrodt plc (OTC:MNKKQ) ("Mallinckrodt" or the "Company") today announced that it has reached agreement with an ad hoc group of first lien term lenders holding approximately $1.3 billion of its outstanding First Lien Term Loans (the "First Lien Term Loan Lenders") to support the Company's previously announced restructuring support agreement ("RSA"). The agreement, which is based on providing new term loans financing to replace the First Lien Term Loans, resolves the open dispute between the Company and the First Lien Term Loan Lenders as to how such Lenders are to be treated under the restructuring plan and serves to extend near-term debt maturities.

    Mark Trudeau, President and Chief Executive Officer of Mallinckrodt, said, "We continue to make substantial progress toward implementing a consensual restructuring that addresses the Company's legal uncertainties and positions us to move ahead with our strategic plans. With the support of our First Lien Term Loan Lenders who have become parties to our RSA, we now have support from many of our largest creditor constituents as we continue to build greater consensus towards an outcome that should maximize value and benefit our patients, employees, customers, suppliers and other partners. As we work to complete this process, we remain focused on developing new therapies, improving patient health outcomes and supporting underserved patients."

    The key terms of the alternative treatment for the First Lien Term Loan Lenders include: 

    • If not otherwise refinanced in full in cash prior to the date the Company's Plan of Reorganization becomes effective (the "Plan Effective Date"), First Lien Term Loan Lenders shall receive term loans on the following terms through a plan of reorganization:
      • Increase in LIBOR margin of 2.50% (to a total interest rate of L+525 bps and L+550 bps for the First Lien Term Loans due in 2024 and 2025, respectively), subject to a 75 bps LIBOR floor;
      • Maturity extension to the earlier of September 30, 2027 or 5.75 years following the Plan Effective Date; and
      • No financial maintenance covenants;
    • Alternatively, the Company may refinance in full in cash the approximately $1.9 billion of currently outstanding First Lien Term Loans at par prior to or on the Plan Effective Date, subject to reduction for payment upon court approval of the 2020 excess cash flow sweep calculated to be approximately $114 million;
    • Exit payment of 50 bps if the First Lien Term Loans are refinanced in full in cash prior to or on the Plan Effective Date, or 100 bps if the First Lien Term Loans are not so refinanced; and
    • Cash Collateral Order to be modified to pay an incremental 50 bps of adequate protection interest during the case, with an agreement to treat adequate protection payments as satisfying the Lenders' interest entitlements  upon the Plan Effective Date.

    As previously announced in October 2020, Mallinckrodt voluntarily initiated Chapter 11 proceedings in the U.S. Bankruptcy Court for the District of Delaware to implement the RSA and key legal settlements – including opioid claims – in a fair, orderly, efficient and legally binding manner. The RSA provides for a financial restructuring designed to strengthen the Company's balance sheet and reduce its total debt by approximately $1.3 billion, excluding the 2020 excess cash flow sweep to First Lien Term Loan Lenders noted above, improving the Company's financial position and allowing the Company to continue driving its strategic priorities and investing in the business to develop and commercialize therapies to improve health outcomes. In addition to the First Lien Term Loan Lenders, upon effectiveness of the amendment, the RSA will be supported by:

    • Holders of approximately 84% of the Company's guaranteed unsecured notes;
    • 50 states and territories and the Plaintiffs' Executive Committee in the opioid multidistrict litigation; and
    • The Multi-State Governmental Entities Group (the "MSGE Group"), which represents more than 1,300 counties, municipalities, tribes and other governmental entities, across 38 states and territories, with opioid-related claims against the Company.

    To become effective, the agreement must be supported by Lenders holding 66.7% of each of the First Lien Term Loans due in 2024 and the First Lien Term Loans due in 2025, the Governmental Ad Hoc Committee, the MSGE Group and majority of the guaranteed bondholders. The implementation of this settlement is subject to the support of all of these parties and approval of a Chapter 11 plan embodying the RSA by the Bankruptcy Court.

    Advisors

    Latham & Watkins LLP, Ropes & Gray LLP and Wachtell, Lipton, Rosen & Katz are serving as counsel, Guggenheim Securities, LLC is serving as investment banker and AlixPartners LLP is serving as restructuring advisor to Mallinckrodt.

    Gibson, Dunn & Crutcher LLP is serving as counsel and Evercore Group LLC is serving as financial advisor to the ad hoc group of First Lien Term Loan Lenders. Paul, Weiss, Rifkind, Wharton & Garrison LLP is serving as counsel and Perella Weinberg Partners LP is serving as financial advisor to the ad hoc group of guaranteed unsecured bondholders. Kramer Levin Naftalis & Frankel LLP, Brown Rudnick LLP and Gilbert LLP are serving as counsel, and Houlihan Lokey is serving as financial advisor to the Governmental Ad Hoc Committee. Caplin & Drysdale is serving as counsel and FTI Consulting is serving as financial advisor to the MSGE Group.

    About Mallinckrodt

    Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

    Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

    CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS

    Statements in this document that are not strictly historical, including statements regarding future financial condition and operating results, legal, economic, business, competitive and/or regulatory factors affecting Mallinckrodt's businesses, and any other statements regarding events or developments the company believes or anticipates will or may occur in the future, may be "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, and involve a number of risks and uncertainties.

    There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include risks and uncertainties related to, among other things: Mallinckrodt's ongoing Chapter 11 cases; the ability of Mallinckrodt and its subsidiaries to obtain approval from the bankruptcy court with respect to motions or other requests made to the bankruptcy court throughout the course of the Chapter 11 cases and to negotiate, develop, obtain court approval of, confirm and consummate the plan of reorganization contemplated by the restructuring support agreement or any other plan that may be proposed, the effects of the Chapter 11 cases, including increased professional costs, on the liquidity, results of operations and businesses of Mallinckrodt and its subsidiaries; the consummation of the transactions contemplated by the restructuring support agreement, including the ability of the parties to negotiate definitive agreements with respect to the matters covered by the term sheets included in the restructuring support agreement, the occurrence of events that may give rise to a right of any of the parties to terminate the restructuring support agreement and the ability of the parties to receive the required approval by the bankruptcy court and to satisfy the other conditions of the restructuring support agreement, including satisfying the milestones specified in the restructuring support agreement; governmental investigations and inquiries, regulatory actions and lawsuits brought against Mallinckrodt by government agencies and private parties with respect to its historical commercialization of opioids, including the amended non-binding agreement in principle reached by Mallinckrodt in connection with the announcement of its filing of the Chapter 11 petitions regarding the terms and conditions of a global settlement to resolve all current and future opioid-related claims; potential delays in Mallinckrodt's Chapter 11 process; the proposed settlement with governmental parties to resolve certain disputes relating to Acthar Gel; the possibility that such settlement will not be consummated and the risks and uncertainties related thereto, including the time and expense of continuing to litigate this dispute and the impact of this dispute on Mallinckrodt's financial condition and expectations for performance; the ability to maintain relationships with Mallinckrodt's suppliers, customers, employees and other third parties as a result of the Chapter 11 cases; the availability of operating capital during the pendency of the Chapter 11 cases, including events that could terminate Mallinckrodt's right to continue to access the cash collateral of Mallinckrodt's lenders; the possibility that Mallinckrodt may be unable to achieve its business and strategic goals even if the Chapter 11 plan is successfully consummated; the possibility that Mallinckrodt's Chapter 11 cases may be converted into Chapter 7 cases under the bankruptcy code; the potential termination of Mallinckrodt's exclusive right to file a Chapter 11 plan; the possibility that certain claims against Mallinckrodt may not be discharged as part of the bankruptcy process; developing, funding and executing Mallinckrodt's business plan and continuing as a going concern; Mallinckrodt's post-bankruptcy capital structure; scrutiny from governments, legislative bodies and enforcement agencies related to sales, marketing and pricing practices; pricing pressure on certain of Mallinckrodt's products due to legal changes or changes in insurers' reimbursement practices resulting from recent increased public scrutiny of healthcare and pharmaceutical costs; the impact of the outbreak of the COVID-19 coronavirus; the reimbursement practices of governmental health administration authorities, private health coverage insurers and other third-party payers; complex reporting and payment obligations under the Medicare and Medicaid rebate programs and other governmental purchasing and rebate programs; cost containment efforts of customers, purchasing groups, third-party payers and governmental organizations; changes in or failure to comply with relevant laws and regulations; Mallinckrodt's and its partners' ability to successfully develop or commercialize new products or expand commercial opportunities; Mallinckrodt's ability to navigate price fluctuations; competition; Mallinckrodt's and its partners' ability to protect intellectual property rights; limited clinical trial data for Acthar Gel; clinical studies and related regulatory processes; product liability losses and other litigation liability; material health, safety and environmental liabilities; potential indemnification liabilities to Covidien pursuant to the separation and distribution agreement; business development activities; retention of key personnel; the effectiveness of information technology infrastructure including cybersecurity and data leakage risks; customer concentration; Mallinckrodt's reliance on certain individual products that are material to its financial performance; Mallinckrodt's ability to receive procurement and production quotas granted by the U.S. Drug Enforcement Administration; complex manufacturing processes; conducting business internationally; Mallinckrodt's ability to achieve expected benefits from restructuring activities; Mallinckrodt's significant levels of intangible assets and related impairment testing; labor and employment laws and regulations; natural disasters or other catastrophic events; Mallinckrodt's substantial indebtedness and its ability to generate sufficient cash to reduce its indebtedness; Mallinckrodt's ability to generate sufficient cash to service indebtedness even if the existing indebtedness is restructured; future changes to U.S. and foreign tax laws or the impact of disputes with governmental tax authorities; and the impact of Irish laws.

    These and other factors are identified and described in more detail in the "Risk Factors" section of Mallinckrodt's Annual Report on Form 10-K for the fiscal year ended December 27, 2019 and Form 10-Q for the fiscal quarters ended September 25, 2020, June 26, 2020 and March 27, 2020. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

    CONTACTS

    Investor Relations

    Daniel J. Speciale

    Vice President, Finance and Investor Relations Officer

    314-654-3638

    Media

    Michael Freitag / Aaron Palash / Aura Reinhard

    Joele Frank, Wilkinson Brimmer Katcher

    212-355-4449

    Government Affairs 

    Mark Tyndall

    Senior Vice President, U.S. General Counsel

    & Government Affairs

    202-459-4141

    Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2021 Mallinckrodt. US-2000496 03/21

     

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  5. DUBLIN, March 4, 2021 /PRNewswire/ -- Mallinckrodt plc, a global biopharmaceutical company, today announced publication of results from its pivotal Phase 3 CONFIRM study to assess the efficacy and safety of its investigational agent terlipressin in adults with hepatorenal syndrome type 1 (HRS-1). HRS-1 is an acute and life-threatening syndrome involving acute kidney failure in patients with cirrhosis,1 and has a median survival time of approximately two weeks and greater than 80 percent mortality within three months if left untreated.2,3 The study was posted online ahead of print publication in the New England Journal of Medicine.

    Terlipressin is an investigational product and its safety and effectiveness have not yet been established by the U.S. Food and Drug Administration (FDA) or Health Canada.

    As previously announced, the Phase 3 CONFIRM study met its primary endpoint of Verified HRS Reversal, which is defined as renal function improvement, avoidance of dialysis and short-term survival. The main objective of the CONFIRM study was to assess the efficacy and safety of terlipressin, together with albumin, versus placebo in adults in the U.S. and Canada with cirrhosis and HRS-1. The trial met three of the four pre-specified secondary endpoints of the study including HRS reversal, HRS reversal without renal replacement therapy (RRT) by Day 30 and HRS reversal in the systemic inflammatory response syndrome (SIRS) subgroup. The fourth pre-specified secondary endpoint of Verified HRS Reversal without HRS recurrence by Day 30 was 50 percent greater in the terlipressin group but did not reach statistical significance.4 Initial results were announced during a late-breaking abstract presentation on November 11, 2019 at The Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases (AASLD).

    In another pre-specified endpoint, avoidance of RRT, terlipressin treated subjects (n=199) showed a significantly lower incidence during the treatment period and a lower incidence at all follow-up assessments through Day 90 versus patients with placebo (n=101).4 This is clinically significant because RRT can increase complications in HRS-1 due to the underlying cirrhosis (i.e. coagulopathy, low blood pressure).  

    "The durability of HRS reversal with terlipressin in CONFIRM persisted to Day 30 without the need for RRT. This is a clinically significant observation, as RRT poses many challenges for patients with advanced cirrhosis," said lead author Florence Wong, MBBS, MD, FRACP, FRCPC, Hepatologist at Toronto General Hospital and Professor of Medicine at the University of Toronto. "Results from CONFIRM provide critical information on a potential treatment option for HRS-1 and these data indicate that, if approved, terlipressin has the potential to reverse the course of HRS-1 in the appropriate patients and help the healthcare community better manage this critically ill and underserved patient population."

    The incidence of adverse events (AEs) of any severity were similar in both groups (88.0 percent of the terlipressin group and 88.9 percent of the placebo group). The most commonly reported AEs in the overall study population were abdominal pain, nausea, diarrhea, hepatic encephalopathy and dyspnea. Serious AEs (SAEs) were reported in 65.0 percent (n=130) of the terlipressin group and 60.6 percent (n=60) of the placebo group. The most commonly reported SAEs included hepatobiliary disorders, respiratory disorders and gastrointestinal disorders.4 

    At present, there are no drug therapies approved for the treatment of HRS-1 in the U.S. or Canada.5 HRS-1 is estimated to affect between 30,000 and 40,000 patients in the U.S. annually.6,7

    In November 2020, Mallinckrodt announced it participated in an end of review meeting with the FDA to discuss the Complete Response Letter issued on September 11, 2020 for the Company's New Drug Application (NDA) for terlipressin. Based on recent discussions with the FDA, Mallinckrodt continues to explore a potential regulatory path forward regarding the NDA. 

    Terlipressin is approved in many countries outside the U.S. and Canada, where it has been a standard of care for decades in the treatment of patients with HRS-1.8,9 Terlipressin, together with albumin, is currently the standard of care for HRS-1 in countries where it is approved and available.10

    "The CONFIRM results provide meaningful insight into the management of HRS-1 in clinical practice, and we are pleased to be able to share these important data broadly with the healthcare community," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "On behalf of Mallinckrodt, I would also like to once again thank all of the patients, caregivers and medical professionals whose contributions made this study possible."  

    About the Pivotal Phase 3 CONFIRM Study (multi-center, randomized, placebo-controlled, double-blind trial in the U.S. and Canada)4:

    • The trial was designed to confirm efficacy and safety of terlipressin for the treatment of HRS-1.
    • In the 35-month study period, 300 patients from the U.S. (89.0 percent) and Canada (11.0 percent) participated in the largest-ever prospective, multi-center, randomized, controlled clinical trial in HRS-1.
    • Patients in the study were critically ill, as indicated by assessments of their liver and kidney function at the start of the trial. Patients in the trial had a mean Model for End-Stage Liver Disease (MELD) score of 33, a mean serum creatinine (SCr) level of 3.5 mg/dL and 61.0 percent were categorized as Child-Pugh Class C.
    • Eligibility criteria included adults with liver cirrhosis and ascites with rapidly worsening renal function and no response to diuretic withdrawal or volume expansion with albumin.
    • Subjects were randomized in a 2:1 ratio to receive terlipressin plus albumin (n=199) or placebo plus albumin (n=101).
    • The primary endpoint of Verified HRS Reversal evaluated renal function improvement, avoidance of dialysis and short-term survival.

    Find out more information about the CONFIRM trial here on the ClinicalTrials.gov website.

    About Terlipressin

    Terlipressin is a potent vasopressin analogue selective for V1 receptors being investigated for the treatment of HRS-1 in the U.S. and Canada. It is an investigational product in these countries as the safety and efficacy have not been established with, nor has approval been granted by, regulatory authorities in either country. Terlipressin is approved for use outside the U.S. and Canada.

    ABOUT MALLINCKRODT 

    Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

    Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

    CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS

    This release includes forward-looking statements with regard to terlipressin, including with regard to interactions with regulators as well as its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

    CONTACT

    Media Inquiries

    Caren Begun

    Green Room Communications

    201-396-8551

    Investor Relations

    Daniel J. Speciale

    Vice President, Finance and Investor Relations Officer

    314-654-3638

    Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2021 Mallinckrodt. US-2000496 02/21

    References

    1 National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: https://rarediseases.org/rare-diseases/hepatorenal-syndrome/. Accessed January 12, 2021.

    2 Colle I and Laterre PF. Hepatorenal syndrome: the clinical impact of vasoactive therapy. Expert Review of Gastroenterology & Hepatology. (2018) 12:2, 173-188, DOI: 10.1080/17474124.2018.1417034. 

    3 Gines P, Sola E, Angeli P, et al. Hepatorenal syndrome. Nature Reviews. (2018) 4:23. 

    4 Wong F, Pappas C, Curry M, et al. Terlipressin plus albumin for the treatment of hepatorenal syndrome type 1. The New England Journal of Medicine. 2020.

    5 Boyer TD, Medicis JJ, Pappas SC, et al. A randomized, placebo-controlled, double-blind study to confirm the reversal of hepatorenal syndrome type 1 with terlipressin: the REVERSE trial design. Open Access Journal of Clinical Trials 2012:4. https://www.dovepress.com/a-randomized-placebo-controlled-double-blind-study-to-confirm-the-reve-peer-reviewed-article-OAJCT

    6 C Pant, B S Jani, M Desai, A Deshpande, Prashant Pandya, Ryan Taylor, R Gilroy, M Olyaee. Hepatorenal syndrome in hospitalized patients with chronic liver disease: results from the Nationwide Inpatient Sample 2002–2012. Journal of Investigative Medicine. 2016;64:33–38.

    7 United States Census Bureau: Quick Facts. Available at: https://www.census.gov/quickfacts/fact/table/US/PST045218. Accessed January 12, 2021.

    8 De Franchis R. Evolving Consensus in Portal Hypertension Report of the Baveno IV Consensus Workshop on methodology of diagnosis and therapy in portal hypertension. J Hepatol. 2005;43:167-176.

    9 Ioannou GN, Doust J, Rockey DC. Terlipressin for acute esophageal variceal hemorrhage. Cochrane Database of Systematic Reviews. 2003;1. doi: 10.1002/14651858.CD002147.

    10 European Association for the Study of the Liver (EASL). Clinical practice guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018;69(2):406-460.

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