MNK Mallinckrodt plc

2.43
-0.07  -3%
Previous Close 2.5
Open 2.55
52 Week Low 1
52 Week High 9.19
Market Cap $205,226,340
Shares 84,455,284
Float 83,187,634
Enterprise Value $4,776,438,210
Volume 1,805,744
Av. Daily Volume 4,392,173
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Upcoming Catalysts

Drug Stage Catalyst Date
Terlipressin
Hepatorenal syndrome (HRS) Type 1
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
StrataGraft skin tissue
Deep partial thickness severe burns - skin defects
BLA Filing
BLA Filing
BLA rolling submission has been completed - June 9, 2020.
MNK-6106
Hepatic Cirrhosis and Chronic Hepatic Encephalopathy (HE)
Phase 2a
Phase 2a
Phase 2 commencement of dosing announced August 12, 2019.
UVADEX (methoxsalen) and Therakos
Acute Graft Versus Host Disease
Phase 3
Phase 3
Phase 3 enrolment to stop following interim analysis February 20, 2019.
H.P. Acthar Gel
Amyotrophic Lateral Sclerosis
Phase 2
Phase 2
Phase 2 trial discontinued due to safety concerns - July 16, 2019.
CPP-1X/sulindac
Familial Adenomatous Polyposis (FAP)
Phase 3
Phase 3
Phase 3 data released May 7, 2019 did not meet primary endpoint.
MNK-812
Pain
CRL
CRL
CRL issued December 12, 2018.
VTS-270
Niemann-Pick Disease
Phase 3
Phase 3
Phase 3 trial did not show a statistically significant separation from placebo.
Stannsoporfin
Jaundice
CRL
CRL
CRL issued August 22, 2018.
RAPLIXA
Hemostasis
Approved
Approved
Approved April 30, 2015.

Latest News

  1. STAINES-UPON-THAMES, United Kingdom, June 17, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE:MNK), a global biopharmaceutical company, will present on Tuesday, June 23, 2020 at the BMO Prescriptions for Success Healthcare Conference. Mark Trudeau, President and Chief Executive Officer, and Bryan Reasons, Executive Vice President and Chief Financial Officer, will represent the company in a fireside chat at 8:00 a.m. Eastern Time. To access the webcast, please refer to the webcast link posted on our site at: http://www.mallinckrodt.com/investors.  A replay of the fireside chat will also be available following the meeting.

    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.

    CONTACTS

    Investor Relations

    Daniel J. Speciale, CPA

    Vice President, Investor Relations and IRO

    (314) 654-3638

    Media Inquiries

    Ron Bartlett

    H+K Strategies

    Senior Vice President

    813-545-2399

    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. © 2020 Mallinckrodt.  06/2020

     

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    SOURCE Mallinckrodt plc

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  2. STAINES-UPON-THAMES, United Kingdom, June 15, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE:MNK), a global biopharmaceutical company, announced its disappointment with the U.S. Court of Appeals for the District of Columbia decision to deny its request for a temporary injunction preventing the U.S. Centers for Medicare and Medicaid Services (CMS) from enforcing a change in Medicaid drug rebate calculation for Acthar® Gel (repository corticotropin injection). Mallinckrodt had asked for the temporary injunction as it appeals a lower court ruling that allowed CMS to reset the base date average manufacturer price (AMP).  The Appeals Court also ordered an expedited briefing and oral argument schedule that will likely lead to fall oral arguments, and…

    STAINES-UPON-THAMES, United Kingdom, June 15, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE:MNK), a global biopharmaceutical company, announced its disappointment with the U.S. Court of Appeals for the District of Columbia decision to deny its request for a temporary injunction preventing the U.S. Centers for Medicare and Medicaid Services (CMS) from enforcing a change in Medicaid drug rebate calculation for Acthar® Gel (repository corticotropin injection). Mallinckrodt had asked for the temporary injunction as it appeals a lower court ruling that allowed CMS to reset the base date average manufacturer price (AMP).  The Appeals Court also ordered an expedited briefing and oral argument schedule that will likely lead to fall oral arguments, and potentially a ruling by end of year. 

    As a result of today's appeals court ruling, Mallinckrodt will change the base date AMP for Acthar Gel, as directed by CMS.  The effect of the change is an immediate recognition of retroactive non-recurring charges (estimated at approximately $650 million through mid-June) and the prospective loss of Acthar Medicaid net sales, which has historically contributed to Acthar Gel net sales of $90 to $100 million annually. The company will continue to appeal the March 16 ruling by the U.S. District Court for the District of Columbia that upheld CMS' position. Barring other arrangements, the cash payments for retroactive Medicaid rebate charges will be processed over time, in accordance with the normal rebate payment schedule, and the company expects the cash outlays will most likely commence in the fourth quarter of 2020.

    Despite the ruling, Mallinckrodt remains committed to ensuring that Medicaid patients have access to Acthar Gel.

    "We are disappointed in the appeals court decision not to issue a temporary injunction to prevent CMS from enforcing this change in Medicaid rebate calculations while our case is still under appeal," said Mark Casey, Executive Vice President and Chief Legal Officer of Mallinckrodt. "We will continue our appeal, which could be decided as early as end of year, and strongly believe that the District Court misinterpreted the statute that governs the Medicaid drug rebate program and failed to hold CMS accountable to the Administrative Procedure Act. CMS twice confirmed in writing its approval of the Acthar Gel Medicaid rebate calculation in use today, before it later reversed its position without giving fair notice or any clear legal basis for doing so."        

    In legal filings requesting the temporary injunction, Mallinckrodt warned that the retroactive non-recurring charges – if allowed to stand by the appeals court – "would have a dramatic impact upon the company's existing financial obligations and its efforts to settle other litigation."  While Mallinckrodt has reached an agreement in principle on a global settlement of opioids litigation, and continues to work collaboratively with the parties involved to expedite a reasonable resolution, the agreement could be in jeopardy if the appeals court upholds CMS' position. The company continues to explore all options to address its long-term liabilities and risks.

    ABOUT MALLINCKRODT

    Mallinckrodt ARD LLC is a subsidiary of Mallinckrodt, 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.

    Mallinckrodt Pharmaceuticals 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 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 concerning the dispute between Mallinckrodt, HHS and CMS with regard to Medicaid drug rebates for Acthar Gel; the litigation filed by Mallinckrodt against HHS and CMS in connection with this dispute including any related appeals; the change of the base date AMP for Acthar Gel and the resulting payment of any retroactive non-recurring charges; the impact of such dispute and any such litigation on Mallinckrodt's ability to fund research and development activities (including COVID-19 related activities) or on its ability to effectuate its proposed opioid settlement; the impact of any of the foregoing on Mallinckrodt's future financial condition, operating results, and other pending litigation; and any other statements regarding events or developments that Mallinckrodt 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: the dispute between Mallinckrodt, HHS and CMS, including the outcome of the lawsuit filed by Mallinckrodt and any related appeals, as well as the time and expense of litigating this dispute; the impact of this dispute on Mallinckrodt's expectations for performance in 2020, as well as the potential retroactive financial impact on Mallinckrodt of an adverse outcome or any other impacts; 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 non-binding agreement in principle regarding terms and conditions of a global settlement to resolve all current and future opioid-related claims; 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 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; future changes to U.S. and foreign tax laws or the impact of disputes with governmental tax authorities; the impact of Irish laws; and the impact of the outbreak of the COVID-19 coronavirus.

    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 the "Risk Factors" section of Mallinckrodt's Quarterly Report on Form 10-Q for the quarterly period ended 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, CPA

    Vice President, Investor Relations and IRO

    314-654-3638

    Media Inquiries

    Ron Bartlett

    H+K Strategies

    Senior Vice President

    813-545-2399

    Government Affairs

    Mark Tyndall

    Senior Vice President, Government Affairs

    & Chief Counsel, Litigation

    202-383-0090

    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. © 2020 Mallinckrodt. 06/20

     

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    SOURCE Mallinckrodt plc

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  3. STAINES-UPON-THAMES, United Kingdom, June 15, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE:MNK), a global biopharmaceutical company, today announced it will present data from the pivotal Phase 3 clinical trial (STRATA2016) of its investigational product StrataGraft®, a regenerative skin tissue therapy in development for the treatment of deep partial-thickness thermal burns, as well as health economics and outcomes research (HEOR) and other data on the treatment of burns as part of the virtual American Burn Association (ABA) 52nd Annual Meeting. The virtual meeting begins today and is accessible online for attendees during the next 90 days. StrataGraft skin tissue is an investigational product, and its safety and effectiveness have not yet been…

    STAINES-UPON-THAMES, United Kingdom, June 15, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE:MNK), a global biopharmaceutical company, today announced it will present data from the pivotal Phase 3 clinical trial (STRATA2016) of its investigational product StrataGraft®, a regenerative skin tissue therapy in development for the treatment of deep partial-thickness thermal burns, as well as health economics and outcomes research (HEOR) and other data on the treatment of burns as part of the virtual American Burn Association (ABA) 52nd Annual Meeting. The virtual meeting begins today and is accessible online for attendees during the next 90 days. StrataGraft skin tissue is an investigational product, and its safety and effectiveness have not yet been established by the U.S. Food and Drug Administration (FDA).

    The preliminary analysis of data from the Phase 3 trial will be presented by Dr. James H. Holmes, IV, via a prerecorded video, and available for attendees as part of the virtual meeting. The video presentation is part of the Education Forum as one of the "Top Five Abstracts," after receiving one of the top scores by blinded reviewers. The abstract from the Phase 3 trial was previously published in the Journal of Burn Care & Research.

    "We are pleased to be sharing the results from our pivotal Phase 3 clinical trial of StrataGraft regenerative skin tissue, as well as data that provides insights into the implications of autografting during this year's virtual ABA Annual Meeting," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "At Mallinckrodt, we are committed to research in support of patients with severe burns. If approved, StrataGraft skin tissue would be a potential new treatment option for deep partial-thickness thermal burns to help reduce or eliminate the need to harvest healthy skin tissue from an uninjured site through autografting."

    Phase 3 Clinical Trial Data

    Title:  

    Preliminary Analysis of a Phase 3 Open-Label, Controlled, Randomized Trial Evaluating the Efficacy and Safety of a Bioengineered Regenerative Skin Construct in Patients with Deep Partial-thickness Thermal Burns 

    Virtual Location:

    Part of the Education Forum

    Session:

    Top 5 Abstracts

    Presentation #:

    T5

    Other Poster Presentations

    Title:

    Skin Graft Donor-Site Morbidity – A Systematic Literature Review 

    Virtual Location:

    Exhibit Hall

    Session:

    Poster Session – R-123 Clinical Sciences: Wounds and Scars 1 

    Poster #:

    522





    Title:

    Healthcare Resource Utilization and Costs of Care Among Pediatric Patients with Thermal Burns Undergoing Inpatient Autografting in a US Managed Care Population

    Virtual Location:

    Exhibit Hall

    Session:

    Poster Session – R-125 Public Health/Epidemiology 1 

    Poster #:

    540





    Title:

    Establishing Thresholds for Clinically Significant Donor Skin Reduction – Initial Findings from a Physician Delphi Panel

    Virtual Location:

    Exhibit Hall

    Session:

    Poster Session – R-224 Clinical Sciences: Wounds and Scars 4 

    Poster #:

    730

    About StrataGraft

    StrataGraft regenerative skin tissue is an investigational treatment being developed to reduce autograft in patients with severe thermal burns. An engineered, bilayer tissue, StrataGraft skin tissue is designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers. StrataGraft skin tissue can be sutured, stapled or secured with an adhesive. StrataGraft skin tissue is cryopreserved in order to deliver viable cells upon application.

    Mallinckrodt is currently conducting a StrataGraft skin tissue continued access clinical trial (StrataCAT, NCT04123548) under an Expanded Access Program (EAP). The trial sites involved in the pivotal Phase 3 trial (STRATA2016, NCT03005106) have the opportunity to participate in this multicenter, open-label study. The company is planning to evaluate StrataGraft skin tissue for the treatment of adults with full-thickness burns (also referred to as third-degree burns). Additionally, Mallinckrodt plans to conduct a study evaluating StrataGraft skin tissue in treatment of pediatric populations. 

    StrataGraft skin tissue is an investigational product, and its safety and effectiveness have not yet been established by the FDA.

    Mallinckrodt announced the completion of the rolling submission of a Biologics License Application to the FDA for StrataGraft skin tissue for the treatment of adult patients with deep partial-thickness thermal burns on June 9, 2020. The FDA has granted StrataGraft skin tissue orphan drug status, and it was among the first products designated by the Agency as a Regenerative Medicine Advanced Therapy (RMAT) under the provisions of the 21st Century Cures Act.

    Funding and technical support for the continued development of StrataGraft skin tissue, including the pivotal Phase 3 clinical study (STRATA2016) and the Biological Licensing Application process for StrataGraft skin tissue in the United States, is being provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, under Project BioShield Contract No. HHSO100201500027C. These efforts are part of BARDA's strategy to build emergency preparedness in response to mass casualty events involving trauma and thermal burns by developing novel medical countermeasures for adult and at-risk populations. In the case of a mass casualty thermal burn event, the Government Accountability Office estimates that more than 10,000 patients might require thermal burn care.[1] The limited number of specialized burn centers and related medical infrastructure in the United States creates a public health need for therapies that could be deployed quickly for use in these and other care sites.

    About Deep Partial-Thickness Thermal Burns

    Deep partial-thickness thermal burns are complex skin injuries in which the damage extends through the entire epidermis (outermost layer of skin) and into the lower part of the dermis (innermost layer of skin).

    Autograft is considered to be a standard of care by many for deep partial-thickness thermal burns. It involves the surgical harvesting of healthy skin tissue from an uninjured site on the patient and transplanting the skin graft to the injury. While this process can be effective in providing closure of the original wound, it has significant limitations related to the donor site wounds created during surgical removal of the skin tissue for grafting. Donor site wounds are painful and can create risks of additional scarring and infection. In addition, the amount of healthy skin available for harvesting is frequently limited in those patients with large burns, necessitating sequential re-harvesting of available donor sites. As a result, there is a need for alternatives to donor site harvesting for the treatment of severe burns.

    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 StrataGraft regenerative skin tissue, including expectations with regard to related regulatory filings, 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.

    CONTACTS

    Media Relations

    Sheryl Seapy

    W2O

    213-262-9390

    Investor Relations

    Daniel J. Speciale, CPA

    Vice President, Investor Relations and IRO

    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.

    ©2020 Mallinckrodt. US-2001050 06/20.

    1 https://www.gao.gov/assets/590/588738.pdf. Accessed February 12, 2020.

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    SOURCE Mallinckrodt plc

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  4. STAINES-UPON-THAMES, United Kingdom, June 11, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE:MNK), a global biopharmaceutical company, today announced publication of findings from a medical chart study to assess the real-world use of terlipressin and other vasopressors in hospitalized patients with hepatorenal syndrome type 1 (HRS-1), an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis.1 The study, funded by Mallinckrodt, found that terlipressin was associated with an improvement in kidney function among HRS-1 patients as measured by a reduction in serum creatinine (SCr). The results of the study were published in the peer-reviewed journal Alimentary Pharmacology and Therapeutics.

    STAINES-UPON-THAMES, United Kingdom, June 11, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE:MNK), a global biopharmaceutical company, today announced publication of findings from a medical chart study to assess the real-world use of terlipressin and other vasopressors in hospitalized patients with hepatorenal syndrome type 1 (HRS-1), an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis.1 The study, funded by Mallinckrodt, found that terlipressin was associated with an improvement in kidney function among HRS-1 patients as measured by a reduction in serum creatinine (SCr). The results of the study were published in the peer-reviewed journal Alimentary Pharmacology and Therapeutics.

    Mallinckrodt is investigating terlipressin for the treatment of HRS-1 in the U.S. Its safety and effectiveness have not yet been established by the U.S. Food and Drug Administration (FDA).

    Medical records of 250 adult patients with HRS-1 from 26 centers in the U.K. were reviewed, 225 of whom were treated with vasopressor therapy. The majority of patients were treated with terlipressin (n=203, 90 percent) with a median duration of therapy of six days, in line with European Association for the Study of the Liver (EASL) guidelines recommending terlipressin for first-line use in patients with HRS-1.2 A complete response (SCr reduction of ≤1.5 mg/dL) was observed in 50 percent of patients treated with terlipressin and 23 percent of those treated with other vasopressors. Overall response, as measured by a complete response or partial response (SCr reduction of at least 20 percent from baseline but SCr >1.5 mg/dL), was demonstrated in 73 percent of patients treated with terlipressin and 59 percent treated with other vasopressors. In addition, lower SCr at the time of treatment initiation was associated with higher complete response rates.3

    "While there are limitations to medical chart study, the findings from this real-world data are encouraging for patients with HRS-1 who have limited treatment options and are often facing a poor prognosis," said lead author Kevin Moore, M.D., UCL Institute of Liver and Digestive Health, Royal Free Hospital, University College London.

    HRS-1 has a median survival time of approximately two weeks and greater than 80 percent mortality within three months if left untreated.4,5 At present, there are no approved drug therapies for HRS-1 in the U.S. or Canada.6 HRS-1 is estimated to affect between 30,000 and 40,000 patients in the U.S.  annually.7,8 The company announced in April the U.S. FDA accepted its New Drug Application for review of terlipressin to treat HRS-1.

    "This retrospective analysis of the use of terlipressin in HRS-1 patients, where it is approved and available, provides important insight into the real-world treatment patterns and outcomes in this rare, acute syndrome," said Tunde Otulana, M.D., Senior Vice President and Chief Medical Officer at Mallinckrodt. "Mallinckrodt is committed to advancing the science to benefit patients with this devastating and rapidly progressing syndrome for which effective treatment options are limited."

    About the Study3 

    The study, titled Real-World Treatment Patterns and Outcomes Using Terlipressin in 203 Patients with the Hepatorenal Syndrome, was a medical chart study to assess treatment and outcomes of terlipressin and other vasopressors in 250 adult patients with HRS-1 hospitalized in 26 centers in the U.K. between January 2013 and December 2017. Ninety percent of patients were treated with terlipressin monotherapy (72 percent in combination with albumin) with an average treatment duration of six days.

    • Results:
      • Terlipressin was associated with improved kidney function: the overall response rate was 73 percent and the complete response rate (SCr <1.5 mg/dL) was 50 percent of patients treated with terlipressin.
      • Lower SCr at the time of treatment initiation was associated with higher complete response rates. Mild, moderate and severe acute kidney injury (AKI) were defined by baseline SCr:
        • Mild AKI (SCr <2.25 mg/dL): 79 percent complete response.
        • Moderate AKI (SCr ≥2.25 mg/dL and <3.5 mg/dL): 55 percent complete response.
        • Severe AKI (SCr ≥3.5 mg/dL): 14 percent complete response.
      • The 90-day survival was 86 percent for all patients (93 percent for overall responders and 66 percent for treatment non-responders, P<0.0001).
      • Adverse events were attributed to terlipressin in 25 percent of patients and 41 percent in those treated with other vasopressors.
      • Fluid overload/pulmonary edema and multi-organ failure were the most commonly reported adverse events. Severe AKI was associated with higher rates of adverse events (41 percent severe AKI versus 25 percent moderate AKI versus 9 percent mild AKI, P<0.001).
    • Study Limitations:
      • Patients in the retrospective chart study likely represented a more heterogeneous population than that included in randomized controlled trials of HRS-1 patients.
      • All patients may not have met the full criteria for HRS-1 diagnosis, as diagnosis relies on clinical judgement rather than an objective diagnostic test.
      • Robustness of between treatment difference is uncertain due to lack of randomization and small number of patients on other vasopressors.
      • Changes to the 2015 International Club of Ascites Hepatorenal Syndrome (ICA-HRS) guidelines, which occurred during the study, may have altered clinicians' judgement on when to initiate treatment.
      • The study's sampling strategy may have led to higher survival and treatment response rates than seen in other settings, leading to a selection bias towards surviving patients.

    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 and the study described in this release, including 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.

    CONTACTS



    For Trade Media Inquiries

    Caren Begun

    Green Room Communications

    201-396-8551

    For Financial/Dailies Media Inquiries

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    H+K Strategies

    Senior Vice President

    813-545-2399

        

    Investor Relations

    Daniel J. Speciale, CPA

    Vice President, Investor Relations and IRO

    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. ©2020 Mallinckrodt. US-2000889. 06/20

    References

    1National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: https://rarediseases.org/rare-diseases/hepatorenal-syndrome/. Accessed June 4, 2020.

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

    3Moore K, Jamil K, Verleger K, Luo L, Kebede N, Heisen M, et al. Real–world treatment patterns and outcomes using terlipressin in 203 patients with the hepatorenal syndrome. Aliment Pharmacol Ther. 2020;00:1-8. DOI: 10.111/apt.15836.

    4Colle 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. 

    5Gines P, Sola E, Angeli P, et al. Hepatorenal syndrome. Nature Reviews. 2018; 4:23. 

    6Boyer 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

    7C 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. J Investig Med. 2016;64:33–38.

    8United States Census Bureau: Quick Facts. Available at: https://www.census.gov/quickfacts/fact/table/US/PST045218. Accessed June 4, 2020.

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  5. STAINES-UPON-THAMES, United Kingdom, June 9, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE:MNK), a global biopharmaceutical company, today announced that Stratatech, a Mallinckrodt company, has completed its rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for StrataGraft®, a regenerative skin tissue therapy in development for the treatment of adult patients with deep partial-thickness thermal burns. The company previously announced initiation of the rolling submission in April. StrataGraft skin tissue is an investigational product, and its safety and effectiveness have not yet been established by the FDA.

    STAINES-UPON-THAMES, United Kingdom, June 9, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE:MNK), a global biopharmaceutical company, today announced that Stratatech, a Mallinckrodt company, has completed its rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for StrataGraft®, a regenerative skin tissue therapy in development for the treatment of adult patients with deep partial-thickness thermal burns. The company previously announced initiation of the rolling submission in April. StrataGraft skin tissue is an investigational product, and its safety and effectiveness have not yet been established by the FDA.

    "Completion of the BLA submission is the culmination of many years of hard work and brings us one step closer to our goal of providing StrataGraft skin tissue as a new treatment option for patients in the United States with deep partial-thickness thermal burns, if approved," said Steven Romano, M.D., executive vice president and chief scientific officer at Mallinckrodt. "We would like to thank the many researchers, clinical trial investigators and patients who helped us reach this important milestone. We look forward to working closely with the FDA during the regulatory review process."

    The StrataGraft skin tissue BLA is based on data from the pivotal Phase 3 STRATA2016 clinical trial, previously published as an abstract in the Journal of Burn Care & Research and accepted for presentation at the American Burn Association 52nd Annual Meeting, with support from the STRATA2011 clinical trial, previously published in Burns.

    The FDA granted StrataGraft skin tissue orphan drug status, and it was among the first products designated by the Agency as a Regenerative Medicine Advanced Therapy (RMAT) under the provisions of the 21st Century Cures Act.

    About StrataGraft

    StrataGraft regenerative skin tissue is an investigational treatment being developed to reduce autograft in patients with severe thermal burns. An engineered, bilayer tissue, StrataGraft skin tissue is designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers. StrataGraft skin tissue can be sutured, stapled or secured with an adhesive. StrataGraft skin tissue is cryopreserved in order to deliver viable cells upon application.

    Mallinckrodt is currently conducting a StrataGraft skin tissue continued access clinical trial (StrataCAT, NCT04123548) under an Expanded Access Program (EAP). The trial sites involved in the pivotal Phase 3 trial (STRATA2016, NCT03005106) have the opportunity to participate in this multicenter, open-label study. The company is planning to evaluate StrataGraft skin tissue for the treatment of adults with full-thickness burns (also referred to as third-degree burns). Additionally, Mallinckrodt plans to conduct a study evaluating StrataGraft skin tissue in treatment of pediatric populations. 

    StrataGraft skin tissue is an investigational product, and its safety and effectiveness have not yet been established by the FDA.

    Funding and technical support for the continued development of StrataGraft skin tissue, including the pivotal Phase 3 clinical study (STRATA2016) and the Biological Licensing Application process for StrataGraft tissue in the United States, is being provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, under Project BioShield Contract No. HHSO100201500027C. These efforts are part of BARDA's strategy to build emergency preparedness in response to mass casualty events involving trauma and thermal burns by developing novel medical countermeasures for adult and at-risk populations. In the case of a mass casualty thermal burn event, the Government Accountability Office estimates that more than 10,000 patients might require thermal burn care.1 The limited number of specialized burn centers and related medical infrastructure in the United States creates a public health need for therapies that could be deployed quickly for use in these and other care sites.

    About Deep Partial-Thickness Thermal Burns

    Deep partial-thickness thermal burns are complex skin injuries in which the damage extends through the entire epidermis (outermost layer of skin) and into the lower part of the dermis (innermost layer of skin).

    Autograft is considered to be a standard of care by many for deep partial-thickness thermal burns. It involves the surgical harvesting of healthy skin tissue from an uninjured site on the patient and transplanting the skin graft to the injury. While this process can be effective in providing closure of the original wound, it has significant limitations related to the donor site wounds created during surgical removal of the skin tissue for grafting. Donor site wounds are painful and can create risks of additional scarring and infection. In addition, the amount of healthy skin available for harvesting is frequently limited in those patients with large burns, necessitating sequential re-harvesting of available donor sites. As a result, there is a need for alternatives to donor site harvesting for the treatment of severe burns.

    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 StrataGraft regenerative skin tissue, including expectations with regard to related regulatory filings, 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.

    CONTACTS

    Media Relations

    Sheryl Seapy

    W2O for Mallinckrodt

    213-262-9390

    Investor Relations

    Daniel J. Speciale, CPA

    Vice President, Investor Relations and IRO

    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.

    ©2020 Mallinckrodt. US-2000850 05/20.

    1 https://www.gao.gov/assets/590/588738.pdf. Accessed February 12, 2020.

     

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    SOURCE Mallinckrodt plc

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