The objective is this study is to test whether use of Acthar gel in the context of sarcoidosis will lead to improved symptoms and lung function and correlate with decreased levels of predictive blood biomarkers, like chemokine ligand 9 (CXCL9).

Start Date03 Nov 2022

Sponsor / Collaborator

The University of California, San Francisco

[+1]

NCT05276817

/ CompletedPhase 1

Microbiological Evaluation of Diode Laser Bacterial Reduction as Adjunct to Periodontal Maintenance Treatment: A Pilot Clinical Study

The primary aim of this pilot study is to determine whether the test methods described feasibly achieve the goal defined for a future clinical study. The purpose is a quantitative assessment of the bactericidal effect of two adjunctive treatments compared to that of conventional periodontal maintenance debridement. Patients who meet eligibility criteria and are enrolled in the study will receive the standard of care, whole mouth periodontal maintenance treatment using ultrasonic scalers to debride deposits within the gingival sulcus. Subsequently, each of three of the quadrants will be randomly assigned to a test group (keeping the fourth quadrant as the control), thus, a "split-mouth" study design. Microbial samples will be collected using sterile paper points inserted into each tooth site involved in the study at baseline (S1) before test treatment and one week after test treatment (S2). Samples will be analyzed with real time qPCR to identify and quantify specific periodontal pathogens. Data analysis will compare the post-treatment results to baseline, the control treatment arm to the test treatment arm, and the test treatments among each other.

Start Date01 Apr 2022

Sponsor / Collaborator

BIOLASE, Inc.

100 Clinical Results associated with Corticotropin

100 Translational Medicine associated with Corticotropin

100 Patents (Medical) associated with Corticotropin

6,772

Literatures (Medical) associated with Corticotropin

01 Apr 2025·Neuropediatrics

Pulsatile Dexamethasone in Patients with Infantile Spasms: A Retrospective Analysis of a Unique Therapy Regime

Article

Author: Brandl, Ulrich ; Vries, Heike De ; Reimer, Dennis

Abstract Objective Infantile spasms (IS) are an age-specific epilepsy syndrome associated with poor outcomes. Sustained and early spasm control remains the main goal of therapy. We aimed to evaluate a unique pulsatile dexamethasone therapy regime in children with IS. Methods Children with IS were treated with oral pulsatile-applied dexamethasone in the Children's Hospital Jena between 2002 and 2021, regardless of duration since IS onset or previous therapy (except ACTH). A prolonged initial pulse was given in case of insufficient response (standard: 5–7 days, prolonged: 10–14 days). We analyzed spasm reduction, electroencephalographic response, adverse reactions, neurodevelopmental status, and epileptic disorders at the last follow-up. Results Included were 26 patients with a median age of 5.5 months (interquartile range 4–8) at IS onset and a mean follow-up of 6.2 years (standard deviation [SD] 3.99). Fifty percent had an unknown etiology. Patients received on average 10.8 pulses (SD 6.0); 69.2% achieved initial seizure freedom, however, 38.9% relapsed. Seventeen patients had an initial prolonged pulse, of those, 14 got initially seizure-free (82.4%). Sixty-four percent of the cases had a sustained spasm cessation after the third pulse. At the last follow-up, half of the patients had no persisting epileptic disorder; 22.2% had a favorable neurocognitive development. Patients with unknown etiology were more likely to achieve seizure freedom during therapy (p = 0.025), had a more favorable neurocognitive outcome (p = 0.049), and were less likely to suffer from epileptic disorders (p = 0.037). No serious adverse effects were observed. Conclusion Our results show that our treatment is safe and leads to outcomes comparable to usually applied hormonal therapy regimes. Etiology remains the most influential factor.

01 Mar 2025·The Journal of Clinical Pharmacology

Subclinical Hyperthyroidism Enhances Gonadotropin‐Lowering Effects of Metformin in Postmenopausal Women

Article

Author: Krysiak, Robert ; Kowalcze, Karolina ; Okopień, Bogusław

AbstractMetformin treatment decreases elevated concentrations of anterior pituitary hormones. The aim of this prospective, cohort study was to investigate whether hyperthyroidism modulates the impact of metformin on gonadotroph secretory function. The study population included 48 postmenopausal women with untreated type 2 diabetes or prediabetes, 24 of whom had coexisting grade 1 subclinical hyperthyroidism. Both groups were matched for age, insulin sensitivity, and gonadotropin levels. Over the entire study period, all participants were treated with metformin (2.55‐3 g daily). Plasma glucose, insulin, thyroid‐stimulating hormone (TSH), total and free thyroid hormones, follicle‐stimulating hormone (FSH), luteinizing hormone (LH), estradiol, prolactin, adrenocorticotropic hormone (ACTH), and insulin‐like growth factor‐1 (IGF‐1) were assayed at entry and 6 months later. At baseline, the study groups differed in levels of TSH and thyroid hormones but not in body mass index, blood pressure, glucose homeostasis markers (fasting glucose, homeostatic model assessment 1 of insulin resistance ratio [HOMA1‐IR], and glycated hemoglobin [HbA1c]), and the remaining hormones. There were no differences between both groups in the degree of reduction in plasma glucose and HbA1c in response to metformin treatment. Although metformin decreased HOMA1‐IR in both groups, this effect was stronger in women with hyperthyroidism than with normal thyroid function (−50 ± 20% vs −30 ± 15%). Similar relationships were observed for FSH (−43 ± 21% vs −21 ± 12%). Only in hyperthyroid women did the drug reduce LH concentration (by 35 ± 17%). Metformin did not affect circulating levels of TSH, total and free thyroxine, total and free triiodothyronine, estradiol, prolactin, ACTH, and IGF‐1. The obtained results indicate that hyperthyroidism enhances the gonadotropin‐lowering effects of metformin, as well as the fact that this agent has a neutral effect on the hypothalamic–pituitary–thyroid axis in case of its overactivity.

01 Feb 2025·Clinical Toxicology

Abnormalities in brain magnetic resonance imaging associated with vigabatrin therapy in an infant with infantile epileptic spasms syndrome

Article

Author: de Sá, Maria Inês ; Proença, Filipa

INTRODUCTIONVigabatrin, an anticonvulsant drug used for refractory epilepsy and as first-line treatment for infantile epileptic spasms syndrome, can rarely cause brain abnormalities detectable on magnetic resonance imaging. These complications, potentially related to dose, young age, and concomitant high doses of adrenocorticotropic hormone and/or prednisolone, can lead to neurological symptoms. Upon withdrawal or dose reduction, symptoms and imaging changes tend to resolve.CASE SUMMARYA 7-month-old infant diagnosed with infantile epileptic spasms syndrome started treatment with vigabatrin and prednisolone. However, spasms recurred, prompting an increase in the dose of vigabatrin and the addition of adrenocorticotropic hormone, which reduced the frequency of spasms. The patient later developed encephalopathy and upper limb tremors.IMAGESMagnetic resonance imaging revealed symmetrical hyperintense lesions with concomitant restricted diffusion localized in the thalami, basal ganglia, brainstem, and cerebellar dentate nuclei.CONCLUSIONWe report an infant with infantile epileptic spasms syndrome treated with vigabatrin who developed abnormalities on magnetic resonance imaging. There is currently no treatment other than drug withdrawal or reduction.

News (Medical) associated with Corticotropin

13 Mar 2025

·www.prnewswire.com

Mallinckrodt plc Reports Fourth Quarter and Fiscal Year 2024 Financial Results and Provides 2025 Guidance

Achieved High End of Full-Year Net Sales Guidance Range and Midpoint of Adjusted EBITDA Guidance Range Grew Full-Year Net Sales by 6.1% to $2.0 Billion, with 14.2% Growth in Acthar® Gel (repository corticotropin injection) and 15.4% Growth in Specialty Generics; Reduced Total Debt by 47% and Net Debt by Approximately 64% Acthar Gel Returned to Growth with Successful Launch of SelfJect™ Device; Uptake of INOmax ® EVOLVE™ DS Delivery System Accelerated in Second Half of the Year Expects 2025 Net Sales of $1.7 Billion to $1.8 Billion and Adjusted EBITDA of $480 Million to $520 Million DUBLIN, March 13, 2025 /PRNewswire/ -- Mallinckrodt plc ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today reported its financial results for the fourth quarter and fiscal year ended December 27, 2024.1 "Our strong performance in 2024 reflects the disciplined execution of our strategy to position Mallinckrodt for long-term success," said Siggi Olafsson, President and Chief Executive Officer. "In Specialty Brands, Acthar Gel returned to growth, marking a key milestone for the brand, with four consecutive quarters of rising net sales. This was driven by prescriber enthusiasm, patient demand and the launch of SelfJect for Acthar Gel, which has exceeded our expectations. We are continuing the commercial rollout of our INOmax EVOLVE DS delivery system to U.S. hospitals nationwide and are pleased with the positive feedback to date. Additionally, we meaningfully grew Terlivaz® (terlipressin) for injection in 2024 and continue to engage with providers about the benefits of early patient identification and treatment." Mr. Olafsson added, "In Specialty Generics, we closed out an exceptional year, with double-digit net sales growth driven by rising demand and our ability to consistently and reliably deliver high-quality products. As we move through 2025 and beyond, we will continue to advance our strategic priorities as we build toward long-term sustainable growth and value creation for all our stakeholders." Fourth Quarter 2024 Financial Results Mallinckrodt's net sales in the fourth quarter of 2024 were $492.1 million, as compared to $469.3 million in the fourth quarter of 2023. This reflects 4.9% growth on a reported basis and 4.8% growth on a constant currency basis. The Company's Specialty Brands segment reported net sales of $265.6 million, as compared to $270.7 million in the fourth quarter of 2023. This 1.9% decrease includes the impact of the Therakos® sale. Excluding Therakos, Specialty Brands net sales grew by 8.9%, driven by growth in Acthar Gel and uptake in SelfJect and Terlivaz. Mallinckrodt's Specialty Generics segment reported net sales of $226.5 million, as compared to $198.6 million in the fourth quarter of 2023. This 14.0% growth was driven by the Company's established track record as a reliable and consistent producer of high-quality products amidst market shortages due to quality and other disruptions, in both the finished dosage products and Controlled Substances active pharmaceutical ingredient (API) businesses, partially offset by a decline in the Acetaminophen (APAP) business as a result of overall softening of the market. The Company's net income for the fourth quarter was $612.8 million, a 41.8% decrease as compared to net income of $1.05 billion in the fourth quarter of 2023. Mallinckrodt's Adjusted EBITDA in the fourth quarter was $124.2 million, essentially flat compared to $123.8 million in the fourth quarter of 2023. This stability was driven by strength in both the Specialty Generics segment and Acthar Gel, largely offset by approximately $9.0 million of transaction-related compensation expenses related to the sale of Therakos, the impact of the Therakos transaction, incremental commercial investments for Acthar Gel and Terlivaz, and the impact of nitric oxide competition in the U.S. Gross profit as a percentage of net sales was 50.2% for the fourth quarter, as compared to 17.2% for the fourth quarter of 2023. Adjusted gross profit as a percentage of net sales was 63.0% for the fourth quarter, as compared to 62.3% for the fourth quarter of 2023. Mallinckrodt's cash balance at the end of the fourth quarter of 2024 was $382.6 million. Total outstanding principal debt was $865.6 million, a reduction of 47% compared to the end of 2023, and outstanding net debt was $492.1 million, a reduction of approximately 64% compared to the end of 2023. Fiscal Year 2024 Results1 Mallinckrodt's net sales were $1.98 billion, an increase of 6.1% compared to $1.87 billion in fiscal 2023. Full-year net sales in the Specialty Brands segment were $1.08 billion in fiscal 2024, essentially flat compared to $1.09 billion in fiscal 2023. Excluding Therakos, Specialty Brands net sales grew 1.4%. Full-year net sales in the Specialty Generics segment were $896.3 million, an increase of 15.4% compared to $776.9 million in fiscal 2023 reflecting the factors discussed above. The Company recorded net income of $477.9 million in fiscal 2024, a substantial improvement as compared to a net loss of $1.67 billion in fiscal 2023. Mallinckrodt's Adjusted EBITDA was $603.7 million in fiscal 2024, an increase of 5.6% compared to $571.9 million in fiscal 2023. Excluding the impact of the Therakos business, Adjusted EBITDA grew by 12.9%. Business Segment Updates & Outlook Specialty Brands Acthar Gel net sales were $138.8 million in the fourth quarter, an increase of 33.0% versus the prior year period, and $485.7 million for the full year, an increase of 14.2%. Growth in the fourth quarter was driven by the successful launch of SelfJect, which accounted for more than 70% of new Acthar Gel prescriptions, as well as prescriber enthusiasm and patient demand. The Company expects Acthar Gel to continue its momentum and grow in the low-single digits in 2025. Terlivaz net sales were $6.1 million in the fourth quarter, up from $5.6 million in the same period last year, and $24.7 million for the full year, up from $15.6 million. The Company continues to engage with healthcare providers to highlight the benefits of early patient identification and treatment initiation. INOmax (nitric oxide) net sales were $60.8 million in the fourth quarter, down 14.0% compared to the prior year period, and full-year net sales were $261.4 million, down 13.8%, primarily due to competitive pressures in the U.S. The Company remains focused on the multi-year rollout of the INOmax EVOLVE DS delivery system and continues to believe this new offering will help stabilize the brand. Specialty Generics Mallinckrodt expects the Specialty Generics segment to deliver flat to low-single digit sales growth in full-year 2025, driven by the Company's strong market position and performance in finished-dosage products, demand for Controlled Substance APIs and the Company's differentiated position as a consistent supplier of high-quality products, moderated by softness in the APAP market, which is expected to continue. Please see "Non-GAAP Financial Measures" included in this release for a discussion of non-GAAP measures and reconciliation of GAAP and non-GAAP financial measures for the fourth quarter. Please see the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Annual Report on Form 10-K for the year ended December 27, 2024 filed with the U.S. Securities and Exchange Commission (SEC) for additional information. 2025 Financial Guidance For the full-year fiscal 2025, Mallinckrodt expects: The Company does not provide comparable GAAP measures for its forward-looking non-GAAP guidance or a reconciliation of such measures because the reconciling items described in the definition of Adjusted EBITDA provided below are inherently uncertain and difficult to estimate and cannot be predicted without unreasonable effort. The variability of such items may have a significant impact on our future GAAP results. Update on Fourth Quarter and Fiscal Year 2024 Conference Call and Webcast Mallinckrodt will no longer host its previously planned quarterly conference call and webcast this morning. Mallinckrodt has issued a separate press release this morning in conjunction with a proposed transaction with Endo, Inc. which includes the details of a joint conference call and webcast to be held this morning. The Company has posted prepared remarks regarding its fourth quarter and fiscal year 2024 financial results on the Investor Relations section of its website at . 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, hepatology, nephrology, pulmonology, and ophthalmology; neonatal respiratory critical care therapies; and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit . 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 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. NON-GAAP FINANCIAL MEASURES This press release contains financial measures, including Adjusted EBITDA, adjusted gross profit, adjusted selling, general, and administrative ("SG&A") expenses, adjusted research and development ("R&D") expenses, net sales growth (loss) on a constant-currency basis, and net debt, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations. Adjusted EBITDA represents net income or loss prepared in accordance with accounting principles generally accepted in the U.S. ("GAAP") and adjusted for certain items that management believes are not reflective of the operational performance of the business. Adjustments to GAAP amounts include, as applicable to each measure, interest expense, net; income taxes; depreciation; amortization from intangible assets and right-of use asset resulting from finance leases; restructuring charges, net; non-restructuring impairment charges; inventory step-up expense; discontinued operations; changes in fair value of contingent consideration obligations; significant legal and environmental charges; divestitures; liabilities management and separation costs; losses on debt extinguishment, net; unrealized gain or loss on equity investment; reorganization items, net; share-based compensation; fresh-start inventory related expenses; and other items identified by the Company. Full-year 2024 adjusted EBITDA for Therakos is calculated consistently with the Company Adjusted EBITDA and also includes operating expenses allocated to the Therakos business. Adjusted gross profit, adjusted SG&A expenses and adjusted R&D expenses represent amounts prepared in accordance with GAAP, adjusted for certain items that management believes are not reflective of the operational performance of the business. Adjustments to GAAP amounts include, as applicable to each measure, the aforementioned items in the Adjusted EBITDA paragraph. The adjustments for these items are on a pre-tax basis for adjusted gross profit and adjusted SG&A expenses. Segment net sales growth (loss) on a constant-currency basis measures the change in segment net sales between current- and prior-year periods using a constant currency, the exchange rate in effect during the applicable prior-year period. Net debt of $492.1 million as of December 27, 2024, reflects $865.6 million in total debt principal outstanding and $9.1 million in undiscounted finance lease liabilities on a GAAP basis less $382.6 million in cash and cash equivalents (unrestricted cash) on a GAAP basis. The Company has provided these adjusted financial measures because they are used by management, along with financial measures in accordance with GAAP, to evaluate the Company's operating performance and liquidity. In addition, the Company believes that they will be used by investors to measure Mallinckrodt's operating results. Management believes that presenting these adjusted measures provides useful information about the Company's performance across reporting periods on a consistent basis by excluding items that the Company does not believe are indicative of its core operating performance. These adjusted measures should be considered supplemental to and not a substitute for financial information prepared in accordance with GAAP. The Company's definition of these adjusted measures may differ from similarly titled measures used by others. Because adjusted financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management strongly encourages investors to review the Company's unaudited condensed consolidated financial statements and publicly filed reports in their entirety. A reconciliation of certain of these historical adjusted financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this release. Further information regarding non-GAAP financial measures can be found on the Investor Relations page of the Company's website. Predecessor and Successor Periods Mallinckrodt's financial results presented in this press release include Successor and Predecessor periods. The year ended December 27, 2024 and the period from November 15, 2023 through December 29, 2023 reflect the Successor periods, while the period December 31, 2022 through, and including, November 14, 2023 reflects the Predecessor period. We do not believe that reviewing the results of the Successor period in isolation would be useful in identifying trends in or reaching conclusions regarding our overall operating performance. Management believes that our key performance metrics such as net sales and segment operating income (loss) for the year ended December 27, 2024 (Successor) provide a meaningful comparison and are useful in identifying current business trends when compared to the year ended December 29, 2023 (Successor). The Company reports its results based on a "52-53 week" year ending on the last Friday of December. The year ended December 27, 2024 (Successor) ("fiscal 2024") and the combined periods of December 31, 2022 through November 14, 2023 (Predecessor) and November 15, 2023 through December 29, 2023 (Successor) ("fiscal 2023") consisted of 52 weeks. The three months ended December 27, 2024 and the combined periods of September 30, 2023 through November 14, 2023 and November 15, 2023 through December 29, 2023 ("three months ended December 29, 2023") consisted of 13 weeks. Mallinckrodt's results of operations as reported in its unaudited consolidated financial statements for the Successor and Predecessor periods are in accordance with GAAP. The comparison of the Predecessor and Successor periods for the periods presented here is not in accordance with GAAP. However, the Company believes that the comparison is useful for management and investors to assess Mallinckrodt's ongoing financial and operational performance and trends. CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS Statements in this press release that are not strictly historical, including statements regarding future financial condition and operating results, expected product launches, legal, economic, business, competitive and/or regulatory factors affecting Mallinckrodt's businesses, the ongoing strategic review, and any other statements regarding events or developments 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 proposed transaction with Endo; potential changes in Mallinckrodt's business strategy and performance; Mallinckrodt's initiative to explore a variety of potential divestiture, financing and other transactional opportunities; the exercise of contingent value rights by the Opioid Master Disbursement Trust II (the "Trust"); governmental investigations and inquiries, regulatory actions, and lawsuits, in each case related to Mallinckrodt or its officers; Mallinckrodt's contractual and court-ordered compliance obligations that, if violated, could result in penalties; compliance with and restrictions under the global settlement to resolve all opioid-related claims; matters related to Acthar Gel, including the settlement with governmental parties to resolve certain disputes and compliance with and restrictions under the related corporate integrity agreement; the ability to maintain relationships with Mallinckrodt's suppliers, customers, employees and other third parties following the emergence from the 2023 bankruptcy proceedings; 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' or other payers' 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; any undesirable side effects caused by Mallinckrodt's approved and investigational products, which could limit their commercial profile or result in other negative consequences; Mallinckrodt's and its partners' ability to successfully develop, commercialize or launch new products or expand commercial opportunities of existing products, including Acthar Gel (repository corticotropin injection) SelfJect and the INOmax Evolve DS delivery system; Mallinckrodt's ability to successfully identify or discover additional products or product candidates; Mallinckrodt's ability to navigate price fluctuations and pressures, including the ability to achieve anticipated benefits of price increases of its products; competition; Mallinckrodt's ability to protect intellectual property rights, including in relation to ongoing and future litigation; limited clinical trial data for Acthar Gel; the timing, expense and uncertainty associated with clinical studies and related regulatory processes; product liability losses and other litigation liability; material health, safety and environmental laws and related liabilities; business development activities or other strategic transactions; attraction and retention of key personnel; the effectiveness of information technology infrastructure, including risks of external attacks or failures; customer concentration; Mallinckrodt's reliance on certain individual products that are material to its financial performance; Mallinckrodt's ability to receive sufficient procurement and production quotas granted by the U.S. Drug Enforcement Administration; complex manufacturing processes; reliance on third-party manufacturers and supply chain providers and related market disruptions; conducting business internationally; Mallinckrodt's significant levels of intangible assets and related impairment testing; natural disasters or other catastrophic events; Mallinckrodt's substantial indebtedness and settlement obligation, its ability to generate sufficient cash to reduce its indebtedness and its potential need and ability to incur further indebtedness; restrictions contained in the agreements governing Mallinckrodt's indebtedness and settlement obligation on Mallinckrodt's operations, future financings and use of proceeds; Mallinckrodt's variable rate indebtedness; Mallinckrodt's tax treatment by the Internal Revenue Service under Section 7874 and Section 382 of the Internal Revenue Code of 1986, as amended; future changes to applicable tax laws or the impact of disputes with governmental tax authorities; the impact of Irish laws; the impact on the holders of Mallinckrodt's ordinary shares if Mallinckrodt were to cease to be a reporting company in the United States; the comparability of Mallinckrodt's post-emergence financial results and the projections filed with the Bankruptcy Court; and the lack of comparability of Mallinckrodt's historical financial statements and information contained in its financial statements after the adoption of fresh-start accounting following emergence from the 2023 bankruptcy proceedings. The "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Mallinckrodt's Annual Report on Form 10-K for the fiscal year ended December 27, 2024, to be filed with the SEC, and its Quarterly Report on Form 10-Q for the quarterly periods ended March 29, 2024, June 28, 2024, September 27, 2024, and other filings with the SEC, all of which are on file with the SEC and available from the SEC's website () and Mallinckrodt's website (), identify and describe in more detail the risks and uncertainties to which Mallinckrodt's businesses are subject. There may be other risks and uncertainties that we are unable to predict at this time or that we currently do not expect to have a material adverse effect on our business. 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. Given these uncertainties, one should not put undue reliance on any forward-looking statements. 1 As a result of emerging from Chapter 11, the year ended December 27, 2024 ("fiscal 2024") and the period November 15, 2023 through December 29, 2023 reflect the Successor periods, while the period December 31, 2022 through, and including, November 14, 2023 reflects the Predecessor period. The combined periods of December 31, 2022 through November 14, 2023 (Predecessor) and November 15, 2023 through December 29, 2023 (Successor) are referred to herein as "fiscal 2023." Please see "Predecessor and Successor Periods" below for further information. CONTACTS Investor Relations Derek Belz Vice President, Investor Relations 314-654-3950 [email protected] Media Michael Freitag / Aaron Palash / Aura Reinhard / Catherine Simon Joele Frank, Wilkinson Brimmer Katcher 212-355-4449 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. © 2025. SOURCE Mallinckrodt plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial StatementBiosimilar

13 Mar 2025

·www.pharmaceutical-technology.com

Mallinckrodt and Endo sign $6.7bn merger deal

The combined company is expected to be listed on the New York Stock Exchange. Credit: Anton Vierietin via Getty Images. Mallinckrodt Pharmaceuticals and Endo have agreed to merge in a $6.7bn deal, combining two pharmaceutical companies that recently emerged from bankruptcy proceedings tied to opioid litigation. According to the 13 March announcement, the merger will create a “larger, more diversified entity”, with Mallinckrodt shareholders holding a 50.1% stake and Endo shareholders receiving 49.9%, along with $80m in cash. Under the terms of the agreement, Mallinckrodt CEO Siggi Olafsson will serve as the president and chief executive of the combined company, while Endo director Paul Efron will take on the role of chairman of the board. Endo will continue to operate as a wholly owned subsidiary of Mallinckrodt, as per the 13 March announcement. This merger comes after both companies faced significant financial and legal challenges due to their involvement in the sale of opioid painkillers. The opioid crisis in the US has led to extensive litigation against pharmaceutical companies accused of fuelling widespread addiction and overdose deaths. Mallinckrodt and Endo were among those sued over allegations that they contributed to the crisis by misrepresenting the risks of opioid products. Mallinckrodt first filed for bankruptcy in 2020 after reaching a tentative $1.6bn settlement with 47 states, territories, and other claimants in the US over its opioid-related liabilities. The company filed for bankruptcy again in 2023 following declining sales of key products. Net sales of the company’s top-selling drug, Acthar – a gel used to treat certain autoimmune and skin diseases – dropped by $90.7m in 2023 from the previous year, as per the company financials. The Dublin-headquartered company emerged from bankruptcy in November 2023, having reduced its total funded debt by $1.9bn. In 2023, it also paid out $700m to victims of the opioid crisis to settle thousands of lawsuits for manufacturing a generic version of Oxycodone. Endo, headquartered in Pennsylvania, US, similarly filed for bankruptcy in 2022 due to opioid-related liabilities. The company agreed to pay $465m to the US government and $450m to state and municipal trusts to support opioid recovery programmes. The company also pleaded guilty to a misdemeanour related to its opioid marketing practices. Both companies have worked to reposition themselves as specialty pharmaceutical firms, divesting non-core businesses. Earlier this week, Endo sold its international pharma unit Paladin to Knight Therapeutics for up to $99m, while Mallinckrodt sold its Therakos division to private equity firm CVC Capital Partners for $925m in August 2024. Mallinckrodt now focuses on generics and specialty medicines, including Acthar Gel and Terlivaz (terlipressin) for hepatorenal syndrome. Endo’s portfolio includes Xiaflex (collagenase clostridium histolyticum) for Dupuytren’s contracture and Peyronie’s disease, as well as a range of generics and sterile injectables. As part of the merger – which is expected to close in H2 2025 – the generics and sterile injectables businesses of both companies will be spun off into a separate standalone entity upon deal completion. The new company will be listed on the New York Stock Exchange and is expected to generate approximately $3.6bn in revenue in 2025.

AcquisitionExecutive ChangeBiosimilarPatent Infringement

13 Mar 2025

·medcitynews.com

Pharma Firms Mallinckrodt and Endo Agree to Merge in $6.7B Cash and Stock Deal - MedCity News

Mallinckrodt and Endo, pharmaceutical companies that have each encountered business struggles, announced Thursday a $6.7 billion merger that they contend will result in a combined entity with the scale and flexibility to grow. When the deal closes, Endo will become a wholly owned subsidiary of Mallinckrodt. The combined company will take on a yet-to-be-determined name and is expected to trade on the New York Stock Exchange. Its headquarters will be in Dublin, where Mallinckrodt is currently based. Headquarters for the U.S., where the combined company will have most of its operations, will be determined at a later date. Globally, the combined business will have 17 manufacturing facilities, 30 distribution centers, and 5,700 employees. Mallinckrodt and Endo each sell branded and generic products. Mallinckrodt’s portfolio includes Acthar Gel, which has approvals for treating several autoimmune and inflammatory disorders. Endo markets Xiaflex, a drug approved for Dupuytren’s contracture and Peyronie’s disease. Each company also market opioid drugs, and both have been involved in opioid litigation that contributed to financial difficulties. Mallinckrodt reorganized under bankruptcy protection twice, first in 2020 and again in 2023. Mallinckrodt was delisted from the New York Stock Exchange following the second bankruptcy. Endo filed for bankruptcy protection in 2022; its shares trade over the counter. The Malinckrodt/Endo merger is expected to close in the second quarter of this year. On a pro forma basis, the combined business is expected to generate $3.6 billion in revenue in 2025. In the combined company’s first year, about $75 million in pre-tax synergies are expected from integrating the two business as well as R&D savings. The plan is for the combined entity to also shed some operations. The generic pharmaceuticals businesses of both legacy companies will be combined with Endo’s sterile injectables business. That combined business will be spun out at a later date, subject to customary approvals. With the merger, Mallinckrodt’s existing debt is expected to be refinanced while Endo’s debt is expected to remain outstanding. The two companies will finance the transaction with cash on hand as well as $900 million that Goldman Sachs has committed to Endo. Under terms of the merger agreement, Endo shareholders will receive $80 million in cash, subject to possible adjustment. Those shareholders will own 49.9% of the combined company; Mallinckrodt shareholders will own 50.1%. The boards of directors of both companies have approved the transaction, which still needs shareholder and regulatory approvals. When the deal closes, Paul Efron, an Endo board member, will be chair of the combined company’s board. Siggi Olafsson, Mallinckrodt’s current president and CEO, will take on that role for the combined company and will also be a member its board. “Our businesses are highly complementary, with durable, on-market products in our branded portfolios and extensive capabilities across the value chain in our generics businesses,” Olafsson said in a prepared statement. “This exciting combination will create a larger and more diversified entity with the scale and resources needed to unlock the full potential of both companies. Additionally, with a strong pro forma balance sheet and compelling synergy opportunities, we will have greater flexibility to invest in innovation and pursue growth opportunities.”

AcquisitionDrug ApprovalExecutive ChangeBiosimilar

100 Deals associated with Corticotropin

External Link

KEGG	Wiki	ATC	Drug Bank
D00146	Corticotropin	H01AA01	DB01285

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Choroiditis	United States	Questcor Pharmaceuticals, Inc.	15 Oct 2010
Iridocyclitis	United States	Questcor Pharmaceuticals, Inc.	15 Oct 2010
Iritis	United States	Questcor Pharmaceuticals, Inc.	15 Oct 2010
Keratitis	United States	Questcor Pharmaceuticals, Inc.	15 Oct 2010
Optic Neuritis	United States	Questcor Pharmaceuticals, Inc.	15 Oct 2010
Uveitis, Posterior	United States	Questcor Pharmaceuticals, Inc.	15 Oct 2010
Ankylosing Spondylitis	United States	Mallinckrodt Pharmaceuticals Ireland Ltd.	29 Apr 1952
Arthritis, Psoriatic	United States	Mallinckrodt Pharmaceuticals Ireland Ltd.	29 Apr 1952
Dermatomyositis	United States	Mallinckrodt Pharmaceuticals Ireland Ltd.	29 Apr 1952
Edema	United States	Mallinckrodt Pharmaceuticals Ireland Ltd.	29 Apr 1952
Erythema Multiforme	United States	Mallinckrodt Pharmaceuticals Ireland Ltd.	29 Apr 1952
Eye Diseases	United States	Mallinckrodt Pharmaceuticals Ireland Ltd.	29 Apr 1952
Juvenile Idiopathic Arthritis	United States	Mallinckrodt Pharmaceuticals Ireland Ltd.	29 Apr 1952
Multiple Sclerosis	United States	Mallinckrodt Pharmaceuticals Ireland Ltd.	29 Apr 1952
Rheumatoid Arthritis	United States	Mallinckrodt Pharmaceuticals Ireland Ltd.	29 Apr 1952
Sarcoidosis	United States	Mallinckrodt Pharmaceuticals Ireland Ltd.	29 Apr 1952
Serum Sickness	United States	Mallinckrodt Pharmaceuticals Ireland Ltd.	29 Apr 1952
Spasms, Infantile	United States	Mallinckrodt Pharmaceuticals Ireland Ltd.	29 Apr 1952
Stevens-Johnson Syndrome	United States	Mallinckrodt Pharmaceuticals Ireland Ltd.	29 Apr 1952
Systemic Lupus Erythematosus	United States	Mallinckrodt Pharmaceuticals Ireland Ltd.	29 Apr 1952

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02226341 (ACTHar, CTgov)	Phase 4	Lupus Nephritis	8	ACTHar Gel+CellCept (CellCept Daily & ACTHar Gel BIW (Two Times Per Week))	bujcdadjjr(tcysgywpqm) = kpzwokjvxx vbycoqyisw (kfefncpyjb, jzuldmxgri - ghkmutfqwq) View more	-	07 Mar 2025
NCT02226341 (ACTHar, CTgov)	Phase 4	Lupus Nephritis	8	ACTHar Gel+CellCept (CellCept Daily & ACTHar Gel TIW (Three Times Per Week))	bujcdadjjr(tcysgywpqm) = nzemaeyeti vbycoqyisw (kfefncpyjb, detcgloxua - udhxoelake) View more	-	07 Mar 2025
NCT02245841 (CTgov)	Phase 4	Dermatomyositis	19	H.P. Acthar Gel	jjphwmvojy(shdoyestlp) = vhxndideza ajfilotbun (twaiwvnhcx, hsrmyigdee - ievvlfvenv) View more	-	11 Jun 2024
NCT03021317 (ACTHAR, CTgov)	Phase 4	Multiple Sclerosis	5	ACTHar	ewszaqnqrj(mjigscohzq) = wgrbyjfeun uhuuqqevwx (gpjrfwbxdn, ljpfsfrdxx - ptcsoovxzv) View more	-	16 May 2024
Biospace Manual	Not Applicable	Sarcoidosis	272	Acthar (African American (AA))	vacwrmneug(kdkavfyftj) = wqnxjpuuft lhwwcekmik (suipxpteho ) View more	Positive	11 Mar 2024
Biospace Manual	Not Applicable	Sarcoidosis	272	Acthar (non-African American (non-AA))	vacwrmneug(kdkavfyftj) = vevctqjbvy lhwwcekmik (suipxpteho ) View more	Positive	11 Mar 2024
ARVO2023	Not Applicable	Limbal stem cell deficiency	4	Acthar Gel	ibykgwgyjf(gynonnuomm) = tiksbsuzry xndhidycge (dwilorprkh )	Positive	23 Apr 2023
NCT02725177 (CTgov)	Not Applicable	Uveitis, Anterior \| Sarcoidosis	9	Repository Corticotropin Injection -Treatment Extension	qlweqqcbqa(rroxvmsjha) = sihepnqkid lcruskqjax (uygebwyjzg, pdsvsyvaml - gdstudsozu) View more	-	15 Feb 2023
NCT03025828 (CTgov)	Phase 4	Glomerulonephritis, Membranous	5	ACTHar	wnepugfbmq(xbiyvpgolm) = hkvwxippas wmaaiujzfc (gxqekfusen, yorxsfjxrj - agwozxncge) View more	-	15 Aug 2022
ASN2021	Not Applicable	Glomerular disease DNA-JB9-positive	15	ACTH	ymccwiyecg(gftluluagh) = rsptbxdvph cizhtuxctt (jsyxnuplkm )	Positive	27 Oct 2021
ASN2021	Not Applicable	Glomerular disease DNA-JB9-positive	15	ACTH + Tacrolimus	ymccwiyecg(gftluluagh) = pjydvxeygj cizhtuxctt (jsyxnuplkm )	Positive	27 Oct 2021
NCT04169061 (CTgov)	Phase 4	Keratitis	36	Acthar	hbbnbcjbfd(cszlopupih) = dnxnghjqlm kanbzahzbu (ztckxyhdjj, ymcuwapjmv - enfijbirnf) View more	-	18 Aug 2021
NCT03126760 (OPTIONS, CTgov)	Phase 4	Multiple Sclerosis, Relapsing-Remitting	35	Acthar Gel (Acthar Gel)	wxroltmtbn(amuwumlzen) = wkiadoamcl emzzypkouu (rgyuxfgrgh, qygvczhvtd - pxrsiakwum) View more	-	03 Jun 2021
NCT03126760 (OPTIONS, CTgov)	Phase 4	Multiple Sclerosis, Relapsing-Remitting	35	Placebo (Placebo)	wxroltmtbn(amuwumlzen) = kvblqypwlm emzzypkouu (rgyuxfgrgh, rnmjjoqklb - htymyscedw) View more	-	03 Jun 2021

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