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

6,970

Literatures (Medical) associated with Corticotropin

01 Dec 2024·Epilepsy & Behavior

Factors influencing efficacy and relapse of adrenocorticotropic hormone in infantile epileptic spasms syndrome

Article

Author: Xu, Yang ; Li, Sixiu ; Mao, Dandan ; Chen, Hui ; Liu, Ping ; Hu, Wenguang

BACKGROUNDInfantile epileptic spasms syndrome (IESS) is a severe epileptic condition characterized by persistent uncontrolled seizures, with some children experiencing recurrent seizures despite multiple pharmacological therapies. The prognostic risk factorsassociated with IESS remain unclear. This study aimed to evaluate the factors influencing the efficacy and relapse of adrenocorticotropic hormone (ACTH) treatment for IESS in infants, as well as to assess the correlation between the Burden of Amplitudes and Epileptiform Discharges (BASED) score and clinical outcomes.METHODSA retrospective analysis was conducted on a cohort of 88 pediatric patients diagnosed with IESS who received ACTH therapy at our hospital from February 2016 to August 2023. Patients were categorized into response (n = 47) and non-response (n = 41) groups based on their treatment response at day 28. Responders were further classified into relapse and non-relapse groups. A modified Poisson regression model and receiver operating characteristic (ROC) curves were employed to evaluate the positive predictive values.RESULTSIn this study, a total of 47 patients (53.4 %) responded to ACTH treatment. Patients in the response group demonstrated significantly greater reductions in BASED scores by day 14 of ACTH treatment, yielding an area under the curve (AUC) of 0.859 (95 % CI: 0.782-0.937, P＜0.05), with a sensitivity of 68.1 % and a specificity of 95.1 %. The optimal cut-off point was established at ≥ 2, corresponding to a Youden index of 0.632. Notably, patientswho were on anti-seizure medications (ASMs) before ACTH treatment and those with developmental delay prior to the onset of spasms exhibited lower short-term response rates (P＜0.05), although these factors did not demonstrate predictive value. Among the responders, 20 cases (42.6 %) experienced a relapse, with only those patients showing specific abnormalities on cranial magnetic resonance imaging (MRI) exhibiting a statistically higher proportion of relapse.CONCLUSIONPatients receiving ASMs before ACTH treatment and those with developmental delays prior to the onset of spasms may have a less favorable therapeutic response. A reduction in BASED scores of 2 or greater by day 14 of ACTH treatment may signify a potentially positive treatment response. Additionally, patients with IESS who present with specific abnormalities on cranial MRI may have an increased likelihood of relapse following ACTH treatment.

01 Dec 2024·Hormones

Examining aldosterone plasma concentration alterations post-ACTH stimulation in healthy subjects: a systematic literature review and meta-analysis on ACTH’s role in aldosterone secretion

Review

Author: Chrousos, G P ; Alexakis, D ; Stathori, G ; Paltoglou, G

PURPOSEAdrenocorticotropic hormone (ACTH), in addition to the renin-angiotensin-aldosterone axis, is a potent aldosterone stimulator, suggesting a potential contribution to conditions associated with increased ACTH concentrations. This study aims to systematically review and synthesize the scientific evidence of alterations of plasma aldosterone concentrations in response to ACTH stimulation during the cosyntropin (Synacthen) test and define the range of aldosterone response.METHODSA systematic search of PubMed, Medline, and Google Scholar databases according to PRISMA guidelines was performed. Only studies that assessed the alterations in plasma aldosterone concentrations following ACTH stimulation in healthy individuals were included. We incorporated studies that utilized the doses of 1 μg, 250 μg, 0.125 μg/m², or 0.5 μg/m² of ACTH. Out of 1599 initially assessed articles, 17 were deemed relevant to our research. The selected articles were assessed by two independent investigators based on the predetermined inclusion and exclusion criteria. Finally, eight full-text articles were included.RESULTSThe analyzed studies revealed a significant increase in plasma aldosterone concentrations in healthy subjects after ACTH stimulation, irrespective of the ACTH dose. The peak aldosterone concentration after the 250 μg dose occurred at 30 min, whereas smaller doses exhibited an earlier peak, at around 15 min. On average, plasma aldosterone concentration increased by 125.5% after the 1 μg and 0.5 μg/m² doses, and by 189.6% after 250 μg.CONCLUSIONThe presented evidence strongly supports the contribution of ACTH to aldosterone secretion regulation beyond the renin-angiotensin-aldosterone axis. Establishing a normal aldosterone response threshold following standardized ACTH stimulation could aid in identifying individuals with ACTH-dependent aldosterone hypersecretion and guide personalized and effective treatment strategies.

01 Nov 2024·Epilepsy Research

Serum matrix metallopeptidase-9 levels in infantile epileptic spasms syndrome of unknown etiology

Article

Author: Hamano, Shin-Ichiro ; Takeda, Rikako ; Hamano, Shin-ichiro ; Takeuchi, Hirokazu ; Koichihara, Reiko ; Hirata, Yuko ; Matsuura, Ryuki ; Kikuchi, Kenjiro ; Oka, Akira

PURPOSEEpileptic spasms are the primary symptom of infantile epileptic spasms syndrome (IESS); however, their direct impact on blood-brain barrier (BBB) function is unknown. Matrix metallopeptidase-9 (MMP-9), degrades type IV collagen, a key component of the blood-brain barrier, while tissue inhibitor of metalloproteinase-1 (TIMP-1) suppresses its activity, protecting BBB integrity. This study aimed to assess serum MMP-9 and TIMP-1 levels in patients with IESS of unknown etiology.METHODSWe prospectively assessed serum MMP-9 and TIMP-1 levels prior to administering vigabatrin or adrenocorticotropic hormone therapy in patients with IESS of unknown etiology at Saitama Children's Medical Center between February 2012 and December 2023. We compared these biomarkers between patients with epileptic spasms and age-matched controls and performed a curve regression analysis between the biomarkers and the frequency of epileptic spasms. Additionally, we assessed whether MMP-9 and TIMP-1 levels were diagnostic predictors of IESS.RESULTSThis study included 22 patients with IESS (11 males) and 12 controls. Serum MMP-9 and MMP-9/TIMP-1 ratios were higher in patients with IESS than in controls (p < 0.001 and p = 0.002, respectively). A high frequency of epileptic spasms also led to higher serum MMP-9 levels (y = 0.0871x² + 0.195x + 195.15, R² = 0.77, p < 0.001). Using MMP >188 ng/mL as the cutoff level, the sensitivity for diagnosing IESS was 95.5 %, the specificity was 75.0 %, the positive likelihood ratio was 3.82 (95 % confidence interval (CI) 1.43-10.22), and the relative risk was 8.75 (95 % CI 1.36-56.5).CONCLUSIONPatients with IESS had elevated serum MMP-9 levels, suggesting an association between epileptic spasms and blood-brain barrier dysfunction. MMP-9 level measurement may be useful for diagnosing suspected patients.

News (Medical) associated with Corticotropin

05 Nov 2024

·www.prnewswire.com

Mallinckrodt plc Reports Third Quarter 2024 Financial Results and Raises Full Year Guidance

Achieves Third Quarter Net Sales of $505.5 Million, Reflecting 1.7% Year-Over-Year Growth Reaffirms Full Year Net Sales Guidance and Raises Full Year Adjusted EBITDA Guidance After Adjusting Both Metrics for the Therakos Transaction Delivers Third Consecutive Quarter of Acthar® Gel Growth, Underscoring Increase in Patient and Prescriber Demand; Expects Brand to Grow Approximately 10% in Full Year 2024 Successfully Launched Acthar Gel SelfJect™ Device and Expanded the Rollout of INOmax ® EVOLVE™ DS Delivery System to U.S. Hospitals Nationwide Specialty Generics Segment Maintains Momentum with Seventh Consecutive Quarter of Year-Over-Year Growth Net Proceeds from Sale of Therakos ® Business Expected to Reduce Net Debt by More Than 60% in the Fourth Quarter DUBLIN, Nov. 5, 2024 /PRNewswire/ -- Mallinckrodt plc ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today reported its financial results for the third quarter ended September 27, 2024.1 "Our third quarter results demonstrate the successful execution of our strategy to stabilize the base business and position Mallinckrodt for long-term growth. We are pleased to reaffirm our full year net sales guidance and again raise our Adjusted EBITDA guidance, even after adjusting for the Therakos transaction," said Siggi Olafsson, President and Chief Executive Officer. "In Specialty Brands, Acthar Gel achieved its third consecutive quarter of growth from rising prescriber referrals and patient demand. We also made important progress on our recent launches, with positive momentum in our Acthar Gel SelfJect device and an expanded rollout of our INOmax EVOLVE DS delivery system to U.S. hospitals nationwide. In Specialty Generics, we delivered our seventh consecutive quarter of solid growth due to our ability to consistently and reliably deliver high-quality products, and we remain on track for another year of double-digit net sales growth in 2024." Mr. Olafsson added, "I am grateful to our teams for their continued commitment to Mallinckrodt, bringing our strategy to life and serving our patients. It is because of their efforts that we are positioned to finish 2024 on a strong note as we continue building on our momentum and advancing our strategic priorities." Third Quarter 2024 Financial Results1 Mallinckrodt's net sales in the third quarter of 2024 were $505.5 million, as compared to $497.0 million in the third quarter of 2023. This reflects an increase of 1.7% on a reported and constant currency basis. The Company's Specialty Brands segment reported net sales of $286.0 million, as compared to $286.2 million in the third quarter of 2023. This stability reflects growth in Acthar Gel, uptake in Acthar SelfJect and Terlivaz® and the continued growth of Therakos, slightly offset by continued competition in the U.S. for INOmax from alternative nitric oxide products. Mallinckrodt's Specialty Generics segment reported net sales of $219.5 million, as compared to $210.8 million in the third quarter of 2023. This 4.1% growth was driven by the Company's established track record as a reliable and consistent producer of high-quality products amidst ongoing market shortages due to quality and other disruptions, in both the finished-dosage products and Controlled Substance active pharmaceutical ingredient (API) businesses, partially offset by a decline in the Acetaminophen (APAP) business as a result of the overall softening of the market. The Company's net loss for the third quarter was $26.2 million, a 98.5% improvement as compared to a net loss of $1.7 billion in the third quarter of 2023. Mallinckrodt's Adjusted EBITDA in the third quarter was $160.6 million, as compared to $180.6 million in the third quarter of 2023, a decrease of 11.1%. This decrease was primarily driven by approximately $7.3 million of transaction-related compensation expenses for the sale of Therakos, as well as incremental commercial investments for Acthar Gel and Terlivaz and the impact of nitric oxide competition in the U.S., partially offset by continued strength in the Specialty Generics segment, and growth in the Specialty Brands segment. Gross profit as a percentage of net sales was 43.7% for the third quarter, as compared to 30.3% for the third quarter of 2023. Adjusted gross profit as a percentage of net sales was 65.4% for the third quarter, as compared to 66.3% for the third quarter of 2023. Mallinckrodt's cash balance at the end of the third quarter of 2024 was $410.5 million. Total outstanding principal debt was $1.64 billion, and outstanding net debt was $1.23 billion. Nine Month 2024 Results1 Mallinckrodt's net sales were $1.5 billion for the nine months ended September 27, 2024, as compared to $1.4 billion for the nine months ended September 29, 2023. This reflects an increase of 6.5%. The Company recorded a net loss of $134.9 million for the nine months ended September 27, 2024, as compared to $2.7 billion for the nine months ended September 29, 2023. Mallinckrodt's Adjusted EBITDA was $479.5 million for the nine months ended September 27, 2024, as compared to $448.1 million for the nine months ended September 29, 2023, an increase of 7.0%. Third Quarter 2024 Business Segment Update Specialty Brands Acthar Gel net sales were $126.4 million in the third quarter, an increase of 3.5% versus the prior year quarter and the third consecutive quarter of year-over-year growth for the brand, reflecting increasing prescriber referrals and patient demand. Additionally, the Company successfully launched SelfJect mid-quarter and has received enthusiastic physician and patient feedback. Given the brand's return to growth and positive momentum, the Company now expects full year 2024 Acthar Gel net sales to grow approximately 10%. Terlivaz net sales were $7.3 million, reflecting 65.9% year-over-year growth and 37.7% sequential growth in net sales. The Company continued to expand adoption in the third quarter through outreach to healthcare providers emphasizing the importance of early patient identification and treatment initiation. Mallinckrodt remains focused on establishing Terlivaz as the preferred first-line treatment for HRS patients with rapid reduction of kidney function. INOmax (nitric oxide) gas net sales in the third quarter were $64.0 million, down 12.2% compared to the prior year period, as it continued to be impacted by competitive pressures in the U.S. Following the successful introduction of the INOmax EVOLVE DS device pilot program earlier this year, the Company expanded the commercial rollout of EVOLVE to U.S. hospitals nationwide late in the third quarter. At quarter end, there were 100 devices in nearly a dozen hospitals across the U.S. The Company is focused on further expanding the rollout of EVOLVE to help meet the needs of neonatal intensive care patients and healthcare professionals by offering improved automation, which enhances safety features, and a streamlined design that elevates the user experience. Therakos net sales were $67.6 million in the third quarter, an increase of 2.4% on a reported basis and 2.2% on a constant currency basis. As previously announced, the Company entered into a definitive agreement to sell the Therakos business to CVC Capital Partners for $925 million, subject to customary adjustments. Mallinckrodt will use net proceeds from the transaction to pay down debt and expects this to reduce the Company's net debt by more than 60% following transaction close. Closing remains on track to occur in the coming weeks, subject to customary closing conditions. Specialty Generics The Specialty Generics segment reported year-over-year net sales growth of 4.1% in the third quarter of 2024. These results were driven by strong performance in finished-dosage products and increased demand for Controlled Substance APIs, slightly offset by softness in the APAP business stemming from excess supply in the broader market. Net sales in the Specialty Generics segment have grown for the past seven quarters, and its third quarter performance is particularly notable given the strong comparable quarter in 2023, which was driven by the launch of lisdexamfetamine dimesylate capsules (generic form of Vyvanse®). 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 third quarter. Please see the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Quarterly Report on Form 10-Q for the quarter ended September 27, 2024 to be filed with the U.S. Securities and Exchange Commission ("SEC") for additional information. 2024 Financial Guidance Update Mallinckrodt today reaffirmed its net sales guidance and raised its Adjusted EBITDA guidance for full year 2024. The Company's updated guidance assumes that the Therakos transaction will close by the end of November and, accordingly, removes approximately $25 million in net sales and approximately $12 million in Adjusted EBITDA that were previously expected to be contributed by Therakos in the month of December. The updated Adjusted EBITDA guidance also reflects approximately $16 million of transaction-related compensation expenses for the sale of Therakos, for a total impact to the Company's full year Adjusted EBITDA of approximately $28 million. The Company's updated guidance is as follows: Mallinckrodt notes that for full year 2024 Therakos is expected to generate approximately $270 million in net sales and approximately $135 million in Adjusted EBITDA. The Company does not provide the 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. Conference Call and Webcast Mallinckrodt will hold a conference call today, November 5, 2024, at 8:30 a.m. Eastern Time to discuss its financial results and performance for the third quarter 2024. The live call and subsequent replay can be accessed as follows: Live Call Participant Registration (including dial-in): Audio Only Webcast Link (live and replay): At the Mallinckrodt website: 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, ophthalmology and oncology; 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 . 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; gains 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. The Company has forecasted a full-year 2024 adjusted EBITDA for Therakos, consistent with the Company's calculation of the consolidated Company Adjusted EBITDA. As such, certain amounts that management considers to be non-recurring or non-operational are excluded from these measures because management and the chief operating decision maker evaluate the operating results of the excluding such items. These items may include, but are not limited to, depreciation and amortization, share-based compensation, net restructuring charges, non-restructuring impairment charges and liabilities management and separation costs. Also, Therakos Adjusted EBITDA excludes allocations of intercompany corporate overhead costs and fresh-start inventory related expenses and other items identified by the Company. 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 $1.2 billion as of September 27, 2024, reflects $1.6 billion in total debt outstanding on a GAAP basis less $410.5 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 Successor period runs for the three and nine months ended September 27, 2024, while the Predecessor period is for the three and nine months ended September 29, 2023. 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 results of operations for the three and nine months ended September 27, 2024 (Successor) provide a meaningful comparison and are useful in identifying current business trends when compared to the three and nine months ended September 29, 2023 (Predecessor). Mallinckrodt's results of operations as reported in its unaudited condensed 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 parties' ability to satisfy the conditions to the divestiture of the Therakos business, including the ability to complete the divestiture on the anticipated timeline or at all; the potential impact of the divestiture on our businesses and the risk that consummating the divestiture may be more difficult, time-consuming and costly than expected; changes in Mallinckrodt's board of directors, 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"); Mallinckrodt's repurchases of debt securities; the liquidity, results of operations and businesses of Mallinckrodt and its subsidiaries; 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; historical commercialization of opioids, including 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, as well as perceptions of the Company's increased performance and credit risks associated with its constrained liquidity position and capital structure; the possibility that Mallinckrodt may be unable to achieve its business and strategic goals even now that the emergence from the 2023 bankruptcy proceedings was successfully consummated; the non-dischargeability of certain claims against Mallinckrodt as part of the bankruptcy process; developing, funding and executing Mallinckrodt's business plan; Mallinckrodt's capital structure since its 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) Single-Dose Pre-filled SelfJect™ Injector and the INOmax Evolve platform; Mallinckrodt's ability to successfully identify or discover additional products or product candidates; Mallinckrodt's ability to navigate price fluctuations; competition; Mallinckrodt's and its partners' 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 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 ability to achieve expected benefits from prior or future restructuring activities; 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; actions taken by third parties, including the Company's creditors, the Trust and other stakeholders; 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 29, 2023, Quarterly Report on Form 10-Q for the quarterly period ended March 29, 2024, Quarterly Report on Form 10-Q for the quarterly period ended June 28, 2024, Quarterly Report on Form 10-Q for the quarterly period ended September 27, 2024 to be filed with the SEC, and other filings with the SEC, which are available from the SEC's website () and Mallinckrodt's (), 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. 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. © 2024. 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

17 Sep 2024

·www.prnewswire.com

Mallinckrodt Announces Publication of Human Factors Studies and Arthritis Foundation Ease of Use® Certification of Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector

– Findings from nine human factors studies, assessing design and user interface, suggest SelfJect functions as an effective delivery device when used as intended1 – – The SelfJect delivery device received the Arthritis Foundation's Ease of Use certification – DUBLIN, Sept. 17, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the publication of findings from seven formative and two validation human factors studies of recently launched Acthar Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector ("SelfJect").2 The manuscript, describing the formative and human factor outcomes, was recently published online in Expert Opinion on Drug Delivery. Approved by the U.S. Food and Drug Administration (FDA) in February of 2024, SelfJect also received the Arthritis Foundation's Ease of Use® certification. This certification recognizes SelfJect for its easy-to-use design, based on testing by an independent third party. Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone (ACTH) analogs and other pituitary peptides.2 Acthar Gel is approved by the FDA for the treatment of several autoimmune disorders and medical conditions known to cause inflammation.2 SelfJect is available in 40 USP units/0.5 mL and 80 USP units/1.0 mL injectors and must be administered by people 18 years of age or older. SelfJect is not to be used for the treatment of infantile spasms. Please see Indications and Important Safety Information for Acthar Gel below. "We're proud of the extensive research and testing conducted to develop SelfJect, including these human factors studies which were critical to our application for FDA approval," said Lisa French, Executive Vice President & Chief Commercial Officer. "These results, and the Arthritis Foundation's Ease of Use certification, are a testament to our commitment to modernize Acthar Gel for our patient community. In keeping with our mission of listening for needs, SelfJect provides an administration option designed to better support patients, caregivers, and medical professionals in managing appropriate conditions." Arthritis Foundation President and CEO Steven Taylor said, "Ease of Use products and packaging are designed to help people with arthritis and those with physical limitations by making everyday tasks easier. We're excited to partner with companies like Mallinckrodt that understand the importance of developing products and packages with the needs of patients at the forefront." About the Studies Human factors studies were conducted utilizing SelfJect to assess the design of the injection device and its user interface, as well as mitigate potential use-related hazards, through observation of participants using the device and participant feedback.1 The published research includes results from nine studies, including seven formative studies, a validation study (with four prior pilot validation studies), and a supplemental validation study with participants including lay users, patients, caregivers, and healthcare providers.1 The formative studies tested and developed various components such as packaging and instructional material, whereas the validation study evaluated administration of the device with the intended-to-market user interface and representative users in representative simulated-use environments.1 Four pilot studies then generated additional protocol recommendations for the validation study.1 In the 160-participant validation study, 91% (n=146) of participants successfully administered their first injection, with 98% (n=156) cumulative success after the second trial.1 Use errors were rare with simulated-use (6.9% [n=194] of all evaluated tasks) and knowledge-based (1.6% [n=56] of all evaluated tasks) testing. The most common use errors were related to not appropriately warming the product before administration.1 Limitations of the studies include1: The controlled study setting may not have accurately replicated real-world complexities that play a role in the administration of Acthar Gel via SelfJect, potentially altering the number of study use errors and deviation. Injections were performed with placebo gel into an injection pad and not a patient. The feedback that a user receives when injecting into skin versus a surrogate injection pad may influence use behavior. A more realistic delivery container could have been used to cue the participant that this product would arrive cold and would need to be stored appropriately. Participant selection bias, reliance on self-reported and qualitative data, and small sample sizes in the formative and pilot studies may have impacted results. If a customer is interested in learning more about SelfJect, they can reach out to their local representative or visit ActharHCP.com. INDICATIONS Acthar Gel is indicated for: Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus Monotherapy for the treatment of infantile spasms in infants and children under 2 years of age Treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown Acthar to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease 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 Symptomatic sarcoidosis Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus Treatment during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis) Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis 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 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. Cases of anaphylaxis have been reported in the postmarketing setting. 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 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 Pregnancy Acthar may cause fetal harm when administered to a pregnant woman 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, hepatology, nephrology, pulmonology, ophthalmology, and oncology; 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 . CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS This release contains forward-looking statements, including with regard to Acthar Gel (repository corticotropin injection), the Acthar Gel Single-Dose Pre-filled SelfJect™ Injector, the potential of these products to improve health and treatment outcomes, their potential impact on patients and the availability of Acthar Gel Single-Dose Pre-filled SelfJect Injector in the U.S. in the future. 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: the effects of Mallinckrodt's recent emergence from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; changes in market demand; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with Acthar Gel and Acthar Gel Single-Dose Pre-filled SelfJect Injector; and other risks identified and described in more detail in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections 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 Green Room Communications 908-577-4531 [email protected] Investor Relations Derek Belz Vice President, Investor Relations 314-654-3950 [email protected] Mallinckrodt, the "M" brand mark, SelfJect, and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2024 Mallinckrodt. US-2400718 09/24 References 1 Linnane A, Lau M, Miranda P, Elliott S. Formative and Validation Human Factors Studies of a New Disposable Prefilled Injection Device for Subcutaneous Delivery of Acthar Gel (Repository Corticotropin Injection). Expert Opinion on Drug Delivery. 2024. . 2 Acthar® Gel (repository corticotropin injection) [prescribing information]. Bridgewater, NJ: Mallinckrodt ARD LLC. 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

Drug ApprovalClinical Result

16 Sep 2024

·www.globenewswire.com

ANI Pharmaceuticals Initiates Closing of Acquisition of Alimera Sciences

PRINCETON, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (“ANI” or the “Company”) announced today that the Company has initiated closing logistics for the previously announced acquisition of Alimera Sciences, Inc. (Nasdaq: ALIM). The Company expects closing of the acquisition of Alimera Sciences to be consummated and announced today, pending satisfaction or waiver of any remaining customary closing conditions. About ANI Pharmaceuticals, Inc. ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high-quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. ANI is focused on delivering sustainable growth by scaling up its Rare Disease business through its lead asset Purified Cortrophin® Gel, strengthening its Generics business with enhanced research and development capabilities, delivering innovation in Established Brands, and leveraging its U.S. based manufacturing footprint. For more information, visit our website www.anipharmaceuticals.com. Forward-Looking Statements This communication, and the documents to which it refers you, contains not only historical information, but also forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements represent the parties’ expectations or beliefs concerning future events, including the timing of the transaction and other information relating to the transaction. Forward-looking statements include information concerning the expected completion and timing of the transaction and other information relating to the transaction. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “forecasts,” “should,” “estimates,” “contemplate,” “future,” “goal,” “potential,” “predict,” “project,” “projection,” “may,” “will,” “could,” “should,” “would,” “assuming” and similar expressions are intended to identify forward-looking statements. You should read statements that contain these words carefully. They discuss ANI’s and/or Alimera’s future expectations or state other forward-looking information and may involve known and unknown risks over which the parties have no control. Forward-looking statements speak only as of the date of this communication or the date of any document incorporated by reference in this document. Further risks that could cause actual results to differ materially from those matters expressed in or implied by such forward-looking statements are described in the parties’ respective SEC reports. Except as required by applicable law or regulation, neither party undertakes to update these forward-looking statements to reflect future events or circumstances. Investor and/or Media Contacts:Lisa M. Wilson, In-Site Communications, Inc.212-452-2793lwilson@insitecony.com

Acquisition

100 Deals associated with Corticotropin

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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	US	Questcor Pharmaceuticals, Inc.	15 Oct 2010
Iridocyclitis	US	Questcor Pharmaceuticals, Inc.	15 Oct 2010
Iritis	US	Questcor Pharmaceuticals, Inc.	15 Oct 2010
Keratitis	US	Questcor Pharmaceuticals, Inc.	15 Oct 2010
Optic Neuritis	US	Questcor Pharmaceuticals, Inc.	15 Oct 2010
Ankylosing Spondylitis	US	Mallinckrodt ARD, Inc.	29 Apr 1952
Arthritis, Psoriatic	US	Mallinckrodt ARD, Inc.	29 Apr 1952
Dermatomyositis	US	Mallinckrodt ARD, Inc.	29 Apr 1952
Edema	US	Mallinckrodt ARD, Inc.	29 Apr 1952
Eye Diseases	US	Mallinckrodt ARD, Inc.	29 Apr 1952
Juvenile Idiopathic Arthritis	US	Mallinckrodt ARD, Inc.	29 Apr 1952
Multiple Sclerosis	US	Mallinckrodt ARD, Inc.	29 Apr 1952
Rheumatoid Arthritis	US	Mallinckrodt ARD, Inc.	29 Apr 1952
Sarcoidosis	US	Mallinckrodt ARD, Inc.	29 Apr 1952
Serum Sickness	US	Mallinckrodt ARD, Inc.	29 Apr 1952
Spasms, Infantile	US	Mallinckrodt ARD, Inc.	29 Apr 1952
Stevens-Johnson Syndrome	US	Mallinckrodt ARD, Inc.	29 Apr 1952
Systemic Lupus Erythematosus	US	Mallinckrodt ARD, Inc.	29 Apr 1952

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02245841 (CTgov)	Phase 4	Dermatomyositis	19	H.P. Acthar Gel	dznliqpyvz(bhkmcalwnm) = rgtcbzuqxr vwhnyfaaox (rwcdewzakl, usxahlxgzc - ziltkwfihk) View more	-	11 Jun 2024
NCT03021317 (ACTHAR, CTgov)	Phase 4	Multiple Sclerosis	5	ACTHar	vdddhknvzo(hvxtxgrslm) = pgbqbjrldd mywxwyugza (fbnrnzjtak, imprzliktq - nvilxtosit) View more	-	16 May 2024
Biospace Manual	Not Applicable	Sarcoidosis	272	Acthar (African American (AA))	grjquhtqqz(snmkgunfam) = qncsjvnprx psllbcwivw (eprfdaxohc ) View more	Positive	11 Mar 2024
Biospace Manual	Not Applicable	Sarcoidosis	272	Acthar (non-African American (non-AA))	grjquhtqqz(snmkgunfam) = jqziynyyvv psllbcwivw (eprfdaxohc ) View more	Positive	11 Mar 2024
Pubmed	Not Applicable	Optic Neuritis	-	Repository Corticotropin Injection (RCI)	crqamljjwh(dvjufzwgwc) = jguqrylelk cjeqlzwbfw (xhiibkpztx ) View more	-	01 Jun 2023
Pubmed	Not Applicable	Optic Neuritis	-	Intravenous Methylprednisolone (IVMP)	crqamljjwh(dvjufzwgwc) = hyefhesdts cjeqlzwbfw (xhiibkpztx ) View more	-	01 Jun 2023
ARVO2023	Not Applicable	Limbal stem cell deficiency	4	Acthar Gel	wpawdcqkcx(wtobplnbvf) = uatghttopc vygjutkkdz (vhfrxtzupg )	Positive	23 Apr 2023
NCT02725177 (CTgov)	Not Applicable	Uveitis, Anterior \| Sarcoidosis	9	Repository Corticotropin Injection -Treatment Extension	izrrwitmbj(ljmpxhaphv) = wdmujvdnos dfnxvrczxx (emhybnnoey, yviqvvuomy - keokztpjlu) View more	-	15 Feb 2023
NCT03025828 (CTgov)	Phase 4	Glomerulonephritis, Membranous	5	ACTHar	jinejozuvo(dervyfzgrl) = irmixttkhx ruvvyemglb (fozmnnnjmi, eryookdtqp - plksxrdbqf) View more	-	15 Aug 2022
ASN2021	Not Applicable	Glomerular disease DNA-JB9-positive	15	ACTH	paasdltrbt(vfhcqfuawd) = vrcmhfywod gqowbioitw (drzhltntcs )	Positive	27 Oct 2021
ASN2021	Not Applicable	Glomerular disease DNA-JB9-positive	15	ACTH + Tacrolimus	paasdltrbt(vfhcqfuawd) = qxlogsckvh gqowbioitw (drzhltntcs )	Positive	27 Oct 2021
NCT04169061 (CTgov)	Phase 4	Keratitis	36	Acthar	ohjibogyxf(vkauspuzlw) = jbhbcststu bsvlqgxfpw (lvujounlok, dcwmsxgofe - njkkhvgpoz) View more	-	18 Aug 2021
NCT03126760 (OPTIONS, CTgov)	Phase 4	Multiple Sclerosis, Relapsing-Remitting	35	Acthar Gel (Acthar Gel)	yiibxlwxli(ioyiplklyx) = lqhdnzliua aurszyqlej (pqiergrmlb, srqutxjgfy - gchwmzzfql) View more	-	03 Jun 2021
NCT03126760 (OPTIONS, CTgov)	Phase 4	Multiple Sclerosis, Relapsing-Remitting	35	Placebo (Placebo)	yiibxlwxli(ioyiplklyx) = nsscbtzdon aurszyqlej (pqiergrmlb, bzxfuegzpq - iegtazigxz) View more	-	03 Jun 2021

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