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Mallinckrodt plc (MNK) is a global specialty biopharmaceutical and medical imaging company. Headquartered in Dublin, the company is renowned for developing, manufacturing, marketing, and distributing specialty pharmaceutical products and medical imaging agents. Its diverse portfolio spans therapeutic drugs for autoimmune and rare diseases in specialty areas such as neurology, rheumatology, nephrology, ophthalmology, and pulmonology. The company also focuses on immunotherapy, neonatal respiratory critical care therapies, analgesics, and central nervous system drugs.
The company's Specialty Brands segment features a range of branded medicines, while the Specialty Generics segment includes generic drugs and active pharmaceutical ingredients. The Global Medical Imaging segment provides contrast media and nuclear imaging agents. Mallinckrodt's expertise lies in the acquisition and management of highly regulated raw materials, regulatory know-how, and specialized chemistry, formulation, and manufacturing capabilities.
Recent achievements include findings from health economics outcomes research on Acthar® Gel, which were shared at the Academy of Managed Care Pharmacy Nexus 2023. Acthar Gel, approved by the FDA for treating various autoimmune disorders and inflammatory conditions, demonstrated cost-effectiveness for patients with advanced symptomatic sarcoidosis and nephrotic syndrome. Additionally, the company presented new data on TERLIVAZ® at the Society of Critical Care Medicine 2024 Critical Care Congress, showing its efficacy in improving kidney function in adults with hepatorenal syndrome.
Mallinckrodt is committed to continuous innovation, evidenced by the FDA's approval of the Acthar Gel Single-Dose Pre-filled SelfJect™ Injector, designed to provide patients with better control over their medication administration. Financially, Mallinckrodt reported a net sales increase to $467.8 million in Q1 2024, driven by growth in both its Specialty Brands and Specialty Generics segments.
Mallinckrodt (NYSE American: MNK) announced the presentation of seven scientific abstracts on TERLIVAZ® (terlipressin) at the AASLD 2022 Liver Meeting, highlighting treatment outcomes for hepatorenal syndrome (HRS). The studies, showcasing clinical and economic outcomes, emphasize the company’s commitment to improving care for HRS patients. Notably, TERLIVAZ is the first FDA-approved therapy for HRS, significantly impacting kidney function. The meeting takes place in Washington, DC from November 4-8, 2022, presenting key findings that underline the urgent needs of HRS patients.
Mallinckrodt announced the presentation of three scientific abstracts on TERLIVAZ (terlipressin) at the ASN Kidney Week 2022, focusing on treatment for adults with hepatorenal syndrome (HRS) involving rapid kidney function reduction. Key findings indicate that initiating terlipressin treatment at lower serum creatinine levels can enhance the probability of avoiding renal replacement therapy. Mallinckrodt emphasizes its commitment to improving the care for critically ill patients, supported by over 70 studies on terlipressin worldwide. The event is scheduled for November 3-6 in Orlando, Florida.
Mallinckrodt plc has received approval to list its ordinary shares on NYSE American, with trading expected to commence under the ticker symbol MNK on October 27, 2022. This listing is part of the company's strategy to drive growth and enhance shareholder value. The President and CEO, Siggi Olafsson, emphasized the significance of this move in advancing therapies for underserved patients. The company will cease trading on the OTC Pink Current Market simultaneously with the NYSE American listing.
Mallinckrodt plc (OTCMKTS: MNKPF) has appointed Susan Silbermann to its Board of Directors effective October 5, 2022. This expansion brings the board to nine directors, with eight being independent. Susan, a seasoned global healthcare executive with extensive experience at Pfizer, will provide crucial insights as Mallinckrodt aims to enhance its operations and deliver innovative therapies. Her previous leadership roles include overseeing public health and managing Pfizer's COVID-19 task force, indicating her capability to drive growth and long-term value for shareholders.
Mallinckrodt (OTCMKTS: MNKPF) announced the FDA approval of Terlivaz (terlipressin), the first and only treatment for adults with hepatorenal syndrome (HRS) involving rapid kidney function reduction. This significant milestone brings a much-needed therapeutic option for critically ill patients requiring hospitalization. The approval is supported by the Phase 3 CONFIRM trial results, which demonstrated terlipressin's efficacy in improving kidney function and avoiding dialysis. Terlivaz is expected to launch in the U.S. soon, aiming to address a condition affecting 30,000-40,000 Americans annually.
Mallinckrodt plc (OTCMKTS: MNKPF) announced the presentation of two scientific posters on hepatorenal syndrome (HRS) at the 2022 International Liver Congress in London. These studies focus on the effects of terlipressin, an investigational treatment for rapid kidney function decline associated with HRS. The research highlights early treatment benefits and explores gender differences in clinical responses. Mallinckrodt aims to enhance understanding of HRS management, crucial for approximately 30,000 to 40,000 Americans annually, with a grim prognosis if untreated.
Mallinckrodt plc (OTCMKTS: MNKKQ) announced findings from a retrospective study on Acthar Gel for refractory rheumatoid arthritis (RA), published in Drugs in Context. The study analyzed medical records of 63 patients and found that Acthar Gel treatment resulted in improved clinical outcomes, reduced concomitant medication prescriptions, and a significant decrease in the Clinical Disease Activity Index (CDAI) score. Most patients were on the recommended dosage for an average of 10.3 months. The results indicate the potential effectiveness of Acthar Gel for patients with high RA disease activity.
Mallinckrodt plc (OTCMKTS: MNKKQ) announced FDA approval for StrataGraft®, an allogeneic product for treating adults with deep partial-thickness burns requiring surgical intervention. This therapy aims to reduce autografting needs, addressing complications like pain and infection. Funded partly by $86 million from BARDA, StrataGraft's pivotal Phase 3 trial showed a 96% success rate in avoiding autografting. This approval represents a significant advancement in burn care, with plans for future studies in pediatric populations and full-thickness burns.
Mallinckrodt plc (OTCMKTS: MNKKQ) announced a restructuring support agreement with an ad hoc group holding approximately $1.3 billion of its first lien term loans. This agreement aims to resolve disputes between the company and lenders while extending debt maturities. The restructuring plan includes provisions such as an increase in LIBOR margin and a maturity extension until September 30, 2027. The company previously filed for Chapter 11 to handle opioid-related claims, with the restructuring expected to strengthen its financial position and reduce total debt.
Mallinckrodt plc (OTCMKTS: MNKKQ) has successfully reached an agreement with an ad hoc group of first lien term lenders holding approximately $1.3 billion of its outstanding loans to support its restructuring efforts. This agreement aims to replace existing loans and mitigate disputes related to the restructuring plan, effectively extending debt maturities. Furthermore, the restructuring plan targets an overall reduction in debt by roughly $1.3 billion to enhance the company's financial position and facilitate ongoing investments in new therapies and patient care.
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