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Mallinckrodt plc announced its emergence from Chapter 11 bankruptcy and Irish Examinership on June 16, 2022, with a restructured financial position and improved balance sheet. The company appointed Sigurdur Olafsson as the new President and CEO, effective June 25, 2022. This transition is aimed at capitalizing on its drug development pipeline and strategic initiatives while resolving significant litigation matters, including opioid claims. The company has reduced its total debt by approximately $1.3 billion and has over $250 million in cash for future investments.
Mallinckrodt (OTCMKTS: MNKKQ) has resubmitted its New Drug Application (NDA) to the FDA for terlipressin, aimed at treating hepatorenal syndrome (HRS), a critical condition without current FDA-approved therapies. The resubmission follows a Complete Response Letter received on February 18, 2022, primarily due to the need for inspection of a new packaging facility. Terlipressin has a long history of use outside the U.S. and is considered standard care in several countries. Over 70 studies support its clinical data.
Mallinckrodt plc (MNKKQ) has announced plans to exit Chapter 11 bankruptcy and complete Irish Examinership proceedings shortly. On emergence, all existing shares will be canceled, with 13,170,932 new shares issued to guaranteed unsecured noteholders. Furthermore, 3,290,675 warrants at a strike price of $103.40 will be allocated to opioid claimants, along with 1,829,068 equity awards for management and key employees. New shares will initially trade over-the-counter until Mallinckrodt relists on a national exchange.
Mallinckrodt announced findings from a retrospective analysis of Acthar Gel's effectiveness in treating advanced symptomatic sarcoidosis among African Americans. Presented at the American Thoracic Society Conference, the analysis involved 168 patients, revealing significant symptom improvement and a notable reduction in glucocorticoid use (from 59.5% to 11.9%) post-treatment. The study highlights existing health disparities and the need for research tailored to African Americans suffering from sarcoidosis.
Mallinckrodt plc announced that the Irish High Court confirmed its scheme of arrangement with creditors on April 27, 2022, facilitating its exit from Chapter 11 bankruptcy. This confirmation aligns with the U.S. Bankruptcy Court's approval of the company's reorganization plan on February 3, 2022. The scheme will take effect concurrently with the U.S. plan, allowing the company to repay its $900 million revolving credit facility post-emergence. Mallinckrodt plans to raise exit financing soon to meet obligations under the reorganization.
Mallinckrodt plc announced the publication of a medical chart review study in Drugs in Context evaluating the use of INOmax® (nitric oxide) therapy in COVID-19 patients with mild-to-moderate acute respiratory distress syndrome (ARDS). The study involved 37 hospitalized patients, showing that 62.2% experienced an increase in their PaO2/FiO2 ratio after treatment. However, INOmax's safety and efficacy for COVID-19 are not FDA-approved. The study highlights the need for further investigation into real-world treatment efficacy for ARDS patients.
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 that the FDA issued a Complete Response Letter (CRL) for its New Drug Application for terlipressin, aimed at treating hepatorenal syndrome (HRS). The CRL was due to the need for a new packaging and labeling manufacturing facility, which delayed FDA inspection. No safety or efficacy issues were noted. Terlipressin is critical for HRS patients, with an estimated 30,000 to 40,000 cases annually in the U.S. Mallinckrodt aims to prepare the facility for FDA inspection, emphasizing their commitment to the patient population in need.
Mallinckrodt has announced the confirmation of its Plan of Reorganization by the U.S. Bankruptcy Court in Delaware, marking a significant step in its Chapter 11 process. This Plan aims to reduce the company's debt by approximately $1.3 billion and resolve ongoing opioid litigation. With broad support from stakeholders and legal settlements, the company anticipates emerging from Chapter 11 in the first half of 2022. The upcoming Examinership Proceedings in Ireland are expected to further streamline the reorganization.
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