Mallinckrodt plc and its wholly owned subsidiaries (Mallinckrodt) develop, manufacture, market and distribute specialty pharmaceutical products and therapies. 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; cultured skin substitutes and gastrointestinal products.
Segments
The company operates its busine...
Mallinckrodt plc and its wholly owned subsidiaries (Mallinckrodt) develop, manufacture, market and distribute specialty pharmaceutical products and therapies. 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; cultured skin substitutes and gastrointestinal products.
Segments
The company operates its business in two reportable segments: Specialty Brands includes innovative specialty pharmaceutical brands; and Specialty Generics includes niche specialty generic drugs and active pharmaceutical ingredients (‘API(s)’).
Specialty Brands segment
The company’s business markets branded pharmaceutical products for autoimmune and rare diseases in the specialty areas of neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; cultured skin substitutes and gastrointestinal products. The company’s diversified, in-line portfolio of both marketed and development products is focused on patients with significant unmet medical needs.
The company’s long-term strategy is to increase patient access and appropriate utilization of the company’s existing products; develop innovative new therapies and next-generation devices for the company’s products; and selectively acquire or license products that are strategically aligned with the company’s product portfolio to expand the size and profitability of the company’s Specialty Brands segment.
The company promotes its branded products directly to physicians in their offices, hospitals and ambulatory surgical centers (including neurologists, rheumatologists, hepatologists, nephrologists, pulmonologists, ophthalmologists, oncologists, neonatologists, surgeons and pharmacy directors) with the company’s own direct sales force of almost 300 sales representatives as of December 30, 2022 (Successor). These products are purchased by independent wholesale drug distributors, specialty pharmaceutical distributors, retail pharmacy chains and hospital procurement departments, among others, and are eventually dispensed by prescription to patients. The company also contracts directly with payer organizations to ensure reimbursement for the company’s products to patients that are prescribed the company’s products by their physicians.
The following is a description of select products in the company’s product portfolio:
Acthar Gel (repository corticotropin injection) (‘Acthar Gel’) is a complex mixture of peptides approved by the U.S. Food and Drug Administration (‘FDA’) for use in 19 indications. The product generates substantially all of its net sales from 11 of the on-label indications, including adjunctive therapy for short-term administration for an acute episode or exacerbation in rheumatoid arthritis (‘RA’), including juvenile RA; monotherapy for the treatment of infantile spasms in infants and children under two years of age; treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus; treatment of acute exacerbations of multiple sclerosis (‘MS’) in adults; including a diuresis or a remission of proteinuria in nephrotic syndrome (‘NS’) without uremia of the idiopathic type or that due to lupus; treatment during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis); treatment of symptomatic sarcoidosis; and treatment of severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, including keratitis and uveitis. The approved indications of Acthar Gel are not subject to patent or other exclusivity.
There is significant clinical data generated to support the effectiveness of Acthar Gel. This data is the result of company-sponsored controlled clinical trials, as well as previously completed and largely independent clinical case series and smaller trials that have expanded the product's evidence base and strengthened its clinical profile. The company continues its data generation efforts through pre-clinical studies and additional independent research, as well as the company’s efforts to extend the value of the product through product enhancements, including the ongoing development of the Acthar Gel self-injection device, which will create an easier and more patient-friendly application for single unit dosage indications.
INOmax (nitric oxide) gas, for inhalation (‘INOmax’) is a vasodilator that, in conjunction with ventilatory support and other appropriate agents, is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks) neonates with hypoxic respiratory failure (‘HRF’) associated with clinical or echocardiographic evidence of pulmonary hypertension. INOmax is also approved in Australia for the treatment of perioperative pulmonary hypertension in adults in conjunction with cardiovascular surgery. Additionally, the company’s Phase 4 registry assessing INOmax for the treatment of pulmonary hypertension in premature (27 to 34 weeks) and term and near-term neonates was completed early in February 2020 due to achievement of the pre-specified primary outcome measure of non-inferiority. The decision to end the study early was made following the second planned interim analysis at 75% enrollment. The interim analysis assessed 54 premature and 84 term and near-term neonates and reflected that the trial achieved the significance level for non-inferiority. Evaluation of significant improvement for each neonate is based on at least a 25% decrease in oxygenation index or surrogate oxygenation index during the INOmax treatment period.
INOmax is marketed as part of the INOmax Total Care package, which includes the drug product, proprietary drug-delivery systems, technical and clinical assistance, 24/7/365 customer service, emergency supply and delivery and on-site training. The development and subsequent FDA submission of a 510(k) premarket notification application was completed in September 2022 for an investigational inhaled nitric oxide delivery system for INOmax gas, for inhalation. If cleared, this next generation inhaled nitric oxide delivery system will offer a compact, portable design that will further enhance the safety of the product, as well as the simplicity and flexibility of use in a number of settings.
Therakos photopheresis (‘Therakos’) is focused on providing innovative immunotherapy treatment platforms that enhance the ability of a patient's immune system to fight disease. Therakos is a global leader in autologous immunotherapy delivered through extracorporeal photopheresis (‘ECP’) and provides the only integrated ECP system in the world. ECP involves drawing blood from the patient, separating white blood cells from plasma and red blood cells that are returned to the patient, and treating the white blood cells with an Ultraviolet-A (‘UVA’) light activated drug. The treated white blood cells are immediately re-administered back into the patient. ECP is approved by the FDA for use in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (‘CTCL’) that is unresponsive to other forms of treatment. Outside the U.S., ECP is approved to treat several other serious diseases that arise from immune system imbalances. Therakos' product suite, which is sold to hospitals, clinics, academic centers and blood banks, includes an installed system, a disposable procedural kit used for each treatment and a drug, UVADEX (methoxsalen) Sterile Solution (‘UVADEX’), as well as instrument accessories and instrument maintenance and repair services.
StrataGraft (allogenic cultured keratinocytes and dermal fibroblasts in murine collagen - dsat) (‘StrataGraft’) regenerative skin tissue is an allogeneic cellularized scaffold product derived from keratinocytes grown on gelled collagen containing dermal fibroblasts indicated for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns). StrataGraft is designed to deliver viable cells to support the body's own ability to heal. StrataGraft contains metabolically active cells that produce and secrete a variety of growth factors and cytokines. Growth factors and cytokines are known to be involved in wound repair and regeneration. The product is designed with both dermal and epidermal layers composed of well-characterized human cells. StrataGraft is intended to be applied in appropriate aseptic conditions, such as the operating room, and can be sutured, stapled or secured with a tissue adhesive.
During the first quarter of fiscal 2022, the company released its first commercial shipment of StrataGraft. The FDA granted StrataGraft orphan drug designation, and it was among the first products designated by the FDA as a Regenerative Medicine Advanced Therapy (RMAT) under the provisions of the 21st Century Cures Act. At the time of approval, the FDA awarded the company a Priority Review Voucher (‘PRV’), which has been sold pursuant to an asset purchase agreement dated June 30, 2022. In June 2021, the FDA had approved the StrataGraft biologics license application (‘BLA’) for deep partial-thickness. The company is conducting a StrataGraft continued access clinical trial under an expanded access program. The trial sites involved in the pivotal Phase 3 trial have the opportunity to participate in this multicenter, open-label study. Overall, 52 patients were enrolled. There were no unexpected wound or StrataGraft-related events. The safety results were consistent with prescribing information and patients treated achieved durable wound closure without autografting and thus showed expected clinical benefit in this population. The company is conducting a Phase 2 trial to evaluate StrataGraft for the treatment of adults with full-thickness burns (also referred to as third-degree burns) and a pediatric study evaluating StrataGraft in the treatment of pediatric populations.
The Biomedical Advanced Research and Development Authority (‘BARDA’) expressed interest in StrataGraft as a medical countermeasure in response to large-scale burn incidents, and provided funding and technical support for the continued development of StrataGraft. These efforts are part of BARDA's strategy to build emergency preparedness in response to mass casualty events involving trauma and thermal burns by developing novel medical countermeasures for adult and at-risk populations. In the case of a mass casualty thermal burn event, the Government Accountability Office estimates that more than 10,000 patients might require thermal burn care. The limited number of specialized burn centers and related medical infrastructure in the U.S. creates a public health need for therapies that could be deployed quickly for use in these and other care sites.
Terlivaz (terlipressin) (‘Terlivaz’) is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (‘HRS’) type 1 (collectively ‘HRS-1’) with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization. The FDA granted Terlivaz orphan drug designation. Terlivaz is one of the most studied pharmacological agents in HRS-1 with more than 70 published manuscripts and presented abstracts on clinical data to date. The FDA approval was based, in part, on results from the Phase 3 CONFIRM trial, the largest-ever prospective study (n=300) conducted to assess the safety and efficacy of Terlivaz in patients with HRS-1 in the U.S. and Canada. The CONFIRM trial met its primary endpoint of Verified HRS Reversal, defined as renal function improvement, avoidance of dialysis and short-term survival. It has been approved outside the U.S. for more than 30 years and is available on five continents for its indications in the countries where it is approved. Terlivaz is recommended for line use by both the American Association for the Study of Liver Diseases and the American College of Gastroenterology guidelines. On September 14, 2022, the company announced the FDA had approved Terlivaz for injection and during the fourth quarter of fiscal 2022, the company released the company’s first commercial shipment of the product.
Amitiza (lubiprostone) (‘Amitiza’) is approved by the FDA for the treatment of chronic idiopathic constipation in adults, irritable bowel syndrome with constipation in women 18 years of age and older, and opioid-induced constipation in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent opioid dosage escalation. Amitiza is a chloride channel type-two activator that increases fluid secretion and motility of the intestine, facilitating passage of stool. Amitiza is a leading global product in the branded constipation market. Of the branded products currently marketed, only Amitiza is approved for three constipation indications in the U.S.
Specialty Generics segment
The company’s Specialty Generics segment is focused on providing the company’s customers high-quality specialty generic drugs and APIs. Specialty Generics include a variety of product formulations containing hydrocodone-containing tablets, oxycodone-containing tablets and several other controlled substances for the treatment of pain. Other controlled substances products include medicines used to treat attention-deficit/hyperactivity disorder (‘ADHD’) and addiction treatment medications. The company’s near-term pipeline in this segment includes the expected launch of several new products in the next few years, with additional products in development long-term. Within this segment, the company provides bulk API products, including acetaminophen, mixed amphetamine salts, opioids and stearates, to a wide variety of pharmaceutical companies, many of which are direct competitors of the company’s Specialty Generics finished dosage business. In addition, the company uses its APIs for internal manufacturing of its finished dosage products.
The company is among the world's largest manufacturers of bulk acetaminophen and the only producer of acetaminophen in the North American and European regions with manufacturing facilities exclusively in the U.S. The company manufactures controlled substances under the U.S. Drug Enforcement Administration (‘DEA’) quota restrictions, and in calendar 2022, the company received approximately 36.4% of the total DEA quota provided to the U.S. market for the controlled substances the company manufactures. The company’s market position in the API business and allocation of quota-governed controlled substance materials from the DEA is a competitive advantage for the company’s API business and, in turn, for the company’s Specialty Generics segment. The strategy for the company’s API business is based on manufacturing large volumes of high-quality product and customized product offerings, responsive technical services and timely delivery to the company’s customers.
The company markets these products principally through independent channels, including drug distributors, specialty pharmaceutical distributors, retail pharmacy chains, food store chains with pharmacies, pharmaceutical benefit managers that have mail order pharmacies and hospital buying groups.
Research and Development
Specialty Brands
The company’s research and development (‘R&D’) resources are primarily devoted to its branded products. The company’s R&D investments center on supporting the company’s late-stage product development, maximizing new product launches and accelerating additional lifecycle management opportunities, inclusive of new product enhancements, line extensions and geo-expansions that provide value to patients, physicians and payers. The company’s strategy focuses on growth, including pipeline opportunities related to late-stage development products to meet the needs of underserved patient populations, where the company execute on the development process and perform clinical trials to support regulatory approval of new products.
Data generation is an important strategic driver for the company’s products, as they extend evidence in approved uses, label enhancements and new indications. The company’s data strategy is realized through investments in both clinical and health economic activities. The company is committed to supporting research that helps advance the understanding and treatment of a variety of different disease states that will further the understanding and development of the company’s marketed products, including Acthar Gel, INOmax, Therakos, StrataGraft and Terlivaz.
Specialty Generics
The R&D efforts in this segment are focused on hard-to-manufacture pharmaceuticals with difficult-to-replicate pharmacokinetic profiles and products that would benefit from the company’s vertically integrated manufacturing capabilities. The company’s Specialty Generics pipeline consists of a number of products in various stages of development. The company performs most of its development work at the company’s Specialty Generics headquarters and technical development center in Webster Groves, Missouri.
The company is developing a number of complex generic pharmaceutical products that take advantage of the company’s API and drug product manufacturing capabilities, as well as the company’s experience in working with API and contract manufacturing organizations. The company has five Abbreviated New Drug Applications (‘ANDA(s)’) at various stages of review with the FDA and a diverse portfolio of oral, solid and parenteral formulations under development. The company’s pipeline is focused on applying its capabilities to develop difficult formulations, utilizing the company’s expertise in working with controlled substances to develop potent products, and expanding both its therapeutic and technology platforms into areas with less competitive pressure. The company utilizes its proven abilities to design around competitor patents to advance both the company’s API and drug product development opportunities and to create the company’s own intellectual property.
To facilitate the company’s development efforts, the company has a multipurpose commercial production facility and pilot plant in St. Louis, Missouri, where the company tests and scales its manufacturing processes for new products. This also allows the company to more rapidly and economically develop certain drug product submissions, all under one roof at the company’s pilot plant, with a limited amount of API or drug product. This facility was converted to dual purpose for both pilot and commercial manufacturing in 2018, and the first product from this facility was approved and launched in 2020.
Intellectual Property
The patents and patent applications that relate to the company’s major marketed products include:
Acthar Gel: The company has four U.S. patents that relate to Acthar Gel. These patents expire from 2031 to 2034. The Acthar Gel is protected primarily by trade secrets. In addition, the company continues its efforts to pursue product enhancements, including the ongoing development of the Acthar Gel self-injection device, for which the company has additional pending patent applications in the U.S.
INOmax. The company has a portfolio of the U.S. and non-U.S. patents and patent applications for INOmax and related technologies. These include over 100 issued patents, expiring between 2023 to 2039, and numerous pending patent applications in the U.S., and over 700 issued patents, expiring between 2026 to 2037, and numerous pending patent applications in other countries.
Therakos. The company has 23 issued patents and two pending patent applications relating to Therakos in the U.S. These issued patents expire from 2023 to 2037. The company also has 235 issued patents, expiring from 2023 to 2036, relating to Therakos in other countries. The company has filed additional patent applications for this product.
StrataGraft. The company’s patent portfolio relating to StrataGraft includes 30 issued patents, expiring from 2022 to 2034, and numerous pending patent applications in the U.S. StrataGraft is protected by a mix of patents and trade secrets.
Terlivaz. The company has one issued patent, expiring in 2037, and a number of pending patent applications in the U.S. that relate to Terlivaz.
Amitiza: The company has four patents listed in the Orange Book that will expire from 2025 to 2027. The company also obtained patent protection in Japan that will expire from 2023 to 2027.
Regulatory Matters
In the U.S., the company must comply with laws, regulations, guidance documents and standards promulgated by the FDA, the Department of Health and Human Services (‘HHS’), the DEA, the Environmental Protection Agency (‘EPA’), the Customs Service and state boards of pharmacy.
The company is also subject to the Foreign Corrupt Practices Act of 1977 (‘FCPA’) and similar worldwide anti-bribery laws in non-U.S. jurisdictions, such as the United Kingdom (‘U.K.’) Bribery Act of 2010, which generally prohibit companies and their intermediaries from making improper payments to non-U.S. officials for the purpose of obtaining or retaining business.
The company has also implemented a comprehensive controlled substances compliance program, including SOM and anti-diversion efforts and the company regularly assists federal, state and local law enforcement and prosecutors in the U.S. by providing information and testimony on its products and placebos for use by the DEA and other law enforcement agencies in investigations and at trial.
The company’s compliance program's design addresses its FDA, healthcare anti-kickback, anti-fraud, and anti-bribery-related risks. The company has complied with reporting obligations of the Sunshine Act and relevant state disclosure laws and have implemented a program across the company to track and report data per CMS guidance and state disclosure requirements.
Outside the U.S., the company must comply with laws, guidelines and standards promulgated by other regulatory authorities that regulate the development, testing, manufacturing, distribution, marketing and selling of medicinal products and medical devices, including, but not limited to, Health Canada, the Medicines and Healthcare Products Regulatory Agency (‘MHRA’) in the U.K., the European Medicines Agency (‘EMA’), the European Commission and member states of the E.U. and their competent authorities such as the Irish Medicines Board, the Therapeutic Goods Administration in Australia, the Ministry of Health and Welfare in Japan, the European Pharmacopoeia of the Council of Europe and the International Conference on Harmonization. Although international harmonization efforts continue, many laws, guidelines and standards differ by region or country. The company markets its products in Canada, in various countries in the E.U., and in the Latin American, the Middle Eastern, African and the Asia-Pacific regions.
Sales, Marketing and Customers
Sales and Marketing
The company markets its branded products to physicians (including neurologists, rheumatologists, hepatologists, nephrologists, pulmonologists, ophthalmologists, oncologists, neonatologists and surgeons), other health care providers, including respiratory therapists, pharmacists, pharmacy buyers, hospital procurement departments, ambulatory surgical centers and specialty pharmacies. The company distributes its branded and generic products through independent channels, including wholesale drug distributors, specialty pharmaceutical distributors, retail pharmacy chains, hospital networks, ambulatory surgical centers and governmental agencies. In addition, the company contracts with group purchasing organizations (‘GPO(s)’) and managed care organizations to improve access to the company’s products. The company sells and distributes API directly or through distributors to other pharmaceutical companies.
Customers
The company’s customers are FFF Enterprise, Inc. and CuraScript, Inc.
Seasonality
The company has historically experienced fluctuations in the company’s business resulting from seasonality. For example, Acthar Gel has typically experienced lower net sales during the first calendar quarter (year ended December 2022) compared to other calendar quarters, which is partially attributable to effects of annual insurance deductibles and the lack of warm temperatures that may exacerbate certain medical conditions.
Research and Development (R&D) Expenses
The company’s R&D expenses for the period June 17, 2022 through December 30, 2022 (Successor) were $64.2 million. R&D expenses for the period January 1, 2022 through June 16, 2022 (Predecessor) were $65.5 million.
Competition
Specialty Generics
Major competitors of the company’s Specialty Generics products include Rhodes Pharmaceuticals LP, Teva Pharmaceutical Industries Ltd., Aurobindo Pharma Ltd., Amneal Pharmaceutical Ltd., Noramco, Inc. and Johnson Matthey plc, among others.
History
Mallinckrodt plc was founded in 1867. The company was incorporated in 2013.
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