United States

Profile: Mallinckrodt Plc (MNK)

MNK on New York Consolidated

24 Jun 2019
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Mallinckrodt public limited company, incorporated on January 9, 2013, develops, manufactures, markets and distributes branded and generic specialty pharmaceutical products and therapies. The Company focuses on various therapeutic areas, such as autoimmune and rare disease specialty areas, including neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal critical care respiratory therapies; analgesics and hemostasis products, and central nervous system drugs. The Company's segments include Specialty Brands and Specialty Generics. The Specialty Brands segment produces and markets branded pharmaceutical products and therapies. The Specialty Generics segment produces and markets specialty generic pharmaceuticals and active pharmaceutical ingredient (API) consisting of biologics, medicinal opioids, synthetic controlled substances, acetaminophen and other active ingredients.

Specialty Brands

The Specialty Brands segment markets branded pharmaceutical products for autoimmune and rare diseases, including in the specialty areas of neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; analgesics and hemostasis products, and central nervous system drugs. The Company's 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 promotes its branded products directly to physicians in their offices, hospitals and ambulatory surgical centers, including rheumatologists, neurologists, nephrologists, pulmonologists, neonatologists, ophthalmologists, surgeons and pharmacy directors, with its own direct sales force.

The Specialty Brands segment's product portfolio includes Acthar, Inomax, Ofirmev, Therakos immunotherapy, Hemostasis products and StrataGraft. Acthar is an injectable drug for use in various indications, such as the treatment of proteinuria in nephrotic syndrome of the idiopathic type (NS); the treatment of acute exacerbations of multiple sclerosis (MS) in adults; the treatment of infantile spasms (IS) in infants and children under two years of age; the treatment of the pulmonology indication of sarcoidosis; the treatment of ophthalmic conditions related to severe acute and chronic allergic and inflammatory processes, and the treatment of certain rheumatology-related conditions, including the treatment of the neuromuscular disorders, dermatomyositis and polymyositis. 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 neonates with hypoxic respiratory failure (HRF) associated with clinical or echocardiographic evidence of pulmonary hypertension.

Ofirmev is an intravenous formulation of acetaminophen indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics and the reduction of fever. Therakos immunotherapy is focused on providing immunotherapy treatment platforms that enhance the ability of a patient's immune system to fight disease. Hemostasis products are offered across the spectrum of surgical bleeding with a suite of products and services to help improve hemostasis management. StrataGraft is a viable, full-thickness product being developed for regulatory approval for severe burns and other skin defects.

Specialty Generics

The Specialty Generics segment markets drugs that include a range of product formulations containing hydrocodone, oxycodone and other controlled substances. The Company's API business provides bulk API products, including opioids and acetaminophen, to a range of pharmaceutical companies. In addition, the Company uses its API for internal manufacturing of its finished dosage products. The Specialty Generics segment's product portfolio includes hydrocodone (API) and hydrocodone-containing tablets; oxycodone (API) and oxycodone-containing tablets; methylphenidate HCl extended-release tablets USP (CII) (Methylphenidate ER), and other controlled substances, including acetaminophen (API) products.

The Company competes with Endo Health Solutions Inc., Johnson Matthey plc, Mylan N.V., Pfizer Inc., Purdue Pharma L.P. and Teva Pharmaceutical Industries Ltd.

Company Address

Mallinckrodt Plc

3 Lotus Park, The Causeway
P: +441784.636700

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