July 16, 2017
Per its agreement with the U.S. Federal Trade Commission, Mallinckrodt has completed the license of Synacthen® Depot, a synthenic ACTH product, to West Pharmaceuticals. The license provides West the rights to develop and pursue possible U.S. Food and Drug Administration (FDA) approval of Synacthen Depot in two indications – Infantile Spasms (IS) and Nephrotic Syndrome (NS), along with the exclusive rights to the Synacthen trademark in the U.S.
Mallinckrodt retains the rights to continue manufacturing and marketing Synacthen Depot to patients in other countries around the world, where the company already has rights and, importantly, can continue to develop the product for all other indications in the U.S.
Mallinckrodt is doing so under the developmental name MNK-1411 and has filed an Investigational New Drug (IND) application with the FDA to assess the drug’s potential in the treatment of patients suffering from Duchenne muscular dystrophy (DMD). The company completed a Phase 1 study for MNK-1411 in healthy volunteers, and is using the information that was derived to determine optimal dosing for patients in the Phase 2 trial, which should begin later this year.
The FDA has granted Mallinckrodt’s request for a Fast Track designation for its IND application, and the agency recently also granted MNK-1411 orphan drug designation.
About MNK-1411 (Cosyntropin Injection)
MNK-1411 (cosyntropin injection) is a depot formulation of tetracosactide, a synthetic 24 amino acid melanocortin receptor agonist. The product is approved and marketed outside of the U.S. for certain autoimmune and inflammatory conditions, but has never been approved for use in patients within the U.S.
About Duchenne Muscular Dystrophy (DMD)
DMD is a genetic disorder characterized by progressive muscle degeneration and weakness. It is one of nine types of muscular dystrophy. DMD is caused by an absence of dystrophin, a protein that helps keep muscle cells intact. Symptom onset is in early childhood, usually between ages 3 and 5. The disease primarily affects boys. Symptoms include muscle weakness, which can begin as early as age 3, first affecting the muscles of the hips, pelvic area, thighs and shoulders, and later the skeletal (voluntary) muscles in the arms, legs and trunk.
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and hemostasis products. The company's core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines and its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
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