September 20, 2017
Lakewood, Colo.--September 20, 2017--Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, announced today that it has expanded its collaboration with Mallinckrodt, a United Kingdom-based business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies, including the THERAKOS® CELLEX® Photopheresis System, an ECP platform. Under the expanded agreement, Terumo BCT will extend its existing Therakos distribution in Latin America and Australia and expand distribution into select countries in Europe and Asia.
"Diseases treated with ECP are generally rare with high unmet patient needs, have high morbidity and limited treatment options. Standard therapy is not always effective. We are pleased to build on our collaboration with Mallinckrodt to leverage our clinical support, technical resources and customer relationships, and to bring photopheresis to more patients," shared Monte Smith, Vice President, Therapeutic Systems, Terumo BCT.
ECP with THERAKOS is a cell-based immunomodulatory therapy that involves collecting peripheral blood that is then centrifuged to separate the white blood cells from the red blood cells and plasma. The red blood cells and plasma are immediately returned to the patient. The white blood cells are treated with a photosensitizing agent and activated by ultraviolet light, which is believed to initiate a reaction from the body's immune system. The treated white blood cells are then promptly reinfused into the patient. While the exact mechanism of action is not known, the treated white blood cells undergo apoptosis, which is believed to trigger an immune response against certain cells.
The Therakos therapeutic platforms, including the THERAKOS CELLEX Photopheresis System, are the only approved, fully-integrated systems for administering autologous immune cell therapy through ECP. The CELLEX system combines state-of-the-art cell collection, photoactivation and reinfusion technologies in a single, integrated, closed system. In addition to enabling a single operator to manage the photopheresis process, the closed-system is designed to reduce the risks of infection, cross-contamination and patient reinfusion errors. Physicians in a variety of countries have used the technology across different immune-modulated conditions based on the individual country marketing authorization.
Terumo BCT is the exclusive distributor in this newly expanded territory, with plans to provide access to CELLEX systems for photopheresis to academic medical centers, hospitals and treatment centers in Australia and in several countries in Latin America, Europe and Asia. This latest generation photopheresis platform will be supported by ongoing service and support managed by Terumo BCT.
"Extending our relationship with Terumo BCT supports our global expansion strategy," said Ron Lloyd, Executive Vice President and President of Hospital Therapies, Mallinckrodt. "Bringing the Therakos clinical experience together with Terumo BCT's global market presence and infrastructure will provide greater access and treatment options for patients globally. Mallinckrodt will concentrate its efforts in European countries, like the UK, Germany and France, where our infrastructure is already well-established and work with Terumo BCT to expand the reach of this important therapy to other markets."
Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction technologies. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.
Therakos immunotherapy is delivered through CELLEX systems to harnesses the power of each individual patient's immune system to fight disease and is used by academic medical centers, hospitals, and treatment centers in more than 25 countries. Therakos ECP systems are fully integrated and U.S. Food and Drug Administration (FDA)-approved for the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) in persons who have not been responsive to other forms of treatment.
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.
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