-- Collaboration with experts in photopheresis field expected to further enhance understanding of photopheresis' effect on immune modulation across a range of severe and critical conditions --
-- Agreement includes joint development activities for potential next-generation photopheresis system that may benefit patients in multiple disease states --
Mallinckrodt plc (NYSE:MNK), a leading global specialty pharmaceutical company, today announced it has entered into a research collaboration agreement with Transimmune AG, a company developing novel immunotherapies based on its unique understanding of the physiologic processes underlying the activation of antigen-presenting cells. The companies will collaborate on translational research to further expand understanding of the underlying mechanism of action (MOA) for extracorporeal photopheresis, and its application toward the development of potential next-generation photopheresis technology, with plans to expand on Mallinckrodt's current THERAKOS(TM) Photopheresis platform through new clinical trials.
Beyond enhancing MOA understanding and advancing the technology platform, it is also anticipated that the insights gained through the joint research endeavor with the Transimmune experts can expand potential clinical applicability across diverse immune-mediated disease states. If clinical evidence is shown, these conditions may include Cutaneous T-Cell Lymphoma (CTCL), Graft-versus-Host Disease (GvHD), organ transplant rejection and all autoimmune diseases - all exclusively licensed to Mallinckrodt under the agreement.
Transimmune was founded by Richard Edelson, M.D., Lerner Professor of Dermatology, Chair and Professor, Department of Dermatology, Yale University School of Medicine, and a photopheresis pioneer. Dr. Edelson has spent decades studying the photopheresis mechanism of action and founded Transimmune to translate those insights into improving photopheresis therapy.
"Mallinckrodt invests in assets and technologies to further their application in conditions with few or limited therapeutic options, and for the treatment of underserved patients with severe and critical conditions," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer, Mallinckrodt. "This agreement is an example of our model of collaboration and partnership with experts in both basic and clinical research - similar to the recent collaborative research partnership announced with Washington University School of Medicine in St. Louis - to expand our access to innovative science and technology in areas of mutual interest."
Mallinckrodt and Transimmune will establish a joint governance committee consisting of representatives from both companies to oversee, review and coordinate the activities under the agreement.
The companies intend to explore a joint commercial collaboration arrangement related to a next-generation Mallinckrodt photopheresis system. Mallinckrodt is the only provider of an integrated closed loop photopheresis therapy, which is delivered through its latest generation THERAKOS(TM) CELLEX(TM) Photopheresis System.
About Therakos ECP Immunomodulation(TM)
The THERAKOS(TM) Photopheresis platform is the world's only approved, fully-integrated system for administering ECP Immunomodulation. Our system is used by academic medical centres, hospitals and treatment centres in more than 30 countries and has delivered over one million treatments globally.
THERAKOS(TM) Photopheresis Systems are the only CE marked devices for the administration of ECP.
CAUTION: READ THE THERAKOS(TM) UVAR XTS(TM) or THERAKOS(TM) CELLEX(TM) PHOTOPHERESIS SYSTEMS' OPERATOR'S MANUAL PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION.
For the THERAKOS(TM) UVAR XTS(TM)/CELLEX(TM) Photopheresis Procedure:
INDICATIONS
The THERAKOS(TM) UVAR XTS(TM) and THERAKOS(TM) CELLEX(TM) Photopheresis Systems are indicated for the administration of photopheresis.
IMPORTANT SAFETY INFORMATION
Contraindications
THERAKOS(TM) Photopheresis is contraindicated in patients possessing a specific history of a light sensitive disease. THERAKOS(TM) Photopheresis is contraindicated in patients who cannot tolerate extracorporeal volume loss or who have white blood cell counts greater than 25,000 mm3. THERAKOS(TM) Photopheresis is contraindicated in patients who have coagulation disorders or who have previously had a splenectomy.
Warnings and Precautions
THERAKOS(TM) Photopheresis treatments should always be performed in locations where standard medical emergency equipment is available. Volume replacement fluids and/or volume expanders should be readily available throughout the procedure. Both men and women should take adequate contraceptive precautions both during and after completion of photopheresis therapy. Safety in children has not been established.
Adverse Events
- Hypotension may occur during any treatment involving extracorporeal
circulation. Closely monitor the patient during the entire treatment for
hypotension.
- Transient pyretic reactions, 37.7-38.9 degrees Celsius (100-102 degrees
Fahrenheit), have been observed in some patients within six to eight
hours of reinfusion of the photoactivated leukocyte-enriched blood. A
temporary increase in erythroderma may accompany the pyretic reaction.
- Treatment frequency exceeding labelling recommendations may result in
anaemia.
- Venous access carries a small risk of infection and pain.
Please see the appropriate THERAKOS(TM) Photopheresis System Operator's Manual for full product information.
ABOUT MALLINCKRODT
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; analgesics and gastrointestinal products.
