Deal would also give firm rights to historical cyclophosphamide dataset.
Accentia has negotiated exclusive, worldwide rights to acquire Baxter’s cyclophosphamide drug, which is marketed as Cytoxan®. Cyclophosphamide is the active ingredient in Accentia’s Phase III-stage Revimmune™ therapy for the treatment of a broad range of autommune diseases including multiple sclerosis.
The deal with Baxter also gives Accentia the right to reference Baxter’s cyclophosphamide dataset for use in the development of Revimmune. The firm will also purchase cyclophosphamide from Baxter. “We believe that the exclusive rights to purchase Cytoxan for designated indications and the ability to reference Baxter’s data related to cyclophosphamide not only assures that Accentia will have access to the highest quality supply of cyclophosphamide, but also facilitates Accentia’s regulatory strategy and reinforces its marketing position,” remarks Samuel S. Duffey, Accentia president. “With this agreement in place, we are planning a robust clinical and regulatory development strategy to advance our mission to establish Revimmune as a new standard of care treatment for patients suffering from autoimmune diseases, including orphan indications with potential accelerated regulatory pathways as well as major indications such as multiple sclerosis.”
Revimmune exploits cyclophosphamide through ultrahigh-dose, pulsed administration that Accentia believes is capable of “rebooting” a patient’s immune system. The treatment is thought to act by completely eliminating mature lymphocytes throughout the body while selectively sparing immune stem cells in the bone marrow, the firm adds. Accentia’s majority-owned subsidiary, Biovest International, is separately developing Revimmune for the treatment and prevention of transplant rejection including bone marrow transplants for sickle cell anemia.
Accentia has licensed the Revimmune technology from its original developers at Johns Hopkins University School of Medicine. The Johns Hopkins researchers have previously published encouraging results from a two-year study evaluating Revimmune in the treatment of aggressive relapsing-remitting multiple sclerosis, the firm points out. In addition to multiple sclerosis, Johns Hopkins scientists have successfully treated a range of autoimmune diseases in preliminary case studies.