Accentia Biopharmaceuticals announced that the FDA
has granted orphan drug status for Revimmune Therapy for the prevention of graft-versus-host disease in Bone Marrow Transplant.
The orphan drug status gives ACcentia seven years of market exclusivity once Revimmune is commercialized for the prevention of graft-versus-host disease in bone marrow transplant.
Accentia obtained worldwide exclusive license to Revimmune for the treatment of autoimmune diseases such as multiple sclerosis from Baxter. Revimmune has the active ingredient which is cyclophosphamide (a chemotherapy agent). Under the agreement with Baxter, Accentia is to obtain cyclophosphamide from Baxter. Revimmune was developed by researchers at John Hopkins University, School of medicine. The product works by delivering a novel, patent-pending, ultra-high dose, pulsed administration of cyclophosphamide to reboot a patient's immune system. By delivering a high-dose of cyclophosphamide, the patient's mature lymphocytes will be eliminated but the process spares immune stem cells in the bone marrow. The company has conducted two phase I/II clinical trials at John Hopkins University to assess the safety and efficacy of Revimmune for the prevention of GVHD following partially matched bone marrow transplants.
Interestingly, according to the company website, Accentia is currently developing Revimmune for autoimmmune diseases such as multiple sclerosis. The company's publicly-held, majority-owned subsidiary Biovest International is developing Revimmune for the treatment and prevention of transplant rejection including marrow transplants for the purpose of curing sickle cell anemia.
