Accentia Biopharmaceuticals, Inc. announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to Revimmune, the company’s proprietary system-of-care based on high-dose administration of Cytoxan (cyclophosphamide), for the treatment of two autoimmune disease indications, systemic sclerosis and autoimmune haemolytic anaemia. Based on a an exclusive world-wide license from Johns Hopkins University and a strategic agreement with Baxter Corporation, Accentia intends to conduct multiple clinical trials evaluating Revimmune therapy for the treatment of a range of autoimmune diseases including multiple sclerosis.

With FDA Orphan Drug Status, Accentia gains seven years of market exclusivity for Revimmune for systemic sclerosis and autoimmune haemolytic anaemia upon its approval by the FDA thereby offering competitive protection from similar drugs of the same class. Orphan Drug Status also provides Accentia with eligibility to receive potential tax credit benefits, potential grant funding for research and development and significantly reduces the requisite filing fees for marketing applications.

Accentia’s chief scientific officer, Dr Carlos Santos, PhD, commented, “There is an urgent unmet medical need for new treatments for systemic sclerosis and autoimmune haemolytic anaemia, as nearly 100,000 patients in the US alone are living with one of these highly debilitating and often deadly autoimmune diseases. Current treatment options, especially in severe cases, are limited with some patients left with no choice but to endure high-risk treatment approaches. However, preliminary open label studies conducted by physicians at Johns Hopkins University have shown that Revimmune therapy is capable of ‘rebooting’ the immune system by eliminating the circulating cells perpetuating the autoimmunity for patients suffering from either systemic sclerosis or autoimmune haemolytic anaemia. Studies published by Johns Hopkins researchers have shown that the majority of those patients treated with Revimmune therapy achieved meaningful clinical benefit and in some cases even underwent complete remissions.”

Last week, Accentia announced that the company had entered into a definitive financing agreement for $ 4 million to support the development of Revimmune. ROTH Capital Partners, LLC acted as the exclusive placement agent to Accentia on the transaction.

Accentia holds the worldwide exclusive license to Revimmune for the treatment of autoimmune diseases, such as multiple sclerosis. Developed by Dr Richard Jones, Dr Robert Brodsky, and colleagues at Johns Hopkins University School of Medicine, Revimmune uses an already-approved active pharmaceutical (Cytoxan) in a novel, patent-pending system-of-care capable of “rebooting” a patient's immune system. Revimmune therapy is believed to act by completely eliminating mature lymphocytes throughout the body while selectively sparing immune stem cells in the bone marrow. Shortly following a course of Revimmune, a natural “rebooting” process takes place as bone marrow stem cells repopulate the immune system with healthy immune cells that no longer possess the traits of autoimmunity.

A strategic agreement with Baxter Healthcare Corporation provides Accentia with the exclusive, worldwide right to purchase Baxter’s cyclophosphamide, which is marketed under the brand name Cytoxan, for the treatment of designated autoimmune diseases including multiple sclerosis.

Accentia Biopharmaceuticals, Inc. is committed to advancing the autoimmune disease therapy, Revimmune, as a comprehensive system of care and drug regimen designed for the treatment of autoimmune diseases.