Revimmune
(High-Dose Cyclophosphamide) for Autoimmune Diseases

While Accentia has great expectations for Revimmune based on highly encouraging preliminary study results, this product has not yet been approved by the U.S. FDA or any international regulatory agency. Revimmune is also being developed by Biovest International, Inc., Accentia's publicly-held, majority-owned subsidiary, for the treatment and prevention of transplant rejection, including bone marrow transplants for the purpose of curing sickle cell anemia.

About Revimmune™

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 (cyclophosphamide) in a novel, patent-pending, ultra-high dose, pulsed administration 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 without memory of the autoimmunity.

Investigators at Johns Hopkins discovered that stem cells uniquely have high levels of a particular protective enzyme that can be measured in advance of therapy, which makes them impervious to Revimmune, and allows the surviving stem cells to give rise to the new immune system over 2 to 3 weeks. The newly reconstituted peripheral immune system typically lacks the misdirected immunity to self-antigens, which is characteristic of autoimmune diseases.

Revimmune is the world's first therapy to propose the restoration of neurologic and physical functions and offer the potential for the elimination of autoimmunity.

Study Results: Revimmune for Multiple Sclerosis

Researchers from Johns Hopkins University have published encouraging results from a two-year study evaluating the treatment of aggressive relapsing-remitting multiple sclerosis with Revimmune.

An article titled "Reduction of Disease Activity and Disability with High-Dose Cyclophosphamide in Patients with Aggressive Multiple Sclerosis" was published in the Archives of Neurology. It concludes that Revimmune was safe and well-tolerated in patients, and that the therapy resulted in a pronounced reduction in disease activity and disability after treatment which was sustained during the course of follow-up for approximately two years. In contrast, existing approved therapies for the treatment of multiple sclerosis are only intended to slow progression of the disease, not improve the patient's functional status.

Accentia believes these preliminary results to be unprecedented with an average functional score improvement of about 40% in these patients who were tracked for two years after receiving therapy with sustained restoration of their functional improvement. Of those nine patients, eight of them had failed other therapies, and during the course of follow-up, five of them had no signs of disease activity, and the other four showed dramatic improvement over the course of follow-up.

• Hopkins Medicine Features Revimmune: "High Time for HiCy" (2008) (pdf)

Frost & Sullivan Award:

Accentia was awarded the Frost & Sullivan 2007 North American Multiple Sclerosis Product Innovation of the Year Award.

According to Frost & Sullivan Analyst, Barath Shankar Subramanian, "The primary endpoint for Accentia's planned Revimmune Phase III study is the restoration of neurological function, which is a paradigm shift from traditional therapies that focus on reducing relapses. Accentia's innovative positioning and approach to treating autoimmune disease is likely to propel the company as a strong participant in the MS market." In recognition of these factors, Frost & Sullivan is pleased to present Accentia with this Award.

Frost & Sullivan concludes that Revimmune could also potentially alter the high cost of MS therapy for patients. For those patients utilizing traditional therapies, they incur a lifetime of treatment costs, while with Revimmune there is just a one time cost of the treatment regimen. Additionally, Revimmune has the potential to emerge as an effective treatment for several other autoimmune disorders, giving Accentia the potential of addressing a significantly larger patient population that lacks significant therapies.

• Frost & Sullivan Report on Revimmune: "North American MS Product Innovation of the Year" (2008) (pdf)

Other Potential Autoimmune Indications:

In addition to multiple sclerosis, investigators at Johns Hopkins have successfully treated the following autoimmune diseases in preliminary studies and case experiences: Systemic Lupus; Myasthenia Gravis; Aplastic Anemia; Autoimmune Hemolytic Anemia; Refractory Scleroderma; Acquired Pemphigus; Rheumatoid Arthritis and Crohn's Disease.