First Therapy to Propose Restoration of Neurologic Function as the primary endpoint and the First to Offer the Potential for Elimination of the Autoimmunity Responsible for Multiple Sclerosis

TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals Inc. (NASDAQ:ABPI) has filed a preliminary Investigational New Drug (pre-IND) application with the U.S. Food and Drug Administration (FDA) for Revimmune™ in the treatment of refractory Multiple Sclerosis (MS). The Company has requested a meeting with the FDA within the next 60 days to discuss a proposed pivotal Phase 3 clinical trial involving approximately 270 patients with relapsing/remitting MS with a primary endpoint of improvement in function (reversal of disability). Unlike Revimmune, no other approved therapy for MS has shown a recovery of neurologic function and all others have been approved on the more limited basis of reducing the risk of disease exacerbation or progression. Accentia’s proposal to use the restoration of neurologic function as the endpoint will be the first filed with the FDA.

Based on a clinical study at the Johns Hopkins University School of Medicine, which showed an unprecedented 42% average improvement in function, the Company believes that Revimmune holds the potential to restore function in many patients who have acute deficits due to MS. In addition, the Company believes that the long-term follow-up with patients in the proposed 48-week trial will demonstrate that Revimmune induces not only a reduction of the risk of exacerbations, but potentially also long-lasting remissions and/or cures in MS patients.

Dr. Howard Weiner, an internationally recognized physician and Professor of Neurology at the Harvard Medical School and Co-Director of the Center for Neurologic Diseases at the Brigham & Women’s Hospital, recently conducted a satellite media tour and participated in interviews with television and radio stations across the U.S. to highlight the benefits of using Revimmune to treat MS patients. Key interviews from the tour can be found at www.accentia.net.

The Principal Investigator for the ongoing MS study with Revimmune at Johns Hopkins University School of Medicine is Dr. Douglas Kerr, Associate Professor of Neurology. The co-Principal Investigators on this study are Dr. Daniel Drachman, Dr. Robert Brodsky, and Dr. Adam Kaplin. The National Multiple Sclerosis Society has supported the clinical protocol at Johns Hopkins University.

Developed by Dr. Richard Jones, Dr. Robert Brodsky, and colleagues at the Johns Hopkins University School of Medicine, Revimmune temporarily eliminates peripheral immune cells, including the immune cells causing the autoimmunity, while selectively sparing hematopoeitic stem cells in the bone marrow. 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 a 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 can be administered as an inpatient or outpatient infusion for 4 hours per day for 4 consecutive days. The treatment is intended to allow patients to recover at home while their immune system reconstitutes itself over a 2 to 3 week period. Revimmune includes a risk management program to enhance patient safety by ensuring appropriate patient selection, supportive care, and tracking of outcomes data.

BACKGROUND ON REVIMMUNE CLINICAL RESULTS

Studies at Johns Hopkins University School of Medicine by Dr. Jones, Dr. Brodsky, and colleagues have demonstrated the potential benefits of Revimmune in a variety of autoimmune diseases.

Multiple Sclerosis:

According to information from the National Multiple Sclerosis Society (http://nationalmssociety.org/), there are approximately 400,000 people in the U.S. with Multiple Sclerosis. For the clinical course, 85% of patients are in the category of relapsing-remitting. Based upon a paper by D. Hirtz et al. "How common are the 'common' neurologic disorders?," the annual incidence of Multiple Sclerosis in the U.S. was approximately 4.2 new cases per 100,000 population in 2005.

Revimmune treatment of 20 Multiple Sclerosis patients has resulted in the following successful outcomes in 2 published studies from C. Krishnan, D. Kerr et al. and D. Gladstone et al.:

• All patients have had a reduction or elimination of new and enhancing lesions on the MRI
• No patient has had a clinical exacerbation following treatment and most patients have had a reduction in EDSS and an improvement in the MSFC following treatment
• During follow-up, no patients increased their baseline EDSS scores by more than 1.0
• No patient had a new lesion on brain magnetic resonance imaging; no patient showed any enhancing lesions

Six medicines are currently approved for the treatment of RRMS: interferon β-1b (Betaseron®), interferon β-1a (Avonex® and Rebif®) glatiramer acetate (Copaxone®), mitoxantrone (Novantrone®) and natalizumab (TYSABRI^®). A systematic review of 21 studies failed to reveal a difference among the interferons and glatirimer acetate in reducing the frequency of relapses (Galetta, Markowitz et al., 2002). Interferons were found to be more potent than glatiramer acetate in reducing gadolinium enhancement on MRI, with an 82-89% reduction from pretreatment levels. Disability progression was found to decrease between 12 and 37% in all the pivotal Phase 3 trials compared to placebo treated patients. The vast majority of patients continued to accrue disability as defined by EDSS, MSFC, neuro-cognitive studies, and brain parenchymal fraction (BPF).