orBecTreatment for Intestinal Graft-versus-Host Disease (iGVHD)
DOR BioPharma Provides Regulatory Update on orBec
MIAMI, June 30, 2006 -- DOR BioPharma, Inc. announced today that it is providing new guidance on the filing of its New Drug Application ("NDA") and Marketing Authorization Application ("MAA") submissions for orBec for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD). DOR's target for submission of the NDA for orBec is now in the July - August timeframe of 2006. DOR's filing target in the EMEA remains by the end of the 3rd Quarter 2006.
Earlier this month, the Company conducted pre-submission meetings with the EMEA assigned rapporteur and co-rapporteur countries, namely the MPA (Medical Products Agency) of Sweden and the Spanish AEMPS (Agencia Espanola del Medicamento and Productos Sanitarios). The meetings were productive, and provided guidance and feedback from the agencies regarding the submission of the orBec MAA in the European Union. The Company will continue to work closely with the EMEA during the next quarter as it prepares its MAA filing.
Michael Sember, President and Chief Executive Officer of DOR commented, "We are very near the end of our NDA assembly and filing program. The delay is due to the complexity and sheer size of the filing process. We remain highly enthusiastic about orBec and its prospects and we are working diligently to file both the NDA and the MAA as soon as possible. Once filed, the NDA will contain additional information specifically requested by the FDA with regard to survival results in a Phase II study of oral beclomethasone (BDP) and our pivotal Phase III orBec study. We have now added positive survival data in support of oral BDP at 200 days post transplant in the Phase II study, and 1 year post randomization and overall survival post randomization from the pivotal Phase III clinical trial. We believe that the additional new survival data will be an important consideration as the regulatory authorities review this dossier."
When approved, we expect that orBec will be indicated for the treatment of GI GVHD associated with allogeneic bone marrow or stem cell transplant (BMT/SCT) procedures. Based on available statistics we estimate that there are approximately 12,000 such procedures annually in the U.S., and a comparable number in Europe. Estimates as to the annual rate of increase in these procedures vary between 2% and 20%. High rates of morbidity and mortality occur in this patient population. The successful treatment of GI GVHD represents an important unmet medical need. The FDA and EMEA have granted orBec an orphan drug designation. Additionally, the FDA has also made a Fast Track Designation. Once submitted, DOR believes that the orBec NDA should qualify for six month priority review from the date of filing.
BMT/SCT is a very costly procedure and requires an intensive use of healthcare resources. Transplant centers are usually reimbursed at a fixed rate of approximately $250,000 per procedure and this is intended to cover all patient follow-up care. Re-hospitalization of these patients places a significant strain on the financial resources of these hospitals. For example, it is estimated that a single re-admission of these patients can cost the institution between $14,000 and $50,000. Under current standard of care, patients have a high rate of re-admission due to relapse of GI GVHD or leukemia. If patients become terminal and enter critical care, the costs mount quickly. In two separate randomized, double-blinded, placebo-controlled trials in GI GVHD, oral BDP and orBec have shown approximately 55% and 67% reductions in mortality at 200 days post transplant.
Posted: June 2006
- DOR BioPharma Announces Results of orBec End of Review Conference with the FDA - December 7, 2007
- DOR BioPharma Receives Not Approvable Letter From FDA for orBec for Treatment of Gastrointestinal Graft-vs.-Host Disease - October 19, 2007
- DOR BioPharma, Inc. Announces 3 Month Extension of FDA PDUFA Action Date for orBec New Drug Application to Review Supplemental Data - July 19, 2007
- DOR BioPharma Files New Drug Application with FDA to Market orBec for GI GVHD - September 22, 2006
- DOR BioPharma Plans FDA NDA and European MAA Filing Strategy for orBec - November 15, 2005
- DOR BioPharma to File NDA for orBec - April 20, 2005