1. 1 orBec ® (oral beclomethasone dipropionate) NDA 22-062 orBec ® (oral beclomethasone dipropionate) NDA 22-062 DOR BioPharma, Inc. Oncologic Drugs Advisory Committee May 9, 2007 DOR BioPharma, Inc. Oncologic Drugs Advisory Committee May 9, 2007 5030.01

2. 2 Christopher Schaber, Ph.D President & CEO DOR BioPharma, Inc. President & CEO DOR BioPharma, Inc. 5031.01

3. 3 AgendaAgenda Introduction orBec ® beclomethasone dipropionate Acute Graft-vs-Host Disease (GVHD) Rationale for oral BDP Randomized, placebo-controlled trials of oral BDP Summary of clinical trial results Benefit/Risk 5032.01

4. 4 PresenterPresenter George B. McDonald, MD Professor of Medicine, University of Washington Head, Gastroenterology/Hepatology Section, Fred Hutchinson Cancer Research Center ModeratorModerator Timothy C. Rodell, MD Medical Monitor DOR BioPharma, Inc. 5158.01

5. 5 External Advisors David Hockenbery, MDMember at the Fred Hutchinson Cancer Research Center Lead Investigator, Study ENT 00-02 Theodore Gooley, PhDMember at the Fred Hutchinson Cancer Research Center Lead Statistician, Study 875 Keith Sullivan, MDDuke University Medical Center Chief, Medical Oncology and Transplantation 5033.01

6. 6 DOR BioPharma, Inc. Focused on treatments for –Life-threatening side effects of cancer treatments –Serious GI diseases Enteron Pharmaceuticals is a wholly owned subsidiary of DOR BioPharma, Inc. 5034.01

7. 7 Beclomethasone Dipropionate Diester of beclomethasone, a potent synthetic corticosteroid Anti-inflammatory and immunosuppressive effects Widely used in topical applications –Inhaled –Intranasal –Enema 5035.01

8. 8 NomenclatureNomenclature BDP –Beclomethasone dipropionate Oral BDP –Formulation  Immediate-release (IR) tablet (1 mg)  Delayed-release, enteric-coated (EC) tablet (1 mg) –Proposed dosing  1 IR and 1 EC 4 times daily orBec ® –Proposed trade name for oral BDP 5036.01

9. 9 Development History 5037.01 1991 Oral BDP development began (Investigator-Initiated IND) 1991 Development funded by FDA Orphan Drugs Division 1995 Phase 1 trial completed (Study 615) 1998 Phase 2 trial completed (Study 875) 1998 Orphan Indication Designation 1999 Ownership was transferred to Enteron Pharmaceuticals 2000 Fast Track Designation 2005 Pivotal Phase 3 trial completed under Special Protocol Assessment (SPA), Division of Gastrointestinal and Coagulation Drug Products (Study ENT 00-02) 2006 NDA 22-062 submitted September 21, 2006

10. 10 Studies of Oral BDP in Patients with GI GVHD Patients enrolled StudyPhaseDescriptionSponsorPlaceboBDPTotal 6151UncontrolledInvestigator initiated042 15001UncontrolledInvestigator initiated016 8752Single-center, randomized, placebo- controlled Investigator initiated293160 ENT 00-023Multicenter, randomized, placebo- controlled Enteron Pharmaceuticals (subsidiary of DOR BioPharma, Inc.) 6762129 Total96151247 5038.01

11. 11 Basis for Approval Approval is merited based on a favorable safety profile and clinical benefits as measured by reductions in –GVHD treatment failure –Mortality at transplant Day 200 –Mortality 1 year post-randomization 5039.01

12. 12 Proposed Indication for orBec ® (oral BDP) orBec is indicated for the treatment of graft versus host disease (GVHD) involving the gastrointestinal (GI) tract in conjunction with an induction course of high-dose prednisone or prednisolone. 5040.01