1

orBecorBec®®

(oral beclomethasone dipropionate)(oral beclomethasone dipropionate)

NDA 22-062NDA 22-062

orBecorBec®®

(oral beclomethasone dipropionate)(oral beclomethasone dipropionate)

NDA 22-062NDA 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

Christopher Schaber, Ph.DChristopher Schaber, Ph.DChristopher Schaber, Ph.DChristopher Schaber, Ph.DPresident & CEO

DOR BioPharma, Inc.

President & CEO

DOR BioPharma, Inc.

5031.01

3

AgendaAgendaAgendaAgenda

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

PresenterPresenterPresenterPresenter

George B. McDonald, MD

Professor of Medicine, University of Washington

Head, Gastroenterology/Hepatology Section, Fred Hutchinson Cancer Research Center

ModeratorModeratorModeratorModerator

Timothy C. Rodell, MD

Medical MonitorDOR BioPharma, Inc.

5158.01

5

External AdvisorsExternal AdvisorsExternal AdvisorsExternal Advisors

David Hockenbery, MD Member at the Fred Hutchinson Cancer Research Center

Lead Investigator, Study ENT 00-02

Theodore Gooley, PhD Member at the Fred Hutchinson Cancer Research Center

Lead Statistician, Study 875

Keith Sullivan, MD Duke University Medical Center

Chief, Medical Oncology and Transplantation

5033.01

6

DOR BioPharma, Inc.DOR BioPharma, Inc.DOR BioPharma, Inc.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

Beclomethasone DipropionateBeclomethasone DipropionateBeclomethasone DipropionateBeclomethasone Dipropionate

Diester of beclomethasone, a potent synthetic corticosteroid

Anti-inflammatory and immunosuppressive effects

Widely used in topical applications– Inhaled– Intranasal– Enema

OCOCH2CH3

OCOCH2CH3

CH3

CH3

H3C

HO

H

HCl

O

O

5035.01

8

NomenclatureNomenclatureNomenclatureNomenclature

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

Development HistoryDevelopment HistoryDevelopment HistoryDevelopment 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

Studies of Oral BDP in Patients with GI GVHDStudies of Oral BDP in Patients with GI GVHDStudies of Oral BDP in Patients with GI GVHDStudies of Oral BDP in Patients with GI GVHD

Patients enrolled

Study Phase Description Sponsor Placebo BDP Total 615 1 Uncontrolled Investigator initiated 0 42 42

1500 1 Uncontrolled Investigator initiated 0 16 16

875 2 Single-center, randomized, placebo-controlled

Investigator initiated 29 31 60

ENT 00-02 3 Multicenter, randomized, placebo-controlled

Enteron Pharmaceuticals (subsidiary of DOR BioPharma, Inc.)

67 62 129

Total 96 151 247

5038.01

11

Basis for ApprovalBasis for ApprovalBasis for ApprovalBasis 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

Proposed Indication for orBecProposed Indication for orBec®® (oral BDP) (oral BDP)Proposed Indication for orBecProposed Indication for orBec®® (oral BDP) (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