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

Slides:

Advertisements

Similar presentations

Single-Patient Use of Investigational Drugs and Biologic Products for Treating Cancer Grant Williams, M.D. Medical Team Leader DODP/CDER/FDA.

Advertisements

1 Oxypurinol for Gout Arthritis Drugs Advisory Committee June 2, 2004 Cardiome Pharma Corp Vancouver, BC Canada.

CR-1 ATACAND ® (candesartan cilexetil) Cardiovascular and Renal Drugs Advisory Committee Bethesda, Maryland July 18, 2002 C.

Clinical Trials Importance in future therapies. What are the Requirements to Produce New Drugs? Drug must work significantly better than a control treatment.

Clinical Trials — A Closer Look. The Food and Drug Administration (FDA) is the main consumer watchdog for numerous products: Drugs and biologics (prescription.

TAXOL® (paclitaxel) for Adjuvant Treatment of Node Positive Breast Cancer Oncologic Drugs Advisory Committee September 17, 1999.

A-1 Pravastatin-Aspirin Introduction Todd Baumgartner, MD, MPH Vice President Regulatory Sciences Pharmaceutical Research Institute Bristol-Myers Squibb.

AGGRENOX TM Advisory Committee Meeting. Manfred Haehl, MD Senior Vice President, Medical & Drug Regulatory Affairs Boehringer Ingelheim Pharmaceuticals,

Clinical Investigation of Neurological Channelopathies (CINCH) Landmarks September 22, 2008 Robert C. Griggs, M.D. Barbara E. Herr, MS, CCRC Richard Barohn,

Effectiveness Evaluation for Therapeutic Drugs for Non-Food Animals

INVESTIGATIONAL DRUG SERVICES IN THE HOSPITAL Sheree Miller, Pharm.D. University of Washington Medical Center

CR-1 Concluding Remarks and Risk/Benefit Summary Mace L. Rothenberg, MD Professor of Medicine Vanderbilt Ingram Cancer Center.

Entrepreneurship in Biotechnology Columbia University Graduate School of Arts and Sciences BIOT 4180 Columbia University GSAS BIOT 4180.

1 The Chemoprevention of Sporadic Colorectal Cancer Issues Surrounding a Benefit/Risk Analysis in Clinical Trials Mark Avigan MD CM Medical Officer Division.

Approved Products for the Treatment of CMV Retinitis in Immunocompromised Patients William M. Boyd, M.D. Division of Anti-inflammatory, Analgesic, and.

1 Lotronex ® (alosetron HCl) Tablets Risk-Benefit Issues Victor F. C. Raczkowski, M.D. Director, Division of Gastrointestinal and Coagulation Drug Products.

July 2015 PRABHAVATHI FERNANDES, PhD Founder, President and CEO How the PATH Act Can Rejuvenate Antibiotic R & D.

ODAC SCHERING-PLOUGH RESEARCH INSTITUTE 1 Temozolomide Oncology Drug Advisory Committee March 13, 2003 Craig L. Tendler, M.D. Vice President, Oncology.

CI-1 Exelon ® (rivastigmine) United States Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory Committee May 17, 2006.

CD-1 Update on the Safety of Erythropoietin Products in Patients With Cancer Martine George, MD Vice President, Therapeutic Area Head Hematology and Oncology.

CI-1 Foradil ® (formoterol fumarate inhalation powder) FDA Advisory Committee Meeting July 13, 2005 FDA Advisory Committee Meeting July 13,

1 Kepivance™ (Palifermin) Basis for Approval and Pediatric Studies Kepivance™ (Amgen) Approved 12/15/04 Joseph E. Gootenberg, M.D. Office of Oncology Drug.

Nonclinical Perspective on Initiating Phase 1 Studies for Small Molecular Weight Compounds John K. Leighton, PH.D., DABT Supervisory Pharmacologist Division.

Investigational Drugs in the hospital. + What is Investigational Drug? Investigational or experimental drugs are new drugs that have not yet been approved.

Joint Meeting of Anti-Infective Drugs & Drug Safety and Risk Management Advisory Committees December 14-15, 2006 Ketek  (telithromycin) Regulatory History.

The SNM Centralized IND & Clinical Trials Network Enabling Implementation Investigational & Approved PET Imaging in Multicenter Clinical Trials George.

Drug - Device Combination Issues : Oncology Perspective Ramzi Dagher, M.D. DODP/CDER/FDA.

1 Proton-Pump Inhibitor (PPI) Template for Pediatric Written Requests Pediatric Advisory Subcommittee of the Anti- Infective Drug Advisory Committee Hugo.

Single Patient Use of Investigational Anticancer Agents: An Industry Perspective Gerard T. Kennealey, MD Vice President, Clinical Research, Oncology AstraZeneca.

CI-1 Certican ® (everolimus) Cardiovascular and Renal Drugs Advisory Committee Meeting November 16, 2005.

CI-1 CRESTOR ® (rosuvastatin calcium) Tablets Endocrinologic and Metabolic Drugs Advisory Committee Bethesda, Maryland July 9, 2003 C.

CI-1 Zelnorm ® (tegaserod maleate) Gastrointestinal Drugs Advisory Committee Meeting July 14, 2004 Gastrointestinal Drugs Advisory Committee Meeting July.

1 1 Zelnorm ® (tegaserod maleate) Advisory Committee Presentation Gastrointestinal Drugs July 14, 2004.

Cardiovascular Risk and NSAIDs Arthritis Advisory Committee Meeting November 29, 2006 Sharon Hertz, M.D. Deputy Director Division of Analgesia, Anesthesia,

May Disclosures Philip L. McCarthy Jr. BMT Program Roswell Park Cancer Institute, Buffalo, NY –Participated in Dor Pharma acute Graft-versus-Host.

Pulmonary-Allergy Drugs Advisory Committee May 1, 2007 FDA Presentation Advair Diskus 500/50 Carol Bosken, MD, ScM, MPH Medical Officer Division of Pulmonary.

1 George B. McDonald, MD Professor of Medicine, University of Washington Head, Gastroenterology/Hepatology Section, Fred Hutchinson Cancer Research Center.

CI-1 Tarceva ® (erlotinib) Tablets in Combination with Gemcitabine as a 1st-line Treatment of Pancreatic Cancer Presentation to the Oncologic Drugs Advisory.

CR-1 Everolimus Benefit/Risk Assessment Howard J. Eisen, MD Thomas J. Vischer Professor of Medicine Chief, Division of Cardiology Drexel University College.

The New Drug Development Process (www. fda. gov/cder/handbook/develop

Food and Drug Administration Center for Drug Evaluation and Research Lessons Learned from Growth Studies with Orally Inhaled and Intranasal Corticosteroids.

History of Pediatric Labeling

AprepitantAprepitant Division of Gastrointestinal and Coagulation Drug Products Division of Gastrointestinal and Coagulation Drug Products Center for Drug.

EXUBERA® (insulin [rDNA origin] powder for inhalation) Endocrinologic and Metabolic Drugs Advisory Committee Meeting September 8, 2005 Dr. Neville Jackson.

CI-1 ATACAND ® (candesartan cilexetil) Cardiovascular and Renal Drugs Advisory Committee Rockville, Maryland February 24, 2005 C.

IN 1 NDA Gastrointestinal Advisory Committee Meeting Gaithersburg, Maryland June 26, 2000 Gastrointestinal Advisory Committee Meeting Gaithersburg,

IN-1 Oncologic Drugs Advisory Committee Bethesda, Maryland January 31, 2002 C.

Understanding Clinical Trials – Part 2 Georgianne Arnold, MD Professor of Pediatrics University of Pittsburgh Medical Center Pittsburgh Children’s Hospital.

BiDil® (isosorbide dinitrate/ hydralazine HCl)

Exjade® (deferasirox; ICL670) NDA

1 Presented at the March 13, 2003 Oncologic Drugs Advisory Committee meeting By Stephen Howell, M.D. Skyepharma, Inc.

TAXOL® (paclitaxel) for Adjuvant Treatment of Node Positive Breast Cancer Oncologic Drugs Advisory Committee TAXOL® (paclitaxel) for Adjuvant Treatment.

What about VIOXX?. Adenomatous Polyp Prevention on Vioxx (APPROVe) Vioxx (rofecoxib) versus Placebo Basic Clinical Trial Objective: Assess whether Vioxx.

1 Pain Arthritis Advisory Committee July 30, 2002 James Witter MD, PhD Division of Analgesics, Anti-Inflammatory & Ophthalmologic Drug Products HFD-550.

Agency Review of sNDA SE-006 DOXIL for Ovarian Cancer Division of Oncology Drug Products Office of Drug Evaluation 1 Center for Drug Evaluation.

ACAMPROSATE Lipha Pharmaceuticals, Inc. May 10, 2002 Psychopharmacologic Drugs Advisory Committee Meeting May 10, 2002 Psychopharmacologic Drugs Advisory.

RAPAMUNE ® TM I-1 RAPAMUNE ® WYETH-AYERST RESEARCH January 24, 2002 Subcommittee of the Antiviral Drugs Advisory Committee on Immunosuppressive Drugs January.

Food and Drug Administration Division of Pulmonary and Allergy Drug Products Summary Comments - Orally Inhaled and Intranasal Budesonide and Fluticasone.

REGULATORY HISTORY of ZOMETA and AREDIA JAW OSTEONECROSIS (ONJ) Oncologic Drug Advisory Committee March 4, 2005 Nancy S. Scher, M.D.

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee July 15, 2003 Steven Hirschfeld, MD PhD CAPT USPHS Division of Oncology Drug.

Drug Regulation in Controversy: Vioxx November 10, 2004 Sandra L. Kweder, M.D. Deputy Director, Office of New Drugs Center for Drug Evaluation and Research.

1 Clinical Studies Section of Labeling Joseph Porres, M.D., Ph.D. Medical Officer Division of Dermatologic and Dental Drug Products FDA.

Drug Development Process Stages involved in Regulating Drugs

Industry Perspective: Expanded Access Programs

Clinical Trials — A Closer Look

Clinical Trials in STS Shreyaskumar Patel, M.D.

Speeding access to therapies

Volume 115, Issue 1, Pages (July 1998)

Suzanne M. Sensabaugh, MS, MBA

Phase 2 to phase 3 clinical trial transitions: Reasons for success and failure in immunologic diseases Dhavalkumar D. Patel, MD, PhD, Christian Antoni,

Presentation transcript:

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

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

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

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

5 External Advisors David Hockenbery, MDMember at the Fred Hutchinson Cancer Research Center Lead Investigator, Study ENT 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

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

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

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

9 Development History 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 submitted September 21, 2006

10 Studies of Oral BDP in Patients with GI GVHD Patients enrolled StudyPhaseDescriptionSponsorPlaceboBDPTotal 6151UncontrolledInvestigator initiated UncontrolledInvestigator initiated Single-center, randomized, placebo- controlled Investigator initiated ENT Multicenter, randomized, placebo- controlled Enteron Pharmaceuticals (subsidiary of DOR BioPharma, Inc.) Total

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

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