Chapter
1. Introduction
1.1. Scope of Report
1.2. Overview of Combination Products
1.3. Rationale for Combination Products (Drug-Drug)
Increased Compliance and Efficacy
Product Life Extensions
-Patent Extensions
-Exclusivity
1.4. Rationale for Drug-Device or Biological-Device Combinations
Chapter 2. FDA’s Guidelines on Combination
Products
2.1. Single Entity Products Regulations
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research
2.2. Combination Products Regulations
Drug-Drug Combinations
-Two Previously Approved Drug Components
-One Previously Approved and One New Molecular Entity
-Two New Molecular Entities
Drug-Device, Drug-Biological, Device-Biological, or Drug-Device-Biological
Combinations
-The Office of Combination Products
-Primary Mode of Action
Chapter 3. Combination Therapies Product Development
3.1. Fixed-Dose Combinations Product Development
Chemistry, Manufacturing, and Controls
-Techniques to Create Fixed-Dose Combination Products
Preclinical Studies
Clinical Studies
-Factorial Studies
Examples of Fixed-Dose Combination Product Studies
-Hyzaar (losartan and hydrochlorothiazide)
-Prevacid NapraPAC (lansoprazole/naproxen)
--Clinical Studies: Risk Reduction of NSAID-Associated Gastric Ulcer
3.2. Drug/Device/Biological Combinations Product Development
Chemistry, Manufacturing, and Controls
Preclinical Studies
Clinical Studies
FDA Review
Chapter 4. Business Issues of Combination Products
4.1. Patents and Exclusivity
The Pharmaceutical Company’s View
Combining Therapies to Extend Patent Life
4.2. Partnering Issues
Vytorin
Sustiva Plus Truvada
Artesunate Plus Amodiaquine
Chapter 5. Marketplace Issues
5.1. Pricing
5.2. Reimbursement Issues
5.3. Development Issues
5.4. Personalized Medicine: Implications of a Race-Based Combination Treatment
Chapter 6. Examples of Combination Therapies
6.1. Fixed-Dose Combinations
Cardiovascular Agents Including Dyslipidemia Combinations
-Antihypertensive Combinations
-Antihypertensive/Lipid-Lowering Combinations
-Lipid-Lowering Combinations
HIV/AIDS
-Guidance for Industry: Fixed-Dose Combination and Co-Packaged Drug Products
for Treatment of HIV
-HIV Medications
--Reverse Transcriptase Inhibitors
--Protease Inhibitors
Inflammation
-Arthrotec
--Costs
-Prevacid NapraPAC
Anti-Infective Combination Therapies
Oral Contraceptives
Biological-Biological Combination Products
-Vaccines
6.2. Drug/Biologic-Device Combination Products
Drug-Device Combination Products
-Coronary Drug-Eluting Stents
-American Heart Association’s Heart Disease and Stroke Statistics - 2004
Update
-PTCA/Balloon Angioplasty
-Stent Procedure
-In-Stent Restenosis
-New Techniques to Prevent Restenosis: Drug-Eluting Stents
-Stent Technology
Antibiotic Bone Cement
Halogen-Light Source Combination
Diagnostic Combination Products
-Helicobacter pylori Detection Test
Drug-Delivery Device Combinations
-Asthma Inhalers
-LidoSite
Device-Biological Combination Products
-Interactive Wound-Care
-Absorbable Collagen Sponge With Genetically Engineered Human Protein
Drug-Biological Combination Products
-Interferon-Ribavirin Combination
-Antibody-Drug Conjugates
Chapter 7. Company Profile: CombinatoRx, Inc.
7.1. Overview: CombinatoRx, Inc.
Technology
Oncology
Immuno-Inflammatory Program
Partnerships
Chapter 8. Conclusions
References
Index
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