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Author / Researcher : Global Business Intelligence Research

Report Statistics

Number Of Pages/Tabs : 87

Number Of Charts : N/A

Published Date : 10/01/2015

Industries : Multiple

Countries : All

Quality Score : 5

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Frontier Pharma: Obesity - Identifying and Commercializing First-in-Class Innovation
Frontier Pharma: Obesity - Identifying and Commercializing First-in-Class Innovation Summary Obesity is a major growing health concern around the world.

In most markets, a person is considered obese if their Body Mass Index (BMI) exceeds 30 kilograms per square meter (kg/m2), calculated by dividing body mass in kilograms by height in meters squared.

With the global prevalence continuing to rise, the disease has placed significant burden on healthcare expenditure, as it is also a major risk factor for cardiovascular diseases, diabetes and cancer. Anti-obesity pharmacotherapy can be used as an adjunct lifestyle modification to improve weight loss in order to significantly reduce obesity-associated health risks in obese patients.

However, the use of currently available anti-obesity drugs is largely limited by poor long-term safety and a modest weight loss effect.

Despite substantial clinical and regulatory challenges, the early-stage obesity pipeline remains robust, containing a high level of first-in-class innovation that has the potential to be translated into effective and safe weight loss treatments. Scope Historically, the obesity market has suffered from long-term safety concerns and modest efficacy with current treatments, both of which contribute to the low prescription rate and limited widespread use. - What are the main safety concerns that lead to significant challenges in gaining drug approval in obesity? - Why is sustainable weight loss difficult to achieve, and what is the implication for future drug development? Analysis reveals a high level of innovation and diversity in the pipeline, with 75 first-in-class programs identified to act on 60 unique molecular targets. - What is the dominant target family across these first-in-class pipeline products? - How well do they align with the underlying signaling pathways governing the central and peripheral regulation of food intake, and energy expenditure? Some first-in-class targets are deemed more likely to be developed into marketable treatments than others, having demonstrated substantial body weight reduction in Preclinical studies and addressing multiple mechanisms underpinning the development of obesity. - What is the scientific rationale behind these targets? How are they likely to surpass existing treatment? - Apart from body weight change, what other parameters are commonly used to measure the effect of investigational therapies? Deals involving first-in-class obesity products are more likely to be made in earlier stages of development than non-first-in-class deals, supported by industry-wide analysis. - What is the dominant molecular target in the obesity deals landscape? - What are the promising first-in-class products still available for future licensing? Reasons to buy This report will allow you to - - Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the available treatment options and their limitations in terms of safety and efficacy. - Visualize the composition of the obesity market to highlight the current unmet needs in order to gain a competitive understanding of the key opportunities. - Analyze the obesity pipeline and stratify by stage of development, molecule type, and molecular target; the diversity of molecular targets in the pipeline is extremely encouraging as obesity is characterized by the complex interplay between central and peripheral mechanisms. - Assess the therapeutic potential of first-in-class targets using a proprietary matrix that assesses and ranks first-in-class products according to clinical potential. - Target the most promising and innovative obesity products for early-stage investment by analyzing trends in licensing and co-development deals and accessing a curated list of first-in-class therapies potentially open to deal-making opportunities.

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1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 3
1.2 List of Figures 3
2 Executive Summary 4
2.1 High Unmet Need Remains in the Obesity Market 4
2.2 Highly Innovative and Diverse Pipeline 4
2.3 Deals Landscape Presents Substantial Investment Opportunities 4
3 The Case for Innovation 5
3.1 Growing Opportunities for Biologic Products 6
3.2 Diversification of Molecular Targets 6
3.3 Innovative First-in-Class Product Developments Remain Attractive 6
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 7
3.5 Sustained Innovation 7
3.6 GBI Research Report Guidance 8
4 Clinical and Commercial Landscape 9
4.1 Disease Overview 9
4.2 Disease Etiology 9
4.2.1 Genetics 9
4.3 Disease Pathophysiology 10
4.3.1 Central Regulation of Energy Homeostasis 10
4.3.2 Endocrine Regulation in Energy Balance 11
4.3.3 Adipose Tissue and Regulation of Energy Expenditure 11
4.3.4 Dysregulation of Adipokines and Contribution to Obesity and Related Metabolic Disorders 12
4.4 Epidemiology 13
4.5 Classification and Diagnosis 13
4.6 Co-morbidities 14
4.6.1 Type 2 Diabetes 14
4.6.2 Hypertension 14
4.6.3 Dyslipidemia and Cardiovascular Diseases 14
4.6.4 Respiratory Complications 14
4.6.5 Osteoarthritis 14
4.6.6 Cancer Risk 14
4.7 Prognosis 15
4.8 Treatment Algorithm and Options 15
4.8.1 Lifestyle and Behavioral Modification 15
4.8.2 Bariatric Surgery 15
4.8.3 Pharmacotherapy 16
4.9 Overview of Marketed Products 18
4.9.1 Molecule Type and Target Analysis 19
4.9.2 Major Drug Withdrawals in the Obesity Market 20
4.9.3 Significant Challenges with Reimbursement in the Obesity Market 20
4.10 Current Unmet Needs 21
5 Assessment of Pipeline Product Innovation 22
5.1 Obesity Pipeline by Molecule Type, Phase and Therapeutic Target 22
5.2 Comparative Distribution of Programs between Obesity Market and Pipeline by Therapeutic Target Family 26
5.3 First-in-Class Pipeline Programs Targeting Novel Molecular Targets 27
6 Signaling Pathways, Genetics and Innovation Alignment 31
6.1 The Complexity of Signaling Networks in Obesity 31
6.2 Signaling Pathways, Genetic Risk Factors and First-in-Class Molecular Target Integration 32
6.3 First-in-Class Target Matrix Assessment 34
7 First-in-Class Target Evaluation 37
7.1 Pipeline Programs Targeting Growth Hormone Secretagogue Receptor 1a and Ghrelin 37
7.2 Pipeline Programs Targeting Neuropeptide Y Receptor 2 40
7.3 Pipeline Programs Targeting Neuropeptide Y Receptor 1 43
7.4 Pipeline Programs Targeting Adipocyte Fatty Acid Binding Protein 4 45
7.5 Pipeline Programs Targeting Sterol Regulatory Element-Binding Protein 1 and 2 47
7.6 Pipeline Programs Targeting Glycoprotein 130 Receptor 49
7.7 Pipeline Programs Targeting Bombesin Receptor Subtype 3 52
7.8 Pipeline Programs Targeting Acetyl-CoA Carboxylase 1 and 2 54
7.9 Pipeline Programs Targeting Stearoyl-CoA Desaturase 1 56
7.10 Pipeline Programs Targeting Bone Morphogenetic Protein-7 59
7.11 Conclusion 62
8 Deals and Strategic Consolidations 63
8.1 Industry-Wide First-in-Class Deals 63
8.2 Licensing Deals 65
8.3 Co-development Deals 72
8.4 First-in-Class Programs Not Involved in Licensing or Co-Development Deals 77
9 Appendix 79
9.1 Abbreviations 79
9.2 References 80
9.3 Methodology 87
9.4 Secondary Research 87
9.5 Contact Us 87
9.6 Disclaimer 87

1.1 List of Tables
Table 1: The International Classification of Underweight, Overweight and Obesity in Adults 13
Table 2: Treatment Options Dependent on Body Mass Index 15

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