“Frontier Pharma: Diabetic Complications – Innovative and Diverse Neuropathies, Nephropathy and Retinopathies Pipelines Demonstrate Shift Towards Disease Modifying Therapies

Summary

Diabetes is a common long-term condition that can lead to a range of disparate and serious complications. It is a lifelong, multi-systemic condition that affects a number of integral organs. Diabetes has a rapidly increasing prevalence – it currently affects 10% of adults globally, and is estimated to become the seventh-leading cause of death by 2030.

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The lack of absolute treatment for the condition and the difficulty in maintaining constant glycemic control, even following adequate treatment, can result in a range of complications. The three main indication groups are diabetic nephropathy, which is a progressive condition caused by damage to the capillaries and kidneys glomeruli as a result of diabetes; diabetic retinopathy, which is defined as damage to the retina as a result of high blood sugar; and a range of diabetic neuropathies, a group of conditions in which nerve damage is caused as a result of diabetes mellitus.

The need for improved therapeutics within diabetic complications is especially prominent in comparison with other multi-systemic conditions, as the market is currently predominantly composed of therapies that symptomatically treat the condition, or at best slow disease progression. However, as the understanding of disease pathophysiology in both diabetes and its complications increases, new targets are being identified and converted into improved therapeutic options that are better aligned with the underlying disease pathophysiology than their predecessors.

The diabetic complications pipeline consists of 429 products that contain an array of targets not currently in use within the market. The increase in molecular target diversity signifies the high potential for changes and improvements in the diabetic complications market. One innovative therapy is CBX-129801, a promising synthetic peptide that is currently in development for diabetic neuropathy. Innovation can also be seen within diabetic retinopathy, with therapies such as BCN070660, a topical ophthalmologic formulation currently in development.

Scope

– What effect do current market therapies have on disease progression?
– Which drug classes dominate the current market?
– What additional benefits have newly approved therapies brought to the market?
– Can the increasing number of peptides in the pipeline prove useful in diabetic neuropathy?
– Can neuroprotective therapies prove an important addition in diabetic retinopathies?
– Can the diverse range of molecule types and molecular targets within the pipeline help reverse disease progression?
– To what degree is the pipeline penetrated by first-in-class innovation?
– What is the clinical potential of first-in-class products, based on their alignment to disease-causing pathways?
– Which are the most promising first-in-class targets in early-stage development?
– Which of the first-in-class products in development are not currently involved in a licensing or co-development deal, and therefore represent investment opportunities?

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Reasons to buy

– Understand the current clinical and commercial landscape. It includes a comprehensive study of disease pathogenesis, diagnosis, prognosis and the treatment options available.
– Visualize the composition of the market for each diabetic complication individually, in terms of dominant molecule types and targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge allows a competitive understanding of gaps in the current market.
– Analyze the pipeline for each diabetic complication individually and stratify by stage of development, molecule type and molecular target. There are strong signs in the pipeline that the industry is seeking more innovative approaches to treating diabetic complications.
– Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix, first-in-class products have been assessed and ranked according to clinical potential. Promising early-stage targets have been reviewed in greater detail.

1 Table of Contents 2
1.1 List of Tables 3
1.2 List of Figures 3

2 Executive Summary 5
2.1 Significant Unmet Needs in Diabetic Complications Market 5
2.2 High Proportion of First-in-Class Innovation Offers Promise in Diabetic Complications 5
2.3 Deal Activity Varies with First-in-Class Status 5

3 The Case for Innovation 6
3.1 Growing Opportunities for Biologic Products 7
3.2 Diversification of Molecular Targets 7
3.3 Innovative First-in-Class Product Development Remains Attractive 7
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 8
3.5 Sustained Innovation 8
3.6 GBI Research Report Guidance 8

4 Clinical and Commercial Landscape 10
4.1 Diabetes Mellitus Overview 10
4.2 Diabetic Neuropathies 11
4.2.1 Disease Overview 11
4.2.2 Signs and Symptoms 11
4.2.3 Epidemiology and Etiology 12
4.2.4 Pathophysiology 12
4.2.5 Diagnosis and Staging 12
4.2.6 Prognosis 13

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