(PharmaNewsWire.Com, May 16, 2017 ) Frontier Pharma: Melanoma Therapeutics - Cytokine and Multiple Targeted Small Molecules and mAbs Dominate Pipeline and First-in-Class Innovation Melanoma is a type of cancer that begins in the melanocytes, often in moles or other pigmented tissues. It most commonly affects the skin, as cutaneous melanoma; however it can also affect other pigmented tissues, such as the eye or intestines, as extracutaneous melanoma. It is the deadliest form of skin cancer and remains one of the most aggressive and treatment-resistant human cancers.
Global prevalence of the disease has risen significantly in the past several decades, primarily due to an increase in exposure to UV light and/or sunlight. This has resulted in an increase in developmental interest with regard to improving disease management, particularly in the advanced metastatic setting. The emergence over the past decade of novel targeted therapies and therapies that manipulate the immune response has improved treatment options for patients. These new drug classes have been highly commercially successful with blockbuster products that are now well established within the treatment algorithm. In spite of these developments, there are still significant unmet needs for both cutaneous and extracutaneous melanoma, and the rationale for investment in first-in-class innovation remains strong. First-in-class products account for a considerable proportion of the melanoma pipeline, which is substantially larger than the current market.
Scope Rising global prevalence and unmet need have resulted in an increase in developmental interest - What is the pathophysiology of melanoma? - How has the emergence of new drug classes in the past decade impacted the treatment algorithm? - What are the most significant unmet needs within the market? The melanoma pipeline is large and innovative in comparison with the current market - Which molecule types and molecular targets are most prominent within the pipeline? - Which first-in-class targets are most promising? - How does the ratio of first-in-class targets to first-in-class products differ by stage of development and molecular target class? - Do melanoma products attract high deal values? - Which molecule types and molecular targets dominate the deals landscape? - Which first-in-class pipeline products have no prior involvement in licensing or co-development deals?
Reasons to buy - Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment strategies currently available. - Visualize the composition of the melanoma market in terms of the dominant classes of therapies. Unmet needs are highlighted to allow a competitive understanding of current gaps in the market. - Analyze the melanoma pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target. There are signs in the pipeline that the industry is seeking novel approaches to meet unmet needs within melanoma. - 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 novel targets have been further reviewed in greater detail. - Identify commercial opportunities in the melanoma deals landscape by analyzing trends in licensing and co-development deals and assessing melanoma therapies that are not yet involved in deals, and may be potential investment opportunities.
Table of Contents 1.1 List of Tables 4 1.2 List of Figures 4 2 Executive Summary 6 2.1 Unmet Need Remains Despite Significant Advances in Therapy Options 6 2.2 Moderately Sized but Innovative Pipeline 6 2.3 Deals Landscape Offers Significant Investment Opportunities for First-in-Class Products 6 3 The Case for Innovation in the Melanoma Market 7 3.1 Growing Number of Opportunities for Biologic Products 8 3.2 Diversification of Molecular Targets 8 3.3 Innovative First-in-Class Product Developments Remain Attractive 8 3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 9 3.5 Sustained Innovation 9 3.6 GBI Research Report Guidance 10 4 Clinical and Commercial Landscape 11 4.1 Disease Overview 11 4.2 Types of Melanoma 11 4.3 Disease Symptoms 13 4.3.1 Cutaneous Melanoma 13 4.3.2 Ocular Melanoma 13 4.3.3 Mucosal Melanoma 13 4.3.4 Melanoma of the Internal Organs and Soft Tissue 13 4.3.5 Advanced Melanoma 13 4.4 Diagnosis 14 4.4.1 Cutaneous Melanoma 14 4.4.2 Ocular Melanoma 14 4.4.3 Mucosal Melanoma 14 4.5 Etiology 15 4.5.1 Phenotypic Characteristics 15 4.5.2 Exposure to Ultraviolet Radiation 16 4.5.3 Inherited Genetic Factors 16 4.5.4 Non-inherited Genetic factors 17 4.5.5 Xeroderma Pigmentosum 17 4.5.6 Parkinson’s Disease 18 4.6 Pathophysiology 18 4.6.1 Cutaneous Melanoma 18 4.6.2 Ocular Melanoma 18 4.6.3 Mucosal Melanoma 19 4.6.4 Underlying Molecular Pathways 19 4.7 Epidemiology 20 4.7.1 Cutaneous Melanoma 20 4.7.2 Ocular Melanoma 21 4.7.3 Mucosal Melanoma 21 4.8 Treatment 21 4.8.1 Surgery 22 4.8.2 Radiation Therapy 22 4.8.3 Pharmacotherapy 23 4.9 Overview of Marketed Products 24 4.10 Current Unmet Need in the Melanoma Market 25 5 Assessment of Pipeline Product Innovation 27 5.1 Melanoma Pipeline by Molecule Type, Stage of Development and Molecular Target 27 5.2 Comparative Distribution of Programs between the Melanoma Market and Pipeline by Molecular Target 31 5.3 First-in-Class Pipeline Programs Targeting Novel Molecular Targets 31 6 Signaling Network and Innovation Alignment 39 6.1 Complexity of Signaling Networks in Melanoma 39 6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration 39 6.3 First-in-Class Matrix Assessment 40 7 First-in-Class Target Evaluation 43 7.1 Pipeline Programs Targeting Insulin Receptor Substrate 2 43 7.1.1 Overview of Pipeline Programs Targeting Insulin Receptor Substrate 2 44 7.2 Pipeline Programs Targeting RAC Serine/Threonine Protein Kinase Alpha, Beta and Gamma 44 7.2.1 Overview of Pipeline Programs Targeting RAC Serine/Threonine Protein Kinase 47 7.3 Pipeline Programs Targeting Thrombospondin-1 47 7.3.1 Overview of Pipeline Programs Targeting Thrombospondin-1 48 7.4 Pipeline Programs Targeting Phosphatidylinositol-4, 5-Bisphosphate 3-Kinase Catalytic Subunit Beta Isoform 49 7.4.1 Overview of Pipeline Programs Targeting Phosphatidylinositol-4, 5-bisphosphate 3-kinase catalytic subunit beta isoform 50 7.5 Pipeline Programs Targeting e3 Ubiquitin Protein Ligase Mdm2 51 7.5.1 Overview of Pipeline Programs Targeting e3 Ubiquitin Protein Ligase Mdm2 52 7.6 Pipeline Programs Targeting Receptor Tyrosine Protein Kinase HER3 53 7.6.1 Overview of Pipeline Programs Targeting Receptor Tyrosine Protein Kinase HER3 54 7.7 Pipeline Programs Targeting Neurogenic Locus Notch Homolog Protein (NOTCH)1, 2, 3 and 4 54 7.7.1 Overview of Pipeline Programs Targeting Neurogenic Locus Notch Homolog Protein 1, 2, 3 and 4 56 7.8 Pipeline Programs Targeting Telomerase Reverse Transcriptase 56 7.8.1 Overview of Pipeline Programs Targeting Telomerase Reverse Transcriptase 58 7.9 Conclusion 58 8 Deals and Strategic Consolidations 59 8.1 Industry-Wide First-in-Class Deals 59 8.2 Melanoma Deals Landscape 60 8.3 Licensing Deals 60 8.3.1 Deals by Region, Deal Value and Year 60 8.3.2 Deals by stage of development and deal value 62 8.3.3 Molecule Type 62 8.3.4 Molecular Target 63 8.4 Co-development Deals 64 8.4.1 Deals by region, deal value and year 64 8.4.2 Deals by Stage of Development and Value 66 8.4.3 Molecule Type 66 8.4.4 Molecular Target 67 8.5 First-in-Class Programs Not Involved in Licensing or Co-development Deals 68
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