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Frontier Pharma: Pancreatic Cancer - Identifying and Commercializing First-in-Class Innovation

Frontier Pharma: Pancreatic Cancer - Identifying and Commercializing First-in-Class Innovation

Summary


Pancreatic cancer is the 12th most common cancer globally, and the fourth most fatal, with a mortality rate of 10.9 deaths per 100,000 people per year. The poor prognosis of pancreatic cancer patients has highlighted a significant need for new and improved approaches to treatment, which is not being met by the current market.

A highly active pancreatic cancer pipeline contains an array of products with varying molecule types and mechanisms of action, which provides a striking contrast to the current, chemotherapy dominated, market. Within the pipeline, there are 185 products that act on a first-in-class molecular target, representing 52% of the total pancreatic cancer pipeline products that have a disclosed molecular target. A drastically different pipeline and market composition implies that the approach to pancreatic cancer treatment is changing and first-in-class innovation is playing a significant role in this.

Scope

  • Gemcitabine based regimens continue to dominate the market, which has seen few new entrants over the past decade. The continued reliance on generic chemotherapies is one reason why the prognosis has shown little improvement.
  • What survival benefits do current therapies provide?
  • What are the current unmet needs that the pipeline needs to address?
  • The pipeline contains a plethora of molecule types and molecular targets not present on the market, including a large focus on therapies targeting common oncogenic pathways and signaling intermediates such as PI3K/Akt.
  • What impact will the emergence of biologics have on the pancreatic cancer landscape?
  • Will pipeline diversity translate to clinically and commercially successful therapies?
  • How will the rise of novel molecular target categories, such as signal transduction, impact future treatment options?
  • 52% of pipeline products act on a first-in-class target, which is higher than the oncology and industry averages.
  • Do first-in-class products show strong progression into the later stages?
  • Why is the greatest number of first-in-class products seen in signal transduction?
  • Numerous early-stage, first-in-class products have high promise, often supported by preclinical evidence.
  • How well are first-in-class targets, such as Akt2, aligned to known disease causing pathways?
  • Does scientific literature provide significant rationale for therapies acting on early-stage promising, first-in-class targets?
  • What does preclinical data on Akt inhibition suggest about its potential as a target in pancreatic cancer?
  • Deals for first-in-class products typically take place in earlier stages than non-first-in-class counterparts, with 79% of first-in-class licensing deals occurring in Phase I or earlier.
  • To what extent does first-in-class status influence deal value?
  • Can biologics command a greater deal value than other molecule types?
Reasons to buy

This report will allow you to -
  • Understand the current clinical and commercial landscape. This includes a comprehensive study of disease pathogenesis, diagnosis, prognosis and the available treatment options available at each stage of diagnosis.
  • Visualize the composition of the pancreatic cancer market 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 pancreatic cancer pipeline, and stratify by stage of development, molecule type and molecular target. There are promising signs in the pipeline that the industry is seeking novel approaches the treating pancreatic cancer.
  • 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 targets, including MAP3K7 and P70-S6 Kinase 1 have been extensively reviewed using peer-reviewed literature and preclinical data.
  • Identify commercial opportunities in the pancreatic cancer deals landscape by analyzing trends in licensing and co-development deals and producing a curated list of pancreatic cancer therapies that are not yet involved in deals and may be potential investment opportunities.


Pancreatic Cancer Treatment Pipeline Dominated by Early-Stage Development, says GBI Research

While the treatment pipeline for pancreatic cancer shows a high level of innovation, with 52% of products categorized as first-in-class, most development is in the early stages, meaning a significant proportion of therapies are unlikely to reach the market in the near future, says business intelligence provider GBI Research.

The company’s latest report* states that while the pancreatic cancer treatment pipeline contains 447 therapeutics in active development across all Phases, compared to 209 currently-marketed products, almost 75% of therapies are in Phase I or earlier.

According to Joshua Libberton, Analyst for GBI Research, 58% of drugs in the pancreatic cancer treatment pipeline are in the Discovery or Preclinical stages, 17% are in Phase I and 21% are in Phase II, leaving just 4% of products in Phase III of development.

Libberton comments: “While the Phase III portion of the pipeline is comparatively small, it is followed by a relatively large Phase II, indicating that there will be a sustained stream of products moving through the later development stages.

“Despite the majority of pancreatic cancer therapy development occurring in very early stages, many of the assessed targets showed promising preclinical results and a strong alignment to known disease-causing pathways, which could translate to clinical and commercial success.”

The analyst adds that the high level of first-in-class development in pancreatic cancer therapeutics is a promising sign of the industry seeking innovative treatment solutions.

GBI Research’s report also states that while the current global treatment market for pancreatic cancer is comprised of 91% small molecules and 9% biologics, some 41% of the pipeline is formed from biologic therapies.

Libberton continues: “This considerable difference is in line with the industry trend of increasing biologic development, following the escalating success of biologics in other therapy areas, such as Herceptin (trastuzumab) and Avastin (bevacizumab).

“Despite this growth in the biologics sector, small molecules remain dominant in the pancreatic cancer pipeline thanks to their versatility and ease of manufacture, as well as a more established understanding of their clinical properties. However, it is clear that drug developers are seeking novel approaches to pancreatic cancer treatment that differ from the present market,” the analyst concludes.

*Frontier Pharma: Pancreatic Cancer - Identifying and Commercializing First-in-Class Innovation

This report analyzes innovation in pancreatic cancer treatment in the context of the overall pipeline and current market landscape. It also provides details on the deals landscape surrounding first-in-class products in pancreatic cancer therapeutics, and pinpoints opportunities for in-licensing.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research’s team of industry experts.

1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Executive Summary
2.1 Large and Diverse Pipeline Contrasts the Limited Market
2.2 Pancreatic Cancer Shows High Levels of First-in-Class Innovation
2.3 High Deal Activity Reflects Dynamic Pipeline
3 The Case for Innovation
3.1 Growing Opportunities for Biologic Products
3.2 Diversification of Molecular Targets
3.3 Innovative First-in-Class Product Developments Remain Attractive
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation
3.5 Sustained Innovation
3.6 GBI Research Report Guidance
4 Clinical and Commercial Landscape
4.1 Disease Overview
4.2 Disease Symptoms
4.3 Epidemiology
4.4 Etiology
4.4.1 Risk Factors
4.4.2 Medical Conditions Leading to Pancreatic Cancer
4.4.3 Genetic Conditions Leading to Pancreatic Cancer
4.4.4 Conclusion
4.5 Pathophysiology
4.5.1 Frequently Dysregulated Pathways
4.5.2 Oncogenes
4.5.3 Tumor Suppressor Genes
4.6 Diagnosis
4.7 Prognosis
4.8 Treatment Options
4.8.1 Surgery
4.8.2 Radiation therapy
4.8.3 Chemotherapy
4.9 Chemotherapeutic Treatment Algorithm
4.9.1 Adjuvant Chemotherapy in Operable Early-Stage Disease
4.9.2 First-Line Treatment of Inoperable Advanced Disease
4.9.3 Second-Line Therapy in Inoperable Advanced Disease
4.10 Overview of Marketed Products in Pancreatic Cancer
4.10.1 Molecule Type and Target Analysis
4.10.2 Innovative Products in the Pancreatic Cancer Market
4.10.3 Unmet Needs
5 Assessment of Pipeline Product Innovation
5.1 Pancreatic Cancer Pipeline by Molecule Type, Phase and Therapeutic Target
5.2 Comparative Distribution of Programs between the Pancreatic Cancer Market and Pipeline by Therapeutic Target Family
5.3 First-in-Class Pipeline Programs Targeting Novel Molecular Targets
6 Signaling Network, Disease Causation and Innovation Alignment
6.1 The Complexity of Signaling Networks in Oncology
6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration
6.3 First-in-Class Target Matrix Assessment
7 First-in-Class Target Evaluation
7.1 Pipeline Programs Targeting HER3
7.2 Pipeline Programs Targeting Akt2 and Akt3
7.3 Pipeline Programs Targeting P70-S6 Kinase 1
7.4 Pipeline Programs Targeting Prostaglandin E2 Receptor EP4 Subtype
7.5 Pipeline Programs Targeting Ghrelin Receptor
7.6 Pipeline Programs Targeting Neurotensin Receptor 1
7.7 Pipeline Programs Targeting CD40
7.8 Pipeline Programs Targeting High-Affinity Nerve Growth Factor Receptor
7.9 Pipeline Programs Targeting Protein Kinase C Alpha
7.10 Pipeline Programs Targeting MAP3K7
7.11 Conclusion
8 Deals and Strategic Consolidations
8.1 Industry-Wide First-in-Class Deals
8.2 Licensing Deals
8.2.1 Licensing Deals by Molecule Type
8.2.2 Licensing Deals by Molecular Target
8.3 Co-development Deals
8.3.1 Co-development Deals by Molecule Type
8.3.2 Co-development Deals by Molecular Target
8.4 First-in-Class Programs Not Involved in Licensing or Co-Development Deals
9 Appendix
9.1 References
9.2 Abbreviations
9.3 Contact Us
9.4 Disclaimer
1.1 List of Tables
Table 1: Tumor Node Metastasis Classification
Table 2: Pancreatic Cancer Therapeutics, ECOG Performance Status Scores and Description
Table 3: Pancreatic Cancer Therapeutics, Common Endpoints in Oncology Clinical Trials and their Description
Table 4: Pancreatic Cancer Therapeutics, Efficacy of Gemcitabine Monotherapy
Table 5: Pancreatic Cancer Therapeutics, Efficacy of Gemcitabine Monotherapy
Table 6: Pancreatic Cancer Therapeutics, Efficacy of Gemcitabine in Combination with Eloxatin
Table 7: Pancreatic Cancer Therapeutics, Efficacy of Gemcitabine in Combination with Cisplatin
Table 8: Pancreatic Cancer Therapeutics, Typical Dosing of Teysuno based on Body Surface Area of Patient
Table 9: Pancreatic Cancer Therapeutics, Adverse Events Associated with Gemcitabine Monotherapy, Teysuno Monotherapy, and with their Combination
Table 10: Pancreatic Cancer Therapeutics, Improvements in Overall Survival with Gemcitabine Drug Combinations
1.2 List of Figures
Figure 1: Innovation Trends in Product Approvals
Figure 2: Sales Performance of First-in-Class and Non-First-in-Class Product Post Marketing Approval
Figure 3: Genetically Altered Signaling Pathways in Pancreatic Cancer
Figure 4: Overview of Marketed Products in Pancreatic Cancer
Figure 5: Overview of Pipeline Products
Figure 6: Breakdown of Pipeline Molecular Targets
Figure 7: Pipeline Products by Stage and Molecular Target
Figure 8: Molecular Target Family Comparison, Pipeline and Marketed Products
Figure 9: Molecular Target Family Comparison, Pipeline First-in-Class and Established Molecular Targets
Figure 10: Percentage of First-in-Class Products within Pancreatic Cancer Pipeline Molecular Target Families
Figure 11: Percentage of First-in-Class Products within Pancreatic Cancer Pipeline Stages of Development
Figure 12: List of First-in-Class Products (Part 1)
Figure 13: List of First-in-Class Products (Part 2)
Figure 14: List of First-in-Class Products (Part 3)
Figure 15: Pancreatic Cancer Signaling Network Assessment (Part 1)
Figure 16: Pancreatic Cancer Signaling Network Assessment (Part 2)
Figure 17: Pancreatic Cancer Target Matrix Assessment (Part 1)
Figure 18: Pancreatic Cancer Target Matrix Assessment (Part 2)
Figure 19: Pancreatic Cancer Target Matrix Assessment (Part 3)
Figure 20: Pancreatic Cancer Target Matrix Assessment (Part 4)
Figure 21: Data and Evidence for ErbB3 as a Therapeutic Target
Figure 22: Pipeline Products Targeting ErbB3
Figure 23: Data and Evidence for Akt as a Therapeutic Target
Figure 24: Pipeline Products Targeting Akt2 and Akt3
Figure 25: Data and Evidence for P70-S6 Kinase 1 as a Therapeutic Target
Figure 26: Pipeline Products Targeting P70-S6 Kinase 1
Figure 27: Data and Evidence for PGE2 as a Therapeutic Target
Figure 28: Pipeline Products Targeting PGE2
Figure 29: Data and Evidence for Ghrelin as a Therapeutic Target
Figure 30: Pipeline Products Targeting Ghrelin Receptor
Figure 31: Data and Evidence for NTR1 as a Therapeutic Target
Figure 32: Pipeline Products Targeting NTR1
Figure 33: Pipeline Products Targeting CD40
Figure 34: Data and Evidence for High-Affinity NGF Receptor as a Therapeutic Target
Figure 35: Pipeline Products Targeting High-Affinity NGF Receptor
Figure 36: Data and Evidence for PKC Alpha as a Therapeutic Target
Figure 37: Pipeline Products Targeting PKC Alpha
Figure 38: Data and Evidence for MAP3K7 as a Therapeutic Target
Figure 39: Pipeline Products Targeting MAP3K7
Figure 40: Industry-Wide Deals by Stage of Development, 2006–2014
Figure 41: Industry Licensing Deal Values by Stage of Development, 2006–2014
Figure 42: Pancreatic Cancer Licensing Deal Values
Figure 43: Pancreatic Cancer Licensing Deals by Year
Figure 44: Pancreatic Cancer Licensing Deals by Phase
Figure 45: Pancreatic Cancer Licensing Deals by Global Distribution
Figure 46: Pancreatic Cancer Licensing Deals by Molecule Type
Figure 47: Pancreatic Cancer Licensing Deal Value by Molecular Target Category
Figure 48: Pancreatic Cancer Co-development Deal Values
Figure 49: Pancreatic Cancer Co-development Deals by Year
Figure 50: Pancreatic Cancer Co-development Deals by Phase
Figure 51: Pancreatic Cancer Co-development Deals by Global Distribution
Figure 52: Pancreatic Cancer Co-development Deals by Molecule Type
Figure 53: Pancreatic Cancer Co-development Deal Value by Molecular Target
Figure 54: Pancreatic Cancer First-in-Class Therapies not Involved in Deals (Part 1)
Figure 55: Pancreatic Cancer First-in-Class Therapies not Involved in Deals (Part 2)
Figure 56: Pancreatic Cancer First-in-Class Therapies not Involved in Deals (Part 3)

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