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A Technology & Pipeline Assessment and Corporate Benchmarking Analysis

The report “Recombinant Coagulation Factors 2013 – The Race to Market and for Market Shares: Technology & Pipeline Assessment and Corporate Benchmarking Analysis” of June 2013 describes a market forecast based on growth of historical sales of recombinant coagulation factors. The report evaluates reasons for failures of novel recombinant coagulation factors and provides detailed profiles of active recombinant coagulation factors in clinical development. Preclinical projects are valued on the basis of the underlying technologies. Emerging alternative therapeutic approaches are described and assessed. The detailed target pipeline assessments put emphasis on the competitive situation regarding stage of development, inhibitor profile, half-life, administration frequency, clinical success and especially time to approval/market. The pipelines of the clinically active companies are described and their competitive position assessed in light of the key success factors. Sources of information are LMP’s proprietary database, scientific literature (abstracts, papers), corporate information (press releases, presentations, reports, SEC filings). All information is referenced.

Combined product sales of the three classes olf recombinant coagulation factors used in hemophilia were US$ 7.172 mln in 2012. The pipeline of new recombinant coagulation factors is maturing and the first molecules are under regulatory review by the FDA and the EMA and many have entered pivotal clinical studies. There are 46 different molecules and R&D approaches for novel recombinant coagulation factors for hemophilia A and B in the pipeline of which 24 are in clinical development of under regulatory review. Given this tight competition, time-to-market will be an important success. This report will explain the potential development and approval timelines of each of the advanced molecules.

What will you find in this report?

• Historical sales data of the recombinant coagulation factors VIII, IX, VIIa and II;
• Historical growth rates and a 5-year sales forecast of each class of recombinant factors;
• Reasons for failure and profiles of failed recombinant coagulation factors;
• Detailed profiles of clinical stage recombinant coagulation factors;
• Technologies used for creation of novel recombinant coagulation factors;
• Preclinical stage recombinant coagulation factors;
• New approaches: alternative procoagulants / adjuncts and gene therapy;
• Pipeline analysis and assessment for each recombinant coagulation factor class;
• Comparative data on clinical inhibitor formation and discussion of its relevance;
• Comparison of half-life prolongation and its impact on administration frequency;
• Comparison of the time to approval for each clinical stage recombinant coagulation factor;
• Company pipeline and competitive position of each major player in the field

Table Of Contents

Recombinant Coagulation Factors 2013 - The Race to Market and for Market Shares: A Technology and Pipeline Assessment and Corporate Benchmarking Analysis
Table of Contents

1 Executive Summary

2 Recombinant Coagulation Factor Markets
2.1 Recombinant Factor VIII (rFVIII) Market
2.1.1 rFVIII Product Sales
2.1.2 rFVIII Market Dynamic
2.2 Recombinant Factor IX (rFIX) Product Sales and Market Dynamics
2.3 Recombinant Factor VII (rFVII) Product Sales and Market Dynamics
2.4 Market Size and Dynamics of Recombinant Coagulation Factors in Hemophilia
2.5 Total Recombinant Coagulation Factors Market

3 Pipeline Changes and Drug Profiles
3.1 Discontinued Development of Recombinant Coagulation Factors
3.1.1 BAY 86-6150
3.1.2 Vatreptacog alfa; NN1731; NNC 0078-0000-0007; rFVIIa-DVQ
3.1.3 N7-GP; NN7128 (SC) / NN7129 (IV); NNC 0128-0000-2011; LA-rFVIIa
3.1.4 BAX 499; ARC19499
3.2 Active Clinical Development of Recombinant Coagulation Factors
3.2.1 Recombinant factor XIII
3.2.2 Recombinant von Willebrand factor
3.2.3 Wild-type and Biosimilar Recombinant Factor VIII
3.2.4 Long-acting Recombinant factor VIII
3.2.5 Wild-type and Biosimilar Recombinant Factor IX
3.2.6 Long-acting Recombinant Factor IX
3.2.7 Wild-type Recombinant factor VIIa
3.2.8 Long-acting Recombinant factor VIIa
3.3 Non-Clinical Development of Recombinant Coagulation Factors
3.4 Technologies and preclinical stage recombinant coagulation factors
3.4.1 Conjugation Technologies
3.4.2 Drug Delivery
3.4.3 Fusion Protein Technologies
3.4.4 Protein Engineering Technologies
3.4.5 Manufacturing and Cell Line Technologies
3.4.6 Biosimilar Recombinant Coagulation Factors
3.5 Alternative Procoagulants and Adjuncts
3.5 Gene and Cell Therapy of Hemophilia
3.5.1 Hemophilia B Gene Therapy
3.5.2 Hemophilia A Gene Therapy

4 Comparative Target Pipeline Analysis and Assessment
4.1 Recombinant Factor VIII Pipeline
4.1.1 Clinical Pipeline of Novel Recombinant Factor VIII Molecules
4.1.2 Preclinical Pipeline of Novel Recombinant Factor VIII Molecules
4.2 Recombinant Factor IX Pipeline
4.3 Recombinant Factor VII Pipeline
4.4 Recombinant Fibrinogen and Thrombin Pipeline
4.5 Recombinant von Willebrand Factor Pipeline
4.6 Recombinant Factor XIII
4.7 Alternative Procoagulants and Adjuncts Pipeline
4.8 Gene Therapy of Hemophilia

5 Corporate Benchmark Analysis
5.1 Stakeholder Overview
5.2 Stakeholders per Company
Baxter
Bayer HealthCare Pharmaceuticals
Biogen Idec
Cangene
Chugai (Roche)
CSL
Green Cross
LFB (rEVO Biologics)
Novo Nordisk
Octapharma
OPKO Health (PROLOR Biotech)
Pfizer
Pharmstandard
5.3 Key Success and Failure Factors
5.4 Opportunities

6 References

7 Tables



Tables

Table 1 Calendar Year Sales of Advate/Recombinate from Baxter
Table 2 Calendar year Sales of Kogenate (FS) from Bayer
Table 3 Calendar Year Sales of Helixate from CSL
Table 4 Calendar Year Sales of ReFacto (AF)/Xyntha from Pfizer
Table 5 Market Shares of Recombinant Factor VIII Products
Table 6 Growth of the Recombinant Factor VIII Market
Table 7 rFVIII Market and Product Growth Rates 2005-2012
Table 8 Sales of BeneFIX in US$ mln
Table 9 Sales of NovoSeven
Table 10 Total Market Size (US$ mln) of Rec Coagulation Factors in Hemophilia
Table 11 Sales of Recothrom
Table 12 Market Shares of Recombinant Coagulation Factor Classes



Tables in the Text

Table 13 Overview of Competitive Situation of Recombinant Coagulation Factors and Novel Therapeutic Approaches for Hemophilia
Table 14 Pipeline of rFVIII Molecules in Clinical Development
Table 15 Inhibitor Formation with Clinical Stage rFVIII Molecules
Table16 Half-life and Administration Frequency of Clinical Stage rFVIII Molecules
Table 17 Clinical Success of rFVIII Treatment and Prophylaxis
Table 18 Calculation of Approval Dates of Clinical Stage rFVIII Molecules
Table 19 Approval Dates of Clinical Stage rFVIII Molecules
Table 20 Preclinical Stage recombinant Factor VIII Molecules
Table 21 Clinical Stage Recombinant Factor IX Molecules
Table 22 Inhibitor Formation with Clinical Stage rFIX Molecules
Table 23 Half-life and Administration Frequency of Clinical Stage rFIX Molecules
Table 24 Clinical Success of rFIX Treatment and Prophylaxis
Table 25 Calculation of Approval Dates of Clinical Stage rFIX Molecules
Table 26 Approval Dates of Clinical Stage rFIX Molecules
Table 27 Preclinical Stage recombinant Factor IX Molecules
Table 28 Clinical Stage Recombinant Factor VIIa Molecules
Table 29 Half-life and Administration Frequency of Clinical Stage rFVIIa Molecules
Table 30 Calculation of Approval Dates of Clinical Stage rFIX Molecules
Table 31 Preclinical Stage recombinant Factor VIIa Molecules
Table 32 Pipeline of Recombinant Fibrinogen and Thrombin
Table 33 Pipeline of Recombinant von Willebrand Factor
Table 34 Pipeline of Recombinant Factor XIII
Table 35 Alternative Procoagulants and Adjuncts
Table 36 Pipeline of Gene Therapy of Hemophilia B
Table 37 Pipeline of Gene Therapy of Hemophilia A
Table 38 Comparative Clinical Portfolio Overview of Major Stakeholders
Table 39 Baxter Coagulation Pipeline
Table 40 Bayer Coagulation Pipeline
Table 41 Biogen Idec Coagulation Pipeline
Table 42 Cangene Coagulation Pipeline
Table 43 Chugai (Roche) Coagulation Pipeline
Table 44 CSL Coagulation Pipeline
Table 45 Green Cross
Table 46 LFB (rEVO Biologics) Coagulation Pipeline
Table 47 Novo Nordisk Coagulation Pipeline
Table 48 Octapharma Coagulation Pipeline
Table 49 OPKO Health (PROLOR Biotech) Coagulation Pipeline
Table 50 Pfizer Coagulation Pipeline
Table 51 Pharmstandard Coagulation Pipeline

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