Biologics Pipelines: Who Has the Next Promising Recombinant Proteins?

Published by: Decision Resources

Published: Apr. 22, 2008 - 40 Pages

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

Introduction

Biologic Markets

Blood-Related Disorders

Alfi meprase (Nuvelo/Amgen’s Cardiovascular Fibrinolytic)

Desmoteplase (Paion/Forest/Lundbeck’s Bat-Plasminogen Activator)

Micera (Roche’s Methoxy Polyethylene Glycol-Epoetin Beta)

Nplate (Amgen’s Romiplostim)

Tifacogin (Novartis’s Tissue Factor Pathway Inhibitor)

Viprinex (Neurobiological Technologies’ Ancrod)

Cardiovascular Recombinant Proteins

Recombinant Proteins for Central Nervous System Diseases

Cancer-Related Recombinant Protein Drugs

Afl ibercept (Sanofi -Aventis/Regeneron/Bayer HealthCare’s Vascular Endothelial Growth Factor

Trap)

Onconase (Alfacell/Par Pharmaceutical’s Ranpirnase)

TransMID (Xenova/Nycomed/Sosei’s Transferrin-CRM107, or Tf-CRM107)

Biosimilar G-CSFs

Complexity in the Marketplace

Antidiabetic Recombinant Proteins

Novel Glucagon-Like Peptide 1 Analogues

Alkermes/Amylin/Eli Lilly’s Exenatide LAR

New Delivery Angles

Pfizer’s Exubera

Novo Nordisk/Aradigm’s AERx Inhaled Insulin

Eli Lilly/Alkermes’s AIR Inhaled Insulin

MannKind’s Technosphere Inhaled Insulin

Generex Biotechnology’s Oral-Lyn, a Buccal Insulin

Musculoskeletal Recombinant Proteins

Phase III Recombinant Proteins for Other Diseases

Albuferon (Albinterferon Alfa-2b)

ZymoGenetics/Merck Serono’s Atacicept (TACI-Ig)

Changing of the Guard

Amgen Feels the Heat as Pressures Mount

Evolving Business Strategies and a Rising Star

Decision Resources, Inc., Analysts Featured

Mary Argent-Katwala, Ph.D., Therapeutic Area Director, Onkos

Marcus Bain, Ph.D., Analyst, Metabolic and Cardiovascular Disorders

Madhuri Borde, Ph.D., Project Director, Treatment Algorithms

Sami R. Fam, Ph.D., Analyst, Cognos

Michael Latwis, M.B.A., Corporate Analyst, Pharmaview

John M. Lebbos, M.D., Vice President, Decision Resources, Inc.

Andrew Merseth, Senior Business Analyst

Jonathan W. Searles, Analyst, Cognos

Amy H. Whiting, Ph.D., Analyst, Immune and Infl ammatory Disorders

Donny Wong, Ph.D., Principal Analyst, Metabolic Disorders

Tables

1. Select Recombinant Proteins in Late-Stage Clinical Development for Blood-Related Disorders

2. Select Cardiovascular Recombinant Proteins in Clinical Development

3. Select Central Nervous System Recombinant Proteins in Clinical Development

4. Select Anticancer Recombinant Proteins in Clinical Development

5. Recombinant Protein Development Programs Announced by Major Biosimilar Developers

6. Select Antidiabetic Recombinant Proteins in Phase III Development

7. Select Musculoskeletal Recombinant Proteins in Clinical Development

8. Select Recombinant Proteins in Phase III Development

Figures

1. Evolving Pharmaceutical Market Segments Based on Technology, 2000-2012

2. Top-Selling Recombinant Protein Brands, 2007

3. Number of Recombinant Proteins in Clinical Development, 2007

4. Recombinant Proteins in Clinical Development by Therapeutic Category, 2007

5. Rho Kinase Pathway: The GTPase Molecular Switch

6. Sales of Five Amgen Brands, 2002-2013

7. Role of GLP-1 in Glucose Metabolism

8. Amgen Financial Analysis, 1988-2006

Abstract

• Biologics markets are evolving into a complex mix of brands, next-generation brands, biosimilars, and second-generation biosimilars. What opportunities are emerging in this rapidly growing market? What market trends will drive this growth? What new business strategies will companies need to stay competitive?
• Recombinant proteins enjoy significant market success, with sales expected to increase from 9% to 10% of the worldwide drug market over the next five years (i.e., from $54.5 billion in 2007 to $75.8 billion in 2012). What company's top position in this market is in jeopardy, and what is this company doing to stay one step ahead of the competition? What lies ahead in the recombinant protein market, and who is the current trendsetter?
• Hundreds of recombinant proteins are in clinical development across diverse therapeutic areas. Which ones are in late-stage clinical development? Which ones show the most promise for future success?

• A review of the evolving therapeutic protein market: technology market segments, top-selling brands, market leaders, impact of safety concerns.
• There were 142 recombinant proteins in clinical development in March 2007: overview of seven therapeutic categories, including blood-related disorders, cardiovascular and central nervous system diseases, cancer, and type 1 and 2 diabetes; companies, indications, and current development.
• Decision Resources analysts give their opinion on the status of recombinant proteins in development for various disease indications: delivery improvements for insulin; a new pegylated interferon for the treatment of lupus nephritis; development of biosimilars for cancer treatments; a new drug to treat acute ischemic stroke.
• Companies cannot afford to rest on the laurels of their past success: gauging when and how to enter a therapeutic recombinant protein market will be the key to success. An example of a trendsetting company that is forging a new path to success in tomorrow's competitive biologics landscape.

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