The Fastest Growing Biotechnology Companies: Growth Strategies, Comparative Analyses and Company Profiles

Published by: Business Insights

Published: Mar. 1, 2008 - 280 Pages

Table of Contents

The Fastest Growing Biopharmaceutical Companies

Executive Summary

Summary of key findings

Comparitive analyses of growth strategies

Theravance, Inc - company profile and analysis

ISTA Pharmaceuticals - company profile and analysis

Palatin Technologies - company profile and analysis

Pharmion Corporation - company profile and analysis

Amylin Pharmaceuticals - company profile and analysis

Trimeris, Inc - company profile and analysis

ViroPharma Inc - company profile and analysis

NPS Pharmaceuticals - company profile and analysis

SIGA Technologies, Inc - company profile and analysis

Idenix Pharmaceuticals - company profile and analysis

Chapter 1 Key findings and industry

analysis

Summary

Overview of the biotechnology sector

Recent developments

Current applications

Structure of the biotechnology industry

The pharmaceutical-biopharmaceutical relationship

Emergence of the biopharmaceutical sector

Characteristics of the biopharmaceutical industry

Collaborative corporate environment

Highly technology and intellectual property

High venture capital investment

High risk and costs associated with drug development

Identifying fast growth companies- Methodology

Purpose and value of the analysis

Candidates identified as fast growth companies

Chapter 2 Comparitive analyses of growth

strategies

Summary

The Fastest Growing Biopharmaceutical Companies

The evolving nature of the biopharmaceutical industry

Comparative analysis of R&D strategies

Revenue versus R&D expenditure

Early Phase R&D Strategies

Late Stage Clinical Development

Sponsored Research Payment Strategies

Analysis by Therapeutic Area

Comparative analysis of commercialization strategies

Platform positioning

The modern extended biopharmaceutical enterprise

Comparative analysis of manufacturing strategies

Comparion of restructuring and cost containment strategies

Case Study: Downsizing R&D at Trimeris, Inc.

Chapter 3 Theravance, Inc.

Summary

Company address and contact details

Company overview and history

Business profile

Discussion and analysis of financial data

Source and details of income

Review of proprietary technologies

Patents and proprietary rights

Strategic approach and positioning

Strategic approach

SWOT Analysis

Strengths

Weaknesses

Opportunities

Threats

Joint ventures, collaborations and M&A activity

Theravance's collaboration with GlaxoSmithKline (GSK)

License, development and commercialization agreement with Astellas

License agreement with AstraZeneca AB

Product development programs

Bacterial infections

Telavancin

TD-1792

Respiratory

Horizon program (formerly Beyond Advair)

Inhaled bifunctional muscarinic anatgonist-beta2 agonist (MABA)

program

Inhaled long-acting muscarinic antagonist (LAMA) program

Gastrointestinal motility disorders

Research programs

Chapter 4 ISTA Pharmaceuticals, Inc.

Summary

Company Address and Contact Details

Company overview and history

Business profile

Discussion and analysis of financial data

Source and details of income

Review of proprietary technologies

Patents and proprietary rights

Strategic approach and positioning

Strategic approach

SWOT analysis

Strengths

Weaknesses

Opportunities

Threats

Joint ventures, collaborations and M&A activity

Xibrom, Istalol, Bepotastine, Ecabet Sodium, Latanoprost and Iganidipine

collaborations with Senju

Vitrase commercialization outside the US

Collaboration with Otsuka Pharmaceutical

Marketed products

Xibrom™ (bromfenac)

Istalol®

Vitrase®

Product development programs

T-Pred (tobramycin and prednisolone acetate combination product)

Bepotastine

Ecabet sodium

Strong steroid product

Chapter 5 Palatin Technologies Inc

Summary

Company address and contact details

Company overview and history

Business profile

Discussion and analysis of financial data

Source and details of income

Review of proprietary technologies

Patents and proprietary rights

Strategic approach and positioning

Strengths

Strength in MC expertise

Weaknesses

Termination of collaborative agreement with King Pharmaceuticals

Limited product pipeline portfolio

Opportunities

Threats

Joint ventures, collaborations and M&A activity

Strategic alliance with AstraZeneca AB

Collaborative development and marketing agreement with King

Pharmaceuticals

Strategic collaboration agreement with Mallinckrodt

Product development programs

Bremelanotide (formerly PT-141)

Male sexual dysfunction (MED)

Female sexual dysfunction (FSD)

Development of novel natriuretic receptor compounds

Chapter 6 Pharmion Corporation

Summary

Company address and contact details

Company overview and history

Business profile

Discussion and analysis of financial data

Source and details of income

Review of proprietary technologies

Patents and proprietary rights

Strategic approach and positioning

Strengths

Vidaza: potential future growth and revenue opportunities

Formation of strategic alliances

Weaknesses

Lack of manufacturing capabilities

Opportunities

Acquisition by Celgene

Inorganic growth

FDA approval of Vidaza NDA supplement for IV administration

Threats

Litigations

Intense competition

Cost containment pressures

Joint ventures, collaborations and M&A activity

M&A history

Acquisition of Cabrellis Pharmaceuticals

Joint ventures and collaborations

Marketed products

Vidaza (azacitidine for injection)

Thalidomide Pharmion

Innohep

Refludan

Product development programs

Amrubicin

Oral azacitidine

Satraplatin

MGCD0103

Chapter 7 Amylin Pharmaceuticals, Inc.

Summary

Company address and contact details

Company overview and history

Business profile

Discussion and analysis of financial data

Source and details of income

Review of proprietary technologies

Patents and proprietary rights

Strategic approach and positioning

Strengths

Strategic alliances

Byetta

New management team

Weaknesses

Reliance on third party manufacturers

Narrow customer concentration

Opportunities

Exenatide (long acting release) LAR

INTO obesity program

Threats

Competition

Joint ventures, collaborations and M&A activity

Joint ventures and collaborations

Marketed products

Byetta (exenatide) injection

Symlin

Product development programs

Diabetes product development

Exenatide LAR program

Obesity product development program

Pramlintide

Pramlintide and Leptin

Pramlintide PYY 3-36

Chapter 8 Trimeris, Inc.

Summary

Company address and contact details

Company overview and history

Business profile

Discussion, analysis of financial data

Details of income

Review of proprietary technologies

Patents and proprietary rights

Strategic approach and positioning

Strengths

Collaboration with Roche

Fuzeon

Weaknesses

T-1249 on hold

Opportunities

HIV drugs market

TRI-1144

Strategic shift in the company’s focus

Threats

Market acceptance of Fuzeon

Intense competition

Joint ventures, collaborations and M&A activity

Joint ventures and collaborations

Marketed products

Fuzeon

Product development programs

FUZEON

T-1249

Next generation fusion inhibitor peptide drug candidates

Chapter 9 ViroPharma Inc.

Summary

Company address and contact details

Company overview and history

Business profile

Discussion and analysis of financial data

Source and details of income

Review of proprietary technologies

Patents and proprietary rights

Strategic approach and positioning

Strengths

Strategic partnerships

Fast track status

Weaknesses

Lack of manufacturing capabilities

Customer concentration

Opportunities

Camvia™ (maribavir)

Threats

Dependence of continued sales of Vancocin

Joint ventures, collaborations and M&A activity

Joint ventures and collaborations

Cytomegalovirus and GlaxoSmithKline

Hepatitis C and Wyeth

Vancocin capsules and Eli Lilly

Picornaviruses and Schering-Plough Corporation

Marketed products

Vancocin

Product development programs

Camvia™ (maribavir)

HCV-796

NTCD (non-toxigenic C. difficile)

Antiviral discovery

Chapter 10 NPS Pharmaceuticals Inc.

Summary

Company Address and Contact Details

Company overview and history

Business profile

Discussion and analysis of financial data

Source and details of income

Review of proprietary technologies

Patents and proprietary rights

Strategic approach and positioning

Strategic approach

Outsource non-core competencies

Build a diversified pipeline of products addressing a variety of

medical conditions

Collaborate or out-license to reduce risk and accelerate the

commercialization of select product candidates

SWOT analysis

Strengths

Weaknesses

Opportunities

Threats

Joint ventures, collaborations and M&A activity

Joint ventures and collaborations

Amgen Inc

AstraZeneca

GlaxoSmithKline

Janssen

Kirin Brewery of Tokyo (pharmaceutical division)

Nycomed

Marketed products

Sensipar®/Mimpara® (Cinacalcet HCI)

Preotact™ (PREOS®)

Product development programs

Teduglutide (ALX-0600)

Calcilytics

Glycine reuptake inhibitors (GlyT-1)

Metabotropic glutamate receptors (mGluRs)

Chapter 11 SIGA Technologies, Inc.

Summary

Company address and contact details

Company overview and history

Business profile

Discussion and analysis of financial data

Source and details of income

Review of proprietary technologies

Patents and proprietary rights

Strategic approach and positioning

SWOT analysis

Strengths

Weaknesses

Opportunities

Threats

Joint ventures, collaborations and M&A activity

Collaborative research and licenses

Product development programs

Anti-infectives

Anti-smallpox drug

Other antivirals in development

Junín

Lassa fever

Ebola/Marburg

HTS discovery campaign

Dengue

Bunyavirus

Sortase

Chapter 12 Idenix Pharmaceuticals, Inc.

Summary

Company address and contact details

Company overview and history

Business profile

Discussion and analysis of financial data

Source and Details of Income

Review of proprietary technologies

Patents and proprietary rights

Strategic approach and positioning

Strategic approach

Focusing on HCV and HIV drug discovery and development

programs only

Discontinuation of the HBV franchise

Trimmed workforce

SWOT Analysis

Strengths

Weaknesses

Opportunities

Threats

Joint ventures, collaborations and M&A activity

Joint ventures and collaborations

Marketed products

Tyzeka®/Sebivo® (telbivudine)

Product development programs

IDX-899

IDX184

Chapter 13 Appendix

Methodology statement

Primary Data and Information Gathering

Secondary data and information gathering

Market share analysis and market forecast predictions

Definitions of Product-Life Cycle stages

Glossary of abbreviations and acronyms

Index

List of Figures

Figure 1.1: Evolution of the biopharmaceutical corporation

Figure 2.2: Analysis of R&D expenditure v revenues, 2006

Figure 2.3: Sponsored Research Payment Strategies

Figure 2.4: Sponsored research payment strategies

Figure 2.5: The principles of the extended enterprise

Figure 5.6: Disease area focus, Palatin Technologies

Figure 5.7: Annual product history, Palatin Technologies

Figure 7.8: Annual product history, Amylin Pharmaceuticals

Figure 7.9: Product pipeline, Amylin Pharmaceuticals

Figure 8.10: Annual product history, Trimeris

Figure 8.11: Product pipeline, Trimeris

Figure 9.12: Annual product history, ViroPharma

Figure 10.13: Annual product history, NPS Pharmaceuticals

Figure 10.14: Product pipeline, NPS

Figure 10.15: Disease area focus, NPS Pharmaceuticals

Figure 11.16: Annual product history, SIGA Technologies

Figure 11.17: Product pipeline, SIGA Technologies

Figure 12.18: Annual product history, Idenix Pharmaceuticals

Figure 12.19: Product pipeline, Idenix Pharmaceuticals

List of Tables

Table 1.1: Top 20 pharmaceutical companies ranked by revenues (2006)

Table 2.2: Summary analysis of the fastest growing biopharmaceutical companies, 2006 ($m)

Table 2.3: Fastest growing biopharmaceutical companies by net income/loss from operations, 2002-06 ($m)

Table 2.4: The top 20 biopharmaceutical companies by revenue in 2006 ($m)

Table 2.5: Summary analysis of fastest growing biopharmaceutical companies 2006 ($m)

Table 2.6: Fastest growing biopharmaceutical companies by revenues and % growth, 2002-06 ($m)

Table 2.7: Fastest growing biopharmaceutical companies by R&D expenditure, 2002-06 ($m)

Table 2.8: Company Analysis: Proprietary Technology versus Therapeutic Area

Table 2.9: Fastest growing biopharmaceutical companies by revenues and % growth, 2002-06 ($m)

Table 2.10: Company analysis by approved marketed product

Table 3.11: Company address and contact details

Table 3.12: Theravance Income Statement, 2002-2006 ($ millions)

Table 3.13: Theravance product development programs

Table 4.14: Company address and contact details

Table 4.15: ISTA Income Statement ($ millions 2002-2006)

Table 4.16: ISTA marketed product sales ($ millions 2005-2006)

Table 4.17: ISTA product development and pipeline

Table 5.18: Company address and contact details

Table 5.19: Palatin Income Statement ($ millions) year ended June 30, 2003-2007

Table 5.20: Palatin product development and pipeline

Table 6.21: Company address and contact details

Table 6.22: Pharmion Income Statement ($ millions 2002-2006)

Table 6.23: Pharmion marketed product sales ($ millions, 2002-2006)

Table 6.24: Pharmion product development and pipeline

Table 7.25: Company address and contact details

Table 7.26: Amylin Pharmaceuticals Income Statement, ($ millions, 2002-2006)

Table 7.27: Amylin Pharmaceuticals Income Statement ($ millions, 2002-2006)

Table 7.28: Amylin Pharmaceuticals product development and pipeline

Table 8.29: Company address and contact details

Table 8.30: Trimeris Income Statement ($ millions 2002-2006)

Table 8.31: Trimeris product development and pipeline

Table 9.32: Company address and contact details

Table 9.33: ViroPharma Income Statement ($ millions, 2002-2006)

Table 9.34: ViroPharma product development and pipeline

Table 10.35: Company address and contact details

Table 10.36: NPS Pharmaceuticals Income Statement ($ millions 2002-2006)

Table 10.37: Marketed products

Table 10.38: Marketed products

Table 10.39: NPS Pharmaceuticals product development and pipeline

Table 11.40: Company address and contact details

Table 11.41: SIGA Technologies Income Statement ($ millions, 2002-2006)

Table 11.42: SIGA Technologies- issued patents as of December 31, 2006

Table 11.43: SIGA Technologies provisional patents and patent applications as of Dec 31, 2006

Table 11.44: SIGA Technologies product development and pipeline

Table 12.45: Company address and contact details

Table 12.46: Idenix Pharmaceuticals Income Statement ($ millions, 2002-2006)

Table 12.47: Idenix Pharmaceuticals product development and pipeline

Abstract

• Identify the fastest growing biotech companies over the 2002-06 period, and use detailed company analysis to measure the performances and outlooks of major players including Theravance, ISTA, Palatin, Pharmion, Amylin, Trimeris, ViroPharma, NPS, SIGA and Idenix.
• Discover which therapeutic areas have been targeted by the fastest growing biotech companies and determine which strategies they have used to exploit proprietary technologies and intellectual property.
• Review the progress of biotech development programs and understand the regulatory status of new products in development, patents held and the current status of marketed products.
• Benchmark the strategies of the fastest growing biotech companies with this report’s assessment of the effectiveness and wider implications of a host of leading strategic implementations.
• Understand how biopharma drug discovery programs are being improved to develop more efficient methods in the screening of new chemical entities (NCEs).

• Biotech losses. Only eleven of the world’s top twenty biotechnology companies currently attain a positive net income. This trend is a key industry-wide issue, with companies now attempting to stabilize financial performance.
• Developmental uncertainty. Biotherapeutic developments continue to face a high level of uncertainty. A wide array of factors can contribute to the delay or late-stage failure of promising products.
• External investment. Time-consuming, risky and expensive biopharma product developments require high levels of investment and investor patience, as market-generated revenues are often late in materializing. Investors often pursue milestone payments, joint ventures, out-licensing deals, or M&A as alternative exit strategies.
• Partnership trends. The majority of dedicated biotech companies have attempted to establish strategic alliances, joint ventures and even mergers between themselves and major pharma companies.

• Theravance, Inc. is the fastest growing biotechnology company in the world, with a growth rate of 12,456% over the 2002-06 period. However, Theravance also has one of the highest levels of net losses within the industry, highlighting the need to sustain more stable, predictable and stronger financial performance.
• ISTA Pharmaceuticals, Inc is the world’s second fastest growing biotechnology company, with a growth rate of 11,773% between 2002-06. Palatin Technologies, Inc. is in third position with a growth rate of 6,928% during the same period.
• Amylin Pharmaceuticals, Inc. recorded the greatest sales gains over 2002-2006, with an increase of $497.4mn during this period.
• The top 10 fastest growing biotechnology companies had a combined R&D expenditure of $734mn in 2006. This constitutes an increase of $324.7mn since 2002, and a five year growth rate of 179%.
• Flexible or adaptive clinical trial designs and proprietary Internet applications are helping to bring products to market faster by improving the efficiency of clincial trials. A prominent example of this is MetaTrial’s Electronic Data Capture (EDC) software.

• Who are the fastest growing biotechnology companies in the world?
• What is their level of R&D expenditure and how does this compare to their revenues?
• What proportion of biotech company revenues are accounted for by marketed products?
• What license agreements, joint ventures and partnerships have been established by the fastest growing biotech companies?
• How profitable is the biopharmaceutical industry?
• What key strategic tactics are being adopted by the fastest growing biotech companies in R&D, product commercialization, cost containment, manufacturing and screening/development of NCEs?
• What are the strengths, weaknesses, opportunities and threats to each of the companies profiled within this report?
• What is the product pipeline status of major biotech companies?

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