Amgen: Pipeline, Products, Performance, Potential

Date: November 22, 2010
Pages: 132
Price:
US$ 1,040.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: A909F83FCECEN
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Amgen: Pipeline, Products, Performance, Potential
Amgen was incorporated in 1980 and is a global biotechnology company that discovers, develops, manufactures and markets human therapeutics. Amgen operates in one business segment, human therapeutics, and markets products in the areas of haematology, immunology, inflammation and oncology. Research and development efforts are focused on novel theraputics for the treatment of haematology, inflammation, oncology, metabolic disorders and neuroscience.

Amgen is one of the world’s largest biotechnology companies in terms of pharmaceutical sales and R&D expenditure. 2009 was a difficult year for Amgen due to slower sales growth coupled with costs incurred from expansion of infrastructure. Amgen believes the short-term loss in income is acceptable in light of the long-term advantages of improved facilities and an expanded product portfolio and pipeline.

The take-overs of Immunex and Tularik in previous years have had a positive impact on Amgen’s growth. In 2006 and 2007, Amgen acquired a further four companies (Abgenix, Ilypsa, Alantos and Avidia). The acquisition of Abgenix is especially significant to Amgen, as it provides the company with full ownership of Vectibix, the company’s latest product release, and Prolia. Vectibix was set to become Amgen’s core oncology product. Part of Amgen’s key company strategy for 2007 was the successful launch of Vectibix in Europe (achieved in the fourth quarter) and the product is being developed in an extensive range of anticancer indications. In clinical trials, Vectibix has compared favourably to one of the current market leaders, ImClone Systems (Eli Lilly)/Bristol-Myers Squibb/Merck KGaA's Erbitux (cetuximab), and has a more patient-friendly dosing regimen than this product.

However, sales are not as high as expected; the European approval for MCRC was for patients for non-mutated KRAS genes only, limiting the potential patient population of the product. In November 2008, the FDA decided that the use of Vectibix for the treatment of colorectal cancer with KRAS mutations was not recommended. Amgen originally forecast peak sales of US$2 billion for its product in the US and EU. Following a decline in 2008, Vectibix sales have since recovered, however achieving the forecasted US$676 million by 2016, will require a global launch for an extended range of new indications which are in various stages of development in the pipeline.

Beyond these compounds, Amgen’s product portfolio and pipeline look promising: Prolia, Neulasta, Enbrel and Sensipar are all forecast to increase their market share, more than offsetting any losses experienced by Aranesp, Epogen and Neupogen. The Medicare Modernisation Act (MMA) was enacted into US law in December 2003 and became effective on 1st January 2005. Changes resulting from the MMA, which lowered reimbursement for Amgen’s products, were expected to impact Amgen’s revenue, however, this has yet to be realised to a significant degree.

In 2006, Amgen increased R&D spending by 45.5 per cent, an indication of its confidence in the commercial potential of its pipeline. However, this high spending was cut back in 2007, with R&D expenditure down by 3.0 per cent. R&D expenditure declined further in 2009 by 5.5 per cent. Motesanib disphosphate is considered a leading candidate compound, is indicated for a number of oncology indications and, in conjunction with the expected success of Vectibix, is expected to become a growth driver for Amgen’s cancer therapy area. Nplate is a first-in-class compound, and is being developed for immune idiopathic thrombocytopenic purpura (ITP), myelodysplastic syndromes and chemotherapy-induced thrombocytopenia. The drug has now been approved for ITP in the US, EU and Australia, and awaits approval in Canada.

Amgen’s business is currently strongly focused in the US, with 78.0 per cent of sales being generated in this market, however, the company is endeavouring to expand its operations in foreign markets. In March 2007, Amgen completed a new European headquarters in Uxbridge, UK, which in conjunction with its expanded Cambridge, UK, R&D facilities, will conduct the company’s largest ever international clinical trial programme across 31 European countries.

2009 could have been a very strong year for Amgen, however, the performance of Aranesp was a significant let down. Safety issues have led to new usage guidelines for the product and others in its class. In the medium-term, this is expected to lead to further losses. Amgen will be hoping it can overcome these difficulties through its new infrastructure and increasingly expanding product portfolio.

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REPORT CONTENTS

EXECUTIVE SUMMARY

A detailed and comprehensive overview of current financial position, company strategy, product and pipeline analysis.

THERAPEUTIC AREA FOCUS

Key product analysis and forecasting
Haematology
  Aranesp/Nespo (darbepoetin alpha)
  Epogen (epoetin alpha)
  Nplate (romiplostim)
Immunology
  Neulasta (pegfilgrastim)
  Neupogen/Granulokine (filgrastim)
Inflammation
  Enbrel (etanercept)
Oncology
  Vectibix (panitumumab)

OPERATIONAL DATA

A wealth of background and detail
A full 5-year financial performance assessment
Key corporate events
Key agreements
Infrastructure
Subsidiaries and joint ventures
Latest Results

EXECUTIVE SUMMARY

Introduction
Current Financial Position
  Company Performance
  Business Segment Performance
  Geographic Segment Performance
Company Strategy
  Mergers, Acquisitions and Divestitures
  Key Agreements
  R&D Strategy
  Production
  Employees
Product Performance Forecasts
Pipeline Analysis
  Discontinued R&D Projects
Conclusions

THERAPEUTIC AREA FOCUS

R&D PIPELINE

HAEMATOLOGY

Launched Products
  Aranesp
  Epogen
R&D Projects
  AMG 145
  AMG 223

IMMUNOLOGY

Launched Products
  Infergen
  Neulasta
  Neupogen

INFLAMMATION

Launched Products
  Enbrel
R&D Projects
  AMG 108
  AMG 191
  AMG 811
  AMG 827

ONCOLOGY

Launched Products
  Kepivance
  Novantrone
  Nplate
  Prolia
  Vectibix
  Colorectal Cancer
R&D Projects
  AMG 102
  AMG 208
  AMG 386
  AMG 479
  AMG 820
  AMG 888
  AMG 900
  Conatumumab
  Dulanermin
  Motesanib diphosphate

CARDIOVASCULAR

R&D Projects
  AMG 151
  AMG 221
  AMG 222
  AMG 423

OTHER

Launched Products
  Sensipar
R&D Projects
  AMG 009
  AMG 157
  AMG 167
  AMG 745
  AMG 747
  AMG 785
  AMG 853

APPENDIX 1 - FINANCIAL PERFORMANCE

Full Year Results 2009

APPENDIX 3 - KEY AGREEMENTS

Anthera Pharmaceuticals Inc
Array BioPharma Inc
AstraZeneca
Biovitrum AB
Boehringer Ingelheim Pharma KG
CombinatoRx
Curagen Corporation
Cytokinetics
Daiichi Sankyo
Gamida Cell Ltd
Genmab A/S
GlaxoSmithKline
Human Genome Sciences Inc (HGS)
ImmunoGen
Infinity Pharmaceuticals Incorporated
InteKrin Therapeutics
InterMune Inc
Isis Pharmaceuticals Inc
Johnson & Johnson
Kirin Brewery Co Ltd/Kirin-Amgen
Kyowa Hakko Kirin
Medarex Inc
MedGenesis Therapeutix
Memory Pharmaceuticals
NPS Pharmaceuticals Inc
Oxford Genome Sciences Ltd
Predix Pharmaceuticals
ProStrakan Group plc
Roche
Takeda
Three Rivers Pharmaceuticals
UCB
Wyeth (Pfizer)
ZymoGenetics Inc

APPENDIX 4 - INFRASTRUCTURE

Research And Development Facilities
Manufacturing Facilities

APPENDIX 5 - KEY PHARMACEUTICAL SUBSIDIARIES / JOINT VENTURES

Subsidiaries
Joint Ventures

APPENDIX 6 - PRODUCT INDEX

LIST OF CHARTS

Sales, Costs and Operating Income
Long-Lived Assets By Geographical Area, 2009
Product Sales By Geographical Area
Top Selling Products, 2009
Kyowa Hakko Kirin's Espo/Nesp Sales (2008-2016)
Amgen's Epogen Sales (2008-2016)
J&J's Eprex/Procrit Sales (2008-2016)
Kyowa Hakko Kirin's Espo/Nesp Sales (2008-2016)
Neulasta Sales (2008-2016)
Neupogen Sales (2008-2016)
Amgen's Enbrel Sales (2008-2016)
Pfizer's Sales of Enbrel (2008-2016)
Takeda's Sales of Enbrel (2008-2016)
FDA ANDA Approvals for Mitoxantrone
Nplate Sales (2008-2016)
Amgen's Sales of Denosumab (2010-2016)
Schematic of EGFr Inhibition in Tumourigenesis
Vectibix Sales (2008-2016)
Motesanib Total Sales (2014-2016)
Motesanib Total Sales (2014-2016)
Sensipar Sales (2008-2016)
Kyowa Hakko Kirin's Sales of Regpara Sales (2009-2016)
Sales, Costs and Operating Income
Profitability and Research Ratios
R&D Expenditure and Capital Expenditure
Current Assets, Liabilities and Ratio
Assets, Cash and Liquidity
Employees and Productivity

LIST OF TABLES

Principal Operating Results
Sales By Geographical Area
Sales By Geographical Area
Long-Lived Assets By Geographical Area
Recent Product Approvals
Major Products, Therapeutic Areas and Sales
Vectibix Sales by Indication (2008-2016)
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