Pharmaceutical company intelligence reports from Espicom provide a full review of the company's activities together with five-year sales forecasts for its key products. The company's financial performance is covered in-depth, from its latest results to a complete analysis of its latest full fiscal year and an outlook for the future. A section on company strategy covers mergers, acquisitions and divestitures, key agreements, products and R&D. An overview of key products and R&D is followed by a comprehensive review of the company's product portfolio and research and development pipeline by therapeutic area. In addition, supplementary appendices provide more in-depth information on financials, agreements and corporate events.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

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Amgen: Pipeline ' Products ' Performance ' Potential
Published on November 2010
Report Summary
Pharmaceutical company intelligence reports from Espicom provide a full review of the company's activities together with five-year
sales forecasts for its key products. The company's financial performance is covered in-depth, from its latest results to a complete
analysis of its latest full fiscal year and an outlook for the future. A section on company strategy covers mergers, acquisitions and
divestitures, key agreements, products and R&D. An overview of key products and R&D is followed by a comprehensive review of
the company's product portfolio and research and development pipeline by therapeutic area. In addition, supplementary appendices
provide more in-depth information on financials, agreements and corporate events.
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
Amgen: Pipeline ' Products ' Performance ' Potential Page 1/5

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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.
More Information...
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
Amgen: Pipeline ' Products ' Performance ' Potential Page 2/5

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Infrastructure
Subsidiaries and joint ventures
Table of Content
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
Amgen: Pipeline ' Products ' Performance ' Potential Page 3/5

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