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Imminent launches of new EPO
products and consolidation of the biogenerics field
Three European
launches of new EPO products to be expected within two years; full pipeline of
biogeneric and innovator
EPO products
BARCELONA, Spain | June 02, 2006 |
The Business Intelligence firm La Merie S.L.
reported today changes in the field of erythropoiesis stimulating agents (ESA)
observed in a follow-up analysis. The first launch of a new ESA in Europe is
expected to be Shire's epoetin omega in the first half of 2007 to be followed by
Roche's next generation pegylated
erythropoietin (EPO)
product CERA in the second half of 2007. As the filing of the first biogeneric
EPO with the EMEA by Stada's Bioceuticals subsidiary is scheduled in June 2006,
its European launch is expected for the first half of 2008. First approvals of
biogeneric hGH and the EMEA guidance of biogeneric development by scientific
advice and specific guidelines contribute to the consolidation of the biogeneric
EPO field. Some players left the field due to higher than expected costs of
development, while others are concluding marketing partnerships throughout
Europe after reduction of the regulatory risk. These results and more were found
in a search conducted by La Merie Business Intelligence. The follow-up
competitor analysis can be acquired at
www.pipelinereview.com ,
La Merie's News Center and Online Store. More information will be provided in
the biogenerics miniseries published in the FREE
daily R&D Newsletter of
PipelineReview.com beginning June 19, 2006.
Global sales of EPO products again exceeded US$ 11 bln in 2005, but did not
further increase compared with 2004. Sales of first generation epoetin alfa by
Amgen (-6 %) and J&J (- 7 %) are successively being converted into sales of
longer-acting darbepoetin alfa (+ 32%) from Amgen. The
European EPO market
accounts only for 20-25 % of the total EPO market, but is exposed to a series of
new EPO launches over the next years and a full pipeline of generic EPO
developments. In addition, five next generation ESAs are in clinical development
stages and include at least two oral small molecules. The acquisition of
European licensing rights of FG-2216 by Astellas from Fibrogen validates the
oral ESA approach. At least ten further innovator ESAs are in non-clinical
stages.
An increasing number of companies have established
EPO manufacturing
capacity in “off-patent” countries such as India and China and are offering low
cost national alternatives to expensive branded products. In contrast, the first
biogeneric products in Europe and the US are to be sold at a 25-30 % discount to
the original products. Asian companies are also entering successively the
innovator field with next generation ESAs.
About R&D Pipeline News
R&D Pipeline News is a premier information source about research and
development projects in the pipeline of the biopharmaceutical industry. The
periodical is directed to all stakeholders in R&D. The weekly publication comes
in a rapid- and easy-to-screen tabular format and provides access to the
original information source via hyperlinks. R&D Pipeline News covers all
relevant treatment modalities and is directly delivered to the desktop via
e-mail. More information about the journal, a free trial and subscriptions are
available via La Merie’s Business Intelligence Center
www.pipelinereview.com .
About La Merie
La Merie S.L. is a Business Intelligence enterprise fully dedicated to provide
high quality R&D information to the biopharmaceutical industry. La Merie offers
individual consultancy services and publishes reports and periodicals.
They publish two weekly
newsletters - apply for a FREE three week trial:
R&D Pipeline News is a premier
information source about research and development projects in the pipeline of
the biopharmaceutical industry and is directed to all stakeholders in R&D. The
weekly publication comes in a rapid- and easy-to-screen tabular format and
provides access to the original information source via hyperlinks. R&D Pipeline
News covers all relevant treatment modalities and is directly delivered to the
desktop via e-mail.
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