Released on = June 2, 2006, 3:46 am

Press Release Author = La Merie Business Intelligence

Industry = Biotech

Press Release Summary = Three European launches of new EPO products to be expected
within two years; full pipeline of biogeneric and innovator EPO products

Press Release Body = BARCELONA, Spain | June 2, 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.


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About La Merie

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quality R&D information to the biopharmaceutical industry. La Merie offers
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information visit www.lamerie.com.


SOURCE: La Merie Business Intelligence


Web Site = http://www.pipelinereview.com/joomla/content/view/3862/1/

Contact Details = Jorge Márquez
La Merie Business Intelligence
C/ Caspe, 33B, 4º, 2ª
E-08010 Barcelona
Tel +34-93-342 91 97
Fax +34-93-342 91 98
e-mail: jorge.marquez@lamerie.com
Website: http://www.lamerie.com
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