Patent expiry of epoetin alfa in Europe attracts 10 companies with biogeneric erythropoietin

Barcelona, October 6, 2005: Ten companies with clinical stage biogeneric versions of recombinant human erythropoietin (EPO) are attacking the US$ 2.3 bln European market of EPO. Patent expiry of epoetin alfa in Europe and a recently issued guideline of the EMEA now paved the way for regulatory approval of biogeneric versions of recombinant proteins (biosimilars or follow-on biologics). These 10 companies have been identified in a research analysis, recently conducted by La Merie Business Intelligence. The results were published in the October 3 issue of R&D Pipeline News, edited by La Merie.

Among the 10 companies with biogeneric EPO projects are subsidiaries or business units of established generic companies as well as new ventures in Europe and expanding Asian manufacturers of recombinant proteins. One of the ten companies was the first to receive a European approval of its biosimilar EPO in Croatia (outside the EU). In addition, Shire Pharmaceuticals (after acquisition of TransKaryotic Therapeutics) is planning European launch of its epoetin delta product which already is approved by the EMEA. Manufacturing sites of the biosimilar EPO versions are located in Europe, e.g. Ireland , The Netherlands, Austria , and in Asia ( India , South Korea and China ).

La Merie's analysis also identified more than 15 manufacturers of EPO in countries not respecting patent protection (“off-patent countries”), such as Cuba , Brazil , Argentina , South Africa , India , China , Taiwan and South Korea with many products in their home markets and in developing countries. Major players of first generation EPO biogenerics are Dragon Pharmaceuticals (China/Canada), LG Life Science ( Korea ) and Wockhardt ( India ).

Apart from first generation erythropoietin molecules, the pipeline of next generation erythropoiesis-stimulating agents (ESA) includes at least 12 different R&D projects. The new ESAs aim at improving potency, pharmacokinetics and bioavailability. These agents include pegylated versions of EPO, EPO-fusion proteins, new peptides and oral small molecules. Current market leaders Amgen/Kirin and Roche/Chugai also have follow-on ESAs to defend and maintain their market stake.

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