BARCELONA, Spain | Oct 17, 2005 | Amgen’s strategy to substitute its first generation granulocyte – colony stimulating factor (G-CSF) product Neupogen (filgrastim) by the longer acting, pegylated G-CSF product Neulasta (pegfilgrastim) appears to be successful in protecting its US$ 2.9 bln combined global sales in 2004. The year 2004 conversion rate of 60 % for Neulasta (in its second year after approval) suggests that only a very small market will be left over for the five European companies with biosimilar versions of G-CSF when only the European patent expires in 2006. More than 20 additional companies with activites in the biogeneric field of G-CSF were identified in a search conducted by La Merie Business Intelligence. The results were published in the October 17 issue of R&D Pipeline News , edited by La Merie.

Biotechnology initiatives in India and China have lead to more than 20 domestic manufacturers of G-CSF and GM-CSF in China and at least seven Indian companies with proprietary manufacturing. As the domestic markets are too small (e.g. Indian market size of only US$ 25 mln due to low price products), Asian companies are collaborating with Western enterprises (GeneMedix, BioPartners and Dragon Pharmaceuticals) to pass the financial, regulatory and quality barriers and catch a piece of the Western market. South American manufacturers of G-CSF so far are exporting to developing countries only.

The real biogeneric challenge for established G-CSF marketers will come with patent expiry of pegylated G-CSF in 2013/15. So far, predominantly North American companies are working on next generation G-CSF products with longer half-life and increased efficacy. All of these projects still are in preclinical stages of R&D. G-CSF so far is indicated for prevention and treatment of neutropenia mainly due to chemotherapy.
Berlex (US-subsidiary of Schering AG) is in advanced clinical development of its GM-CSF product for treatment of Crohn’s disease which could more than double its sales once approved for this up side indication.


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. For more information visit www.lamerie.com .

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 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.
More information about the journal, a free trial and subscriptions are available via the website, www.lamerie.com.

SOURCE: La Merie Business Intelligence

---