Amgen notes delay in launch of Aranesp

Amgen has forecast a slight delay in its launch schedule for Aranesp(darbepoetin alfa), a follow-up to its flagship anemia drug Epogen (epoetin alfa), because the US Food and Drug Administration is taking longer than expected to review the dossier for the drug. Ana lyst Denis Harp at Deutsche Banc Alex Brown has cut his forecast for 2001 sales of the new product to $150 million from $250 million because of the delay.

Nevertheless, Mr Harp retains a strong buy rating on Amgen, and this positive view was echoed by a report on Morningstar.com which noted that Aranesp is still likely to receive approval from the FDA in the second quarter of this year, although Amgen had hoped it would get the go-ahead by the end of this month. In addition, three other major products are under review at the FDA and should be launched in either 2001 or 2002, including the firm's rheumatoid arthritis drug anakinra, Plenaxis (abarelix depot; with Praecis) for prostate cancer and a sustained-release version of Neupogen (filgrastim), called pegfilgrastim (see also page 4).

The European Committee for Proprietary Medicinal Products has already recommended approval for Aranesp (Marketletter March 26) and Amgen has said it is ready to launch the product in Germany and the UK as soon as full approval comes.