No FDA Approval This Month for New Amgen Anemia Treatment

Amgen Inc. said Friday that it won’t receive government approval of its second-generation anemia treatment by the end of this month, as it had expected. The Thousand Oaks-based biotechnology company had forecast Food and Drug Administration clearance for Aranesp during the first half of 2001.

Amgen, the world’s largest biotechnology company, said discussions about what to put on the label are continuing with the FDA and are encouraging. The company declined to provide details on those talks but said the FDA hasn’t asked for more data.

The label has competitive importance to Amgen, which touts Aranesp as a longer-lasting version of its first-generation anemia treatment, EPO.

The European Union this month OKd use of Aranesp for kidney disease and dialysis patients weekly or every other week. That dosing schedule makes Aranesp more convenient than EPO, which is sold in Europe and many U.S. markets by Johnson & Johnson under a marketing agreement with Amgen. The approved dosing of EPO is three times a week.

Amgen declined to predict when the FDA might act on Aranesp, a protein that, like EPO, spurs the growth of red blood cells. But analysts, many of whom anticipated the regulatory delay, believe that the drug will be approved before the end of the year.

Wall Street believes that Aranesp has blockbuster potential, as does Amgen. Chairman and Chief Executive Kevin Sharer told investors in March that worldwide sales of Aranesp could exceed those of EPO, sold under the name Epogen, which had revenue last year of $1.9 billion.

Amgen sells Epogen in the domestic dialysis market; dialysis patients are chronically anemic because they lack the protein needed for red blood cell production. Johnson & Johnson markets EPO to non-dialysis patients in the U.S., and in Europe, it markets it to all segments, including those on dialysis. Johnson & Johnson’s EPO sales totaled $2.7 billion last year.

Amgen’s shares closed Friday at $60.68 down $1.99 on Nasdaq. Johnson & Johnson shares also fell, closing down $2.24 at $49.96 on the New York Stock Exchange.