West Coast Editor

As expected, the European Commission gave its marketing nod to Aranesp and Neulasta, the strong-selling U.S. oncology products from Amgen Inc.

The company's stock (NASDAQ:AMGN) closed Wednesday at $45.18, down 3 cents.

Amgen did not return repeated phone calls seeking comment, but Leah Rush Cann, senior vice president at Wachovia Corp. in New York, said in a research note that the approvals in Europe "could provide some potential upside to our numbers, but we think it will be important to observe how sales ramp in Europe."

Historically, Cann wrote, "drugs tend to ramp more slowly in countries outside of the U.S. due to differences in pricing and reimbursement structure."

Aranesp (darbepoetin alfa) will be called Nespo in Europe, and Neulasta (pegfilgrastim) will be called Neupopeg.

In June, an advisory panel in Europe recommended approval of both drugs, which also comes two months after Amgen disclosed it was paying Roche Holding AG $137.5 million to gain control over European assets and business related to Neulasta and to Neupogen, the first and shorter-acting version of Neulasta. (See BioWorld Today, May 9, 2002.)

Neulasta is approved in Europe to shorten duration of neutropenia and the incidence of febrile neutropenia in chemotherapy patients with malignancies, excluding chronic myeloid leukemia and myelodysplastic syndromes.

Unlike Neupogen, which is injected daily, Neulasta is given only once per chemotherapy cycle. Roche had to sell the rights because of the upcoming merger of its Japanese subsidiary and Chugai Pharmaceutical Co. Ltd., a Tokyo-based company that has a competing product. Neulasta was approved in the U.S. in February and was launched April 1.

Aranesp, which won FDA approval in July for oncology indications, is an erythropoietic protein with greater in vivo activity and a longer half-life than other recombinant human erythropoietins, which also allows for less-frequent dosing. It's the second generation of Amgen's blockbuster, Epogen (epoetin alfa), and was first approved in the U.S. in September as a red blood cell booster for dialysis and non-dialysis patients with chronic renal failure.

In Europe, Aranesp is approved for the treatment of anemia in adult cancer patients on chemotherapy with solid tumors (non-hematological malignancies).

Analyst Elise Wang, with Salomon Smith Barney in New York, estimated worldwide sales for Aranesp at $350 million for fiscal 2002 and $800 million for fiscal 2003. For Neulasta, the estimated numbers are $350 million and $700 million for the two respective fiscal years.

In March, the European Commission approved Amgen's Kineret (anakinra) for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in patients with an inadequate response to methotrexate alone. The FDA approved Kineret, an interleukin-1 blocker, in November. (See BioWorld Today, Nov. 15, 2001.)