US biotechnology giant has presented clinical data showing that its anaemia drug Aranesp appears to be safe and effective when the dosing is extended.

Results of a Phase II trial, presented at the 14th European Cancer Conference in Barcelona, Spain, indicate that extending the dosing of Aranesp (darbepoetin alfa) paired with chemotherapy treatment (every two or three weeks depending on chemotherapy regimen) appeared to be effective in maintaining levels of haemoglobin and, importantly, no unexpected adverse events were observed compared to weekly dosing.

This study is the first prospective trial that demonstrates how different dosing regimens can be paired with chemotherapy administered across a range of dosing schedules, the group said. "Flexibility in dosing is important for physicians to optimise anemia management and meet patient needs," explained Timothy Rearden, a haematology oncology consultant. "In this study, Aranesp was consistently effective regardless of dosing frequency, providing healthcare professionals with the ability to adapt Aranesp treatment as required," he added.

In addition, Amgen said that results from two analyses suggest that patients treated with Aranesp needed less blood transfusions and experienced an improvement in haematologic response. Furthermore, there was no evidence to suggest a negative impact on overall survival or progression-free survival between patients receiving chemotherapy with Aranesp and those that did not receive the drug, it noted.

Safety concerns

Aranesp was first approved by the US Food and Drug Administration in September 2001 for the treatment of anaemia associated with chronic renal failure. But sales of the drug have been in decline since its safety, and that of others in the erythropoiesis-stimulating class, came into question after studies indicated an increased risk of death, blood clots, strokes and heart attacks in patients when ESAs were given at higher than recommended doses. Consequently, stronger warnings were added to the drugs’ labels.

To make matters worse, Medicare has restricted reimbursement for the ESA class, a move that Amgen is currently contesting. According to one analyst, "Amgen will likely lose at least 40% of their US Aranesp revenue by 2008 with even greater downside possible for both Aranesp and Epogen (epoetin alfa) if reimbursement and regulatory decisions go against them."

And just to days ago Amgen unveiled plans to lay off more than 1,000 employees, including 675 at its headquarters in California and the remainder at its facility in West Greenwich, Rhode Island, according to media reports, as part of moves announced last month.

In August, Amgen's chief executive Kevin Sharer initiated a massive cost-cutting effort, which included the loss of between 2,200 and 2,600 jobs as part of a bid to save between $1 billion and $1.3 billion in 2008.