Epogen is a human erythropoietin produced in cell culture using recombinant DNA technology, and is manufactured from Amgen’s Longmont facility in Colorado. However, late last week the firm announced it was halting manufacture of the drug and all other production operations at its Longmont and nearby Lake Centre facilities.
“We are suspending manufacturing in Colorado based on our current product and pipeline requirements,” Amgen spokeswoman Ashleigh Koss told Biopharma-Reporter.com.
However, she continued, “Amgen will maintain appropriate production capacity in Colorado and may resume manufacturing in the future based on pipeline and inventory requirements.”
The bulk drug substance for Epogen is made at Longmont, Koss confirmed, but this will discontinue after April 30 2014. At present, the firm has enough of the drug to meet its projected demands.
Epogen is approved to treat treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy, and according to a US Government Accountability Office report last June, was responsible for Medicare expenditure of $2bn in 2010.
Job Cuts
Koss also spoke to us about jobs at the facilities, and with the end of manufacturing “approximately a third of the current 650 full-time staff members” – about 220 – will be affected.
“Amgen continuously reviews our staffing levels to ensure we are organized in the most efficient and effective way to fulfill our mission to serve patients,” she said, adding: “Colorado continues to have approximately 430 staff members in the areas of process development, quality, information systems, and corporate support functions.”
Biosimilar Competition
In last week’s Q4 2013 earnings conference call, Amgen’s EVP Global Commercial Operations Tony Hooper told stakeholders US sales of the drug had increased 10% year-over-year, due to the recall and withdrawal of Affymax and Takeda’s rival anaemia drug Omontys.
However, Hooper added sales of Epogen in Europe had continued to slowdown due to “price pressures” including “competition from [Roche’s] Mircera,” a long-acting erythropoietin receptor activator also indicated for the treatment of patients with anaemia associated with chronic kidney disease.
In Europe there are several Epoetin alfa biosimilars approved including Sandoz’ Binocrit and Medice Arzneimittel Pütter’ Abseamed, as well as fellow EPO drug Retacrit, marketed by Hospira.
In our original article we stated that Roche's Mircera was a biosimilar of Epogen approved in the EU in 2007. This is not the case and the article has been updated to reflect this.