Amgen unveils plan to close Epogen plant
pharmafile | August 14, 2012 | News story | Manufacturing and Production | Amgen, Epogen, cuts, omontys
Amgen has said it will close down a manufacturing facility in Longmont, Colorado, in the face of declining sales of its red blood cell-boosting treatments.
The plant will cease operations in the next 12 to 15 months, with the 485 people employed there now waiting to hear whether they will be offered employment elsewhere in the Amgen group.
The nearby LakeCentre facility in Boulder – which employs around 240 staff and manufactures products such as osteoporosis, arthritis and cancer treatment denosumab – is unaffected by the cutbacks.
The bulk ingredient for Epogen (epoetin alfa) is the only product made by Amgen at Longmont, and sales of the drug – used as a supportive therapy in patient with cancer or chronic kidney disease – have been in decline.
In the first half of this year Epogen sales fell 10% to $971 million as a result of new competition from Affymax/Takeda’s Omontys (peginasetide) – which was approved for marketing in the US in March – but also safety concerns which emerged in 2010 and have pegged back demand.
Amgen’s long-acting variant Aranesp (darbepoetin alfa) has also been affected, with sales down by 10% to $1.05 billion in the first half. The bulk active for Aranesp is made in Amgen’s Juncos plant in Puerto Rico.
Sales of Epogen were $2.5 billion in 2010 but fell to $2.0 billion last year. The company has insisted that its brand strength will help Epogen remain a key product in the marketplace, but the latest decision suggests it is trying to reduce costs in order to retain profitability from the epoetin franchise.
A key factor in the decision is likely to be the upcoming expiry of epoetin alfa’s patent protection in the US next year, opening the door for biosimilar competitors from the likes of Novartis/Sandoz, Roche and Hospira.
Meanwhile, Amgen has been trying to defend its epoetin alfa products from Omontys by signing supply contracts with DaVita and Fresenius, the two biggest dialysis clinic chains in the US.
Local media reports indicate that while the production elements of the Longmont facility will be closed, operations there which provide quality control and process engineering and development services across the Amgen group will be retained. At present it is not clear whether these will remain at Longmont or be moved elsewhere.
Production will ramp up over the coming months and then cease and the plant will be idled, said a report in the Longmont Times.
Phil Taylor
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