Amgen announced Aug. 23 that it filed an application with the U.S. Food and Drug Administration to begin operations at a retrofitted manufacturing plant in West Greenwich.
The 200,000 square-foot cell-culture manufacturing facility, which cost $450 million to upgrade, has been retrofitted to produce ENBREL, the hugely successful rheumatoid arthritis drug developed by Seattle-based Immunex, which Amgen acquired in July.
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Fabrizio Bonanni, Amgen’s senior vice president for quality and compliance, said that the timing of the FDA filing was in line with previous expectations, and he called it an important milestone in Amgen’s efforts to boost production of the drug. Amgen said previously that it hopes to begin commercial production at the plant during the first quarter of 2003.
Thousands of patients are on a national waiting list to receive ENBREL, which is expected to take in $1.2 to $1.4 billion in revenues during fiscal 2002. Amgen cut its estimate from $1.6 billion last month, citing short supply of the drug.
A second, 250,000 square-foot facility is under construction at the same location in West Greenwich and is set for completion in 2005.
