FDA Licenses Amgen's Colorado Epogen, NESP Facility

Amgen (Thousand Oaks, CA) has received U.S. Food and Drug Administration licensure for the company's new, state-of-the-art, multi-product manufacturing plant in Longmont, CO, where Amgen will manufacture its established anemia drug Epoetin alfa. Amgen also expects to manufacture its new anemia drug, Novel Erythropoiesis Stimulating Protein (NESP), currently under FDA review, at the Longmont facility.

Longmont, built on 22 acres of a 234-acre site, was designed to manufacture recombinant proteins using mammalian cell lines and is staffed by more than 275 employees. The site comprises four buildings including a 200,000 square-foot manufacturing facility, a 50,000 square-foot central utility plant, a 100,000 square-foot laboratory and support building and a 100,000 square-foot warehouse. The manufacturing plant ultimately will have three times the Epoetin alfa production capacity of Amgen's current plant, which is located in Thousand Oaks.

Construction on an additional 200,000 square-foot expansion consisting of laboratory and office space is being planned.

The Longmont Manufacturing Facility is now licensed for manufacturing Epoetin alfa. Amgen is currently manufacturing test lots of NESP at the facility and plans to file a supplemental license application once NESP receives marketing approval.

NESP, a recombinant protein being explored for its potential to stimulate the production of red blood cells in less frequent doses than Epoetin alfa, will be targeted for individuals anemia associated with chronic kidney failure.

People with diabetes and hypertension, among other diseases, are at risk for progressing to chronic kidney failure. In December 1999, Amgen filed regulatory license applications for NESP with the FDA and the European Medicines Evaluation Agency for use in CRI and chronic kidney disease patients on dialysis. It is planned that, upon FDA approval, NESP will be manufactured at the Longmont facility.

In addition, phase 2 clinical studies are underway in treating cancer patients with anemia resulting from chemotherapy.

Amgen sells Epoetin alfa as Epogen in the United States for treating anemia associated with end stage renal disease for dialysis patients. A hormone, Epogen stimulates red blood cell production and was approved by the FDA in June 1989. U.S. sales totaled $1.8 billion in 1999.

Edited by Angelo DePalma