Amgen building stronger bones

Drug maker fortifies Colorado operations for osteoporosis medication

Rachel Brand, Rocky Mountain News

Published February 23, 2006 at midnight

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Amgen Colorado is ramping up its operations in anticipation of the commercial launch of an experimental osteoporosis drug.

The drug helped strengthen bones of older women better than a placebo, a company-funded trial showed. The study was published today in the New England Journal of Medicine.

In the past year, Amgen has hired 250 manufacturing and quality assurance employees in Boulder and Longmont to prepare for the marketing of "denosumab," and it may hire more depending on the drug's momentum .

As people age, their bones tend to grow thinner, lighter and more likely to fracture. A bone mineral density test shows the amount of minerals, such as calcium in bones, and indicates bone strength.

Denosumab, which is taken twice a year, increased patients' bone mineral density up to 6.7 percent, the trial showed. The drug appeared to work at least as well as Merck's Fosamax, though the trial wasn't designed to compare the drugs.

Amgen is conducting a final study to obtain regulatory approval.

Like Amgen's Epogen, the key protein in denosumab is made in the cells of Chinese hamster ovaries.

Scientists insert the genetic code for a particular protein into the hamster cells and then manipulate the cells to make millions of copies of that genetic code.

As a consequence, the cells produce enormous amounts of the protein, acting as a factory for the therapeutic ingredient.

Amgen's Colorado manufacturing facilities are currently producing test lots of denosumab in preparation for FDA inspection.

"This step will give us and the FDA and other regulatory authorities the confidence that we are producing a consistent quality process for patients," Amgen spokeswoman Debbi Ford said.

"We have grown quite a bit in the past few years in part because of denosumab and other products in our pipeline," she said. "The growth in Colorado will depend on that momentum."

If approved, denosumab would compete with Fosamax, which must be taken weekly, and with Boniva, the once-a-month treatment sold by GlaxoSmithKline and Roche.

Doctors consider Amgen's twice- yearly dosing regimen a potential advantage.

"Long-acting doses of denosumab should enhance our pharmaceutical arsenal for the treatment of osteoporosis by improving convenience and compliance for some patients," Michael Whyte, a doctor at the Center for Metabolic Bone Disease and Molecular Research at Shriners Hospital for Children in St. Louis, wrote in an editorial that accompanied the study.

Battling osteoporosis

• What the drug may do: Increase bone density in postmenopausal women

• Where it is in the approval process: The company is conducting phase III trials.

• Notable: Denosumab's name is a combination of "den" for density, "os" for bone, "u" for human and "mab" for monoclonal antibody.

Amgen

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brandr@RockyMountainNews.com or 303-892-5269. Bloomberg News contributed to this report.

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