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6/27/2004

Amgen seeks approval for drug sales

By Tony Kindelspire
The Daily Times-Call

LONGMONT — Amgen last week asked the Food and Drug Administration for a license to begin selling its drug Palifermin, which is used to treat people who experience painful side effects after undergoing a bone marrow transplant. If approved, the bulk of the drug’s manufacturing would be done at the company’s Boulder facility.

Eric Bergenson, vice president of operations for Amgen-Colorado, said the submission was made under a new program the FDA calls “Fast Track” designation.

“If not the first, we’re one of the first to come through in this new pilot program,” Bergenson said.

According to Amgen spokesperson Debbie Ford, the FDA has two criteria for getting into the Fast Track program: A drug must treat either a serious or life-threatening condition, or an “unmet medical need.” Palifermin, Ford said, falls under the latter category.

Palifermin was designed to treat bone marrow-transplant patients who are suffering from oral muscositis — or mouth sores — which can make eating, swallowing and sleeping difficult.

Amgen officials said in a press release that approximately 11,000 Americans undergo bone marrow transplants each year. According to Bergenson, Palifermin is the first such treatment out there for patients with mouth sores.

Another part of the Fast Track designation is that Amgen may provide “rolling submissions” of testing data to the FDA as the company awaits a “biologic license” for Palifermin.

Amgen’s “Lake Center” facility in Boulder employs about 150, while approximately 550 work at its Longmont facility. Bergenson said that if the company is granted its license, the manufacturing of Palifermin will continue at the Boulder facility.

“From what we understand what the demand will be, we certainly have the capacity to do that manufacturing (in Boulder),” Bergenson said.

In other Amgen news, Lancaster Laboratories, a commercial testing laboratory, has hired approximately 30 local workers as part of a contract it signed to conduct analytical tests for Amgen in the company’s Longmont laboratories.

“It’s the first time we’re doing this in Colorado, as a contract like this,” Bergenson said. “There’s sort of a steady state of work around supporting the manufacturing of our products.”

Bergenson added that his company is going through a “peak period of work in the analytical area” at the moment. “This work is in anticipation of other products that we hope will be coming out of this facility in the future.”

As for the length of time the Lancaster-hired scientists will be working at Amgen in Longmont, Bergenson said he couldn’t say for sure. The contract “should last at least a year,” he said, noting that the timetable was dependent upon many factors.

“Of course, things change and business drivers change, so we have to evaluate at that point in time whether they continue or not,” he said.

Founded in 1961 and based in Lancaster, Pa., Lancaster Labs has 650 employees and annual sales of approximately $50 million.

Tony Kindelspire can be reached at 303-776-2244, Ext. 291, or by e-mail at tkindelspire@times-call.com.