Tennessee Company Doubts They’ll Prevail, But Appeals FDA Rejection Of Bone Graft Drug Anyway

Designed for use in the place of bone grafts in orthopedic surgery, Augment uses the body's own wound-healing proteins to create new bone tissue. Image: BioMimetic

Designed for use in the place of bone grafts in orthopedic surgery, Augment uses the body’s own wound-healing proteins to create new bone tissue. Image: BioMimetic

The new owners of a Franklin-based company say they don’t understand why the FDA rejected its signature product.  Wright Medical of Memphis bought BioMimetic last year, in a deal worth $380 million. Wright Medical was banking on US approval for the drug, known as Augment, which is meant to be used in the place of bone grafts.  But last month, the FDA said a clinical trial didn’t include enough high-risk patients.

Wright Medical CEO Bob Palmisano told institutional investors in New York last week that he’ll appeal the FDA’s decision…but he’s not counting on a positive outcome.

“I don’t think these appeals have a high likelihood of success,”  he said. “But we think it’s worth going through the process to see if there’s some agreement we can make with the agency  to go forward.”

If the appeal fails, Palmisano says he doesn’t have the appetite” to launch another trial, citing the expense and the amount of time it would take Instead, he says the company will focus Canada, Australia, and New Zealand, where regulators have already approved the drug’s use.


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