FDA Rejects Wright’s Augment Bone Graft

The FDA has rejected Memphis-based Wright Medical Group, Inc.’s PMA application for its Augment Bone Graft.

“Augment Has Left the Building, ” wrote BMO Capital Market analyst (and one of our favorite headline writers) Joanne Wuensch. “Augment Exits Stage Wright, ” was Jefferies analyst Raj Denhoy’s headline.

On August 8, 2013, the company issued a statement saying it received an 18 page “not approvable” letter from the FDA for the product. The FDA said it was “concerned that the population enrolled was predominately low risk and, therefore, may hot have warranted the use of either autograft or Augment Bone Graft.”

New Study Required

The agency said the company would have to perform a new clinical study that evaluates the product as substitute for autograft in hindfoot and ankle fusion procedures in a well-defined high risk target population. The agency specifically had concerns about the “the patient population studied in the clinical study, the amount of graft material implanted, and the uncertainty as to whether any graft material would be needed or if the use of no graft material in a fusion procedure of the hindfoot and ankle in the population studied would have achieved similar results.”

Contentious FDA Panel Meeting

The FDA letter echoed comments from an FDA panel meeting in May 2011, where panel member Brent Blumenstein, Ph.D., a statistical consultant said, “The trial has no meaning.” Augment was then owned by BioMimetic Therapeutics Inc. However, the final vote was 12-6 in favor of approving Augment as a safe treatment for ankle surgery after a rare public rebuke by panel members of FDA staff for failing to present safety evidence for the company’s dental product. Panel members said they thought the agency came to the meeting with an agenda.

The panel then went on to vote 10-8 that Augment for ankle fusion surgery was effective and, finally, voted 10-8 that the product when used by surgeons in hindfoot and ankle surgery, delivered benefits that outweighed the risks.

Wright paid $380 million for BioMimetic earlier this year.

New Opportunity

Denhoy said the FDA response has several implications: the market size, if it is confined to high risk patients, will be much smaller than the 100, 000-patient and $300 million annual opportunity suggested by Wright. “That market size is not sufficient to justify the $10s of millions needed to conduct another PMA trial.”

Needham & Company analyst Mike Matson wrote that Augment was only part of the story at Wright. Even without Augment, he thinks the company should be able to grow its revenue in the double digits for the next few years. Biologics sales are likely to continue to decline, however. “We now expect Wright’s biologics business to decline by 7% in 2013, 4% in 2014, and 1% in 2015. If Wright decides to abandon Augment, it could potentially use some of the cash (up to $190 million) it would have owed BioMimetics for milestones to develop or purchase other types of biologics such as high-end synthetics or allograft with stem cells.”

Wright Medical CEO Robert Palmisano said, “We are continuing to study the FDA’s position and expect we will work collaboratively with the agency to determine an appropriate path forward.”