BioMimetic soars on trial results

Positive data from bone graft test gets Franklin company closer to crucial FDA approval

Email | Print By Erin Lawley

BioMimetic Therapeutics released top-line clinical trial results for its bone graft product late Tuesday that indicate the product performs as well as, and in some cases better than, the current standard of care.

BioMimetic’s Augment Bone Graft is a fully synthetic product designed to promote bone healing. The randomized controlled trial, which looked at hindfoot and ankle fusion surgery, was designed to show that Augment is as effective as autograft – the standard of care procedure that requires surgeons to harvest healthy bone from the patient and transplant it to the surgery site.

Patients who received Augment had bone fusion rates of 61.2 percent after 24 weeks compared to a 62 percent rate for autograft. For patients who received treatment in multiple joints, 66.5 percent of joints treated with Augment fused on CT scans compared to 62.6 percent of joints treated with autograft.

“We’re extremely pleased with the outcome of the study so far,” said BioMimetic CEO Sam Lynch on a Wednesday conference call discussing the results. “We met our primary endpoint of non-inferiority to autograft, as well as all secondary endpoints for which we have data available so far.”

Additionally, Augment produced better outcomes than autograft in several areas, including pain at the harvesting site – since bone harvesting is unnecessary – a 16 percent relative reduction in risk of failure and a 30 percent drop in risk for infections, explained Gregory Wade, senior vice president of equity research for Wedbush Morgan Securities.

“So while the endpoint of equivalence was achieved, there looks to be evidence that the Augment bone graft approach is better,” Wade said.

However, BioMimetic’s stock initially slid big time in Tuesday after-hours trading, falling 16 percent to $10.90 per share. Wade said investors might have been confused by some additional statistics provided by BioMimetic (Ticker: BMTI) that included patients who, though they were randomized for the trial, ultimately did not receive Augment.

But the stock rebounded and powered higher today, reaching a 52-week high of $15.25. Shares were trading around $15.06 at 2 p.m., up 19 percent on the day. Volume was very heavy, with more than 3 million shares changing hands versus the stock's daily average of about 140,000.

The clinical data is the last of three components required by the Food and Drug Administration for approval consideration as a medical device. The company expects to submit the data to the agency by the end of the year and, following an FDA panel review, receive approval in late 2010 for commercialization in 2011.

A similar product by BioMimetic has been approved by the FDA for bone and periodontal regeneration in the jawbone.

“This package is as strong, if not stronger than many products that have been approved on the market throughout the spectrum of devices,” said Russ Pagano, vice president of clinical and regulatory affairs for BioMimetic, on the conference call.