FDA grants BioMimetic Therapeutics orphan drug designation for rhPDGF-BB in treatment of OCD

Aug 12 2010

BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced that it has received orphan drug designation from the Food and Drug Administration (FDA) for its protein therapeutic, recombinant human platelet derived growth factor (rhPDGF-BB), to be used in conjunction with autograft and/or commercially available osteochondral allograft for the treatment of osteochondritis dissecans (OCD) of the knee, elbow or ankle. OCD is a joint condition in which cartilage, along with a fragment of the bone beneath it (subchondral bone), becomes detached from the end of a bone due to a loss of blood supply. Orphan drug status, designated to drugs that have the potential to treat rare diseases, provides an accelerated path to FDA approval and may provide seven years of market exclusivity.

“OCD can be a severely painful joint disorder for which there is a lack of consensus on an optimal therapeutic treatment. Surgery is often required, but rarely completely alleviates the disorder.”

"We are fortunate that our rhPDGF-BB platform technology has the opportunity to improve healing across a broad array of injuries. In sports medicine, we've had a robust product development program for some time evaluating product candidates for tendon, ligament and cartilage repair. This orphan designation should facilitate this work in the cartilage area," said Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics. "OCD can be a severely painful joint disorder for which there is a lack of consensus on an optimal therapeutic treatment. Surgery is often required, but rarely completely alleviates the disorder."