BIOMIMETIC'S ONJ TREATMENT RECEIVES ORPHAN DRUG STATUS

BioMimetic Therapeutics has received orphan drug designation from the FDA for its recombinant human-platelet-derived growth factor (rhPDGF-BB) for the treatment of osteonecrosis of the jaw (ONJ). ONJ is a growing problem that occurs in patients receiving high doses of bisphosphonates for the treatment of severe osteoporosis and other diseases, according to the company. Orphan drug status, granted to drugs that have the potential to treat rare conditions, provides an accelerated path to FDA approval and seven years of market exclusivity.

"Based on the ability of rhPDGF-BB to stimulate bone and tissue healing, we believe that rhPDGF-BB has the potential to help [ONJ] patients," Samuel Lynch, president and CEO of BioMimetic, said. "Thus, ONJ represents another potential to leverage our platform rhPDGF technology and be assured of market exclusivity in this indication."

BioMimetic's product and other product candidates use rhPDGF-BB, one of the principal wound healing stimulators in the body. The company believes that rhPDGF-BB is well suited for various therapeutic applications due to its stimulation of a broad spectrum of cellular events critical for the initiation and progression of healing of musculoskeletal tissues including bones, tendons, ligaments and cartilage.

The protein acts like a magnet to attract cells necessary for tissue healing through a process known as chemotaxis, while also stimulating an increase in the number of healing cells through a process known as mitogenesis, according to the company. In addition, published in vivo and in vitro studies demonstrate that rhPDGF-BB may enhance processes important in new blood vessel formation at the wound site, angiogenesis, which is critical for wound healing.