New 'Growth Factors' Mere Months from Commercialization
BY ROBIN R. YOUNG CFA, AUGUST 30, 2004
On July 13/2004 a small group of researchers and businessmen presented to an FDA panel the results of 15 years of research and clinical study the net effect of which was a unanimous panel approval for a new, recombinant platelet-derived growth factor (PDGF). Called GEM 21, the product is owned by a Tennessee company, BioMimetics. (BioMimetics will be making its first public presentation of this growth factor since the FDA panel meeting this October 15th at the HealthpointCapital Biomaterials Summit).
Shortly after the FDA panel unanimously recommended approval for BioMimetic's recombinant PDGF, another company, CeraPedics, began to make their first, tentative public statements about their 'growth factor' which is actually a peptide. As it turns out, CeraPedics is also well along the way to obtaining FDA approval.
The CeraPedics's product, called P-15, is a synthetic 15 amino acid peptide that initiates the cascade of events leading to the formation of new bone. This is a significant new bone growth stimulator and the company has agreed to 'go public' with its news at the HealthpointCapital Biomaterials Summit in New York on October 15th.
Finally, two other peptides, OrthoLogic's Chrysalin, probably the best known and best studied of all the growth peptides, and Acologix's AC-100, were selected to be featured at the HealthpointCapital Biomaterials Summit in New York this coming October 15th.
Growth factors and other compounds that stimulate bone formation have exploded onto the surgical landscape and now comprise over a quarter billion in annual sales. The lead product, of course, is InFuse', a recombinant growth factor commercialized by Medtronic Sofamor Danek. Stryker's OP-1 is also available for limited indications but is also working its way through the regulatory process to broader use, including in the spine.
Still, what is notable about this year's presenting companies is how far along the regulatory process some of them are. BioMimetics and CeraPedics, for example, are within 12 months of FDA approval for some bone regenerating indications.
In terms of BioMimetics, there are well over 200 publications on their recombinant PDGF product that deal specifically with its beneficial effect on wound healing. These studies were conducted in a variety of models and systems including in vitro self-culture systems using primary cultures of osteoblast or well qualified osteoblast, like cellnoids, primary cultures of periodontal ligament cells and gingival fibroblast cells and many, many other cell types. In addition, PDGF was the first recombinant human growth factor to be FDA approved as a wound healing agent. Johnson & Johnson currently market it under the trade name Regranex. On the market for over 5 years, it has an absolutely well documented safety record with no elicitation of antibodies or any adverse responses in commercial use.
No wonder it received unanimous approval.
CeraPedics's P-15 bone healing peptide compound, as well, has a long history of clinical use. It was originally approved in 1999 by the FDA for use in intrabony osseus periodontal defects (dental bone repair). Its safety record is excellent and, to use the FDA's own words, demonstrated in clinical trials that it was 'nonsensitizing, nontoxic, nonhemolytic and nonmutagenic.' Two multi-center clinical studies supported P-15's last PMA approval and the data showed that P-15 was clearly superior to allograft demineralized bone matrix in periodontal bone repair.
CeraPedics and BioMimetics join returning presenter, Acologix in headlining the growth factor section of this year's HealthpointCapital Biomaterials Summit. See you at the Summit!
