Grafix regulatory update

Osiris said it reached an agreement with FDA that allows Grafix to remain on the market to treat acute and chronic wounds, including diabetic foot ulcers. In September, FDA sent Osiris an "untitled letter" saying that Grafix does not meet all criteria to be solely regulated under the agency's regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps). Products regulated as HCT/Ps do not require BLA approval. On a conference call to discuss its 3Q13 earnings, Osiris said after discussions with FDA, the agency affirmed that Grafix is solely regulated as an HCT/P to treat acute and chronic wounds and thus can remain on the market. However, a BLA is required to expand Grafix's label to include claims of enhanced wound healing properties. Osiris plans to submit a BLA for enhanced label claims using existing clinical data, including data from the U.S. Phase IV Protocol 302 trial, within 12-18 months.

In August, Osiris said data from Protocol 302 showed that Grafix met the primary endpoint of improving the proportion of patients with complete wound closure in patients with confirmed Type I or II diabetes. In an SEC filing for its 2Q13 earnings, Osiris said it initiated Protocol 302 to show Grafix results in an overall cost savings for the healthcare system to gain full reimbursement for Grafix in the indication (see BioCentury, Aug. 19). ...