Osiris Therapeutics, Inc. (NASDAQ: OSIR), issued a statement today correcting certain inaccuracies in media reports following the announcement of its favorable agreement with the United States Food and Drug Administration (FDA) regarding Grafix®.
- Grafix is and will continue to be available on the market for the treatment of both acute and chronic wounds, including diabetic foot ulcers, despite media reports suggesting otherwise. As part of the agreement Osiris detailed in its October 21 press release, FDA affirmed that Grafix, indicated as a wound cover for the treatment of acute and chronic wounds, is regulated solely as a human cells, tissues, and cellular and tissue-based product (HCT/P) under section 361 of the Public Health Service Act (PHS Act).
- A Biologics License Application (BLA) is not required for Grafix to remain on the market for the treatment of acute and chronic wounds, despite media reports suggesting otherwise. Osiris has the opportunity to receive approval of Grafix as a licensed biologic under the BLA pathway. This approval, if obtained, would enhance the claims Osiris would be able to make regarding the wound healing properties of Grafix. Osiris believes this would create significant product differentiation in the market place and increase the value for the Grafix brand. Osiris is actively pursuing submission of a BLA.
- Osiris has never received a “warning letter” from FDA, contrary to media reports stating otherwise. Furthermore, Osiris Biosurgery, including the products mentioned in the FDA letter, has been inspected twice by the FDA without a single finding of deficiency.
It should be noted that Osiris may not be aware of and may not correct all current or future inaccuracies in media reports.
About Osiris Therapeutics
Osiris Therapeutics, Inc. is the leading stem cell company, having developed the world’s first approved stem cell drug, remestemcel-L, for graft versus host disease. Osiris’ products include Grafix® and Ovation® for acute and chronic wounds, Cartiform®, a viable cartilage mesh for cartilage repair and the latest addition to Osiris’ line of products, OvationOS™, a viable bone matrix. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution. Osiris has developed an extensive intellectual property portfolio to protect the company's technology and commercial interests.