First Launch Of Apligraf For Ulcers

Organogenesis and Novartis have launched Apligraf Human Skin Equivalent(also known as Graftskin) in Canada for the management of venous ulcers. The approval of the treatment by Canada's Health Protection Branch in April marked the first time that a living, manufactured human organ - skin - had been approved for marketing by a major regulatory agency.

Apligraf is a living, dual-layered skin which features both an epidermis and dermis, composed of living human keratinocytes and fibroblasts respectively. The epidermal layer is fully differentiated and includes a stratum corneum. It costs C$950 per patch.

Apligraf is pending approval at the US Food and Drug Administration and a launch is expected in late-1997 or early-1998. Novartis is also in the process of filing for approval of the patch in Europe.