Cambrex, Ortec seek Humanitarian Device Exemption for OrCel

By Elaine Rigoli

Tampa, Fla., July 17 - Cambrex Bio Science Walkersville, Inc., a subsidiary of Cambrex Corp., and Ortec International, Inc. have submitted a Humanitarian Device Exemption (HDE) application to the Food and Drug Administration requesting approval to market cryopreserved OrCel for the treatment of patients with recessive dystrophic epidermolysis bullosa.

The FDA has about 75 days to respond to the application.

The FDA had previously advised that it could approve, without additional clinical data, an HDE supplement allowing the use of cryopreserved OrCel in patients with recessive dystrophic epidermolysis bullosa undergoing hand reconstruction as well as to cover donor sites created during the surgery (the area where skin was removed from another part of the patient's body).

In February 2001, the FDA granted Ortec an HDE for this indication for a non-cryopreserved version of OrCel.

Cambrex Bio Science Walkersville and Ortec previously signed a multi-year agreement for Cambrex to manufacture, market and distribute OrCel in the United States. Upon approval by the FDA, Cambrex Bio Science Walkersville will provide the product to patients.

Ortec is a New York-based company focused on advancing regenerative medicine and stem-cell therapy.

Cambrex is a global life-sciences company based in Walkersville, Md.

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