Herceptin, a humanized monoclonal antibody developed by Roche against Her2, has been used for the treatment of breast cancer and recently of gastric cancer. Compared with the IV formulation of Herceptin which takes up to 90 minutes for administration, SC formulation takes less than 5 minutes and has occupied more than 50% of Herceptin market in Europe.
Alteogen, Inc. is developing SC formulation of trastuzumab with an ALT-B4 enzyme—recombinant novel human hyaluronidase—which showed improved enzymatic activity and thermal stability. Alteogen’s trastuzumab SC formualtion is a ready-to-use liquid formulation with longer shelf-life. Alteogen aims at reducing the amount of trastuzumab in SC formulation (600 mg in a vial) using an ALT-B4 enzyme, similar to the amount of trastuzumab in IV formulation (440 mg in a vial).”