Theratechnologies completed the evaluation and development of the F8 Formulation of tesamorelin, which based on internal studies, is bioequivalent to the original formulation of tesamorelin, or F1 Formulation, commercialized as EGRIFTA®. The F1 Formulation is no longer available in the United States and has been replaced by EGRIFTA SV®. The F8 Formulation has a number of advantages over the current formulation of EGRIFTA SV®, or F4 Formulation, itself bioequivalent to the Formulation F1. Specifically, it is two times more concentrated resulting in a smaller volume of administration and is intended to be presented in a multi-dose vial that can be reconstituted once per week. Similar to the current formulation of EGRIFTA SV®, the F8 Formulation is stable at room temperature, even once reconstituted.

In parallel, Theratechnologies is currently working on the development of a multi-dose pen injector to be used with the F8 Formulation. Theratechnologies intends to seek marketing approval of the pen in conjunction with the F8 Formulation. We plan to file a supplemental Biologics License Application (sBLA) for the F8 Formulation and multi-dose pen injector in early 2022 for the treatment of lipodystrophy in people living with HIV.