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TACROLIMUS IND APPROVED BY FDA - JANUARY 2015

The FDA approved Auritec’s IND submission of a pharmacokinetic (PK) and safety study of a sustained release (SR) injectable formulation of the immunosuppressive calcineurin inhibitor - tacrolimus monohydrate. The formulation has been developed using Auritec’s proprietary injectable technology - Plexis®. There is a large database for conventional delivery of tacrolimus in animals, and we have demonstrated safety of the Plexis® platform in animals with tacrolimus, as well as with other APIs. Therefore, we believe that the risk-benefit ratio strongly favors carrying out this study.

Each year more than 100,000 solid organ transplants are performed worldwide and it is estimated that between 250,000 and 500,000 people are living with solid organ transplants requiring immunosuppression. The market for immunosuppressive drugs is estimated at $4.3B. Global annual sales of tacrolimus products total more than $2.1B. Of the major players in the anti-graft rejection market, none have a sustained release formulation of their product. Auritec’s technology is ideally suited to the molecular structure and dissolution characteristics of tacrolimus, allowing us to obtain superior release characteristics compared to other methods.

This is exploratory study is crucial to our understanding of how and whether sustained release tacrolimus delivery via an injection could be a feasible method for treating patients for the prophylaxis of transplant rejection and psoriasis. The long-term goal of this program is to develop a sustained release formulation of tacrolimus, and thus to improve the treatment of transplant rejection by significantly improving adherence to therapy and also potentially reducing renal toxicity. The development of such a formulation could have both significant commercial potential, and important societal benefits.