TAFA93
What is TAFA93?
TAFA93 was announced on May 21, 2003. TAFA93 is a novel prodrug of the mTOR inhibitor rapamycin which has successfully completed Phase 1 clinical development. mTOR inhibitors are currently used in the prevention of organ rejection in transplantation, the treatment of autoimmune and oncological diseases, and as a component of coated stents for the treatment of coronary artery disease.
On September 29, 2005, Isotechnika signed an exclusive worldwide licensing agreement with Atrium Medical Corporation ("Atrium") for the use of TAFA93 and voclosporin specifically with drug eluting devices for the non-systemic treatment of vascular, cardiovascular disorders, target vessel and tissue disorders.
A summary of the terms of the agreement is as follows:
- Isotechnika received an upfront licensing fee of US$3,000,000;
- Atrium will pay milestone and royalty payments to Isotechnika upon approval of a medical device product which incorporates TAFA93, voclosporin or the combination of both drugs;
- Isotechnika is required to complete Phase 1b trial for TAFA93 (results announced August 2006);
- Atrium will conduct and be financially responsible for all development costs of the medical device product program;
- Isotechnika will manufacture and supply both drugs for use in clinical trials and post commercialization on a cost plus basis;
- Atrium will be soley responsible for marketing the Products which incoporate the TAFA93 and voclosporin compounds; and
- The license provided is for the use of TAFA93 and voclosporin in conjunction with medical devices only. No rights are granted for the oral or topical administration of either TAFA93 or voclosporin in any indication.