Updated on November 9, 2016
http://ir.aezsinc.com/fact-sheets
NEAR-TERM VALUE DRIVERS: TWO PIVOTAL PHASE III TRIALS COMPLETION EXPECTED BY YEAR-END
Zoptrex™ (zoptarelin doxorubicin) – Targeted (LHRH receptor) cytotoxic drug for the treatment of advanced (stage III & IV) endometrial cancer (EC)
Ongoing pivotal Phase 3 trial for treatment of advanced EC under Special Protocol Assessment
If approved, will be the first FDA-approved treatment for advanced EC
Successful out-licensing for non-US territories: China, Hong Kong & Macau (Sinopharm A-Think); Taiwan & Southeast Asia (Orient EuroPharma); Israel & Palestine (Rafa Labs); Australia and New Zealand (Specialised Therapeutics Asia); further out-licensing discussions continue
Pivotal Phase III trial top-line results expected in Q1 2017; If Phase III results sufficient, submit NDA in H2 2017
Macrilen™ (macimorilen) – Oral ghrelin receptor agonist for assessing Adult Growth Hormone Deficiency (AGHD)
If approved, will be the only FDA-approved drug for assessing AGHD
Granted orphan drug status
Significant market expansion opportunity for traumatic brain injury (TBI) patients at risk of developing AGHD
Pivotal Phase III trial top-line results expected in Q1 2017; If Phase III results sufficient, submit NDA in H1 2017 |
