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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; $300M - $500M U.S. annual market opportunity 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 completion expected by year-end 2016; If Phase III results sufficient, submit NDA in 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 with approximately 40,000 AGHD tests conducted annually (US) Significant market expansion opportunity for traumatic brain injury (TBI) patients at risk of developing AGHD Pivotal Phase III trial completion expected by year-end 2016; If Phase III results sufficient, submit NDA in H1 2017
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