a) Orascovery Program – Extension of Athenex’s territories to worldwide apart from Korea. In previous agreements, Athenex in-licensed the rights of the Orascovery Program from Hanmi Pharmaceutical for the US, Europe, Latin America, Japan, China and the rest of Asia (apart from Korea). The revised agreement will also provide Athenex with rights to the Middle East and North Africa (“MENA”) as well as South Africa. Given the excellent progress that has been made in the various clinical programs, Athenex and Hanmi Pharmaceutical believe that global development of the Orascovery Program under Athenex will result in more rapid advancement of the clinical and regulatory process across the globe. Hanmi Pharmaceutical, as a leader of the pharmaceutical industry in Korea, will continue to oversee the development and regulatory efforts in Korea. b) KX-01 Oral Formulation – Athenex will receive back from Hanmi Pharmaceutical the rights to KX-01 Oral Formulation for Korea, China and other Asian territories. As recently announced, KX-01 Ointment (KX2-391) was shown to be effective and safe for actinic keratosis (AK) in two Phase 3 clinical studies conducted in the US, with both studies having met their primary endpoint of 100% clearance of AK lesions at Day 57 within the treatment areas, with statistical significance (p<0.0001). The arrangement will allow Athenex to explore the potential of KX-01 Oral Formulation globally.
