Next generation pegylated interferon

Our company's platform is based on a novel site-specific pegylation platform that has resulted in its lead product, a next generation pegylated interferon, P1101 (Peg-P-IFN-alpha-2b). P1101 is a single predominant (>90%) positional isomerthat has better controlled purity as compared to other older pegylated interferons (PEG-lntron from Merck and Pegasys from Roche). P1101 has been shown to have a much more tolerable side effect profile, several-fold higher maximum tolerated dose, and less frequent administration vs. other on-market interferons. Our partner, AOP Orphan Pharmaceuticals (Austria), is running a Phase III trial which started enrolling in September 2013 in our lead indication (PolycythemiaVera, PV). Resultsshould read outin 1H15. Our company's licensed EU rights to AOP in 2009, while retaining rights outside of EU. At ASH 2012, AOP an¬nounced promising Phase II data for P1101/AOP2014 with >90% 1 year response rates, decrease in spleen size, sustainable reduction in JAK2 allele burden., as well as a benign side effect profile. P1101/AOP2014 has received Orphan Drug Designation from US and EU for PV. When the Phase III EU started enrolling, PharmaEssentia had a successful face-to-face meeting with FDA regarding future steps in the US, where FDA informed us about the sufficiency of EU data for US filing. We completed a GMP biologies production plant in Taiwan in 2013 for drugs of Phase III studies. The plant will be inspected by FDA and EMA once market authorizations are submitted. In addition to the Phase III trial for PV in EU, Phase II trials for HCV-GT1 and HBV, Phase III trials for HCV-GT2 are actively ongoing in Asia with a Phase II trial for CML in EU; Phase II trials for PMF (Primary Myelofibrosis) and ET (Essential Thrombocythemia) are initiated in 2H14. Lastly PharmaEssentia is developing oraxol (oral taxol) and KX01 (for psoria¬sis), PEG-EPO, PEG-GCSF.