Phase III trial data barely qualified; maintaining drug approval schedule
​Reiterate BUY but cut TP to NT$232: PharmaEssentia released phase III clinical trial results of P1101 for treating Polycythemia Vera (PV) on Dec 5. P1101 met the primary endpoint, but 52-week trial results are not superior to the control arm (Hydroxyurea, HU), increasing difficulty in marketing. The company and AOP will apply for drug approval in 2017 as planned, and a Conti-PV trial is being undertaken to observe drug efficacy and adverse events (AE) on patients after two-three years of treatment. Given P1101’s barely qualified trial results, initial sales after launch may be a challenge. We lower 2017/18F EPS to NT$-2.5/0.13 from NT$0.83/6.13, and trim our NPV-based TP to NT$232 from NT$280. We maintain BUY as we believe the company could get approval and launch P1101 to market in late-2017 to early-2018.
PharmaEssentia Corp. is engaged in the research, development, production and sale of new drugs. The Company research and development of new drugs, which are used for treatment of hematology, such as meloproliferative neoplasms (MPN), neutropenia, anemia; infectious disease, such as hepatitis C and hepatitis B; dermatology, such as psoriasis, and neurology, such as multiple sclerosis, among others. The Company's products include KX01, P1101, Polycythemia Vera (PV), PEG-GCSF, PEG-EPO and others. The Company distributes its products within domestic market and to overseas markets.
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