PharmaEssentia

► Home ﹥Our Projects ﹥Bio-Tech Products ﹥PEG ﹥P1101 PEG IFN-α-2b

Project overview
PharmaEssentia has been developing a third-generation PEGylated interferon-α-2b using the company's novel PEGylaltion technology platform. P1101, PEG-Interferon-alpha-2b (PEG-IFN-α-2b), which is a common-used protein drug for HBV and HCV, is the first new drug candidate of PharmaEssentia; the protein is produced with our newly designed PEG-IFN-α-2b as well as the novel PEGylaltion platform, resulting in a single compound without any positional isomers and with a longer regimen. With various technological breakthroughs and posted patents, PharmaEssentia is set to achieve what Roche, the pharmaceutical company currently dominating the PEG-interferon market, cannot: a PEGylated interferon with a dosage regime of once every two weeks.

PharmaEssentia's P1101 has completed preclinical studies and is in the process of IND filing, and scheduled for its Phase I clinical trial in Q1, 2009 and Phase II in Q3, 2009. PharmaEssentia plans to out-license P1101 for the indication of hepatitis C Once the drug has entered its Phase II clinical trial. Cconservative estimates for the total package for out-licensing P1101 when processing Phase II will be about US$150 million (about NT$4,500 million) for a US or European pharmaceutical company, US$15 million (about NT$450 million) for Japan, and US$10 million (about NT$300 million) for Malaysia.

The advantages of PharmaEssentia's P1101:
1. Dosing Regime/Efficacy
    a. PK/PD data from monkey studies suggest that a once every two or more weeks dosing regimen in man is
        anticipated.
    b. Lower dosage, fewer side effects. Phase 1 clinical studies in both the US and Taiwan will be conducted in Q1,
        2009
2. Production Cost
    a. Higher production yield of modified IFN-α-2b.
    b. Quality control advantages.