藥華力拚國人開發新藥首例 明年掛牌上櫃【經濟日報╱記者黃文奇／即時報導】2013.05.29 12:18 pm國發基金轉投資的新藥公司藥華醫藥，今天與凱基證券、安永會計師事務所簽署輔導上櫃合約，預計於今年底前登陸興櫃，最快明年申請股票上櫃。業界表示，藥華旗下新藥長效型干擾素P1101，有望成為國人在台開發新藥上市的首例。藥華醫藥成立於2003年，目前資本額約16.81億元，主要股東除了行政院開發基金外，泛公股還包括耀華玻璃、中鋼；其餘民股股東則有由張添所領導的宏亞食品家族，還有科技產業的閎泰企業旗下的閎泰投資，及光寶科技等。藥華醫藥為台灣新藥研發專家林國鐘所創辦，其研發的藥物「P1101」於2009年已授權給德國藥廠AOP，但藥華仍掌握生產權，由於P1101在歐洲的臨床二期結果良好，這項藥品已陸續取得歐、美藥品管理單位的「孤兒藥」認定，由於孤兒藥西方各享有七到十年的獨賣權，且在北美市場超過百億美元，前景可期。【2013/05/29 經濟日報】
PharmaEssentia has developed a next generation of pegylated interferon product P1101 (Peg-P-IFN-alpha-2b, also as known as AOP2014). P1101/AOP2014 is a single predominant (90%) positional isomer in solution as compared to the 8-14 isomers in PEG-Intron (Merck) and Pegasys (Roche). As a result, P1101 showed a higher stability than PEG-Intron and a longer half-life than Pegasys. Therefore, a dosing regimen of once in more than two weeks is anticipated from the current studies. The clinical trials so far (Phase I and II) for Polycythemia Vera(PV)) treatment support P1101 at a higher dosage possibly given at a lowering dosing frequency with more than 90% response rate in one year. P1101/AOP 2014 is also expected to be the treatment of MPD (Myeloproliferative Diseases, including Essential Thrombocythemia(ET), Myeloid Fibrosis(MF), Chronic myeloid leukemia(CML), , Hepatitis and caner. Additionally, PharmaEssentia exclusively licensed P1101 to AOP Orphan Pharmaceuticals (AOP) for MPD treatment in 2009, and the authorized territory covers Central Europe, Middle East and CIS; P1101/AOP2014 has received Orphan Drug Designation from US and EU for Polycythemia Vera(PV) in 2011 & 2012. AOP has announced with the promising Phase II data that P1101 showed better efficacy and less side-effects for PV treatment and it is applied every two weeks for patients; the result from the Phase II trial was presented by AOP at America Society of Hematology (ASH) Annual Meeting and Exposition, Atlanta, U.S.A, 2012. With those supportive results AOP initiates a Phase III trial for PV in Europe in Q1 2013 and in the meantime PharmaEssentia also plans a Phase III trial for PV based on AOP's data in U.S.A, Japan, Taiwan, Korea and Australia. Besides of PV, PharmaEssentia puts efforts on clinical trials for P1101 to treat Hepatitis B and Hepatitis C (HCV-GT1 & HCV-GT2) in Taiwan. The Phase II trials for HBV and HCV were permitted by TFDA and USFDA, and the trial is currently proceed at the best 15 hospitals in Taiwan, hence the Phase II trial for HBV is expected to initiate in Q3 2013 while Phase III trial for HCV is expected to start in Q4 2013. Furthermore, PharmaEssentia has already completed a cGMP biologics production plant in Taiwan to deliver the drug for the Phase III studies. The plant is planned to be certified by TFDA, EMA and US FDA subsequently. In 2014, PharmaEssentia will be a fully integrated biopharmaceutical company which creates and provides novel products to improve the quality of life for patients suffering from various diseases.
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