Tuesday, March 25, 2014

中裕砍 中研院零流感Tamiphosphor 虧損黑洞(Chi-Huey Wong and Jim-Ming Fang)

中裕新藥:基於公司整體經營策略性考量,擬終止退回零流感開發計畫 2014/3/13鉅亨網提供 第三十四條第81.契約或承諾終止日期:103/03/132.契約或承諾內容:零流感(Tamiphosphor)新藥開發3.契約或承諾相對人:中央研究院4.與公司關係:5.終止之原因:本公司基於公司整體經營規則及商業價值上之考量,聚焦於愛滋病領域之新藥開發,於103313日書面通知中央研究院終止原9712月簽訂之零流感授權契約,退回該項零流感開發計畫與中央研究院 6.對公司財務、業務之影響:無重大財務、業務影響7.其他應敘明事項:

中裕新藥終止零流感開發計畫 今富族網記者陳伃安/報導2014-03-14 中裕新藥(4147)於昨(13)日公告將終止零流感開發計畫,已書面通知中央研究院終止原200812月簽訂之零流感授權契約,退回該項零流感開發計畫給中央研究院。 中裕新藥表示,此次決定終止零流感開發計畫,主要基於整體經營策略性考量,認為開發過程耗損資金過大,恐會加大虧損黑洞。該公司目前股本19.41億元,董事會日前通過2013年財報,其中稅後虧損2.51億元,每股稅後虧損1.3元,並訂於64日召開股東常會,會中除了討論去年虧損撥補案外,亦將討論有關申請上櫃以及辦理現金增資發行新股為公開承銷之股份來源案。

Tamiphosphor is a small molecule inhibitor of influenza virus neuraminidase. Dr. Chi-Huey Wong and Jim-Ming Fang from Academia Sinica invented this phosphonate analog of oseltamivir . It has been demonstrated both in vitro and in vivo activity against wild-type influenza strains. In 2008, TaiMed Biologics in-licensed this Pre-IND, pre-clinical program from Academia Sinica. US provisional application was filed in August 2007 and US and PCT application were filed in August 2008. Tamiphosphor has shown significant in vitro activity and has been shown to have higher potency than oseltamivir against wild-type neuraminidases, both H1N1 and H5N1 viruses. In vitro, oseltamivir-resistant neuraminidase is cross-resistant to Tamiphosphor. Furthermore, Tamiphosphor analogs retain potent activity against oseltamivir-resistant (H274Y) H5N1 neuraminidase.  In vivo, mouse challenge studies have shown Tamiphosphor's superior activity against wild type H1N1 when compared to oseltamivir. Tamiphosphor has also been shown to have comparable activity against wildtype H5N1. TaiMed Biologics plans to demonstrate sufficient potency against a panel of representative influenza virus isolates, both in vivo and in vitro. A collaboration has been formed with the NIH to perform cross-resistance testing is expected to be complete by 2H 2009. In 2010, TMB plans to complete the necessary PK, bioanlytical and manufacturing work in parallel with GLP tox in order to submit IND and initiate a phase 1 trial.

「零流感」是應用於流行性感冒治療的神經胺酸酶抑制劑,此藥物來自中央研究院基因體研究中心的授權。它是一種環已烯磷酸鹽的化合物,分子結構與羅氏藥廠的「克流感」(Oseltamivir/Tamiflu) 近似。零流感將克流感化學結構內的羧酸基團(carboxyl)以磷酸基團(phosphonate)取代,在體外實驗中,能有效抑制H1N1H5N1流感病毒。其中,零流感的胍類衍生物(guanidine analog)能有效抑制具有克流感抗藥性的H5N1突變種(H274Y mutant),藉以阻止病毒感染。由美國國家衛生研究所(NIH)補助執行的抗流感病毒實驗中,零流感的磷酸單酯胍類衍生物(phosphonate monoester guanidine analog)表現傑出,除了能同時抑制不同種的野生流感病毒之外,對於具有克流感抗藥性的流感病毒也一樣有效。

中裕新藥正進行零流感合成製程開發、相關的藥物動力學與毒物實驗,為將來進入美國FDA的核准新藥試驗(IND filing) 程序進行籌備。

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