亞諾法開發偵測肺癌第一期檢驗試劑

亞諾法新藥 明年將量產 【2011/07/05 經濟日報】亞諾法（4133）生技日前獲日本國立癌症研究中心授權，將生產ACTN4肺癌第一期的體外診斷檢驗試劑，將於今年第三季送美國食品暨藥物管理局（FDA）審查，預估將於明年正式量產。亞諾法昨（4）日股價以79.5元作收，上漲0.1元；公司今年首季稅後純益約3,900萬元，每股稅後純益0.66元，較去年同期稍微下滑。法人表示，亞諾法去年營收成長14%，獲利表現不俗，但是產品九成外銷，去年底及今年上半年皆受匯損影響。亞諾法表示，目前該公司正建置200坪規模的實驗中心，預估肺癌體外檢驗試劑產品，今年第三季前可望順利送交FDA申請藥證，最晚明年第三季應可獲得好消息；公司指出，該產品通過審查後，將分別進軍美國及大陸市場。亞諾法說，目前正在國內積極尋求大型醫院通路合作，提供第一期肺癌的血液或切片檢體，以利進行FDA藥證申請。分析師指出，目前肺癌是全世界罹患率最高的癌症，超過1,400萬病患人口，而大陸因為吸菸人口眾多，因此也成為全球肺癌罹患最多的國家，亞諾法該產品若正式投產，後續市場潛力可期。除了發展肺癌檢測試劑之外，亞諾法日前也宣布成功使用微脂體技術，希望藉由新產品，推升蛋白質產品的營收比，從目前的15%至20%提高至20%至30%。

 

Abnova Gains ACTN4 Stage 1 Lung Cancer In Vitro Diagnostic Worldwide Exclusive License and Initiates Multinational Clinical Studies Neihu, Taiwan (April 18, 2011) Abnova Corporation announced today that it has been granted an exclusive license of actinin-4 (ACTN4) biomarker from National Cancer Center Research Institute, Japan for the development and commercialization of in vitro diagnostic (IVD) for stage 1 lung cancer. Due to early detection and prevention programs, majority of the lung cancer patients are being diagnosed with stage 1 disease. Despite early stage diagnosis, a substantial number of lung cancers relapse after surgery. Currently, there is no standardized treatment of adjuvant therapy after surgery for stage 1 lung cancer patients. The goal of ACTN4 biomarker is to distinguish stage 1 lung adenocarcinoma patients with favorable five year survival after surgery versus those which have a higher risk of recurrence thus requiring adjuvant therapy. The ACTN4 diagnostic test requires a combination of antibody immunohistochemistry (IHC) for qualitative assessment of protein expression and fluorescent in vitro hybridization (FISH) test for quantitative measurement of gene amplification. This combination test is analogous to the Her-2/neu IHC and FISH testing for breast cancer in the commercial setting. Abnova's ACTN4 IVD development starts with ISO13845 certification along with North America and Asia Pacific clinical studies followed by first regulatory submission this year. Dr. Kazufumi Honda and Dr. Tesshi Yamada at the Japan National Cancer Center first discovered the role of ACTN4 as a novel actin-bundling protein associated with cell motility and cancer invasion. As a candidate oncogene, it has been extensively studied and implicated in a number of cancers including breast, colorectal, ovarian, and lung by the Japanese group and researchers worldwide. Most recently, Dr. Honda and Dr. Yamada have examined and validated the role of ACTN4 as a diagnostic biomarker of stage 1 adenocarcinoma of the lung in a retrospective analysis of multiple cohorts totaling >1700 patients who underwent resection of the lung adenocarcinoma. Their finding demonstrated that protein expression and gene amplification of ACTN4 significantly distinguish stage 1 lung adenocarcinoma with an extremely high risk of recurrence. Hence, patients with IHC and FISH positivity for ACTN4 ought to be followed closely and may receive benefits from adjuvant chemotherapy such as platinum-based drug. The efficacy of platinum-based postsurgical adjuvant for patients with advanced lung cancer has been well reported in a number of clinical trials. The worldwide IVD market is estimated at $44.4 billion in 2009 and is expected to grow to $58.6 billion by 2014. Histology test, which is microscopic examination of cells and tissues, is one of the fastest growing sectors in the IVD industry, principally driven by innovations in cancer diagnosis. This is attributed to the introduction of new biomarkers, epitope-specific antibody for immunohistochemistry, and increased sophistication using fluorescent in situ hybridization technique. Lung cancer affects over 1.4 million patients. Non-small cell lung cancer, which accounts for approximately 87% of all lung cancers, is one of the leading causes of death, killing more patients than breast, colon and prostate cancer together and accounting for nearly 30% of all cancer deaths. Survival rates are among the worst for any cancer with a large and growing unmet clinical need.