台耀/台康 鎖定 大廠抗體抗癌藥複合產品 (ADC), FDA 2011/ Adcetris; FDA 2013/ Kadcyla

台耀 「藥」進開發領域2015-08-18 03:10:16 經濟日報 記者黃文奇／台北報導  台耀化學（4746）董事長程正禹昨（17）日表示，將跨入藥品開發領域，除了攜手蛋白質藥廠台康共同建構抗體抗癌藥複合體平台（ADC），也正攜手北醫、台大開發抗癌新藥，現正執行人體臨床。程正禹說，旗下開發新藥的子公司台新藥，今年會正式分割並引進投資夥伴，陸續建構全新藥物產品線；ADC產品未來希望打造一條龍生產線，往下游製劑領域邁進。台耀昨日舉行第2季營運法說會，由程正禹親自主持，他對公司下半年起的營運表示樂觀；展望明年，原料藥產能擴充完成後，即可貢獻營運。台耀昨日收盤54元，上漲1元。台耀今年第2季營運衰退，程正禹表示，主要因原料藥客戶產品出貨遞延，導致每股稅後純益（EPS）僅0.2元；另外，台耀另有未實現的匯兌損失與若干利息費用，全年可能侵蝕約3,600萬元獲利，但下半年因台幣走貶趨勢明顯，回正機率高。展望下半年，法人認為，原料藥出貨量繼續放大，紫外線吸收劑訂單能見度也不錯，下年營運成長五成有機會。台耀積極擴張產能，上半年資本支出2.5億元，下半年因應降膽固醇／磷酸鹽原料藥產線飽和，將持續投資約2.15億元擴產，明年第3季可望投產，產能有望增加30%。另外，公司也將持續建構高活性原料藥廠，產線包括維他命D衍生物、細胞毒性、賀爾蒙、抗體藥物複合體高效能產品等多項產線，也在明年下半年陸續上線。程正禹說，目前公司正攜手台康，透過他們的蛋白質藥開發能力，再結合台耀的小分子技術能量，已經鎖定某個國際大廠已上市的ADC產品分析，並建構自己的平台，長期將以開發ADC新藥為主。

Antibody–drug conjugates  Stephen Ornes, Science Writer  Ideally, targeted therapies attack diseased cells while leaving healthy ones alone. It's a strategy that could result in more effective treatments for cancer (or other diseases) with fewer toxic side effects than traditional chemotherapies. A burgeoning class of targeted therapies, called antibody–drug conjugates (ADC), deliver dual therapies in a single, cancer cell-killing package. An ADC contains two parts: a monoclonal antibody and a small amount of a highly potent cytotoxic drug, linked to the antibody. Like a key sliding into a lock, the ADC's antibody binds with a particular receptor on the target cell's surface. Then the linkage breaks, and the ADC releases a lethal toxin into the cell. Monoclonal antibodies are laboratory-made imitators of the body's own immune system, and researchers are looking for ways to specifically match the antibodies to those found on diseased cells. Monoclonal antibodies have already been used to treat autoimmune diseases and as cancer therapies in drugs, such as Cetuximab (brand name Erbitux), used to treat metastatic colorectal cancer and head and neck cancers, and Trastuzumab (brand name Herceptin), prescribed to treat some breast and gastric cancers. Both drugs are designed to block a diseased cell's ability to receive certain chemical signals that tell it to grow. The second part of the ADC is the potent drug attached to the monoclonal antibody. In 2011, brentuximab vedotin (brand name Adcetris) became the first Food and Drug Administration (FDA)-approved ADC and, remarkably, the first new FDA-approved therapy for Hodgkin lymphoma in more than three decades. (Adcetris is also the first therapy specifically approved for anaplastic large-cell lymphoma.) The phase II clinical trial was small but promising: of 102 Hodgkin lymphoma patients treated with the new drug, 32% had complete remission for 20.5 months on average, which meant all detectable traces of the tumor disappeared during that time. An additional 40% of patients had partial remission—where the tumor shrank by more than half—for 3.5 months on average. The antibody in Adcetris is nearly ineffective on its own, and its potent poison is far too toxic to be used on its own. Only in combination do the two parts safely give the drug its punch. Other ADCs are coming down the pipeline. In February 2013, the FDA approved ado-trastuzumab emtansine (brand name Kadcyla) for patients with metastatic HER2-positive breast cancer. The drug uses the Herceptin antibody to deliver a chemotherapeutic drug that's being investigated in other ADCs as well. In clinical trials, the drug provided benefits even to those patients whose disease has become resistant to Herceptin acting alone. Early clinical studies suggest evidence for optimism, but many hurdles remain. Researchers face pressure both inside and outside the laboratory. Inside, researchers have to find the right combination of drugs and a stable conjugate to use as a linker, as well as antibodies that flag cancer cells while leaving healthy cells alone. Outside the laboratory, researchers must identify the subgroup of cancer patients most likely to respond favorably. History offers a warning, too: In 2000, the FDA approved an ADC called Mylotarg for patients with acute myeloid leukemia. However, in June 2010 the drug's manufacturer, Pfizer, pulled the drug after follow-up studies showed that the drug did not extend survival and was associated with a high rate of fatal toxicity .