文德藥業 專責 行銷 太景 抗生素

太景抗生素新藥「太捷信」 將委託文德藥業銷售 2015-03-2518:00 〔記者陳永吉／台北報導〕F-太景（4157）100%持股的太景生技今天宣布正式與文德藥業簽署太捷信®（學名: 奈諾沙星）在台灣地區之口服與針劑劑型經銷合約。 太景指出，文德是一家具有30年以上推廣抗生素經驗的專業醫藥行銷公司，具備醫藥之學術推廣、販售及物流團隊，提供醫藥機構高品質之產品。雙方的合作，將使台灣的醫界得以利用此一最新的藥物醫治病患。 太景表示，太捷信目前已經在健保藥價審查的最後階段。據太景了解，中國部分也已經到上市審查前的最後階段。樂觀預估，今年第二季結束以前，可望取得藥證與生產許可，兩岸上市時間可能相距不遠。

Nemonoxacin Gets FDA Fast Track Designation TaiGen Biotechnology Receives Qualified Infectious Disease Product and Fast Track Designations from the U.S. Food and Drug Administration for Nemonoxacin (Taigexyn(R)) TAIPEI, Dec. 23, 2013 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") today announced that the U.S. Food and Drug Administration (FDA) has granted nemonoxacin (Taigexyn®) Qualified Infectious Disease Product (QIDP) and Fast Track designations for community-acquired bacterial pneumonia (CAP) and acute bacterial skin and skin structure infections (ABSSSI). These two designations should enable TaiGen and/or its partners to benefit from certain incentives for the development of nemonoxacin as a new antibiotic, including an additional five year extension to new chemical entity (NCE) market exclusivity, priority review, and fast track status provided under the Generating Antibiotic Incentives Now (GAIN) act. GAIN was included in the FDA Safety and Innovation Act (FDASIA) that was signed into law by US President Obama in 2012. Nemonoxacin is a NCE, broad spectrum antibiotic available in both oral and intravenous formulations. TaiGen have completed a multi-center Phase 3 of the oral formulation in CAP in Taiwan and mainland China and submitted NDA to regulatory authorities in both countries earlier this year. The clinical development of the intravenous formulation in CAP is ongoing in Taiwan and mainland China with Phase 2 completed and initiation of Phase 3 plan for 1Q, 2014. In the US, TaiGen have completed two Phase 2 clinical studies, one in CAP and the other in diabetic foot infections (DFI) with demonstrated efficacy and safety. In the clinical trials conducted to this point, nemonoxacin have shown activity against drug-resistant bacteria such as methicillin-­resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA as well as quinolone-resistant Streptococcus pneumoniae. TaiGen owns the worldwide patent portfolio of nemonoxacin that protects composition, use, and processes until 2029. Dr. Ming-Chu Hsu, Chairman and CEO of TaiGen said "The recognition of nemonoxacin for QIDP and Fast Track designations highlights the need of new antibiotics in the treatment of life-threatening bacterial infections and the value of nemonoxacin to treat CAP, which is one of the most common respiratory infections that can lead to hospitalization. In addition, we have seen efficacy and high tissue penetration in the Phase 2a DFI trial. Taken together, nemonoxacin is well positioned to treat ABSSSI."

About TaiGen Biotechnology TaiGen Biotechnology is a leading research-based and product-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, China. In addition to nemonoxacin, TaiGen has two other in-house discovered NCEs in clinical development under IND with US FDA: TG-0054, a chemokine receptor antagonist for stem cell transplantation and chemosensitization, in Phase 2 and TG-2349, a HCV protease inhibitor for treatment of chronic hepatitis infection, in Phase 2. Both TG-0054 and TG-2349 are currently in clinical trials in patients in the US.