基亞組聯盟 攻生物製劑 2016-03-11 02:53 經濟日報 記者高行／台北報導 基亞生（6547）昨（10）日與荷蘭UCAB研發中心及MABXIENCE等三家國際藥廠簽訂生物相似性藥品開發聯盟合約，鎖定蛋白質藥物研發及生產，強化生物製劑領域布局。基亞生昨日和荷蘭UCAB研發中心、歐洲MABXIENCE、中東SPIMACO及南美洲LIBBS等國際藥廠結盟，簽訂生物相似性藥品開發聯盟合約，進軍預防嬰幼兒呼吸道融合細胞病毒（RSV）感染的生物相似藥品。公司指出，新成立的研發聯盟由全球知名的非營利醫藥研發機構UCAB中心統籌全案並主導臨床試驗，擅長於蛋白質藥物生產的MABXIENCE藥廠負責生產製造及後續技術移轉，以確保藥物開發及生產品質。聯盟各成員共同分擔研發費用及共享研發及臨床成果，並於各自取得區域申請藥證、生產及銷售權利。
基亞生與3藥廠簽約 共同開發藥品2016年03月10日16:08 基亞生(6547)宣布，與UCAB研發中心及歐洲MABXIENCE公司、中東SPIMACO公司及南美洲LIBBS公司三家國際藥廠簽訂聯盟合約，將共同開發預防嬰幼兒呼吸道融合細胞病毒（RSV）感染之生物相似藥品。本研發聯盟由全球知名的非營利醫藥研發機構UCAB中心統籌全案，聯盟各成員共同分擔研發費用及共享研發及臨床成果，並於各自取得之區域申請藥證、生產及銷售。本案由UCAB主導臨床試驗，擅長於蛋白質藥物生產的MABXIENCE公司負責生產製造及後續的技術移轉，以確保藥物開發及生產品質。 基亞生(6547)取得本案於台灣及亞洲區主要國家之銷售、技術移轉及生產等商業權利，未來將參與聯盟研發及臨床試驗活動，並移轉生物相似藥物生產技術至竹北生醫園區之生物製劑廠。 透過此聯盟合作開發案，基亞生表示，除了原有的細胞培養疫苗業務外，再納入蛋白質藥物研發及生產，強化公司生物製劑領域佈局。此外，與國際性研發機構及大型藥廠策略結盟，將有助於公司提升研發及生產能量，並得以進入主流之國際醫藥社群。(江俞庭／台北報導)
基亞生與荷蘭UCAB研發中心等三家國際藥廠簽訂生物相似性藥品開發聯盟合約 2016/03/10 15:21 證交所重大訊息公告(6547)基亞生-本公司與荷蘭UCAB研發中心及MABXIENCE等三家國際藥廠簽訂生物相似性藥品開發聯盟合約1.事實發生日:105/03/10 2.契約或承諾相對人:荷蘭UCAB研發中心及歐洲MABXIENCE公司、中東SPIMACO公司及南美洲LIBBS公司等三家國際藥廠。 3.與公司關係:無。 4.契約或承諾起迄日期(或解除日期):105/03/10 5.主要內容(解除者不適用): 本公司與上述機構簽訂研發聯盟合約，開發用以預防嬰幼兒呼吸道融合細胞病毒(RSV)感染之生物相似藥品。本研發聯盟由全球知名的非營利醫藥研發機構UCAB中心（Utrecht Centre of Excellence for Affordable Biotherapeutics for public health）統籌全案並主導臨床試驗，擅長於蛋白質藥物生產的MABXIENCE公司負責生產製造及後續的技術移轉，以確保藥物開發及生產品質；另聯盟各成員共同分擔研發費用及共享研發及臨床成果，並於各自取得之區域申請藥證、生產及銷售。本公司取得本案於台灣及亞洲區主要國家之銷售、技術移轉及生產等 商業權利，未來將參與聯盟研發及臨床試驗活動，並移轉生物相似藥物生產技術至竹北生醫園區之生物製劑廠。 6.限制條款(解除者不適用):無。 7.對公司財務、業務之影響(解除者不適用):本公司在產品研發期間依約需共同分擔費用，如產品研發成功，將對公司之財務及業務具有正面影響。 8.具體目的(解除者不適用):透過此聯盟合作開發案，本公司除了原有的細胞培養疫苗業務外，再納入蛋白質藥物研發及生產，強化公司生物製劑領域佈局。此外，與國際性研發機構及大型藥廠策略結盟，將有助於公司提升研發及生產能量，並得以進入主流之國際醫藥社群。 9.其他應敘明事項: UCAB中心網址：http://www.uu.nl/en/organisation/utrecht-centre-of-excellence-for-affordable-biotherapeuticsMABXIENCE 網址：http://www.mabxience.comSPIMACO網址：http://www.spimaco.com.sa/網址：http://www.libbs.com.br/en/about-us/who-we-are/
First consortium of local manufacturers to make affordable biosimilars available for low income countries At the initiative of the World Health Organization, and with the support of Utrecht University, local manufacturers in low income countries will collaborate to bring a biological drug to market for the lowest possible price. The drug, called palivizumab, protects against the common virus RSV. According to the World Health Organization (WHO), this virus is the second most common cause of death in children up to one years of age in low income countries. The four companies, mAbXience, Libbs, Medigen and SPIMACO, have signed a contract for the production of this drug with Utrecht University and the WHO on Wednesday, 9 March.
"This is the first time that commercial parties in low income countries will deal with a global health issue on their own", explains project founder and Professor of Pharmaceutical Biotechnology at Utrecht University, Huub Schellekens. By sharing the development costs, the companies in the consortium will be able to offer the drug for a much lower price. Utrecht University and University Medical Centre Utrecht will be responsible for the pre-clinical and clinical research and for quality control of the locally produced medicines.
#RSV The cold virus RSV can cause serious respiratory tract infections, especially in premature infants. The disease occasionally requires treatment in a hospital, even in the high income countries. In low income countries, the number of premature births is much higher than in more prosperous countries; around 20% of all births. Unfortunately, prevention is impossible due to the high price of the drug palivizumab, so according to the WHO tens of thousands of children die of the disease every year.
#Biosimilars The active substances in palivizumab are natural proteins of the type that have been used in biological pharmaceuticals available on the market since the early 1990s. As soon as a patent for a biological pharmaceutical expires, other companies release a cheaper biosimilar version of the drug to the market. Unfortunately, local pharmaceutical manufacturers in low income countries often lack the biotechnological knowledge to produce these biosimilars, so they must be imported and remain too expensive for the people who need them.
#UCAB To address this problem, the World Health Organization went looking for a university that had the biotechnological expertise to produce the biosimilars, and that was willing to transfer that knowledge. The WHO chose Utrecht University's Department of Pharmaceutical Sciences in part due to its leading position in the field. Utrecht University in turn set up the UCAB Foundation to implement the project.
#Lunamab The biosimilar for palivizumab will be developed by UCAB and the pharmaceutical company mAbXience. They will then transfer the necessary technology and knowledge to the other partners in the consortium. UCAB will also arrange for the drug to be approved for release to market in the low income countries. The drug will be named Lunamab, after Prof. Huub Schellekens' granddaughter Luna. He expects that the drug will be available on the market in the first countries by late 2017.
#mAbXience mAbXience is a subsidiary of the international pharmaceutical firm Chemo. Chemo founder and CEO Hugo Sigman van Chemo has supported Prof. Schellekens' initiative from the very beginning. The other partners are the Brazilian Libbs, the Taiwanese Medigen and the Saudi Arabian SPIMACO.
Life Sciences : This research is closely related to Utrecht University's strategic research theme Life Sciences. Contact: Monica van der Garde, Press Spokesperson, 31 (0)6 13 66 14 38; m.vandergarde@uu.nl Roy Keeris, Press Spokesperson, +31 (0)30 253 24 11; r.b.keeris@uu.nl
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