安成 藥品獲美FDA認證【經濟日報╱記者黃文奇／台北報導】 2013.02.06 02:55 am興櫃製藥公司安成（4180）昨（5）日宣布，其「骨骼肌鬆弛症用藥（Amrix）」已獲美國食品藥物管理局（FDA）核可，將申請「第四類簡化新藥上市程序」（Paragraph IV）資格，挑戰跨國藥廠Teva專利，一旦成功可搶攻1億美元（約新台幣29.5億元）銷售額。安成生技為旅美華人生技專家陳志明返台創立的公司，在興櫃股中屬於高價族群。安成藥業總經理陳志光表示，公司發展的「骨骼肌鬆弛用藥」，原開發廠為全球最大學名藥廠Teva的子公司Cephalon，過去有至少3家藥廠挑戰該藥品P4專利，都無功而返；安成為第4家挑戰者，也是唯一在安全、有效性方面，通過美國FDA審查的藥廠。安成所挑戰的P4，是美國FDA對學名藥廠的利多政策，以「6個月專賣期」為誘因，鼓勵學名藥廠挑戰專利藥品。業界表示，若順利挑戰P4，不僅可享有專賣權，並想藥價優惠、先期進入市場卡位的機會。【2013/02/06 經濟日報】
Teva's Cephalon Wins Ruling on Challenge to Amrix Patents By Susan Decker on April 16, 2012 Cephalon Inc. (TEVA) won an appeals court ruling that could help it block generic versions of the muscle- relaxant Amrix. The U.S. Court of Appeals for the Federal Circuit in Washington today said a trial judge erred in invalidating two patents on the medicine. Mylan Inc. (MYL) and Par Pharmaceutical Cos. (PRX), which won a patent challenge at the lower court, can seek victory on other grounds, including allegations of patent misuse and antitrust violations. Cephalon, bought by Petah Tikva, Israel-based Teva Pharmaceutical Industries Ltd. last year, and partner Eurand NV (EURX) sought to block low-cost versions of the medicine from entering the market until the patents expire in 2023 and 2025. They cover a dosage form of a skeletal muscle relaxant and a method of relieving muscle spasms. Mylan began selling generic Amrix in May 2011 after winning the ruling that the patents covered obvious variations of earlier known research. U.S. District Judge Sue Robinson ordered Mylan to hold off selling the drug until the appeals court ruling. The Federal Circuit said that sales ban will remain in effect until Robinson gets the case back. Amrix generated $109 million in U.S. sales in 2010, before the generic versions entered the market.The case is Eurand Inc. v. Mylan Pharmaceuticals Inc., 2011-1399 and 2011-1409, U.S. Court of Appeals for the Federal Circuit (Washington. The lower court case is Cyclobenzaprine Hydrochloride Patent Litigation, 09-2118, U.S. District Court, District of Delaware (Wilmington).To see the patents, click: 7,387,793, 7,544,372.
No comments:
Post a Comment