2014年10月29日讯 /生物谷BIOON/ --导读：满满的都是泪啊！曾经叫嚣收购阿斯利康的巨头辉瑞居然低头认输了！为打造疼痛产品组合，辉瑞（Pfizer）2011年斥资36亿美元收购King制药，看中的一个重要产品是止痛药Remoxy。不过，Remoxy监管之路异常艰难，先后2次被FDA拒绝，辉瑞2013年大张旗鼓进行第3次尝试。然而，在Remoxy遭拒同时期，该领域其他竞争对手迅速跟进，近期已有新产品获批上市，导致Remoxy市场前景急剧缩水。近日，辉瑞终于低头认输，忍痛放弃寄托在Remoxy上的全部希望，同时金盆洗手，不再染指Remoxy任何后续开发工作。
Remoxy是辉瑞于2011年耗资36亿美元收购King Pharma后获得，但FDA出于对生产工艺和化学成分的担忧，分别于2008年和2011年2次拒绝Remoxy，给该药的前景蒙上了一层阴影。之后的2013年秋季，辉瑞甚至正式宣告卷土重来，进行第3次尝试，继续推进Remoxy的III期项目。然而，近日，辉瑞终于低头认输，将Remoxy的全部权利归还给合作伙伴Pain Therapeutics和Durect，同时表示不再掺合Remoxy任何进一步的开发工作。
受此消息影响，Pain公司周一一早股价暴跌，市值消失一半还多。而Durect公司也受牵连股价暴跌46%，该公司在12年前向Pain公司提供了技术和Remoxy对外授权(Out License)。之后，Pain公司与King Pharma达成合作协议，后者随后于2011年被辉瑞收购。
不过，Pain公司却声称对此变故感到高兴，该公司首席执行官Remi Barbier在声明中表示，辉瑞放弃Remoxy，意味着Pain公司将重新获得该项III期资产在价值20亿美元市场中的全球权力，并期待着重新提交Remoxy新药申请（NDA），同时也热衷于与潜在的合作伙伴就Remoxy资产展开讨论。
Remoxy是常见止痛药羟考酮（oxycodone）的凝胶缓释胶囊，而羟考酮已被广泛滥用。Remoxy是一种抗滥用、缓释羟考酮制剂，其剂型为凝胶样高粘性胶囊，难以通过压碎或与水及其他溶剂混合将内容物积攒，能够有效防止羟考酮滥用。正因如此，Remoxy具有广阔的市场前景，该药也是辉瑞当年斥资39亿美元收购King Pharma的主要兴趣之一。
回到2011年，在FDA第二次拒绝Remoxy之时，辉瑞正在对研发进行重大重组，但时至今日，辉瑞似乎愿意承受努力打造疼痛药物组合所付出的沉重代价。此前，辉瑞原计划2015年中期第三次提交Remoxy的上市申请，这距离2008年Remoxy首次遭拒整整7年之久。
然而，在这段时间里，该领域的其他制药商一直在快速推进各自的羟考酮防滥用配方产品，这些产品很可能极大地侵蚀任何后入场其他同类药物的市场份额。例如，Purdue制药开发的新产品Targiniq近日获批上市，该药将羟考酮与纳洛酮配伍，当压碎并经鼻吸入后，纳洛酮可阻断羟考酮成瘾的欣快感。
英文原文：Pfizer finally abandons all hope in Remoxy, and Durect/Pain Therapeutics feel the sting
Pfizer ($PFE) had hung on to high hopes for the drug Remoxy long after the tamper-resistant pain therapy endured its second rejection at the hands of the FDA in 2011. It even officially re-upped for the late-stage comeback try last fall, committing to see it through a third try. But today Pain Therapeutics says that the pharma giant has finally thrown in the towel, handing back rights to the long-delayed treatment and washing its hands of any further development work.
The news pushed Pain's shares ($PTIE) into meltdown mode Monday morning, blasting away more than half of the company's share value. Durect's stock ($DRRX) was part of the collateral damage. The biotech, which provided the technology and outlicensed the therapy to Pain 12 years ago, saw its shares plunge by 46%. Pain later did a deal with King Pharma, which was subsequently bought out by Pfizer.
Remoxy, an extended-release version of oxycodone designed to leave a bad taste in the mouth of anyone who tried to chew the tablet for an illicit rush, had been one of the primary attractions for Pfizer when it bought out King for $3.6 billion. The FDA's second rejection for the therapy came as Pfizer was undergoing a huge reorganization of R&D, but until today the company seemed willing to endure heavy costs in an effort to build its pain drug portfolio, planning to wrap up its complete response to the FDA's rejection letter in the middle of next year--a full 7 years after the first rejection.
Over that time a number of drug developers have been making speedy progress with tamper-resistant oxycodone therapies of their own, which would likely have cut deep into the value of any other similar drugs coming into the market later. Purdue Pharma, for example, won a recent approval for Targiniq, which pairs oxycodone with naloxone. Crush it and snort it, once a common recreational high, and the naloxone--a drug used to counter opioid overdoses--blocks the euphoric high that addicts are after.
Pain Therapeutics CEO Remi Barbier, though, professed to be delighted by the turn of events.
"It's a privilege to reacquire worldwide rights to an unencumbered Phase III asset that targets a $2 billion market," said the CEO in a statement. "We look forward to the prospects of resubmitting the REMOXY NDA under our control. We are also enthusiastic about initiating discussions with potential pharmaceutical partners around this drug asset."