2015年3月12日讯 /生物谷BIOON/--著名止痛药生产者Zogenix公司最近宣布，公司已经将其研发的最新缓释止痛药Zohydro以1亿美元的价格出售给了新泽西制药商Pernix Therapeutics。协议同时还规定了近3亿美元的销售里程碑奖金。曾几何时，Zogenix公司希望以Zohydro为契机扩大公司在止痛药市场的影响力，随着该笔交易的进行，这一计划或将宣告破产。
为何如此？作为临床中使用最为普遍的药物，止痛药市场本该是前景最为广阔的药物市场之一。然而，由于目前的许多止痛药都属于阿片类药物，这种药物极易造成患者的药物依赖。在开发Zohydro的过程中，Zogenix公司同样遇到了类似的诘问，并被迫修改了Zohydro的剂型配方。就在一个月之前，FDA批准了这种新剂型缓释止痛药物的上市。新的Zohydro采用了公司最新的BeadTek技术能够有效防止药物成瘾者破坏药物并萃取其中的成瘾性成分。
面对重重困难，或许放弃Zohydro是摆在Zogenix公司面前的一个好的选择。事实上，近年来随着美国市场药物成瘾性问题伴随的药物滥用情况日趋恶劣，FDA的审查人员对止痛药的审批采取了越来越严格的态度，许多止痛药生产厂商被迫放弃在该领域的市场。
另一方面，Zogenix的收购方Pernix Therapeutics公司也认为这次收购将会有利于公司在中枢神经系统领域的积累。按照计划，公司将雇佣100名销售代表大力推广Zohydro产品。同时，公司还计划与Zohydro搭配销售治疗失眠药物Silenor以扩大公司产品市场。
详细英文报道：
Zogenix ($ZGNX) is selling off its extended-release painkiller franchise Zohydro to New Jersey's Pernix Therapeutics ($PTX) for $100 million and up to $283.5 million in milestones based on sales. At one point, Zogenix looked at Zohydro as its flagship, but now it appears the company is backing away from pain management altogether.
The FDA approved a tamper-resistant reformulation of Zohydro just a month ago. The extended-release opioid agonist makes use of Zogenix's BeadTek formulation, which is designed to make it more difficult for potential abusers to crush and snort the drug. Instead it forms a viscous gel.
Zohydro originally faced its share of critics as an all-hydrocodone painkiller likely to be abused, leading the company to reformulate with BeadTek. But it turned out the FDA approval didn't allow abuse deterrence as a selling point on the label, making it difficult for the San Diego company to silence its critics until it submitted further data supporting the painkiller's effectiveness, which it had planned to do by the second half of this year.
Now, though, Zohydro is off to Pernix, which will continue to offer the normal extended-release products in the line, as well as the abuse-deterrent option. Pernix said in a statement that it would assume regulatory and financial responsibility for the ongoing efforts to reform the label to include abuse-deterrence claims.
"Zohydro ER is an ideal strategic fit for Pernix, having tremendous synergy with our existing CNS franchise," Pernix CEO Doug Drysdale said in a statement. Pernix plans to hire 100 sales representatives to push Zohydro forward, as well as its insomnia treatment Silenor, the two working in conjunction for patients with pain and sleep issues.
"The submission and recent approval of the supplemental New Drug Application (sNDA) for Zohydro ER with BeadTek was an important catalyst for increasing strategic interest in the brand," Zogenix CEO Roger Hawley said. "We are very pleased to have selected Pernix for this transaction as we believe they are well positioned to continue raising awareness of the important clinical benefits of Zohydro ER for patients suffering with severe chronic pain who are in need of around-the-clock opioid therapy."