摘要: 在此次进行的临床三期研究显示,患者在接受这种新型疗法治疗后,出现术后恶心呕吐的现象降低了19.4%,远低于对照组。Acacia公司的CEO Julian Gilbert表示这一结果在他的预料之中。目前市面上已经有数种治疗PONV的疗 ...
在此次进行的临床三期研究显示,患者在接受这种新型疗法治疗后,出现术后恶心呕吐的现象降低了19.4%,远低于对照组。Acacia公司的CEO Julian Gilbert表示这一结果在他的预料之中。目前市面上已经有数种治疗PONV的疗法。虽然这些疗法能够显着降低患者手术后出现PONV的概率,但是对于一些PONV高危患者来说,这些疗法的疗效就大打折扣了。Acacia公司敏锐的发现了其中的市场并在这一领域进行了细致的研究。 此次临床三期研究的数据向市场和投资者证明了公司开发的PONV疗法的有效性,然而目前摆在公司面前的另外一个大问题则是如何将这一疗法真正的商业化。这家位于英国剑桥地区的生物技术公司目前仅有三名正式员工和数名兼职员工,公司需要大量的资金才能真正完成这一疗法的上市审批事宜。Julian Gilbert表示,要解决这一问题主要有两种选择,其一是将公司直接出售给一些大型生物医药公司,其二是公司独立进行IPO以募集研发资金。 近年来,随着生物医药产业的不断发展与科研单位成果转化的不断加速,小型生物技术公司的创新能力越来越受到市场和制药巨头的重视。由于面临着专利悬崖的考验,一些大型生物技术公司已经开始将收购小型生物医药公司作为增强公司创新能力和产品多样性的有效途径之一。 详细英文报道: Acacia Pharma says it gleaned positive results from a Phase III study of its experimental therapy designed to prevent postoperative nausea and vomiting (PONV). And now it's brought in the investment banker J.P. Morgan Cazenove to advise the board on what its next steps should be as it tries to position the treatment for regulatory approval and commercialization. In the study, the Cambridge, U.K.-based biotech says it tracked a 19.4% risk reduction in PONV, a sharp plunge from the results seen in earlier, and much smaller, studies sponsored by Acacia. CEO Julian Gilbert, though, says he wasn't surprised by the drop, which reflects similar fluctuations in related late-stage trials. There are already a couple of different remedies available for these patients, he adds, but high-risk patients in danger of failing those treatments are in need of a third option--which is wher Acacia sees an opportunity. And rather than shoot for a quick regulatory OK, with its primary focus on the U.S. market, Gilbert wants to pursue some additional trial work ahead of a filing in order to get some information in the label that will help position the drug. "We will be doing a study looking at the efficacy of our drug in combination with current anti-emetics, and one or two looking at our drug as a rescue treatment following failure of a prophylactic,"says Gilbert, who counts himself as quite pleased by the fact that Acacia got through Phase III on its own while pushing a pipeline with 4 programs. But first, the company--which has a lean-and-mean virtual staff of three full-timers and several part-time workers--has to make some decisions on funding. "We don't have the money to take those programs through to the market,"says the CEO, "but we do have supportive investors. We have started working with strategic advisers on which route we want to go down." Just about everything is on the table right now, he adds. They could sell the company, perhaps file an IPO, raise more cash or execute a licensing pact. |
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