By Brian Orelli
updated 4/21/2012 4:30:10 AM ET
The data dump at this week's European Association for the Study of Liver Disease for hepatitis C drugs is nothing short of amazing. Early data suggests the drugs are working really well without the need for Merck's PegIntron or Roche's Pegasys, which have to be injected and have unpleasant side effects. - Gilead Sciences' GS-7977 plus ribavirin looked good in multiple studies. Between 59% and 88% of patients had early cure rates. Good thing, since it paid $11 billion for Pharmasset, mainly for this drug.
- GS-7977 worked even better in combination with Bristol-Myers Squibb's daclatasvir, with early cure rates between 91% and 100%, depending on the strain of virus.
- Daclatasvir plus another Bristol drug, asunaprevir, hit a 77% cure rate, but that isn't too shabby, since it was in difficult-to-treat patients and was measured 24 weeks after treatment. The early cure rates -- measured four weeks after treatment -- in the GS-7977 trials are preliminary and will probably come down a little.
- Don't forget about Abbott Labs. The company doesn't get as much press -- not making acquisitions will do that -- but combining two of its drugs with ribavirin resulted in an 82% cure rate 36 weeks after treatment. Another combination looked even better, with cure rates between 93% and 95%, although that was only after 12 weeks of treatment.
No doubt, those are rule-breaking results. Add a few more drugs to the cocktail, and we might have long-term cure rates approaching 100%.
But investors should keep in mind that these are only phase 2 studies. The drugs still have to go through the final stage of clinical trials before they can go in front of the FDA. With hepatitis C drugs, efficacy data typically translates well from phase 2 to phase 3. The bigger risk is that side effects might crop up when the drugs are tested in a larger population. Data from one of the Abbott trials, for instance, was based on a whopping 11 patients.
The trials will also take some time to complete. Vertex Pharmaceuticals presented phase 2 data for Incivek as early as late 2006 and didn't get the hepatitis C drug approved until last May. It probably won't take quite that long for this generation of drugs, but the drugs are still years away from an approval.
Enjoy the data party; just realize revenue from the drugs is a way away and still not guaranteed.
布赖恩认为奥利尼
2012年4月21日4点30分一十秒更新东部时间上午
在本周举行的欧洲丙型肝炎药物的肝脏疾病研究协会的数据转储是令人惊叹。早期的数据表明药物的工作而不需要对默克公司的佩乐能,罗氏的派罗欣,其中有被注入,有不愉快的副作用,真的很好。
Gilead Sciences公司“GS-7977加利巴韦林看了好多个研究。之间的59%和88%的患者有早期的治愈率。一件好事,因为它为Pharmasset支付110亿美元,主要用于这种药物。
GS-7977工作更好地结合施贵宝的daclatasvir,早期治愈率91%和100%之间,取决于病毒株。
daclatasvir加上另一个布里斯托尔药物,asunaprevir,创下了77%的治愈率,但不是太寒酸了,因为它是难以治疗的患者中,治疗24周后测定。早期的治愈率 - 治疗4周后测量 - 在GS-7977试验是初步的,可能会降下来一点。
不要忘了雅培。公司没有得到尽可能多的记者 - 不收购将做到这一点 - 但它的两个药物结合与利巴韦林在治疗36周后,82%的治愈率。另一个组合看起来甚至更好,治愈率在93%和95%之间,虽然这仅是12周的治疗后。
毫无疑问,这些都是违规的结果。添加一些更多的药物鸡尾酒,我们可能有长期的治愈率接近100%。
但投资者应该牢记,这些都是只有第2阶段研究。这些药物仍然必须通过临床试验的最后阶段,才可以走在前面的FDA。丙型肝炎的药物,疗效数据通常转换从第二阶段到第三阶段。更大的风险是可能出现副作用,当药物被测试在一个较大的人口。例如,数据从雅培审判之一,是基于高达11例。
试验还需要一些时间来完成。顶点Pharmaceuticalspresented早在2006年年底第一阶段2 Incivek数据并没有得到C型肝炎的药物,直到去年五月批准。它可能不会需要相当这一代药物,但药物仍从距今批准。
享受数据党,只是实现从药品的收入,是一种距离,仍不能保证。
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