Replies to post #212123 on Biotech Values

[north40000]

MRK will be concerned overall re AMRN's Reduce-It clinical trial(8000 patients) 80% event results, and IDMC recommendation.

[upndown1313]

Dew, I think this is really about the risk/benefit. This drug is known to accumulate in adipose tissue with a very long half life, so while primary efficacy endpoint was met, they will need to look closely at all other safety indicators which i am sure will take some time. Still a big surprise that efficacy against statins alone was statistically significant suggesting some other benefit wrt to HDL raising. Also, no obvious toxicity (they would have stopped the study) which is also surprising given the accumulation issue.

[DewDiligence]

MRK flattish on very modest benefit in Anacetrapib CVOT (HR=0.91):

http://www.mrknewsroom.com/news-release/research-and-development-news/merck-announces-results-reveal-outcomes-study-anacetrapib (MRK PR)
http://www.cardiobrief.org/2017/08/29/merck-reveals-a-slightly-positive-cetp-inhibitor-trial/ (CardioBrief)
http://www.epvantage.com/Universal/View.aspx?type=Story&id=727690&isEPVantage=yes (EPVantage)
https://www.reuters.com/article/us-merck-cholesterol-idUSKCN1B90J5 (Reuters)

The clinical benefit may be insufficient for MRK to bother submitting an NDA.

MRK announced in June that the trial hit its primary endpoint, without further details (#msg-132527139).