Building on their first surprising round of positive cardio results for their industrial strength fish oil Vascepa, Amarin today outlined a fresh set of data that they hope to use to build a blockbuster case for the drug by demonstrating extended benefits that improve with time.
In an exploratory analysis — translation: something that is immediately controversial — their researchers involved in the REDUCE-IT study pointed to a 30% reduction in cardiovascular events compared to the placebo arm. That would amount to a drop of 159 MACE events for every 1,000 high-risk patients treated over 5 years.
Those numbers would include an average drop of “12 deaths, 42 heart attacks (myocardial infarctions), 14 strokes, 76 coronary revascularizations and 16 episodes of hospitalization for unstable angina. There was also a 28% reduction of total events in the key secondary endpoint of 3-point MACE in the intent-to-treat population consisting of a composite of cardiovascular death, nonfatal heart attack and nonfatal stroke.”
“This is an impressive degree of risk reduction,” said principal investigator Deepak Bhatt. “From a patient’s perspective — and from my perspective as a physician — we care about repeat events and the risk of surviving a first stroke or heart attack only to go on to have a subsequent, and potentially fatal, event. The degree of benefit that this analysis reveals is quite large, especially considering that this is an additional layer of benefit on top of what statin and other therapies have already provided.”
Amarin triggered an unending stream of M&A chatter, criticism and argument when they unveiled their first big data batch on the outcomes study last November. On top of the 25% reduction in the risk for the first occurrence of a major cardio event, the primary hit which drove the instant fervor for this drug, Amarin offered up a 26% reduction for 3-point MACE — the key secondary looking at a composite of cardiovascular death, nonfatal heart attack and nonfatal stroke.
Now they want to prove that it can offer even more protection — and that will in turn trigger even more M&A chatter, criticism and argument.
Their stock $AMRN, which has been on a roller coaster ride, is down 3% mid-morning.
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