The study also measured, as a pre-defined secondary endpoint, the absolute percent change in kidney GL3 from baseline to six months. The result: Amigal 41% reduction compared to placebo 6% reduction. Again, the difference was not statistically significant but it sure seems like Amigal is doing what's it's designed to do. [We'll leave the debate about the magnitude of GL3-lowering effect for another time.]
I can't wait to see in February how a median 6% reduction in kidney GL3 led to nine of 32 placebo patients posting a response of greater than 50% reduction. Those nine placebo patients must have been super-duper responders.
Also important: 12-month kidney response rates from the study. We'll want to see if the GL3 reductions seen in Amigal-treated patients remains or improves further, while placebo patients switched to Amigal at six months show similar improvements.
Until then, Amicus is down but not yet out.I couldn't close the Mailbag for 2012 without one more comment on Amarin (AMRN) and its prescription fish-oil pill Vascepa. Anyone still fixated -- mistakenly -- on the idea that Amarin is going to be bought out imminently should read Forbes' Matt Herper's take on the negative results announced Thursday from a large cardiovascular outcomes study of Merck's (MRK) niacin combination pill Tredaptive. The fallout from the failed Merck study -- the niacin combination pill didn't reduce heart attacks, strokes and deaths and caused more serious adverse events -- is now engulfing Amarin. No drug maker will open its wallet to buy Amarin without first seeing positive data from the ongoing Vascepa outcomes study in high triglyceride patients. Unfortunately for Amarin, that study won't be completed until 2016. Moreover, I'd say odds that FDA approves an expansion of Vascepa label into the "Anchor" population of high triglyceride patients just went down. I could see FDA wanting to see positive data from the outcomes study as pre-approval requirement following the failure of the Merck Tredaptive study.
Dave J. asks, "Is there any value left in Oncothyreon (ONTY) now that Stimuvax has failed? Where do you see the stock trading in the coming months?" Let's start the discussion with the baseline assumption that Stimuvax is dead, as is ONT-10, the company's next-generation cancer immunotherapy. Maybe you believe there's life still in these drugs, but the market certainly won't.
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