Tuesday, February 25, 2014

No Surprise, After June 2102 FDA Clank: Merck Tells Ariad "It's Not You; It's Me. Wait. It's. . . YOU." -- Rid Of Ridaforolimus Obligations

Ariad just made it made it official, but we all knew this was coming, back in June of 2012 -- as I wrote then. The breakup is finally complete, as of this past week. Merck served its notice.

"We're just. . . friends. Not room-mates any more." Heh.

Here's a bit of the very-cogent take of FierceBiotech; do go read it all:

. . . .Ridaforolimus, an mTOR inhibitor with potential in various cancers, made its way through a Phase III trial in advanced sarcomas, but the resulting data weren't enough to sway regulators, who in 2012 took issue with the drug's risk-benefit profile and demanded another trial. In the lead up to ridaforolimus' FDA rebuke, Merck paid Ariad roughly $200 million of a deal that could have reached about $708 million had everything gone according to plan. . . .

So Merck continues to hone its R&D commercialization focus. Getting out for around $200 million is actually a win, as that would have been perhaps a tenth of the amount needed, from here, to see Ridaforolimus through to commercialization, after new studies (if FDA would have ever granted approval -- and that was at best a dicey bet). And with that risk/benefit profile, sales would have been likely scarce -- if approved, at all. So it goes.

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