Friday, September 2, 2016

Immaterial: Plug Pulled On Odanacatib -- Long Delayed Osteoporosis Candidate

This was expected; and may ironically be slightly positive news. Afterall, Merck will no longer burn new cash chasing a doubtful next-gen osteoporosis program we, since about February 2013, have been skeptical would ever win full FDA approval. [And that Ferbruary 2013 disappointment was a sharp reversal from July 2012 -- when its efficacy looked quite promising. It is a 2008 era legacy Schering Plough candidate, if memory serves. I was mistaken about that -- thanks, Anon.!] All that back story is why I think this news has been factored into Merck's NYSE trading price, since at least late 2014.

So -- just a short link to FiercePharma, which coverage, I think, overstates the negativity of this development:

. . . .Two years’ ago [Kenilworth] announced it was to delay a filing with the FDA after Phase III results showed that while the drug could reduce fractures, it also increased the risk of atrial fibrillation and stroke.

It had hoped for a 2015 U.S. approval, but was forced to hold fire on the safety concerns. Today, finally, Merck has officially said it will bury the program. Odanacatib works by inhibiting cathepsin K, an enzyme that plays a key role in bone resorption.

It had once been touted as a major blockbuster potential for Merck. . . .

I'll be silent a bit -- rewriting the previous post, based on a very well-taken anonymous comment, from a true FDA regulatory maven (i.e., not my longest suit, by any stretch). Be excellent to one another -- today and always -- much barbequed rib competition ahead, for the long weekend!


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