Another of those "Hassan-Era Hangovers" is being remediated, post bust-up here in late 2010 -- as Merck ends another program with only marginal chances to produce near-term revenue.
This one (to be fair) was an in-license acquisition by old Organon in early 1999, but by Q4 2007 -- then Schering-Plough Chairman and CEO Hassan should have been able to see that if Cortex could not get an FDA green-light for an ADHD indication, an approval for depression or schizophrenia would be a much longer path*. We now (allegedly) know why he was distracted -- and not tending to his knitting.
So, Ampakine stayed on Schering-Plough's active anti-psychotic research roles. It drew funding. It lived on -- until this past Friday, that is.
In any event, here is Friday's wire story, from the good people at Pipeline Review.com:
. . . .As part of an ongoing prioritization process, Merck has decided not to proceed further with its AMPAKINE development program, and has returned its exclusive rights to develop AMPAKINE compounds for the treatment of depression and schizophrenia to Cortex.
"The return of these rights to Cortex now allows us to develop our lead AMPAKINE compounds for these serious psychiatric disorders," said Mark Varney, Ph.D., President and Chief Executive Officer of Cortex. "Data from animal models suggests AMPAKINE compounds could treat the cognitive deficits that occur in as much as 75% of individuals with schizophrenia. In addition, recent animal work suggests AMPAKINE compounds like CX1739 could be effective therapies for depression, and couldpotentially provide a much more rapid onset of antidepressant activity and represent a completely new mechanism of treating this disorder. . . ."
I am sure development on the Ampakine family of candidates will proceed apace back under Cortex's wing. I just wonder how many of more of these Whitehouse Station is going to have to write-off -- from its post-bust-up books. And Fast Fred pockets perhaps $225 million for his trouble. What a world.
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* Background: in October of 2007, Cortex learned that FDA was not going to approve an ADHD indication for one of the Ampakine candidates (CX717 -- the one depicted, upper right).
We may need a table of all these Hassan Hangovers -- I'll likely get it done, after the Bears game tonight.
3 comments:
"Data from animal models suggests AMPAKINE compounds could treat the cognitive deficits that occur in as much as 75% of individuals with schizophrenia. In addition, recent animal work suggests AMPAKINE compounds like CX1739 could be effective therapies for depression, and could potentially provide a much more rapid onset of antidepressant activity and represent a completely new mechanism of treating this disorder. . .
It certainly would be interesting to know what he bases these statements on. Animal models need to be proven to correlate findings of effects in animals with clinical effects in humans. It's one thing to correlate seizures or cardiac toxicity that occur in several species and may be dose related. It's quite another to show a correlation with cognitive functioning in humans especially when it's difficult to show effects in humans period, and even more so when the human studies haven't even been done yet.
Salmon
Since most of Big Pharma is leaving CNS research, I'm interested to see what this company comes up with, especially WRT atypical antidepressants, bipolar disorder, and ADD. Salmon raises some good points - could knockout mice be used? (I guess that's really a better question for Derek Lowe's In The Pipeline blog, though.)
Great stuff here, both of you!
As to Salmon's very pointed question about the Cortex claims for the Ampakine family of candidates:
My hunch -- as a one-time regulatory lawyer -- is that one of Cortex's outside counsels has come to the conclusion that since there is no approved version of an Ampakine drug, for any indication (and, apparently, no filed NDA or ANDA either!), it cannot be an FDA matter.
Now, it may be an SEC matter, if such (putative) hyperbole is supporting the stock price -- but presumably, the outside counsel would say "you'll need to modify that, and really pull your horns in" when Cortex gets ready to actually file an NDA on any of the variants of Ampakine.
It is an interesting story, but. . .
Time to see if the Bears can beat the Giants, and run it to 4-0.
Namaste, to you both.
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