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In reply to the discussion: Asperger’s/Mental Illness/Gun control are Red Herrings? Adam was taking controversial drug FANAPT [View all]No Compromise
(373 posts)But this drug in particular has a crazy history, and our FDA is not looking out for us...
Fanapt: the rise and fall of an antipsychotic
Fanapt is born
Cooked up in the labs of Novartis Pharmaceuticals, Fanapt was intended as a replacement for Clozaril, a true blockbuster with, unfortunately, an expired patent. That meant Clozaril could be sold cheaply, generically, and Novartis could no longer command the high prices they had come to count on. Enter Fanapt.
Fanapt is dumped
During the development process, Novartis ran into problems. Whatever they found, it wasnt good, because they basically tossed Fanapt into the garbage.
But another pharmaceutical company, Vanda, snatched it up and ran with it - all the way to the FDA.
Vanda goes to the FDA - and loses
In July 2008, the FDA issued a not approvable letter on the new drug. (In other words: no dice, Vanda.)
Vanda ignores the FDA - and wins
Vanda did none of those things. Instead, in November, they simply resubmitted the drug to the FDA, using leftover data from the original clinical trials.
It was such a jaw-dropping long shot that Vandas investors couldnt get rid of stock fast enough. Stock prices fell below $1, and the companys worth plummeted to less than cash on hand. At Vanda, there were layoffs and cutbacks, followed by a proxy fight trying to force Vanda to shut down, sell off its assets, and give any remaining money back to the shareholders.
Then, on May 6, 2009, stock analyst Adam Feuerstein observed something strange: Hell froze over Wednesday night, right before a squadron of flying pigs took to the sky.
For reasons only clear to the FDA, the new schizophrenia drug had been approved.
...
http://www.examiner.com/article/fanapt-the-rise-and-fall-of-an-antipsychotic