"I am extremely pleased with the successful submission and acceptance of the Fiapta(TM) NDA filing in 2007. This important achievement would not have been possible without the commitment and dedication of the Vanda team," stated Mihael Polymeropoulos, M.D., President and CEO of Vanda. "I am looking forward to an exciting 2008 during which we expect the results from our VEC-162 Phase III chronic insomnia clinical trial and the PDUFA action for Fiapta(TM)."
OK it's got a name (weird name - perhaps they were foreshadowing its potential market performance compared to its remaining patent life i.e. a Fiasco). Also it looks like it's going to have the same kind of activating problems that come with Geodon and Abilify given the insomnia trial. Doesn't really bode well for use in severe schizophrenics who most medical staff would prefer to keep sedated...
The PDUFA date is July 27 so I wonder when we're going to hear about the sales force issue. Do they really plan to go it alone? (perhaps it was discussed on yesterday's call -- anyone know?)
Friday, February 15, 2008
Vanda's Atypical Antipsychotic iloperidone has a new name.... Fiapta
Tuesday, February 12, 2008
No News, Vanda, Wyeth, Seroquel, Abilify depression, risperidone generic
It's been a month, and there's basically no news on the atypical antipsychotic front. Vanda still has no sales force for iloperidone, Wyeth still has no chance with bifeprunox, and Seroquel still dominates the marketplace. The only thing new is that Abilify is making a foray into the PCP arena now that they have the adjunctive depression label. Risperdal and Zyprexa continue to lose share. Clearly the big event or perhaps non-event of 2008 will be generic risperidone, and I don't think anyone knows how that will play out.
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