"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
Thursday, November 1, 2007
Pipeline Products
I'm trying to get a list of pipeline products together. Perhaps others can help. Please feel free to comment in your products. A few off the top of my head are:
bifeprunox - Wyeth/Solvay - got an approvable letter from FDA this year that basically puts any launch on hold until at least 2009. This product has a nice side effect profile especially with regards to weight; BMS/Otsuka and Pfizer are loving that this little piggie might not be coming to market since it might've munched on their share.
iloperidone - Vanda - this product has been around a long time; Vanda is the latest owner and they say they will commercialize it on their own, but would still consider partnering. Um, yeah. OK, this product's little claim to fame is that you can do a blood test to see if your patient is likely to suffer bad side effects from the drug and maybe learn about possible efficacy too. That's swell. Know many psychiatrists who like to do blood tests before tossing a product into this week's cocktail? Yeah me neither. What we've got in iloperidone is a product with little time left on its patent, from a company currently with ZERO CNS sales reps, and a story that requires a change in physician behavior. Good luck with that and your latest debt offering too. Ouch. Glad I sold that one.
asenapine - Pfizer/Organon - Oops, I meant just Organon because Pfizer saw the trial data and walked away. Now that's a ringing endorsement. This one actually may have the best chance of making it to market though. Time will tell.