Wyeth says good-bye to Solvay and bifeprunox

From potential blockbuster to zilch in about 6 mths. Without Wyeth's marketing power and a nonapprovable letter requiring a second positive maintenance study in schizophrenia, bifeprunox is as good as dead.

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.

JNJ Invigorating Invega?

Not really. Despite an overall positive call and decent antipsychotic numbers, the news on Invega is little changed from what I suggested earlier. In today's conference call Dominic Caruso, JNJ's CFO stated "With respect to Invega, we still continue to see in Invega as a promising product for the treatment of schizophrenia. I would tell you that we continue to see restrictions in the use of Invega based on formulary status, so whether it is prior authorization, et cetera, we continue to see that. It is a very difficult environment for new products in a new reimbursement arena. Those pressures are difficult to overcome without additional data on the product, especially additional data comparing it other products." In other words, uptake of Invega is still a trickle and whoever was handling payor negotiations has probably been replaced by now.

Oh, and he also touted the study I said they'd tout in the call..."Now you may know that we have just recently, this past weekend, had a session on the head to head trial of Invega and Seroquel so it is recent data. That trial showed that Invega performed very nicely against the Seroquel placebo in terms efficacy and is very well-tolerated and in fact, the dropout rate for Invega patients is far lower than either Seroquel or even placebo." Um, maybe so, because everyone already knows patients (esp. severe acute schiz. pts.) drop out when the product they're taking doesn't work and Seroquel isn't much better than a placebo in short-term study of acute schizophrenia so yes, Invega had a lower dropout rate. Perhaps Dominic would also like to comment on the incidence of acute AE's in the study...I guess not.

This is probably the best quote though: "We have taken a realistic view of Invega in both our guidance for this year and in the cost improvement programs that were previously announced." We here at JNJ accept that our product has failed to launch successfully, but we'll just cut some jobs and take what we can get until Risperdal goes generic. Hey, at least we got the product approved by the FDA *thumbs nose at Wyeth's bifeprunox failure*.

Enough on Invega, there's 5 other products out there to discuss...