Comments and a Comment

I think I should stop posting and just wait for comments. It seems like a quiet period in the world of atypicals. In case you've missed them, natalie and stephany have been asking so interesting questions in the comment section. Join us there!

OK, OK, one brief comment on the use of atypicals in elder care facilities. I think it's pretty unethical to be basically sedating non-psychotic grandmothers simply because the nursing staff doesn't want to come up with behavioral alternatives or are too understaffed to properly care for their patients. If sales reps are hitting up these places, they should turn in their tchotchkes.

Happy new year to all 2 of my readers :-)

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...

Invega Betters Seroquel, but to What Advantage?

Where do I even start? I guess I should start by pointing to one of the articles on this new trial data release. So, big shocker...in a trial of 400 patients with acute exacerbations of their schizophrenia symptoms who were willing to submit to hospitalization for at least 10 days, Invega showed better efficacy scores on the PANSS than did Seroquel *yawn*. Anyone care to guess what percentage of the US population meets those criteria? An even better question is what percentage of Seroquel's patient population is at risk? It's got to be at least 2 maybe 3 patients. Why even bother with this study? OK, and I'm reaching here, perhaps Janssen is considering a re-launch with a focus on more severe patients representing a new willingness to cannibalize its own Risperdal share and perhaps steal some share from the perennial metabolic whipping boy Zyprexa. At least now JNJ will have something to tout on their conference call.

One point I failed to mention in my last post on Invega is mentioned in the article. With regards to the slow uptake it notes "Invega sales got off to a slow start earlier this year partly because managed-care plans didn't give the drug as favorable a position on their preferred-drug lists as J&J, New Brunswick, N.J., would have liked." There's little doubt that this is true. JNJ was trying to suggest Invega was at price parity with Risperdal when in fact a one-day supply was about twice the cost. MCO's saw through it and either didn't add them to formularies or placed them on a different tier than JNJ had forecasted. Someone with more knowledge than me around managed care formularies should comment here to further elaborate.

Invega

Let's talk about Invega. Invega is the "newest" atypical antipsychotic on the market. It was launched at the beginning of 2007 by Janssen. Janssen also carries Risperdal and wouldn't you know it, Risperdal is going to lose patent protection in the middle of 2008. How convenient that a new product would arrive to fill the sales reps bag and the physicians' sample closets just as the old product becomes generic. Perhaps a little too convenient. You see Invega is really not that different from Risperdal. In fact, it's actually a metabolite of Risperdal so the chemical structure is virtually identical. One would think Janssen would be spending the next year trying to convert as many patients as possible over to Invega since Risperdal revenue will dry up midway through next year when multiple generic versions of risperidone hit the market. However, it appears that rather than have a conversion strategy, they instead are trying to pass Invega off as a truly new and unique product. This would be the correct strategy if they could actually convince doctors of its veracity. But, given the uptake to date, they're not really winning the docs over. It's so bad that when Johnson and Johnson report earnings, they combine Risperdal and Invega revenues together to avoid showcasing Invega's launch numbers. At least that's what they've done for the first 2 quarters. Quarter 3 numbers come out on 10/16 and although prescriptions have probably risen, it's unlikely that there's anything Janssen can do to change the path of the product's uptake at this time. (I thought this picture floating out on the web was pretty funny - that's the last cake that marketing team is getting for a long time.)

About the ads

So you can't help but notice there are ads on this site. These are Google ads. I have no control over the content. Due to the nature of my blog it's likely that ads from major pharmaceutical companies will show up here. For example, the ad showing on my blog at the time of this post is for psychiatry24x7.com. Although this ad touts information about antipsychotic drugs, it's really a site paid for by Janssen-Cilag which is likely the European subsidiary of Janssen in the US which promotes Risperdal. You have to dig to figure this out. By the way, Janssen is one of the Johnson and Johnson companies. Anyway, my point is that you should take the offerings with a grain of salt and look to see who is sponsoring the site before you fully trust its content. Be especially suspicious if they don't even spell the product name correctly in the ad - geez.

The Atypical Antipsychotics

Wow, what a scary name for a class of drugs...

The drugs in this class include: Abilify, Clozaril, Geodon, Invega, Risperdal, Seroquel, and Zyprexa.