First Generic Atypical Antipsychotic (Risperdal becomes risperidone)

Yesterday Teva announced they received FDA approval to produce a generic version of Risperdal. We all knew this was coming. Teva was ready with product to ship and JNJ was ready with their own in-house generic version in hopes of cannibalizing some Teva sales at the expense of their former cash cow.

What does this mean for the common man?

Well if you're schizophrenic, bipolar, autistic, or an off-label user, it means that the price you pay just got a whole lot cheaper AND after Teva's 180 days of exclusivity as the sole competitor allowed to sell risperidone, the price will drop even lower as more competition enters the market.

If you're a sale rep. for Invega (the bastard child of Risperdal), your sales goals just got a wee bit more difficult now didn't they because who wants to buy Risperdal-lite when you can get the original for pennies on the dollar. Wonder what that already stellar *saracasm* Invega uptake curve is gonna look like now.

And what if you're Abilify, Geodon, Seroquel or Zyprexa? Well, you hope and pray that your marketing and sales folks have done a good job differentiating their product from the competition because the price differential between you and the generic just went exponential.

And what of the insurers you may ask. Can you say fail first? I'm sure it's already begun.

Ooh, exciting times in the Atypical Antipsychotic Market!

Abilify for the Kids

Bristol-Myers Squibb released their earnings last week. No real news on the Abilify front. It continues to grow year over year and now has the pediatric bipolar and adolescent schizophrenia indications in its pocket to be the kid-friendly atypical anti-psychotic. Analysts didn't really press on Abilify since the Mead Johnson IPO idea started all their wheels turning.

Guess we can look for the Abilify reps in our pediatrician's office the next time the kids' need a sports physical.

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.

Pfizer Inks Deal with Taisho for Schizophrenia Drug

Anytime the behemoth gets behind a drug, it's news. Geodon will be long gone by the time this hits the sample closets. Perhaps their reps will have something to talk about then...

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.