Astrazeneca and Seroquel Escape Lawsuits

Back in April 2010, Astrazeneca settled the federal investigation into its marketing practices for Seroquel for a mere $520 million. I say "mere" because Seroquel alone brings in this much revenue to AZN in a few weeks. They made almost $5 billion on the drug last year. The settlement is barely dissuasive in the financial sense. We all know if you can get your product used in off-label areas where you can be the first atypical used, then your foothold will be strong and marketing costs will stay low. If you happen to get the indication later, then that's just icing on the cake (See Seroquel in Bipolar and Depression and Austism).

Now, Astrazeneca is settling its lawsuits with individuals. Yesterday they announced that 17,500 of the suits had been settled for only $198 million. I don't know which firm AZN retains, but those suits earned every penny. $198 million barely registers. Probably 2 weeks of Seroquel sales. This is all great news for AZN as they work to put the bad press behind them. There are many lawsuits left, which is good because there isn't much time left for Seroquel which goes off-patent in March 2012 if AZN can fend off Teva for that long. That's plenty of time to transition physicians and patients to XR though which currently has a patent through 2017.

Astrazeneca Saves Seroquel

Astrazeneca got incredibly great news today from a NJ court that Novartis and Teva will not be able to pursue their desired genericization of Seroquel. This stands in stark contrast to yesterday's post on Risperdal which just went generic. This is good news for all the branded atypicals as now there is just risperidone as the sole generic. Had Seroquel gone generic it would've turned the atypical market upside down. Seroquel and Seroquel XR as branded products make up over a 30% share of all atypical antipsychotics as it is and with juggernaut new indications coming in Major Depressive Disorder and Generalized Anxiety Disorder, it's not going to get any smaller anytime soon. Had it gone generic, it's likely that Abilify and Geodon would have been particularly hard hit so I'm sure their respective marketing teams are exhaling a sigh of relief.

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!

Astrazeneca's Major Depressive Disorder (MDD) filing for Seroquel on 2/29

Well, this answers the burning question of how many licks it takes to get to the Tootsie Roll center of a Tootsie Pop. The answer varies widely. Oops that's a different question. I meant how many filings does it take for Seroquel to get an MDD indication? 7? Well, maybe. Let's see we've got 4 for monotherapy, 2 for adjuctive therapy to ongoing anti-depressant therapy (like Abilify), and 1 more for maintenance. That's quite a shotgun effect. How exactly to you plan positioning for a product in MDD with this many possible outcomes?

The answer is it doesn't matter. Because regardless of the indication you still have to deal with the sedative, weight, and metabolic issues attached to your product and the class.

I wonder how many they'll bring for Generalized Anxiety Disorder (GAD) in the next couple of months. Should be interesting...

Atypical Anti-psychotic Monopoly

Perhaps it's more of a quintopoly. Since Abilify's launch in late 2002, Astrazeneca, Jansen, Eli Lilly, BMS/Otsuka, and Pfizer have had free reign over the atypical anti-psychotic market. Starting with schizophrenia but gradually expanding to bipolar disorder, autism, major depression, and generalized anxiety disorder coming soon, these products are infiltrating every corner of the mental health market in all age groups. I don't have a lot to say here, just that's interesting how the increasingly more restrictive FDA is crushing potential competition through its tenor. bifeprunox is dead. asenapine is alive and may actually get the bipolar mania label. And, Fiapta (iloperidone) is crippled by its patent life, lack of sales force, and second-line at best status in schizophrenia.

Damn it must feel good to be one of the big five.

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 :-)

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.

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.