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.

Eli Lilly's long-acting Zyprexa short-lived

The FDA issued a non-approvable letter for the long-acting injectable version of Zyprexa due to concerns over excessive sedation. That won't do much to stem Zyprexa's hemorrhaging market share. Guess that's just a little less milk for this cash cow.

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.