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 In other words, uptake of Invega is still a trickle and whoever was handling payor negotiations has probably been replaced by now.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...
Tuesday, October 16, 2007
JNJ Invigorating Invega?
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Have you seen this?
"Invega, the new atypical antipsychotic from Johnson & Johnson subsidiary Janssen-Cilag and follow-up to its blockbuster Risperdal is beginning to distinguish itself from both Risperdal, and from rival antipsychotics such as AstraZeneca’s Seroquel, according to research presented at psychiatry meetings on both sides of the Atlantic.
Schizophrenic patients treated using Invega (paliperidone) are much less likely to show weight gain than those treated with either Risperdal (risperidone) or Seroquel (quetiapine), says Dr Zafar Sharif, Columbia University College of Physicians and Surgeons, New York, USA. He believes that Invega’s extended-release delivery (via the osmotic delivery system developed by Alza Corp) smoothes peaks and troughs in plasma drug levels, leading to less histamine antagonism and therefore less weight gain.
According to data presented by Dr Sharif, only 8% of Invega-treated patients show a more than 7% increase in body weight, compared with 19% for risperidone and 23% for Seroquel. His colleague Dr Prakash Masand, Duke University Medical Centre, Durham, NC, USA, told a briefing held this week in Vienna, Austria (where both clinicians are attending the European College of Neuropsychopharmacology meeting) that weight gain is the leading reason for schizophrenic patients stopping antipsychotic medications.
In the USA, data from a placebo-controlled, double-blind study presented at the 20thAnnual US Psychiatric and Mental Health Congress, Orlando, Florida (Canuso C et al) showed significantly greater efficacy for Invega versus Seroquel (Positive and Negative Syndrome Scale, PANSS).
Dr David Walling of the Collaborative Neuroscience Network, UK, told the Vienna briefing that studies of Invega in other indications were now well advanced. Data from recently completed studies of Invega in bipolar disorder were currently ‘in house’ with J&J and should be available “within months”. Studies were also progressing of Invega in schizoaffective disorder “If these prove positive, it will be first time we will have a medication for schizoaffective disorder in the US – at the moment all treatment for schizoaffective disorder is off-label,” he said."
Do you really think it is possible that Invega has lower incidence of weight gain than other atypicals? If this is really true, don't you think that Seroquel, the cure for all that ails you, might be ripped off its market share horse?
Natalie,
You asked "Do you really think it is possible that Invega has lower incidence of weight gain than other atypicals? If this is really true, don't you think that Seroquel, the cure for all that ails you, might be ripped off its market share horse?"
To your first question, no. I would believe it has a better weight issues than Risperdal. It could be the same or better than Seroquel. It won't be better than Abilify or Geodon. And, of course it's better than Zyprexa.
To your second question, not a chance. Invega's use is heavily weighted towards schiz. pts. Seroquel's is largely not schiz. In fact, it's largely not on label at all. Psychiatrists use it in so many cocktails, and PCP's feel comfortable prescribing it too. The Seroquel sleep effect is very desirable across so many psychiatric dosorders. Seroquel's market share is safe until at least mid next year until Risperdal goes generic then all bets are off.
Thanks for your comment and the data.
Do you think they will try bifeprunox again? the Invega injectable is going to flood inpatient psych wards. Currently, Haldol and Geodon are most used, and if Clozaril came in intramuscular form, that would be the all time rx for outpatient settings and inpatient. That is guaranteed, and I want to know why Clozaril hasn't been shifted into the injectable form? to most ppl's surprise, Clozaril is used quite a lot in hospitals and out patient settings.
stephany,
The hospital market, like the payer area, is not really my forte, but I'll try. I don't think a Clozaril IM is a slam-dunk winner in the hospital. Hospital-based docs have lots of experience with Clozaril and its side effect profile. Any of the newer atypical IM's is probably safer from a side effect perspective (i.e. Abilify, Geodon, or Zyprexa). However, anytime an IM is used, physicians are looking for immediate efficacy and probably sedation is an important part of that efficacy. So, haldol is always a good bet. With all this competition, which manufacturer is going to pick up generic clozapine and take the time to re-formulate it into an IM for one time use. The real money in atypicals is to be made through conversion. That is, if you get a Geodon IM in the hospital, then Pfizer would like it very much if you just continue on Geodon once the patient is returned to the community. This is easier said than done, but it's the goal, and you can't achieve this with Clozapine. Thanks for your comment.
Oh, you asked about bifeprunox. I really have a hard time envisioning this product coming to market at this point. It's a shame. I know Wyeth was counting on it. I'm sure BMS/Otsuka and Pfizer are counting their lucky stars because it had potential to take share from both. Maybe I should do a pipeline note...
Hi, thanks for responding and I forgot I asked the questions!
Re: IM Clozaril, there is a market for it for long term care use out patient. It's commonly used, that may surprise people, and I'm positive that when ppl have mental health court orders to take meds[yes those orders do and can happen]the long term [say an injection that stays in the system 3-4 weeks]injection would be used in that regard. I'm not saying I agree with that out patient forced medication use, but it's there.
Also, re: Haldol, take a look into the Stanley Foundation Haldol under the skin disk. Just for those purposes.
The world of antipsychotic medication is a different one in hospital/court settings, and one that needs to be taken seriously.
Re: Bife..well it appears from what I've read not to have any more benefit than anything else out there, except for marketing possibilities.
Re: not posting until receiving comments? I think more information here, if you have it, will boost your blog.
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