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Double win for J&J's schizophrenia franchise

Pharma company wins appeal against $1.2bn fine and Risperdal follow-up proves itself in trial
Risperdal - Johnson & Johnson

Johnson & Johnson (J&J) will not have to pay a $1.2bn penalty for alleged mis-selling of its schizophrenia drug Risperdal in the US, according to a court ruling.

Added to that, the pharma company has just stopped a trial of its three-monthly formulation of Risperdal (risperidone) follow-up paliperidone palmitate on positive results, setting up a filing later this year.

The news is a massive boost to J&J's schizophrenia franchise, which collectively added more than $3bn to its $28.1bn pharmaceutical turnover last year, although Risperdal's sales are only a fraction of that since its patent expired a few years ago. Its share of the franchise has now largely replaced by longer-acting follow-up Risperdal Consta.

Two years ago, a $1.2bn fine was levied on J&J and its Janssen Pharma unit after a jury in Little Rock, Arkansas, found the company guilty of mis-marketing Risperdal and defrauding the state's Medicare system by claiming in letters to doctors that it had a superior side-effect profile to other drugs in the atypical antipsychotic class.

On appeal, the Arkansas Supreme Court has tossed out one of the lower court's judgments on the grounds that the wrong law had been used in the prosecution of the case, and J&J's legal position had been prejudiced by the admission into evidence of an FDA warning letter focusing on the use of Risperdal.

The Supreme Court Judge, Justice Karen Baker, has also sent a deceptive trade practices complaint back to the lower court for reconsideration.

The net effect is that the $1.2bn fine - plus a little over $180m in legal fee awards - has been stopped in its tracks. Other cases, including a $327m judgment against the company in South Carolina, are still working through the appeals process, while J&J successfully overturned a $330m penalty in Louisiana earlier this year.

Last year, J&J agreed to pay $2bn to settle Risperdal mis-selling charges brought by the US Department of Justice (DoJ) and pleaded guilty to a single misdemeanour violation.

Three-monthly paliperidone

Meanwhile, J&J could have another new schizophrenia therapy on its hands next year if it manages to secure approval of the three-monthly paliperidone product.

Paliperidone is already on the market as Invega and in a one-month depot formulation known as Invega Sustenna, but a formulation that provides three months' cover would give it a leg-up in the market over competitors such as Lilly's Zypadhera (olanzapine) and Lundbeck's Abilify Maintena (aripiprazole), which has just been introduced in Europe.

J&J said yesterday the phase III trial of the long-acting version had been stopped after it became apparent that it achieved a significant difference compared to placebo on the primary objective of lengthening the time to first schizophrenia relapse in patients initially stabilised using Invega Sustenna.

The decision was taken at an interim analysis prompted when 60 per cent of the 500 or so patients in the study had relapsed.

"We are really excited about this news because a medication's ability to delay time to relapse in schizophrenia has significant clinical and societal implications,” said J&J's neuroscience R&D head Husseini Manji.

Article by
Phil Taylor

21st March 2014

From: Research, Sales, Marketing, Regulatory



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