1 Boring Old Man

Ark. judge says no new trial in J&J Risperdal case
The Associated Press
June 20, 2012

^{An Arkansas judge has denied a request for a new trial after he fined Johnson & Johnson and a subsidiary $1.2 billion for downplaying and concealing risks associated with the antipsychotic drug Risperdal. Judge Tim Fox ruled earlier this year that Janssen Pharmaceuticals Inc. and its parent company would have to pay $5,000 for each of the nearly 240,000 Risperdal prescriptions issued to state Medicaid patients over a 3 1/2-year period in addition to other fines. Fox this week denied the new trial request. Janssen attorney James Simpson did not respond to a phone or email message. A spokesman for Attorney General Dustin McDaniel says they’re grateful for the judge’s ruling, which upholds the verdicts of a Pulaski County jury.}

J&J reportedly close to Risperdal settlement
Reuters
June 20, 2012

^{Johnson & Johnson is close to reaching a settlement with the U.S. Justice Department over allegations it promoted anti psychotic drug Risperdal for unapproved uses that could cost the health care conglomerate at least $1.5 billion, the Wall Street Journal reported on Wednesday. The report, citing anonymous sources familiar with the matter, said the sides are discussing a deal of between $1.5 billion and $1.7 billion that could be completed in a few weeks. It also said the final amount could exceed $2 billion.}

J&J set out to turn a middle-weight antipsychotic into a widely indicated drug across the psychiatric spectrum – and succeeded. While the risk benefit profile of the drug was not dis-similar to the previous generation of antipsychotics, that was not true for the other ways the drug was being used. It appears that J&J was well aware that they were promoting a potent and toxic drug as benign. So there’s nothing frivolous about these suits and the large settlements. At issue – why are the people behind this conscious, active, and damaging scenario able to simply pass the costs on to the J&J stockholders without loss of personal gain or criminal liability?

Research and Markets: R&D Trends: Autism Spectrum Disorders – Pipeline Growth Reflects Increasing Interest in Autism
Business Wire
June 25, 2012

^{Research and Markets [http://www.researchandmarkets.com/research/vlhmzc/randd_trends_auti] has announced the addition of the "R&D Trends: Autism Spectrum Disorders – Pipeline Growth Reflects Increasing Interest in Autism" report to their offering. This report reviews the key trends in the autism spectrum disorders pipeline. The analysis is intended to support R&D decision-making by evaluating the dynamics of the pipeline and hypothesizing future treatments of autism spectrum disorders. The autism spectrum disorders [ASDs] market is a challenging one to penetrate; since 2006 only two products have been successful in entering this marketplace: Risperdal [risperidone; Johnson&Johnson] and Abilify [aripiprazole; Bristol-Myers Squibb]. However, as additional agents near the market, increasing interest in ASDs has led to a sizable growth in the clinical pipeline.}

^Scope

^{– Overview of drugs in late- and early-stage clinical development for autism spectrum disorders.}
^{– Identification of the target product profile for future autism spectrum disorders treatments.}
^{– Summary of clinical trial design in autism spectrum disorders including exploration of key endpoints and assessment methodology.}
^{– Identification of key challenges associated with the conduct of clinical trials in autism spectrum disorders.}
^{– Exploration of future treatment in autism spectrum disorders including the development of personalized treatments and the use of biomarkers.}

^Highlights

^{– The autism spectrum disorders (ASDs) pipeline remains sparse relative to other conditions that are treated with psychotropic medications. The unknown etiology of ASDs poses a fundamental challenge to the therapeutic discovery process. However, the pipeline growth is encouraging and reflects an increased interest in ASDs.}
^{– The two approved therapies for the management of autism spectrum disorders both target the symptoms of irritability. The comparator therapy identified by Datamonitor is Risperdal (risperidone; Johnson & Johnson) as it was the first to be approved in this indication, demonstrates a strong efficacy profile, and is regarded as a first-line therapy.}
^{– Key challenges associated with the conduct of clinical trials in autism spectrum disorders are: the unknown etiology of the disorders and heterogeneous symptomology. Communication and language impairments commonly associated with autism spectrum disorders further compound these challenges}

^{Questions examined include:}

^{– How many drugs are in clinical development for the treatment of autism spectrum disorders? What deters companies from investing in this area?}

^{– What symptoms and mechanisms of action are most frequently targeted? What key companies are involved in the pipeline?}

^{– What is the target product profile and most appropriate comparator therapy?}

^{– What are the key challenges in conducting clinical trials in autism spectrum disorders?}

^{– How is the treatment of autism spectrum disorders likely to evolve over the next 10 to 20 years?}

^{Companies Mentioned Include:}

^{– Celgene Corporation
– Commerzbank AG
– Forest Laboratories Inc.
– GlaxoSmithKline Plc
– Hutchison 3G UK Limited
– Informa plc
– Janssen Pharmaceuticals Inc.
– LVMH Moet Hennessy Louis Vuitton SA
– Wolters Kluwer nv}