US biopharma company Intra-Cellular Therapies, Inc. (ITI) has appointed former NICE Chairman Professor Sir Michael Rawlins to its Board of Directors.

Rawlins’ experience in the field of drug assessment, from both clinical and economic perspectives, will be of value to ITI’s ambitious programme of drug development to treat psychiatric and neurological disorders.

As Chairman of NICE from its inception in 1999 to March 2013, Rawlins had a complex relationship with the pharmaceutical industry, which respected his expertise but sometimes challenged his priorities.

With a background in medical practice and clinical pharmacology, Rawlins recently became President of the Royal Society of Medicine, and has received numerous medical awards.

Sharon Mates, CEO of ICT, said: “We are excited to have Sir Michael Rawlins join our board. His expertise in the cost-effectiveness of new pharmaceuticals and other issues in health economics will be invaluable to Intra-Cellular Therapies.

“I look forward to working closely with Michael as we transition our clinical programs through late-stage development and commercial approval.”

Rawlins commented: “ITI has set itself on a course to develop outstanding new pharmaceuticals to treat CNS diseases, surely an ambitious task, but one in which I am pleased to join and help.”

Based in New York, ITI aims to develop drugs for the treatment of dementia and major psychiatric disorders. Its novel antipsychotic ITI-007 is currently undergoing phase II clinical trials as a treatment for schizophrenia.

Pharmaceutical companies Otsuka and Lundbeck have expanded their collaboration to include the promotion of schizophrenia drug Abilify (aripiprazole) in 14 EU countries from 1 April.

The two companies will co-promote Abilify, which is currently marketed by Otsuka, in the UK and six other European countries.

Lundbeck will promote the antipsychotic drug in Ireland and six other EU countries.

The collaboration covers all forms of Abilify that are available: three oral formulations and the rapid intramuscular injectable version.

Abilify is now the biggest-selling drug in the US, despite the limited incidence of schizophrenia (an estimated 1% of the population).

Otsuka and Lundbeck will jointly promote Abilify in Denmark, Finland, Germany, Italy, Spain, Sweden and the UK, while Lundbeck will promote it in Austria, Belgium, Ireland, the Netherlands, Poland, Portugal and Romania.

Taro Iwamoto, President of Otsuka, said: “The agreement will further strengthen the Abilify brand in Europe and also position Otsuka and Lundbeck to successfully develop and launch up to five more new products there.”

The partners are about to launch a new monthly injectable version, Abilify Maintena, in the US, and submitted it to for EMA approval in December 2012.

Ulf Wiinberg, CEO of Lundbeck, commented: “Abilify Maintena represents a treatment option for patients and their physicians and caregivers seeking an alternative long-term maintenance treatment for schizophrenia, and we are pleased to join Otsuka in launching this first product as part of our extensive global alliance.”

Aripiprazole is a partial D2 dopamine receptor agonist that has been shown to reduce the risk of relapses in people suffering from schizophrenia.

Otsuka and Lundbeck signed an agreement to collaborate in the development and promotion of drugs to treat central nervous system disorders in November 2011.

Johnson & Johnson’s incoming CEO, Alex Gorsky, could be ordered to give sworn testimony in a Risperdal lawsuit, according to US government lawyers.

J&J has declined to make Gorsky available for a deposition in the case, which concerns the alleged payment of ‘kickbacks’ to health provider Omnicare.

The US government claims that millions of dollars paid by J&J to Omnicare as ‘market share rebates’ were inducements to buy and recommend Risperdal.

J&J claims that the rebates and the promotion of Risperdal were ‘common commercial practices’ that did not violate any law.

The case forms part of J&J's ongoing struggle to defend its marketing of the antipsychotic drug in the US against claims that it exaggerated the drug’s benefits and downplayed or concealed its risks.

Risperdal (risperidone) is approved as a treatment for schizophrenia and bipolar disorder in adults and behaviour problems in young people.

The company faces a cluster of lawsuits, both civil and criminal, based on allegations that it over-promoted the drug.

The US government has claimed that from 1999 to 2004, J&J gave Omnicare “market share rebate payments conditioned on Omnicare engaging in ‘active intervention’ programs for J&J drugs,” which it provided to nursing homes.

Gorsky succeeds Bill Weldon as CEO of J&J on April 26.

While with J&J subsidiary Janssen, Gorsky “was in a position to know why J&J chose not to inform Omnicare (or members of Janssen’s own sales staff) that, in January 1999, the FDA had warned J&J that marketing Risperdal as safe and effective in the elderly would be false and misleading,” the US filing stated.

Attorney Robert D. Keeling of Sidley & Austin, representing J&J, said that “Mr Gorsky has no reasonable connection to the subject matter of the government’s complaint,” and that the request for his testimony “unnecessarily targets – and thus would unduly harass – J&J’s top executive”.

Omnicare agreed in 2009 to pay $98m to settle civil claims by the US government and various states that it accepted kickbacks from J&J, but the company did not admit liability.

Bayer HealthCare has agreed to pay an average of $220,000 per patient to settle 500 lawsuits over the safety of its birth control pills Yaz and Yasmin (drospirenone).

The German company is accused of misleading patients and clinicians about the risk of venous thromboembolism (VTE), leading to cardiovascular events, to women taking the drug.

The settlement means Bayer will pay a minimum total charge of $110m – and if rolled out across all the current lawsuits, could cost the company over $2bn.

Safety reviews of drospirenone-containing birth control pills led to FDA’s decision to include VTE risk warnings in the product labels.

Bayer is currently facing more than 11,000 lawsuits in the US alleging harm caused by the use of Yaz, Yasmin or authorised generic equivalents.

Yaz is one of Bayer’s most successful brands, earning $1.1bn in 2011.

Rosemarie Yancosek, a spokesperson for Bayer, said: “Bayer HealthCare confirms that some cases pending in the current Yaz/Yasmin litigation in the US are being settled.”

Bayer’s settlement strategy contrasts with the more defensive approach taken by Johnson & Johnson over the marketing of its antipsychotic drug Risperdal.

Johnson & Johnson has been fined $1.2bn by an Arkansas circuit court for fraudulent marketing of its antipsychotic drug Risperdal (risperidone).

The judge said the company and its US subsidiary Janssen Pharmaceuticals had lied about the drug’s benefits and risks in order to obtain Medicare reimbursement.

The fine is among the largest ever imposed in a US state fraud case involving a drug company.

J&J, which denies any improper conduct or actual harm, is calling for a retrial.

The judge, Tim Fox, fined the companies $1.19bn for nearly 240,000 violations of the state’s Medicaid fraud law and $11m for violations of its law on deceptive practices.

To date, 11 states have prosecuted J&J over its marketing of Risperdal, which is approved as a treatment for schizophrenia and bipolar disorder in adults and behaviour problems in young people.

Prosecutors have claimed that J&J inaccurately stated Risperdal to be more effective than generic alternatives, while concealing the increased risks of diabetes, stroke and weight gain associated with the drug.

Since reimbursement for Risperdal was available through the state-funded Medicaid system, J&J is accused of defrauding state authorities.

Arkansas attorney general Dustin McDaniel commented that the court’s verdict “sends a clear signal that big drug companies like Johnson & Johnson and Janssen Pharmaceuticals cannot lie to the FDA, patients and doctors in order to defraud Arkansas taxpayers”.

The fine was based on minimum penalties for each individual violation of state law through a prescription or marketing message – coming in this case to over 250,000 violations.

Janssen spokeswoman Teresa Mueller said the company would call for a retrial and, if that was denied, would appeal against the state verdict.

The court “did not show any Arkansas patient was ever harmed by using Risperdal” or “that any Arkansas physician or Arkansas Medicaid was ever misled by the drug’s label or package insert,” she asserted.

In the last year, J&J has reached a $158m settlement with Texas over the marketing of Risperdal and been fined $327m by South Carolina.

At the federal level, the company is in talks with the Justice Department to settle a misdemeanour criminal charge. However, the JoD has rejected a $1bn offer from J&J to settle all outstanding civil charges.

NHS spending on drugs fell in 2011 due to patent expiry affecting a number of major products – and 2012 will see the trend accelerate.

The NHS in England spent £8.81bn on prescription drugs in primary care last year, compared to £8.83bn in 2010, according to the NHS Information Centre.

This fall, which reflects pressure on GPs to reduce their drug budgets, contrasts with the previous trend of drug spending increasing by 3–4% each year.

Therapy areas where the NHS pharmaceutical market was strongly affected by patent expiry in 2011 include cardiovascular care and CNS disorders – while diabetes care showed a new trend towards the selection of cheaper drug classes.

Cardiovascular drugs showed the steepest drop in sales: from £1.51bn in 2010 to £1.35bn in 2011. A major factor in this was the generic erosion of the anti-platelet drug Plavix from Sanofi and BMS, revenues from which fell from £46m to £12m.

By contrast, NHS spending on Pfizer’s statin Lipitor increased by £5m to a massive £310.8m – but that blockbuster will fall over the patent cliff in May, with wholesale shifting of GPs to generic versions expected.

The NHS spent £1.95bn on drugs for CNS disorders last year, but this therapy area is facing major generic erosion due to the recent patent expiry of AstraZeneca’s antipsychotic Seroquel and Pfizer and Eisai’s Alzheimer’s drug Aricept, which between them cost the NHS £170m in 2011.

In diabetes care, growing demand and the impact of new treatments is balanced by growing cost pressure forcing a retreat to older and cheaper drugs.

On the one hand, spending on Novo Nordisk’s new injectable GLP-1 drug Victoza increased from £9.6m to £21.9m last year, while AstraZeneca’s new oral medicine Januvia saw its revenue rise from £27m to £45m.

On the other hand, NHS spending on Novo Nordisk’s fast-acting insulin NovoRapid fell from £63.4m to £62.7m last year, due to pressure from the National Prescribing Centre to switch to the cheaper isophane insulin.

The UK pharmaceutical market thus faces both generic erosion and a new trend towards the choice of drug classes that reduce costs, but may not represent the standard of care.

Teva UK has launched generic versions of AstraZeneca’s blockbuster antipsychotic Seroquel and the extended-release Seroquel XR on the first day of patent expiry.

The launch follows the decision by a UK court that the patent on Seroquel XR, extending the brand’s exclusivity, is not valid.

The new generic Quetiapine and Quetiapine (Sondate) XL were also launched on the day that AZ lost its appeal against the FDA’s decision to allow generic competition to Seroquel in the US.

Quetiapine is indicated for treatment of schizophrenia and moderate to severe manic episodes, while Quetiapine XL is indicated for treatment of schizophrenia and bipolar disorder and for adjuvant treatment of major depressive disorder in patients whose response to antidepressant monotherapy is sub-optimal.

Both generics are available on Teva’s PriceWatch service, which matches the lower of Teva’s list price and the month’s average market price.

Kim Innes, Teva UK’s Commercial Director, said: “With the launch of Quetiapine and Quetiapine XL, we’re making more medicines accessible for more people. Launches like these help towards saving the NHS over GBP9bn on generic prescriptions.”

The Seroquel brand accounted for 17% of AstraZeneca’s revenue in 2011, with sales of $5.7bn including Seroquel XR sales of $1.49bn. The Seroquel patent cliff in Europe and the US is expected to impact severely on AZ in 2012.

Teva UK is part of Israel-based Teva Pharmaceutical Industries, the world’s largest generic drug manufacturer.

AstraZeneca’s patent on an extended-release version of its blockbuster antipsychotic drug Seroquel (quetiapine) has been ruled invalid by a British court.

The patent would have given Seroquel a new lease of patent exclusivity in the face of generic competition from Teva and other companies.

The decision comes nine days after AZ’s decision to sue the FDA for allowing generic competition to Seroquel in the US.

The UK patent on Seroquel expires on 23 March 2012. The formulation patent of AZ’s extended-release version, Seroquel XR, would last until May 2017.

The Seroquel XR patent was challenged by Accord Healthcare, Intas Pharmaceuticals, Hexal and Sandoz and Teva UK, leading to a court ruling that the patent is invalid in Britain.

The company’s share value fell by half a percent in London following the verdict.

AZ filed suit against the FDA on March 13, seeking to block the agency from allowing generic competition to Seroquel in the US until December 2 2012.

Seroquel is facing patent expiry in the US from March 26, with generic versions due to be released on the same day.

The Seroquel brand accounted for $5.7bn, 17% of the company’s total revenue in 2011, with Seroquel XR sales totalling $1.49bn.

AstraZeneca is anticipating a revenue drop of more than 10% in 2012, largely due to the Seroquel patent cliff in Europe and the US.

Johnson & Johnson has agreed to pay $158 million to settle a US lawsuit brought by the state of Texas, alleging that it promoted off-label use of its antipsychotic drug Risperdal (risperidone) and misled doctors about its risks.

Witnesses stated that J&J officials concealed data indicating the drug posed a high risk of weight gain and type 2 diabetes, and that it instructed its sales force to promote the drug’s off-label prescription for minors.

The settlement is the latest chapter in the ongoing dispute over J&J’s marketing of Risperdal in the USA (for more details, click here).

The state of Texas had originally sought $579 million in damages, but the company’s payment is reported to settle the dispute – though several other states, including most recently Massachusetts, intend similar lawsuits.

In the Texas court hearing, Harvard Medical School psychiatrist Joseph Glenmullen said that a clinical trial, Study 113, found that about half of people given Risperdal developed diabetes after a year of therapy. In 2000, when the FDA investigated potential links between antipsychotics and diabetes risk, J&J did not provide the results of Study 113 and two related studies.

Earlier in the trial, the court saw an internal memo instructing J&J’s sales representatives to “flood clinics with Risperdal stuff” as part of a 2004 campaign to increase off-label prescriptions for the drug in children and adolescents.

In his final ruling, Judge Roger Couch said of the Study 113 data: “It is apparent to this court that this information was not disclosed because it did not fit the marketing department’s vision for the promotion and marketing of this drug.”

Lundbeck has launched the first sublingual treatment for bipolar 1 disorder, also known as manic depression, in the UK.

Sycrest (asenapine) is a new type of antipsychotic that stabilises manic episodes and has been shown to cause less weight gain than standard antipsychotic drugs such as olanzapine.

The launch accompanies the publication of a study showing that over three-quarters of patients taking antipsychotics suffer unwanted weight gain, and nearly half consider their medication unsatisfactory.

Bipolar disorder affects an estimated 623,000 patients in the UK, including many high-performing professionals.

In two active-controlled monotherapy trails, Sycrest was shown to be significantly more effective than olanzapine in reducing both manic and depressive symptoms over three weeks.

In a third trial, the use of Sycrest as an adjunctive therapy to lithium was shown to be more effective over 12 weeks than lithium alone in patients who did not respond well to lithium monotherapy.

In addition, patients given Sycrest experienced a mean weight gain of 1.9kg over 12 weeks, compared to 4.1kg in patients given olanzapine.

A recent Patient Insight Research study, conducted by Lundbeck in partnership with four UK mental health charities, showed that weight gain is a major issue with existing antipsychotics: of 988 patients taking antipsychotics, 78.5% said they had suffered unwanted weight gain and 44% that they considered their medication unsatisfactory.

Professor Allan Young of Imperial College and West London Mental Health Trust said: “Many bipolar patients are concerned about the side-effects of taking antipsychotics. The availability of a new treatment option is likely to be valuable in my daily practice.”

“We are pleased that people with bipolar disorder experiencing manic episodes will have the option of this new treatment, which offers hope for effective management of distressing symptoms,” commented Marjorie Wallace, Chief Executive of UK mental health charity SANE.

Based in Denmark, Lundbeck is a pharmaceutical company specialising in the treatment of central nervous system disorders.