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.

London-based pharma company Dainippon Sumitomo Pharma Europe (DSP Europe) has changed its name to Sunovion Europe.

The new name reflects the development of DSP’s European subsidiary into a more active commercial organisation, shortly to launch a new schizophrenia drug.

Sunovion Europe will focus on products to treat mental health and neurological disorders – including the atypical antipsychotic lurasidone hydrochloride, which it plans to launch in Europe shortly.

The company will also develop and market specialised drugs for disease areas where there is unmet medical need.

Lurasidone hydrochloride, a generic drug, has been submitted to the European Medicines Agency (EMA) for treatment of schizophrenia by DSP’s European partner, Takeda.

Dr Mike Taylor, Managing Director of Sunovion Europe, said: “This represents a significant landmark in the evolution of our European business as we prepare to commercialise our first drug in the UK.

“At Sunovion Europe we focus on the development and introduction of innovative medicines that improve people’s health and well-being. We will continue to focus on psychiatry and neurology, and over time will grow the European business to include other areas.”

Dainippon Sumitomo Pharma (DSP) is a multi-billion dollar company based in Japan. It was formed by the merger in 2005 of Dainippon Pharmaceutical Co. and Sumitomo Pharmaceuticals Co.

With a growing product portfolio and pipeline, DSP aims to become a major supplier of innovative treatments in psychiatry, neurology and oncology.

Vanda Pharmaceuticals has withdrawn its application for a central marketing authorisation with the EMA for its schizophrenia drug Fanaptum (iloperidone).

The company decided to withdraw its application after it was unable to supply data requested by the EMA within a set timeframe. 

The application was originally submitted by Vanda to the EMA in June 2011. But in December 2012, the Agency’s Committee for Medicinal Products for Human Use (CHMP) failed to recommend Fanaptum for marketing authorisation.

Last month, Vanda requested that the EMA re-examine the recommendation. However, the company stated that the missing data, which the CHMP identified during its recommendation, would not be available within the timeframe acceptable in the centralised procedure. 

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.

New innovations from ten of the world’s leading drug companies will compete for the most prestigious distinction in pharmaceutical research later this year – a globally revered Prix Galien medal.

Twelve medicines have made the shortlist for the final of UK Prix Galien, which will return to the House of Commons this coming September.

The shortlist reflects the strength and diversity of pharmaceutical innovation, with treatments for a broad range of disease areas set to be assessed by Prix Galien’s esteemed judging panel – led by NICE Chairman Professor Sir Michael Rawlins. Medicines developed to treat schizophrenia, hepatitis C, MS, DVT, constipation, coronary disease and a variety of cancers will battle it out for the Innovative Drug Award. A treatment for the rare bone cancer in adolescents, osteosarcoma, will be considered for the Orphan Drug Award. All shortlisted products were launched or granted a new indication in the UK between 1 January 2010 and March 31 2012.

The 2012 ceremony comes at a time when the value of medical innovation finds itself under great scrutiny in the UK. The Innovation Health and Wealth Review, published at the end of 2011, outlined the growing need to accelerate the adoption and diffusion of innovation in the NHS – setting out a blueprint designed to ensure innovations that can improve health outcomes actually reach their target patients.

“The challenge for the UK pharmaceutical industry is to demonstrate that its medicines truly add value, and can help the NHS meet its quality and productivity goals. The ethos of Prix Galien is very much aligned with the aspirations of both QIPP and Innovation Health and Wealth. It provides the perfect platform for the UK industry to promote its position as world leaders in pharmaceutical research and development,” says Karen Westaway, Joint Chief Executive at WG Consulting, which has owned the UK Prix Galien franchise for eight years and managed the process since 1996.

UK Prix Galien takes place every two years and is judged by a highly respected panel of influential, eminent and experienced NHS professionals. Alongside Professor Sir Michael Rawlins, the judging team includes experts such as Professor Dame Carol Black, Professor Parveen Kumar, Professor Gordon Duff and the current National Cancer Director, Professor Sir Michael Richards.

“The judges are all high-achieving, influential stakeholders who have shaped, and are still shaping, healthcare,” says Karen Westaway. “Their continued commitment to Prix Galien is itself an endorsement of the process.”

UK Prix Galien 2012

The 2012 ceremony will take place on Wednesday 26 September at the House of Commons, London. The Rt. Hon. Kevin Barron, MP, a former shadow health minister and chair of several all-party parliamentary groups including those relating to the pharmaceutical industry and health, takes over from Lord Walton of Detchant as the Parliamentary Sponsor. Current Secretary of State for Health, Andrew Lansley, is a long-standing supporter of UK Prix Galien and was the Parliamentary Sponsor for many years. The Health Secretary presented the most recent UK Prix Galien awards in 2010, describing them as a ‘fascinating occasion’ that allows people to acknowledge ‘the volume of innovation and new medicines that have been coming through.’

The 2010 Prix Galien medal for innovation was won by Xarelto (rivaroxaban), Bayer Healthcare’s revolutionary treatment for the prevention of venous thromboemolism (VTE). Shire Pharmaceuticals’ Firazyr (icatibant), a treatment for hereditary angioedema, won the Orphan Drug Award.

Prix Galien around the world

Prix Galien is internationally renowned, with a further ten national franchises conducting ceremonies around the globe, as well as an International Prix Galien every two years. The award has been described as ‘the highest distinction which may honour a pharmaceutical product’, and ‘a prestigious testimony and acknowledgement of the vitality of our pharmaceutical research.’ In 2008, US President Barack Obama said: “The Prix Galien is a welcome initiative to stimulate creative research and promote excellence.”

For more information about UK Prix Galien, please visit www.prixgalien.co.uk

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.

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.

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.

Regulators have issued warnings that thousands of packets of Nurofen Plus could have been mixed up with anti-psychotic drug, Seroquel XL.

The Medicines and Healthcare products Regulatory Agency (MHRA) issued the alert after three packets of Nurofen Plus were found containing individual blister packs of Seroquel XL in branches of Boots in the Victoria, Beckenham and Bromley areas of London.

The MHRA decided not to recall thousands of batches of the 32-tablet packs, but to urge “extra vigilance” to consumers, as the affected packets could be in pharmacies across the UK.

Nurofen Plus’ manufacturer, Reckitt Benckiser said “serious investigations” were underway to establish how the mix-up occurred, as Seroquel XL is manufactured by another drug firm, AstraZeneca.

A number of theories have been offered, but the drug makers are not believed to be at fault. The first suggestion hinted a simple mix-up at a wholesaler, but neither company is ruling out sabotage at this time.

Siân Boisseau, Director of Virgo Health, a public relations firm which represents Reckitt Benckiser, told the Guardian that there has been a “suggestion that the packets were deliberately put in the wrong boxes”.

The two drugs are very different. Reckitt Benckiser’s Nurofen Plus is one of the most popular brands of painkiller, whereas Seroquel XL by AstraZeneca is a prescribed anti-psychotic medicine to treat several disorders, such as schizophrenia, mania and bipolar depression.

People who accidentally take Seroquel XL may experience drowsiness and are advised to not drive or operate any tools or machinery until they know how the tablets have affected them. Other side effects include dizziness and headache.

The large capsules of Seroquel XL 50mg have gold and black packaging while the Nurofen Plus tablets are smaller and have silver and black packaging.

Ian Holloway from the MHRA's Defective Medicines Report Centre (DMRC), said: “People should check to see if they have any affected packets of Nurofen Plus. If you do, return them to the pharmacy where you bought them from”.

“If you have taken a tablet and you have any questions, speak to your GP,” he added.

A statement from AstraZeneca said: “Patient safety is the primary concern of AstraZeneca and the company is taking this issue seriously. AstraZeneca is collaborating with the MHRA and Reckitt Benckiser to investigate the root cause.”

Janssen-Cilag’s antipsychotic Xeplion (paliperidone palmitate) has received approval from the European Commission for the treatment of schizophrenia.

Xeplion is given as a once-monthly injection and has been proven to control symptoms and delay relapse in patients with schizophrenia in four controlled studies.

The drug is indicated as a maintenance treatment in adult patients stabilised with paliperidone or risperidone.

Prevention of future relapses is a crucial goal of schizophrenia therapy and patients who are non-adherent to medication are up to five times more likely to relapse than those patients who continue on medication.

It is hoped that as a long-acting, once-monthly treatment, Xeplion will help to improve medication adherence.

Professor Fernando Cañas, Head of Department of Psychiatry, Hospital Dr Rodríguez Lafora, Madrid, said: “Long-acting injectable antipsychotics such as Xeplion can help patients to maintain continual treatment, thereby reducing the likelihood of relapse. This is imperative not only to reduce the suffering and cost burden associated with relapse in schizophrenia, but to improve the future outlook and overall quality of life for these patients.”

In a longer-term, flexible-dose study involving 849 patients, just 10% of patients treated with Xeplion experienced a relapse compared to 34% of those taking a placebo.

“Xeplion provides healthcare professionals with the opportunity to rethink their overall approach to how they treat schizophrenia by using long-acting therapies,” said Dr Christophe Tessier, Medical Affairs Director, Psychiatry, Janssen EMEA.

“As a once-monthly injection, Xeplion can help healthcare professionals address the issue of non-adherence to medication thus ensuring symptom control and allowing patients to focus on shaping their lives.”