The European Medicines Agency (EMA) has been told to accept the gagging orders of two US pharma companies pending a decision by the EU General Court.

Legal challenges by AbbVie and InterMune to the EMA’s policy of publishing clinical trial data relevant to its drug assessments must be accepted until a final judgement is made, the court said.

The US companies’ action contrasts with the growing trend in European pharma, with GSK and Roche both pledging to improve their clinical trial data transparency.

In accordance with a policy declared in 2010, the EMA is granting access to all clinical and non-clinical information (including clinical study reports) submitted by companies in their applications for marketing authorisation.

This is the first time that its policy of full disclosure of clinical trial data following the authorisation decision has been legally challenged.

The EMA is considering whether to appeal the interim decision that the AbbVie and InterMune clinical trial data cannot be made public. It has stated the need for clinical data transparency to enable scrutiny of its recommendations.

Since the filing of the two legal challenges in March, the EMA has received statements of support from the European Ombudsman, national competent authorities, members of the European Parliament, academic institutions and scientific journals.

The Agency will continue to draft its policy on clinical trial data.

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.

Janssen has submitted a Marketing Authorisation Application to the EMA for the approval of a fixed-dose therapy which would combine canagliflozin and immediate release metformin for the treatment of type 2 diabetes.

Canagliflozin is an investigational, oral medication for adult patients which blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels.

Metformin is a first-line pharmacotherapy which is used either alone or in combination with other medications, including insulin, to treat type 2 diabetes.

When combined, the fixed-dose therapy may offer adult patients a convenient medication in a single pill.

Janssen submitted a similar application to the US FDA for canagliflozin on 31 May 2012 and for a fixed-dose therapy combining canagliflozin and immediate release metformin on 12 December 2012.

AbbVie is seeking a legal injunction to block the European Medicines Agency (EMA) from publishing clinical trial data relating to its rheumatoid arthritis drug Humira.

The biopharmaceutical company claims that publishing the trial data would violate both commercial confidentiality and patient confidentiality.

AbbVie’s position contrasts with that of GSK, which has committed to publishing all its future and past clinical trial data, and shows that the pharma industry is becoming polarised on this issue.

The EMA has committed to publish all clinical trial data once a drug has completed marketing authorisation from the start of 2014.

The AllTrials ‘open data’ movement, which GSK now supports, has been driven by medical authorities including the Cochrane Collaboration and the BMA.

The AllTrials position is that secrecy around clinical trial data rewards dishonesty in the planning and reporting of trials, and that transparency is in the interests of all patients and all honest pharma companies.

AbbVie, which recently split off from Abbott, has the support of the European Federation of Pharmaceutical Industries and Associations (EFPIA) in seeking to protect clinical trial data as ‘confidential’.

By preventing the EMA from publishing the clinical trial data relating to Humira (adalimumab), AbbVie seeks to ensure its own right to select which data are available to prescribers and patients.

Sanofi’s new paediatric six-in-one vaccine, the first in liquid form, has been recommended by the European Medicines Agency (EMA).

The new vaccine will be marketed as Hexyon by Sanofi Pasteur MSD in western Europe and as Hexacima by Sanofi Pasteur in eastern Europe.

It confers protection against pertussis (whooping cough), hepatitis B, diphtheria, poliomyelitis, tetanus and the HIB bacterium.

GSK’s Infanrix Hexa is currently the only six-in-one child vaccine on the market, with global revenues of £775m last year.

The EMA’s approval of Sanofi’s previous vaccine, Hexavac, was withdrawn after its effectiveness in protecting against hepatitis B was questioned.

According to Sanofi Pasteur, Hexyon has “a similar high immunogenicity profile for all antigens” to Infanrix Hexa, while its liquid formulation makes it more convenient for injection.

It will be used for primary and booster vaccination of infants aged six weeks to 24 months.

Jean-Paul Kress, President of Sanofi Pasteur MSD, said the recommendation “validates the clinical data supporting the vaccine’s effective and safe use for infants. Furthermore, its unique ready-to-use formulation will provide healthcare professionals with a simpler, more convenient vaccination process."

Olivier Charmeil, the head of Sanofi Pasteur, predicted the new vaccine would be a “key growth driver” for the company in 2013.

The European Organisation for Rare Diseases (EURORDIS) has given its annual Company Award for medical innovation in rare diseases to Celgene.

The award recognises the biotech firm’s leading position in the treatment of orphan diseases, as well as its dialogue with patient groups.

Celgene has 17 orphan drug designations from the EMA, including products to treat types of leukaemia and myeloma, and is currently developing products to treat 45 rare diseases.

Orphan diseases are defined by the EMA as conditions affecting no more than five per 10,000 people. ‘Orphan drugs’ developed to treat them have a special regulatory status.

EURORDIS is the largest European patient organisation in the field of rare diseases. Its awards recognise outstanding contributions by companies, researchers and others to reducing the impact of rare diseases on people’s lives.

“We are honoured to receive the EURORDIS Company Award for our work in rare diseases, which is a testament to the strong partnerships we have throughout Europe with the people focused on treatment options for some of the most difficult-to-study and difficult-to-treat conditions,” said Stefano Portolano, Celgene’s Vice President for Haematology, Europe.

“In the nearly 13 years since the Orphan Drug Regulation was enacted, there has been growing recognition of the need for treatments for rare diseases that help patients live longer and higher quality lives. Celgene is proud to be recognised for its contributions in this area.”

Yann Le Cam, CEO of EURORDIS, commented: “We are proud that the rare disease community is becoming a model for multi-stakeholder partnership and international collaboration as well as for solidarity and unity throughout Europe.”

Celgene Corporation, based in the US with a European subsidiary based in Switzerland, specialises in developing drugs to treat cancer and inflammatory diseases through gene and protein regulation.

The Scottish Medicines Consortium (SMC) has accepted Eliquis (apixaban) for prevention of strokes in patients with atrial fibrillation (AF).

The drug, produced by Pfizer and Bristol-Myers Squibb (BMS), has also been provisionally recommended by NICE.

Its use in Scotland with AF patients over 40 is predicted to prevent nearly 1,000 strokes and over 300 deaths per year.

Following its EMA approval in November 2012, the SMC has accepted Eliquis for prevention of strokes in patients with non-valvular AF who have one or more risk factors (e.g. hypertension, diabetes).

Based on recent clinical trials, the SMC said Eliquis was superior to warfarin in preventing strokes and was associated with fewer major bleeds.

It also requires no monitoring and dosage adjustment, thus reducing the cost of treatment and avoiding the risks associated with poor monitoring.

AF affects over 60,000 people in Scotland over the age of 40. It causes a fivefold increase in stroke risk, resulting in 7% of all strokes. Strokes due to AF are more severe, and more likely to recur, than strokes with other causes.

Difficulties in setting the dosage of warfarin, the standard anticoagulant, mean that fewer than half of Scottish AF patients at high risk of stroke are receiving it.

Dr Derek Connelly, Consultant Cardiologist at the Royal Infirmary, Glasgow, said: “The SMC acceptance of apixaban is an important step forward for patients with atrial fibrillation in Scotland. The availability of a new treatment option that does not require [clotting time] monitoring may help decrease the impact atrial fibrillation has on the quality of life of patients, their families and carers.”

According to Amadou Diarra, BMS General Manager, UK and Ireland, the risk of stroke in patients with non-valvular AF is “a serious public health concern” that Eliquis can help to address.

NICE has provisionally recommended Eliquis in the same indication, with final guidance expected shortly.

The alliance between BMS and Pfizer to develop drugs against cardiovascular disease began in 2007.

A pill that inhibits binge drinking has gained approval from the European Medicines Agency (EMA) for marketing in the EU.

Selincro (nalmefine) from Lundbeck blocks pleasure centres in the brain, and has reduced regular alcohol intake by 79% in a year-long clinical trial.

This is the first drug to reduce alcohol intake without abstinence: social drinking remains possible without ill effects.

Lundbeck plans to target Europe with the drug – starting with Russia in the first half of 2013.

The EMA has approved Selincro as a treatment for men who drink more than 60g (12 units), and women who drink more than 40g (eight units) of alcohol a day – eight units is one bottle of wine.

The drug is taken an hour before drinking commences. It attaches to opiate receptors in the brain, blocking pleasure signals and undermining the mechanism of alcohol dependency.

According to the EMA, it should be used together with “support that focuses on treatment adherence and reducing alcohol consumption”.

In a phase 3 clinical trial, alcohol consumption in alcoholic patients fell from 75g per day (average) to 16g per day after a year of treatment, while the side effects (insomnia and nausea) decreased with time.

Alcohol consumption in Europe is 40% higher than in the US and twice the global average. If the drug is successful in Europe, Lundbeck will seek approval for it in the US and elsewhere.

An analyst at Jefferies International in London predicted that peak sales of Selincro could pass €200 million.

Alcohol abuse is a major risk factor for mental illness, liver disease, heart disease and cancer.

An established blood cancer drug is now available in a subcutaneous form, cutting the administration time from two hours to five minutes.

The subcutaneous (SC) form of Roche’s MabThera (rituximab), used to treat non-Hodgkin lymphoma (NHL), could improve patient experience while freeing up time in chemotherapy suites.

MabThera SC uses a new biological technology from Halozyme that locally and reversibly breaks down sub-skin tissues.

The SABRINA phase III trial compared the effects of MabThera SC and MabThera IV in patients with previously untreated follicular lymphoma.

It proved the non-inferiority of MabThera SC, with an objective response rate (proportion of patients whose cancer shrinks by over 50%) of 90.5% for SC and 84.4% for IV.

Roche has applied to the European Medicines Authority (EMA) for an updated licence to allow NHL patients in the UK to receive MabThera SC.

MabThera IV is the standard treatment for NHL. In MabThera SC the drug is combined with the human enzyme hyaluronidase, which temporarily increases the penetrability of the tissue layer under the skin, allowing rapid absorption.

Dr Andrew Davies, Consultant in Medical Oncology at the University of Southampton, said: “This is a new formulation of a drug we are very familiar with and have been using for many years. In Southampton, we have observed a high degree of patient preference and satisfaction with this new formulation of rituximab.”

NHL is one of the most common cancers in elderly people; over 12,200 people are diagnosed with it each year in the UK.

Halozyme has four technology partnerships involving the use of hyaluronidase to facilitate SC injections. Its partnership with Roche has also produced an SC version of Herceptin.

The company’s other partnerships to exploit this technology are with Baxter Healthcare, ViroPharma and Intrexon.

The public row over Tamiflu has intensified with the rejection by the Cochrane group of Roche’s offer of an “advisory board” to discuss the issue.

Roche suggested that the “debate” over its non-disclosure of trial data on the antiviral be resolved through joint discussion of what kind of analysis public health studies require.

The Cochrane Collaboration, Europe’s leading drug appraisal authority, rejected the implied criticism of its methods and insisted that Roche honour its 2009 promise to publish the data.

Tamiflu (oseltamivir) neared £3 billion sales worldwide in 2009, allegedly due to Roche telling governments that it was about to publish trial data proving its effectiveness in combating ‘swine flu’.

Roche has still not released most of the data, citing lack of confidentiality as the reason. The available data are described by the Cochrane group as not supporting the drug’s widespread use.

Weeks ago, the BMJ published an ‘open letter’ to Roche insisting that it should publish the trial data or be disgraced in the medical world.

Editor-in-chief Fiona Godlee said that “billions of pounds of public money” had been spent on Tamiflu, but the evidence of its value “remains hidden from appropriate and necessary independent scrutiny”.

Peter Gøtzsche, head of the Nordic Cochrane Centre in Copenhagen, argued that doctors should boycott Roche’s products until it published the missing data.

Don MacLean, Roche’s lifecycle leader for Tamiflu, wrote to the Cochrane group, offering to construct an expert advisory board with their input “to agree on a statistical analysis plan outlining the types of analyses that would be useful in a public health discussion on Tamiflu.”

MacLean argued that this proposal “is a sensible, fair and transparent way of addressing this public debate” and ensuring the need for transparency is balanced with the need to respect commercial sensitivity.

The Cochrane Collaboration responded: “We have requested these data numerous times and have yet to receive a single full study report from Roche.

“There is no debate nor can there be any debate about the data whilst you do not honour your promise.”

It rejected the implicit criticism of its study methods: “Given the same methods and analyses have now been applied to over 5000 reviews in the Cochrane Library, what are your disagreements?”

With the European Medicines Agency moving towards an ‘open data’ policy, the pharma industry is under increasing pressure to be more transparent.