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.

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. 

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.

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.

GlaxoSmithKline (GSK) has declared its support for the AllTrials campaign, which calls for the publication of all clinical trial results.

In addition to its existing website detailing clinical trial results, the company will now publish all the clinical study reports (CSRs) it sends, or has sent, to regulators.

The support of a leading pharmaceutical company increases the momentum of the AllTrials campaign, which is supported by the BMA, the Cochrane Collaboration, and other medical bodies.

Triggered by the ‘Tamiflugate’ controversy over the non-disclosure of clinical trial data relevant to Roche’s blockbuster antiviral, AllTrials has become a key issue for the pharmaceutical industry.

According to GSK, all clinical trials sponsored by the company are registered, and the results disclosed, on a public website that has details of 5,000 drug trials.

The company has now committed to publish all the CSRs it uses to apply for approval from regulatory bodies such as the EMA.

Each CSR will appear on GSK’s clinical trials website when the drug in question has been either approved or discontinued, and the trial data have been published.

GSK will deal with patient confidentiality issues – cited by some companies as a reason for non-disclosure of trial data – by removing patient information from the CSRs before publication.

In addition, the company has said it will publish CSRs for all of its existing approved medicines. This will require work by a dedicated team over a number of years, starting with the most prescribed drugs.

Ana Nicholls, Healthcare Analyst at The Economist Intelligence Unit, noted that GSK paid a $3bn fine in the US in 2012 after admitting that it had withheld safety data on its antidepressants. “By signing up to alltrials now, GSK takes back the moral high ground,” she commented.

An open letter to the European Medical Association (EMA) calling for all clinical trial results to be published has been signed by 53 trial participants.

The fact that half of clinical trials are withheld from publication by their industry sponsors is a “betrayal of our trust”, the letter said.

However, the ABPI argued that clinical trial results contain “commercially confidential information” whose publication could harm investment.

The letter is part of the growing campaign for an end to industry control of medical trial data, fuelled by the ‘Tamiflugate’ scandal.

A petition with 8,000 signatories, including the Cochrane Collaboration and the Medical Research Council, calls for the inclusion of all clinical trial data in a public register to be mandatory.

According to a 2010 study by the National Institute of Health Research, half of all clinical trials are never published, and those with results supporting the use of a drug are twice as likely to be published as those with negative findings.

The Commons Health Select Committee has backed the call for a legal obligation on pharmaceutical companies to share all trial data.

The letter from 53 clinical trial participants, some of whom are seriously ill, said that the right of companies and researchers to withhold results is “dangerous and expensive” and “holds backs good medicine”.

“It is a betrayal of our trust in clinical trial regulation and the trust of the families of those patients who volunteer for trials having had a terminal diagnosis,” the letter added.

The ABPI insisted, however, that trial protocols and results are “commercially confidential information” whose publication “could undermine investment in research and development of future medicines.”

The Drug Information Association (DIA), a global forum for therapeutic innovation and regulatory science, has appointed the experienced Jytte Lyngvig as its new European Director.

The new Director for DIA Europe joins from the Danish Medicines Agency, where she served as CEO.

Dr Ling Su, DIA President, said the appointment would be “a real boost” to the Agency’s European office.

The new recruit is no stranger to the DIA. She has previously worked as an advisor and recently acted as co-chair of DIA Europe’s Annual EuroMeeting.

Prior to working at the Danish Medicines Agency, Lyngvig served on the EMA Management Board as Vice-Chair for five years and as Chair of the Management Group, Heads of Medicines Agencies, for six years.

“We are all very much looking forward to working with Jytte,” added Dr Ling Su.

Jytte is expected to begin her new role on 10 January 2013.