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.

AbbVie’s Humira (adalimumab) is now available in the UK for treatment of paediatric Crohn’s disease (CD), a painful bowel disorder that can inhibit children’s growth.

The drug is licensed for treatment of patients aged six to 17 years with severe active CD who do not respond well to conventional therapies.

This new indication for a drug already used to treat arthritis and psoriasis offers the first new biological therapy for paediatric CD to gain EU approval in five years.

It also represents AbbVie’s first UK drug launch since its split from Abbott to form a stand-alone research-based biopharmaceutical company.

CD, which affects 90,000 people in the UK, is an inflammatory bowel disorder that causes severe pain and diarrhoea. In young patients, it can inhibit growth and the onset of puberty.

Conventional treatments include hospital-based injection of corticosteroids and immunomodulator drugs. Humira can be injected by children and their families outside the hospital, allowing for more flexible treatment with less disruption.

“Paediatric Crohn’s disease is a chronic bowel disease that may have a significant impact on a child or young person,” said Dr Richard Russell, Consultant Paediatric Gastroenterologist, Royal Hospital for Sick Children, Glasgow. “For patients who do not respond to standard therapies, this new treatment option addresses a significant unmet need.”

Richard Driscoll, Chief Executive of the charity Crohn’s and Colitis UK, commented: “Paediatric Crohn’s disease is known to be increasing in frequency among children and young adults of all ages. We welcome this new treatment that is being made available in the UK, as the symptoms can be very severe and have a significant debilitating effect on the child and their family.”

AbbVie separated from Abbott in early January as a manufacturer of research-based biological medicines.

The Scottish Medicines Consortium (SMC) has approved the use of RoActemra (tocilizumab) as a single therapy for rheumatoid arthritis (RA).

The Roche drug is an alternative to the standard therapy, methotrexate (MTX), which one-third of RA patients cannot tolerate.

The approval reflects the priority of helping patients to achieve remission from a chronic disease that damages the joints, leading to progressive disability.

Tocilizumab is a biological therapy: it targets specific chemical signals or receptor cells.

It has been found to offer remission rates four times better than the most prescribed alternative, adalimumab (Humira), and to offer a reduction in joint swelling and disability.

The drug is available in combination with MTX in England, but the Scottish decision represents its first approval as a monotherapy for RA.

An auto-immune disease, RA affects 646,000 people in the UK, causing disabling joint damage within a decade in 50% of cases.

Dr David Marshall, Consultant Rheumatologist at NHS Greater Glasgow & Clyde, said: “RA is a progressive disease which can lead to irreversible joint damage and disability. We need to treat patients as quickly and aggressively as possible, using the most efficacious treatments available.

“Remission in RA is achievable for many patients and this is what we should be aiming for. This news will make a real difference to the treatment of RA and to patients’ lives, who until now have had limited treatment options.”

The European Commission has approved the use of Abbott’s Humira (adalimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

The approval sees Humira become the first and only self-injectable biologic therapy for UC in adults who have failed to respond to conventional therapy.

Marco Greco, Chairman of the European Federation of Crohn’s & Ulcerative Colitis Associations, said the approval “represents an important new therapeutic option”.

Humira is already indicated for the treatment of several other inflammatory diseases. Dr John Leonard, Senior Vice President, Pharmaceuticals R&D, Abbott, says the latest indication highlights the treatment’s usefulness.

He commented: “The approval of Humira for the treatment of moderately to severely active ulcerative colitis further demonstrates Humira’s versatility in treating a wide range of immune-mediated inflammatory diseases”.

UC is a chronic inflammatory bowel disease that causes ulcers in the colon and may eventually lead to life-threatening complications. Around 1.2 million Europeans suffer with UC.

“Having one more option to treat this disease provides new hope that some patients will be able to achieve remission of their disease,” said Marco Greco.

The approval of Humira – which was first approved in the EU in 2003 for the treatment of rheumatoid arthritis – was based on two Phase III global trials including more than 800 patients.

Roche’s rheumatoid arthritis (RA) drug RoActemra has shown greater effectiveness than Abbott’s market-leading rival Humira in a phase IV clinical test.

The ADACTA head-to-head study indicated that RoActemra (tocilizumab) performed better on all primary and secondary measures of clinical efficacy than Humira (adalimumab).

The trial result will boost Roche’s attempts to win market share for RoActemra, whose sales rose to $675m last year – a long way behind Humira’s $7.9bn.

Preliminary analysis showed a similar safety profile for the two drugs.

However, the antibody RoActemra is only available via an hour-long intravenous infusion, whereas Humira and other TNF inhibitors can be administered by subcutaneous injection.

Roche is developing a subcutaneous injection version of RoActemra, which will be filed for regulatory approval later this year.

The ADACTA study showed that patients given RoActemra achieved a significantly greater reduction in disease activity after 24 weeks than those given Humira.

RoActemra also performed better on key secondary endpoints including remission and low disease activity.

The finding reflects the growing importance of phase IV (head to head) trials in a pharmaceutical market driven by value-based pricing.

Sales of anti-inflammatory drug Humira (adalimumab) helped Abbott Laboratories post strong sales and earnings growth in Q4 of 2011.

Revenues from Humira increased 15.89% to $2.18 billion and helped overall pharmaceutical sales climb 6.7% to $4.78bn in the quarter.

Miles D. White, Chairman and CEO, Abbott, said that despite “another challenging year” the company “again delivered leading performance”.

An increase in sales of Humira helped Abbott record net income of $1.62bn (+12.3%) with group sales also up 4.1% to $10.38bn.

But sales of ‘established pharmaceuticals’, which includes branded generics outside the US, dropped 4.6% to $1.39 billion. Sales of HIV drug Kaletra (lopinavir/ritonavir) were also down 15.6% to $288 million. TriCor (fenofibrate) and TriLipix (fenofibric acid) also saw revenue fall 4.3% to $409 million.

However, the news was better for prostate cancer therapy Lupron (leuprolide) which rose 4.0% to record sales of $208 million and for Synthroid (levothyroxine) which saw revenue increase by 2% to $163 million.

Abbott, which recently revealed plans to split into two separate companies, says it is now “on track” to complete the switch by the end of 2012.

A quarter of the NHS drugs spending of £4.1 billion last year went on just ten medicines, according to a new report.

IMS Health found that total prescribing costs in England, including primary care and community prescriptions, reached a record £12.86 billion in 2010, an increase of 4.8% from the previous year.

This total in English hospitals has increased by 7.7%.

The report, commissioned by the NHS, says that this growth is likely to be related to the introduction of new, more expensive treatments.

The top 10 drugs (Figure 1) were mainly biologics used to treat either autoimmune diseases or cancers.

The most expensive were two arthritis drugs, Abbott’s Humira (adalimumab), with an increase of 19% to £180.5 million, and Pfizer and Amgen’s Enbrel (etanercept), costing £179.6 million.

Novartis’ Lucentis (ranibizumab) treatment for eye disease cost £128.9 million, overtaking Roche’s breast cancer medicine Herceptin.

The report noted the difficulty in biologics, as they are unlikely to be copied and manufactured into generics, consequently costing for the NHS more for branded medication. Manufacturers are likely to make more innovative forms of existing drugs, which would also push prices up.

However, the primary care drugs bill, which takes up 66% of the £12.9 billion spending of medicines in the English NHS, is expected to decrease by £1 billion over the next four years due to a series of patent expiry dates.

NICE has recommended Simponi (golimumab) in final guidance as a treatment option for adults with active or severe ankylosing spondylitis.

Simponi has been recommended if used as described for other tumour necrosis factor (TNF) inhibitor treatments, and if MSD provides the treatment under the terms of an agreed Patient Access Scheme.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, says the treatment “demonstrated comparable clinical and cost effectiveness” to existing options.

Ankylosing spondylitis is an inflammatory disease which results in back pain and stiffness. Humira (adalimumab) and Enbrel (etanercept) are already recommended.

MSD agreed a Patient Access Scheme with the DH in which the 100mg dose of the treatment will be available to the NHS at the same cost as the 50mg version.

Professor Longson said that NICE is “pleased” to recommend another treatment for patients.

“Ankylosing spondylitis causes a great deal of pain and discomfort for individuals, impacting significantly on day-to-day life,” she said.

“It’s good news for people with this disabling condition that golimumab now joins adalimumab and etanercept as NICE-recommended treatment options for ankylosing spondylitis.”