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AbbVie guards Humira data

Published on 13/03/13 at 10:44am
Humira image

AbbVie has issued two injunctions against the European Medicines Agency to prevent the regulator revealing data about rheumatoid arthritis drug Humira.

Transparency is the mood music which backs most discussions of pharma at the moment, with companies being encouraged to make all trial data publically available.

But AbbVie objects to detailed patient data being made available to rivals, and has filed the legal actions in a bid to “protect AbbVie’s confidential and commercially-sensitive information”.

“AbbVie supports transparency of clinical research and safety information for the benefit of patients and healthcare professionals,” insisted Dirk van Eeden, AbbVie’s senior director, public affairs.

“Accordingly, AbbVie posts all of its clinical trial results on clinicaltrials.gov,” he went on. “We do not support the disclosure of CCI [commercially confidential information] that does not meaningfully contribute to the scientific review or evaluation of our products.”

UCB, thought to be one of the companies which asked the EMA for information on Humira, declined to comment. It was UCB chief executive Roch Deliveux who warned last month that pharma must resist what he called data ‘voyeurism’.

Small wonder that AbbVie wants to keep as much information about Humira private as possible: it is the driving force behind the firm, with sales of $9.3 billion last year, up 16.8% on 2011.

The rheumatoid arthritis brand has eight indications in Europe and seven in the US but its US patent expires in December 2016.

The Cochrane Collaboration has fought a highly public battle with industry to improve information access, in particular with Roche over its Tamiflu data.

It is perhaps ironic, therefore, that AbbVie is justifying its action over Humira by citing recent Cochrane analysis which found that pharma companies - rather than researchers - were behind the majority of requests for data filed with the EMA.

“This underscores our concern that commercially confidential information contained in EMA filings could be used by other companies to compete against the originator of the medicine,” concluded van Eeden.

US firm InterMune has also brought a similar case against the EMA regarding third party access to information about its lung disease drug Esbriet.
 
The EMA told Pharmafocus it could not comment further on the cases but the regulator is known to be working on exactly how it will release clinical trial data from next year.

Reports from its working parties are expected next month - however, European pharma trade body EFPIA has already said it is against what it calls ‘indiscriminate’ transparency

Last month GlaxoSmithKline became the first pharma company to support AllTrials, the group calling for clinical trials to be registered and the disclosure of their results plus clinical study reports to help improve transparency and aid research.

Ben Goldacre, whose book Bad Pharma was highly critical of what he sees as manufacturers’ undue secrecy, said GSK’s move was a ‘historic moment’.

Adam Hill

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