AbbVie, InterMune Sue to Block Clinical-Trial Data Release

AbbVie Inc., the drugmaker that was split off from Abbott Laboratories at the start of this year, and biotechnology company InterMune Inc. sued the European Union’s pharmaceuticals regulator in a bid to block publication of clinical-trial data.

AbbVie filed two lawsuits against the European Medicines Agency at the European Union General Court in Luxembourg “seeking to protect AbbVie’s confidential and commercially sensitive information,” the company said in an e-mailed statement today. InterMune said it’s challenging a separate EMA decision to let a competitor see information concerning its Esbriet lung remedy.

The EU regulator promised in 2010 to bolster its transparency by disclosing -- on demand -- clinical trial data for every drug reviewed. Drug safety activists pressed for the move amid concerns over suicide risks linked to Sanofi’s failed diet pill Acomplia.

AbbVie, based in North Chicago, Illinois, said while it supports transparency of clinical research and safety information “for the benefit of patients and healthcare professionals,” it opposes the publication of information “that does not meaningfully contribute to the scientific review or evaluation of our products.”

‘Commercially Confidential’

Jim Goff, a spokesman for InterMune, said the Brisbane, California-based company is challenging the EMA’s decision “to disclose to a competitor parts of documents” in its application for a marketing authorization for Esbriet. “We consider this information to be commercially confidential.”

Esbriet is a treatment for idiopathic pulmonary fibrosis, or IPF, a rare disease that causes unexplained scarring in the lungs and makes it hard for patients to breathe.

While the company agrees that “as much information about medicinal products as practicable” should be given to the public, the disclosure of certain data could harm a company’s commercial interests, Goff said.

The EMA will “await the outcome” of the cases, Monika Benstetter, a spokeswoman for the London-based regulator, said in an interview. “At the moment we continue with our policies until the court rules otherwise.”

An advisory group is expected to present a plan to the EU agency in April about how to publish clinical trial data and a policy should be drafted by mid-year, she said.

The AbbVie lawsuits were filed in January and Brisbane, California-based InterMune’s case was filed in February, according to the EU court’s website.

The Financial Times reported earlier that AbbVie was suing the EMA.

The cases are: T-29/13 Pending Case, AbbVie v. EMA, T-44/13 Pending Case, AbbVie v. EMA, T-73/13 Pending Case, InterMune UK and others v. EMA.

(Updates with InterMune challenge, starting in first paragraph.)
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