AbbVie Drops Court Bid to Block Clinical-Trial Data Release

Apr 03, 2014 1:08 pm ET

(Updates with call to InterMune in seventh paragraph.)

April 3 (Bloomberg) -- AbbVie Inc. dropped its court challenge to the European Medicines Agency, paving the way for the release of clinical-trial data from the company.

AbbVie said it decided to withdraw its lawsuits at the European Union General Court, the bloc’s second-highest tribunal, after the EMA accepted redacted documents from the company and also its “rationale for removing certain commercially confidential information from the clinical study reports that are at the center of the litigation.”

“A significant portion of data will be disclosed while protecting the information that is commercially sensitive,” North Chicago, Illinois-based AbbVie said in an e-mailed statement.

The drug industry has been voluntarily disclosing more information about the tests that lead to the approval of medicines amid pressure from regulators, researchers and patient advocates. Novartis AG, Sanofi and GlaxoSmithKline Plc are among companies that have agreed to grant more access to details of their clinical trials.

The EU regulator promised in 2010 to bolster 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 had challenged two decisions by EMA, one from 2012 and one from 2013, that gave access to documents of the marketing authorization of medical products. Biotechnology company InterMune Inc. has a similar appeal against EMA pending.

InterMune said that it won’t drop its challenge.

Single Product

“InterMune is a small company with a single product,” the Brisbane, California-based company said in an e-mailed statement. “The disclosure to competitors of confidential non- clinical and clinical information regarding that product would be likely to prejudice the company’s interests very substantially.”

The EMA fought interim decisions by the EU General Court that blocked the authority from releasing clinical-trial data as long as the challenges by AbbVie and InterMune were pending. The EU’s top court in November said the injunctions blocking EMA had to be re-examined by the lower court.

‘Irreparable’ Harm

AbbVie had told the EU court that companies could suffer “serious and irreparable” harm from the publication of the data.

BEUC, the European Consumer Organization, which was an official participant in the case in favor of EMA, was informed about AbbVie’s request to withdraw the case by the European Court of Justice, Ilaria Passarani, head of the organization’s food and health department, said in an e-mail today.

“The fact AbbVie has dropped its lawsuit against the European Medicines Agency disclosing drug trial data is a significant first step,” Passarani said. “It is our strong hope that InterMune, the other complainant, will follow suit.”

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

--With assistance from Andrea Gerlin in London and Caroline Chen in New York.