GlaxoSmithKline's ($GSK) move to rehabilitate its reputation with a commitment to open up its data vault on approved drugs has won widespread acclaim, and at least limited support from Roche ($RHHBY). But the silence from the rest of the industry so far has been deafening. And now AbbVie ($ABBV) has stepped forward to take the lead role in the industry backlash. It's suing the European Medicines Agency in an effort to block the release of Humira data, part of an extensive plan to safeguard a multibillion-dollar drug franchise.
|Humira serves as AbbVie's foundation.--Courtesy of Kaiser Permanente|
The legal action was fired up after InterMune and UCB filed freedom of information requests to the EMA to get their hands on the data, which follows a pledge by the EMA to provide more transparency on the data it's used to review drugs. And analysts believe that AbbVie's actions will provide a test case for other biopharma companies also anxious to keep their data under lock and key--primarily due to fears that competitors will be able to use the information to come up with better rival therapies. While transparency has largely been viewed as a consumer right in the face of past incidents when pharma companies kept damaging safety data from prying eyes, the Humira case also highlights how competitors are using the transparency trend to get their hands on trial information that can be useful to them.
In a statement to the Financial Times, AbbVie said it backs "transparency of clinical research and safety information for the benefit of patients and healthcare professionals [but not] the disclosure of commercially confidential information that does not meaningfully contribute to the scientific review or evaluation of our products."
AbbVie has a huge amount at stake. Its growing Humira franchise brought in more than $9 billion last year, making it the biggest cash cow in the industry. The company, which split from Abbott ($ABT) at the beginning of the year, has also made it clear that it will defend each of the 200 patents covering the production of the drug as biosimilar competition looms. -- John Carroll, Editor-in-Chief. Follow me on Twitter and LinkedIn.