* AbbVie drops lawsuits against European Medicines Agency
* Decision follows EMA acceptance of redactions to documents
* AbbVie says move will preserve commercial confidentiality
* Legal fight between EMA and InterMune continues
(Adds EMA and BEUC comment, background)
LONDON, April 3 AbbVie, one of the two
U.S. companies trying to stop Europe's drugs regulator from
releasing previously secret clinical trials data, said on
Thursday it had withdrawn lawsuits against the watchdog.
The decision follows a move by the London-based European
Medicines Agency (EMA) to accept a new set of redacted documents
submitted by AbbVie, along with the company's rationale for
removing certain commercially confidential information.
"A significant portion of data will be disclosed while
protecting the information that is commercially sensitive,"
AbbVie said in a statement. "As a result, AbbVie has withdrawn
The EMA said the "very limited redactions" would have no
significant impact on the readability of the clinical study
reports that were at the centre of the litigation.
The legal row between the EMA, AbbVie and a second
drugmaker, InterMune, has thrown a spotlight on
attempts by parts of the pharmaceutical industry keep its data
secret, even as many doctors and campaigners demand greater
For AbbVie, the case was significant because the clinical
trial data at stake related to its blockbuster rheumatoid
arthritis treatment Humira, which is the world's top-selling
Medical researchers and patient groups want access to
detailed clinical trial data to improve third-party scrutiny of
the drugs industry and to allow independent scientists to
stress-test claims about drugs.
But many companies fear that complete disclosure of all
information will damage their businesses and undermine the
ability to defend patents.
The London-based watchdog has been on a collision course
with much of the industry since pledging in 2010 to lift the lid
on previously secret trial data submitted by companies as part
of the application process for new medicines.
The scale of the data releases was to have been increased
significantly this year under the EMA plans. But the process was
stalled by the legal battle with AbbVie and InterMune.
The European consumer organisation BEUC, which was involved
in the case as an official participant in favour of the EMA,
said AbbVie's decision was a significant first step forward.
"It is our strong hope that InterMune, the other
complainant, will follow suit," said Ilaria Passarani, head of
BEUC's food and health department.
The EMA said the other court case brought by InterMune
against the agency, challenging a decision to grant access to
clinical-study reports, was ongoing.
AbbVie's decision to drop its lawsuits comes just one day
after the European Parliament voted in favour of new legislation
governing clinical trials that will force drug companies to be
more transparent in releasing study results.
(Reporting by Ben Hirschler and Kate Holton; Editing by Jane
Merriman and Anthony Barker)