LONDON (Dow Jones)--AstraZeneca PLC (AZN.LN) said Friday it will not appeal a ruling by a British regulatory panel that found the U.K. drug maker failed to accurately reflect side-effects of its key antipsychotic medicine Seroquel in an advertisement to doctors.
A preliminary ruling by the Prescription Medicines Code of Practice Authority, or PMCPA, found that AstraZeneca breached three points of the British pharmaceutical industry's code of practice with a marketing claim that Seroquel had "a favorable weight profile across the full dose range" compared with similar drugs. The ad appeared in the British Journal of Psychiatry in 2004.
AstraZeneca, which received notification of the PMCPA's ruling on Monday, said Friday in a statement that "in response to these complaints, AstraZeneca UK asserted to the PMCPA that it believed the content of the advertisement to be a fair and balanced reflection of the overall evidence relating to weight change associated with atypical usage at the time concerned. Given the historical nature of the complaint, AstraZeneca UK will not appeal the decision."
The Prescription Medicines Code of Practice Authority is the self-regulatory arm of the Association of the British Pharmaceutical Industry, or ABPI.
The PMCPA ruling found AstraZeneca's 2004 advertisement breached ABPI Code clauses 7.2, 7.4 and 7.9, all of which relate to the validity of promotional claims made in company materials. The PMCPA also ruled that a breach occurred of ABPI Code clause 9.1 relating to high standards.
Seroquel is one of the 10 best-selling drugs in the world, generating $4.87 billion in sales for 2009, but it belongs to a class of therapies that has come under fire for safety risks and questionable marketing practices.
AstraZeneca faces more than 10,400 pending lawsuits in the U.S. which allege that Seroquel caused diabetes or other injuries. The U.K.'s second-biggest drug maker after GlaxoSmithKline Plc (GSK) has incurred more than $650 million in legal defense costs for the Seroquel litigation, and its ultimate liability could go higher if juries award damages or if AstraZeneca settles lawsuits.
-By Sten Stovall, Dow Jones Newswires; +44 207 842 9292; sten.stovall@dowjones.com
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