What is EMEA looking for?
Any sign of a problem with cardiovascular and cardio-renal safety, such as incidence of heart attack, stroke, hypertension or cardiac failure. It will then decide whether there is a need to change the drugs’ existing marketing authorisations, such as labelling and so on.
What companies are affected?
EMEA is looking at five COX-2s. Merck Sharp & Dohme will be under the spotlight for Arcoxia (etoricoxib,) which launched in the UK in April 2003. Then there is Prexige (lumiracoxib) from Novartis and three brands owned by Pfizer: Celebrex (celecoxib), Bextra (valdecoxib) and Dynastat (parecoxib).
Does this affect any PR agencies?
Galliard Healthcare Communications handles PR for Arcoxia and Athena Medical PR promotes Prexige.
What about the Pfizer brands?
The pharma giant is in the process of consolidating global PR for its pain franchise, which includes the three brands under review: Celebrex, Bextra and Dynastat. Burson-Marsteller, Hill & Knowlton, Ogilvy PR Worldwide and Porter Novelli were all in the frame but no winner has yet been announced. Manning Selvage & Lee, which covered Celebrex and Weber Shandwick (Bextra) chose not to repitch. Pfizer’s most visible PR activity so far is to issue a statement saying it is ‘confident the EMEA review will reaffirm the cardiovascular safety profile of its COX-2 portfolio’.
Has anything like this happened before?
Quite recently. The EMEA reviewed COX-2 inhibitors last year, but will now be reviewing newly available data.