The European Commission asked for the across-the-board review following the worldwide withdrawal in September 2004 of Merck's Cox-2, Vioxx. Since then, Pfizer's Bextra has also been suspended. The EMEA was looking for incidences in Cox-2 users of heart attack, stroke, hypertension or cardiac failure. Doctors were warned to be 'cautious' about giving them to patients at risk of heart disease.
So who's now doing PR for Prexige?
Clew Communications is working on the business for Novartis. PR plans are 'currently in development', according to Jason Browning, head of comms at the manufacturer. The agency reports to him.
Do they have anything specific in mind?
Hard to say. The product will initially be promoted as a secondary care drug, for use by hospital experts. But Browning tells PRWeek: 'We will have to look at the landscape, the patient and prescriber population, and decide. There is still a significant, unmet need among patients in pain.'
So Prexige is pushing at an open door?
Not quite. PROs for Prexige and the two other Cox-2s in the European market – Pfizer's Celebrex and Merck's Arcoxia – will have their work cut out as the EMEA has imposed new contra-indications and warnings throughout the class. There is a worry that this will affect take-up by medical practitioners. Sales of Celebrex slumped last year after Vioxx was withdrawn.
What are Prexige's selling points?
Novartis says Prexige's cardiovascular safety is in line with other Cox-2 inhibitors, but it is better on gastrointestinal safety than non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, which are also used to treat arthritis.
When was Prexige first ready for launch?
More than two years ago. Prexige was actually approved – before the EMEA review – by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for osteoarthritis as far back as September 2003.