The FDA has requested the submission of Novartis' [NVS] TARGET study report as well as additional clinical data for COX-II inhibitor Prexige. Delayed entry into the already saturated COX-II inhibitor market is bad news for the Swiss company, which hopes to capture market share from leaders Pfizer [PFZ.L] and Merck & Co [MRK].
COX-II inhibitors became leading therapies for arthritis and pain since their arrival on the market in 1999. Global sales of branded products exceeded $6.2 billion in 2002.
COX-II inhibitors were designed to avoid gastrointestinal (GI) complications commonly associated with traditional non-steroidal anti-inflammatory drugs (NSAIDs). However, in a turn of fate, they were found to be associated with cardiovascular (CV) problems not found with the use of older NSAIDs. Because arthritis patients are a target population, the high proportion of elderly sufferers means the associated risk of CV problems is high.
The comparably high cost of COX-II inhibitors to traditional NSAIDs (which are considered equally efficacious) combined with the CV risks mean that growth of the COX-II inhibitor market is in decline.
Indeed, market leaders, including Pfizer's Celebrex (celecoxib) and Merck's Vioxx (rofecoxib), experienced a 2% and 1% fall in global sales respectively in 2002. To combat market saturation and to differentiate Prexige from rivals, Novartis is planning to promote its drug based on a superior safety profile thereby gaining a competitive advantage.
Prexige was recently approved in the UK for osteoarthritis and short-term relief of moderate to severe pain. However, approval in the US is now dependent on the results of Novartis' therapeutic arthritis research and gastrointestinal event trial (TARGET) study, which is the first to assess both GI and CV safety.
The FDA request for additional data will push back Prexige's launch date to around mid-2005. By this time, Prexige will be the sixth COX-II brand to enter the market. The need to differentiate Prexige from rivals with positive TARGET findings will be as important as ever if Novartis is to capture Pfizer and Merck's considerable market share.