NOVARTIS' OSTEOARTHRITIS DRUG APPROVED IN EUROPE, CANADA

Novartis announced that Prexige, a selective COX-2 inhibitor anti-inflammatory drug, has been cleared for approval in the European Union as a new treatment option for patients with osteoarthritis. Prexige (lumiracoxib) has successfully completed the Mutual Recognition Procedure in the European Union, and all EU member states have agreed to issue national approval.

In addition to the EU, Prexige is already approved in more than 25 countries, including the approval also granted in Canada. It is expected to become available in European countries during 2007 and 2008. Novartis plans to resubmit the drug for U.S. approval in 2007.

Prexige will be available in 100-mg tablets (for once-daily dosing) and indicated for the symptomatic relief in the treatment of knee and hip osteoarthritis. The TARGET study, the largest published one-year study of gastrointestinal safety outcomes in osteoarthritis patients, has demonstrated that Prexige significantly reduced the incidence of serious upper gastrointestinal complications by 79 percent compared with ibuprofen and naproxen in patients not taking aspirin. In further sub-analyses, Prexige reduced the risk of ulcer complications within the first month of use and offered significant benefit compared with naproxen in older patients at greater gastrointestinal risk.

Prexige differs from other selective COX-2 inhibitors by targeting the site of pain, rapidly clearing from the blood and being quickly absorbed in the inflamed joint, according to Novartis. Prexige offers similar pain relief to the commonly used osteoarthritis medication celecoxib. Furthermore, compared to NSAIDs, Prexige demonstrated a similar cardiovascular safety profile and a significantly smaller effect on blood pressure, according to Novartis.