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Lumiracoxib Cleared by European Union

Basel, November 7, 2006 - Novartis announced today that Prexige® (lumiracoxib), an oral selective COX-2 inhibitor anti-inflammatory drug, has been cleared for approval in the European Union as a new treatment option for patients suffering from osteoarthritis. This is the most common form of arthritis and a leading cause of chronic pain[2].

Prexige has successfully completed the Mutual Recognition Procedure (MRP) in the European Union, and all 26 EU member states have agreed to issue national approval. Initial approval for Prexige was granted in the United Kingdom, where it has been available since December 2005.

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

Prexige will be available in 100 mg tablets (once daily dosing) and indicated for the symptomatic relief in the treatment of knee and hip osteoarthritis. The decision was based on data from clinical trials involving 34,000 patients - the largest-ever body of evidence supporting the launch of an anti-inflammatory agent.

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[3]. Prexige offers similar pain relief to the commonly used osteoarthritis medication celecoxib[4],[5], [6], [7]. However it has demonstrated a superior gastrointestinal safety profile to traditional non-steroidal anti-inflammatory drugs (NSAIDs)[1].

"Many patients cannot tolerate the gastrointestinal side effects associated with NSAID pain treatments. In addition, not all osteoarthritis patients respond to currently available pain medications," said Dr. Gerd Burmester, Professor of Medicine at the Humboldt University in Berlin, Germany, and one of the leading investigators of the TARGET study. "Lumiracoxib has been extensively studied for both efficacy and safety and has the potential to provide a valuable new treatment option for physicians."

Gastrointestinal safety concerns for patients using NSAIDs are much more serious than an upset stomach or heartburn. Up to 16,500 people in the US[8] and 2,500 in the UK[9] die each year as a result of severe bleeding ulcers in the stomach and intestine, which usually occur without warning[10].

The TARGET study, the largest published one-year study of gastrointestinal safety outcomes in osteoarthritis patients to date (n=18,325), has demonstrated that Prexige significantly reduced the incidence of serious upper GI complications by 79% compared with the NSAIDs ibuprofen and naproxen in patients not taking aspirin[1]. In further sub-analyses, Prexige reduced the risk of ulcer complications within the first month of use[11] and offered significant benefit compared to naproxen in older patients at greater gastrointestinal risk[12].

Furthermore, compared to NSAIDs, Prexige demonstrated a similar cardiovascular safety profile and a significantly smaller effect on blood pressure[13], [14].

"Novartis has worked closely with the health authorities to ensure a full review of all Prexige efficacy and safety data, especially the cardiovascular data, to confirm the benefit for patients," said James Shannon, MD, Global Head of Development for Novartis Pharma AG. "We are delighted that Prexige will soon be available to patients in Europe, and we are committed to providing physicians with the information they need to appropriately prescribe and select patients for Prexige."

Health authorities, including the European Medicines Agency and the US Food and Drug Administration (FDA), have concluded that the benefit/risk ratio for NSAIDs and selective COX-2 inhibitors remains positive when used in their target patient populations. Both Novartis and the health authorities agree that anti-inflammatory treatments should be used at the lowest possible dose for the shortest possible duration.

References
1. Schnitzer T, et al. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), reduction in ulcer complications: a randomized controlled trial. Lancet. 2004; 364(9435): 665-674.

2. Wolf AD, Pfleger B. Burden of Major Musculoskeletal Conditions. Policy and Practice. Special Theme-Bone and Joint Decade 2000-2010. Bulletin of the World Health Organization 2003, 81 (9): 646-656.

3. Rordorf C, et al. Clinical pharmacology of lumiracoxib: a selective cyclo-oxygenase-2 inhibitor. Clin Pharmacokinet 2005; 44(12):1247-1266.

4. Pavelka K, et al Lumiracoxib is effective and well tolerated in the long-term treatment of knee osteoarthritis. Ann Rheum Dis 2005;64(Suppl. 3):353 (Abstract FRI0319).

5. Sheldon E, Beaulieu A, Paster Z, Dutta D, Yu S, Sloan VS. Efficacy and tolerability of lumiracoxib in the treatment of osteoarthritis of the knee: a 13-week, randomized, double-blind comparison with celecoxib and placebo. Clin Ther 2005;27(1):64-77.

6. Lehmann R, Brzosko M, Kopsa P, Nischik R, Kreiss A, Thurston H, Litschig S, Sloan VS. Efficacy and tolerability of lumiracoxib 100 mg once daily in knee osteoarthritis: a 13-week, randomized, double-blind study vs. placebo and celecoxib. Curr Med Res Opin 2005;21(4):517-526.

7. Berenbaum F, Grifka J, Brown JP, Zacher J, Moore A, Krammer G, Dutta D, Sloan VS. Efficacy of lumiracoxib in osteoarthritis: a review of nine studies. J Int Med Res 2005;33(1):21-42.

8. Singh G, Triadafilopoulos G. Epidemiology of NSAID induced gastrointestinal complications. J Rheumatol 1999; Suppl.56: 18-24.

9. Tramer M, et al. Quantitative estimation of rare adverse events, which follow a biological progression: a new model applied to chronic NSAID use. Pain 2000; 85:169-182.

10. Wolfe M, Lichenstein D, et al. Gastrointestinal toxicity of nonsteroidal inflammatory drugs. N. Engl. J. Med.1999; 340:1888-1899.

11. Hawkey CJ, et al. Early reduction of ulcer complications with lumiracoxib compared with nonselective NSAIDs in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET). Ann Rheum Dis 2006;65(Suppl. II):231 (Abstract THU0378).

12. Hawkey CJ, et al. Improved gastrointestinal safety profile with lumiracoxib compared with naproxen and ibuprofen in patients at least 65 years old at increased risk of gastrointestinal events. Gastroenterology 2006;130(4)(Suppl. 2) (Abstract 218493).

13. Farkouh M, et al. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: a randomized controlled trial. Lancet. 2004; 364(9435): 675-684.

14. Matchaba P, et al. Cardiovascular Safety of Lumiracoxib: A Meta-analysis of All Randomized Controlled Trials >=1 Week and up to 1 Year in Duration of Patients with Osteoarthritis and Rheumatoid Arthritis. Clin Ther 2005; 27(8):1196-1214.

Source: Novartis Source:

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