Data reinforce favorable tolerability and safety profile of Prexige® [1,2]
Basel, December 6, 2004 - New data from two studies provide strong evidence that the selective COX-2 inhibitor Prexige® (lumiracoxib), taken daily at 100 mg offers reduced pain intensity while improving the functional status of patients' osteoarthritis (OA) of the knee. These data were presented at the Osteoarthritis Research Society International (OARSI) annual meeting in Chicago on December 4.
The data shows that over the 13-week study Prexige 100 mg once daily significantly reduced OA pain intensity in the target knee compared to placebo and was comparable to celecoxib 200 mg once daily [1,2,3]. In the first study, Prexige demonstrated significant improvements in pain intensity from the first measurement at Week 2 with a significant reduction of 42% in pain intensity at study end (p<0.01 vs placebo) [1].
A similar decrease was observed in the second study with significant improvements throughout the study and a 38% decrease in pain intensity by study end (p<0.001 vs placebo) [2]. Throughout the study Prexige and celecoxib demonstrated significant improvements in functional status in both studies compared with placebo, with no statistically significant difference observed between active treatment groups [1,2,3].
In both trials, the number of patients discontinuing treatment due to adverse events, including serious adverse events, was similar between placebo and the active treatment groups [1,2,3]. Furthermore, no significant difference was observed between all treatment groups for the incidence of liver enzyme elevations, defined as alanine aminotransferase/aspartate amino-transferase levels above three times the upper limit of normal. In the first study enzyme elevations with Prexige were 0.2%, celecoxib 0.5% and placebo 0.5%, and Prexige/celecoxib 0.3% and placebo 0.0% in the second study [1,2,3]. These data reinforce the existing body of evidence showing a favorable safety and tolerability profile for Prexige.
Though data regarding gastrointestinal (GI) and cardiovascular (CV) adverse events were not evaluated separately in these trials, results from the landmark TARGET (Therapeutic Arthritis Research & Gastrointestinal Event Trial of lumiracoxib), which were published in August 2004 in The Lancet, demonstrated a significant 79% reduction in the incidence of upper gastrointestinal (GI) ulcer complications without compromising cardiovascular (CV) safety. The TARGET trial demonstrated that Prexige has a cardiovascular profile similar to conventional non-steroidal anti-inflammatory drugs (NSAIDs) ibuprofen and naproxen.
The two similarly designed 13-week, randomized, placebo and active-controlled trials compared Prexige 100 mg once daily, Prexige 100 mg once daily with a loading dose of 200 mg once daily for the first two weeks and celecoxib 200 mg once daily to placebo. Both trials were designed using three co-primary efficacy variables including functional status assessment criteria: OA pain intensity in the target knee, patient's global assessment of disease activity and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC(TM)) questionnaire. Improvement in patient's functional status was further assessed using the OMERACT-OARSI functional status criteria.
Novartis has filed applications for regulatory approval throughout the world based on data from more than 40 pre-clinical and clinical studies in OA, rheumatoid arthritis, acute pain and primary dysmenorrhea involving more than 31,000 adult patients around the world (including TARGET). In addition to the United Kingdom, Prexige has been approved in 21 countries to date, including Australia, New Zealand and several countries in Latin America, including Argentina, Brazil and Mexico. On November 30, 2004, Novartis announced that it had temporarily withdrawn the dossier for Prexige from the Mutual Recognition Procedure in Europe to await the outcome of the EMEA cardiovascular safety review of all COX-2 inhibitors.
The foregoing press release contains forward-looking statements that can be identified by express or implied discussions regarding potential future regulatory filings, approvals or future sales of Prexige (lumiracoxib). Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that any current or future regulatory filings will satisfy the FDA's and other health authorities' requirements regarding Prexige, that Prexige will be approved by the FDA or by any additional country's health authorities for any indication, or that Prexige will be brought to market in the US or any other country, or will reach any particular level of sales. In particular, management's expectations regarding Prexige could be affected by, among other things, regulatory actions or delays or government regulation generally; the public debate and regulatory activity regarding COX-2 inhibitors like Prexige which has followed Merck's withdrawal of Vioxx® from the market; uncertainties relating to clinical trials and product development; and competition in general; as well as factors discussed in the Company's Form 20-F filed with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
About Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2003, the Group's businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion. The Group invested approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 80,000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
References
1. Lehmann R, Brzosko M, Kopsa P, et al. Lumiracoxib 100 mg once daily is effective and well tolerated in the management of knee osteoarthritis. Poster Presentation 335 at 9th OARSI World Congress, Chicago, December 2-5 2004.
2. Beaulieu A, Sheldon E, Paster Z et al. Lumiracoxib 100 mg once daily is an efficacious and well tolerated therapy for knee osteoarthritis. Poster Presentation 140 at 9th OARSI World Congress, Chicago, December 2-5 2004.
3. Sheldon E, Beaulieu A, Paster Z et al. Lumiracoxib 100 mg once daily is effective in treating osteoarthritis as assessed by OMERACT-OARSI criteria. Poster Presentation at 9th OARSI World Congress, Chicago, December 2-5 2004.
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