BASEL, Switzerland, Nov. 30, 2004 (PRIMEZONE) -- Novartis Pharma AG announced today that it has withdrawn the application for the EU Mutual Recognition Procedure for Prexige(R) (lumiracoxib) to await the outcome of the European Medicines Agency (EMEA) review of all selective COX-2 inhibitors. Novartis remains committed to Prexige and is continuing to work closely with regulatory authorities. The company plans to further document the safety and efficacy profile of Prexige in its regulatory dossiers by incorporating additional data.
"Novartis remains confident that Prexige offers physicians and patients a new safe and effective treatment option to relieve the symptoms of osteoarthritis and acute pain," said Dr. Jorg Reinhardt, Head of Development, Novartis Pharma AG.
New data from two clinical trials demonstrating the efficacy and tolerability of Prexige at 100 mg daily will be presented during the Osteoarthritis Research Society International (OARSI) meeting in Chicago from December 2-5, 2004. Both trials were conducted in patients with osteoarthritis (OA) and evaluated the pain intensity reduction and improvement in the functional status of patients.
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 trial demonstrated that Prexige has a cardiovascular profile similar to conventional non-steroidal anti-inflammatory drugs (NSAIDs). Results also showed there was no significant difference in serious hepatic events between Prexige and the NSAID groups. TARGET was the largest GI safety outcomes study performed to date with 18,325 patients that compared Prexige against the NSAIDs ibuprofen and naproxen.
Novartis has filed applications for regulatory approval throughout the world based on data from more than 40 pre-clinical and clinical studies in osteoarthritis, rheumatoid arthritis, acute pain and primary dysmenorrhea involving more than 31,000 adult patients around the world. 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.
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 future regulatory filings will satisfy the requirements of any health authorities regarding Prexige, that Prexige will be approved under the EU Mutual Recognition Procedure or by the FDA or other country's health authorities for any indication, or that Prexige will reach any particular level of sales. In particular, management's expectations regarding Prexige could be affected by, among other things, uncertainties relating to clinical trials and product development, including any additional clinical trials which must be conducted in the future in order to satisfy the requirements or regulatory authorities; regulatory actions or delays or government regulation generally; the ability to obtain or maintain patent or other proprietary intellectual property protection; government, industry, and general public pricing pressures; 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 81,000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
To view this release as a .pdf visit the following link: http://hugin.info/134323/R/970635/142080.pdf
-0- CONTACT; Eric Althoff Novartis Global Pharma Communications +41-61-324-6392 (direct) +41-79-593-4202 (mobile) John Gilardi Novartis Global Media Relations +41-61-324-3018 (direct) +41-79-596-1408 (mobile)