BASEL, Switzerland, Feb. 10, 2004 (PRIMEZONE) -- Novartis Pharma AG (NYSE:NVS) announced today that its application for the new enteric-coated immunosuppressant, Myfortic (mycophenolate sodium) successfully completed the European Mutual Recognition Procedure (MRP) in 17 countries. Myfortic is a life-long adjunctive therapy in combination with ciclosporin, such as Neoral(r) (ciclosporin microemulsion), and corticosteroids for the prevention of acute rejection of kidney allografts (transplants) in adult patients. All countries involved in the MRP are expected to issue a marketing authorization in the coming months. "This is extremely good news for transplant patients and healthcare professionals as Myfortic provides a valuable new immunosuppressive treatment option that combines excellent efficacy and good tolerability," said Professor Georges Mourad, Director, Department of Nephrology and Transplantation, Hospital Lapeyronie, France. "Gastrointestinal side effects frequently observed under current mycophenolate mofetil or MPA therapy are a cause of discomfort for patients and may result in dose reduction or treatment discontinuation. This can pose difficult treatment decisions for transplant physicians, as these dose reductions or interruptions are associated with decreased graft survival."
A recent study (retrospective analysis) has demonstrated that more than 70% of patients taking mycophenolic acid (MPA) treatments such as mycophenolate mofetil (MMF) require at least one dose change, with 21% of these dose changes being the result of gastrointestinal side effects. In the majority of cases, dose change involved dose reduction. Patients who undergo an initial reduction in MMF dose are eight times more likely to suffer acute allograft rejection than those who have not had a dose adjustment.(1)
Myfortic is designed to avoid these MPA-related gastrointestinal side effects by delaying the release of MPA until it reaches the small intestine, with the goal of minimizing dose reductions. Results of two pivotal global multicentre trials indicate that Myfortic and MMF are therapeutically equivalent in de novo renal transplant patients and that the conversion to Myfortic from MMF is safe in maintenance renal transplant patients. (2, 3)
"We are pleased that the European health authorities recognize the exceptional benefits that Myfortic can offer transplant patients," said Tony Rosenberg, Head, Transplantation and Immunology Business Unit, Novartis Pharma AG. "Myfortic, the latest Novartis transplant drug, is a much anticipated addition to our transplant product portfolio, setting us apart from other companies in the transplant field."
At the completion of the MRP, the following countries have endorsed the mutually agreed summary of product characteristics: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Iceland, Italy, Luxemburg, Netherlands, Norway, Portugal, Spain, Sweden and the United Kingdom. Myfortic received approval from the French regulatory authorities in October 2003.
The Novartis Transplantation and Immunology Team is committed to developing a new and innovative range of therapeutic products for the prophylaxis of organ rejection in order to provide the most extensive choice of drugs to the transplant community and to maintain Novartis' role as a global market leader in this field of medicine.
This release contains "forward-looking statements," relating to the Company's business, which can be identified by the use of forward-looking terminology such as "are expected", or similar expressions, or by express or implied discussions regarding the approval, marketing, or potential futures sales of Myfortic. Such statements reflect the current views of the Company with respect to future events and are subject to certain risks, uncertainties and assumptions that may cause actual results with Myfortic to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantees that Myfortic will be commercialized in any market. Any such commercialization can be affected by, among other things, uncertainties relating to clinical trials, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, increased government price pressures, as well as factors discussed in the Company's Form 20-F filed with the 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 the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis AG 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 78 500 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
References: (1) Pelletier RP, Akin B, Henry ML, et al. The impact of mycophenolate mofetil dosing patterns on clinical outcome after renal transplantation. Clin Transplant 2003; 17: 200-205. (2) Salvadori M, Holzer H, De Mattos A, et al. Enteric-coated mycophenolate sodium is therapeutically equivalent to mycophenolate mofetil in de novo renal transplant patients. Am J Transplant 2004; 4(2): 231-236 (3) Budde K, Curtis J, Knoll G, et al. Enteric-coated mycophenolate sodium can be safely administered in maintenance renal transplant patients: results of a 1-year study. Am J Transplant 2004; 4(2): 237-243.
Novartis International AG Novartis Communications CH-4002 Basel Switzerland
Internet Address: http://www.novartis.com
Please see full press release under the following link: