New Novartis transplant drug Certican® approved in first European market

| Source: Novartis Pharma AG Novartis Pharma AG

Basel, 23 July, 2003 - Novartis announced today that the Swedish Medical Products Agency (MPA) has granted marketing authorization for Novartis' new immunosuppressant drug Certican® (everolimus) for use in kidney and heart transplantation. Sweden will be the Reference Member State in the Mutual Recognition Process for Certican  within the European Union.
 
Certican is a novel proliferation signal inhibitor that is designed to target the primary causes of chronic allograft dysfunction or late graft loss, including acute rejection, cytomegalovirus (CMV) infection, calcineurin inhibitor (CNI) nephrotoxicity and vascular remodeling1),2),3). Preventing chronic allograft dysfunction or late graft loss is a major unmet medical need in transplantation.4)
 
The Novartis Transplantation and Immunology Team is committed to developing a new and innovative range of therapeutic products for the prevention of organ rejection in order to provide an 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 certain "forward-looking statements," relating to the Company's business, which can be identified by the use of forward-looking terminology such as "increases treatment choice", "will be", "is committed to developing", "to maintain", or similar expressions, or by express or implied discussions regarding potential future sales and approvals of Certican. Such statements reflect the current views of the Company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. There can be no guarantees that Certican will be approved for use in any other market or that it will reach any particular sales level. Any such commercialisation can be affected by, among other things, uncertainties relating to product development and clinical trials, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection, competition in general, increased government price pressures, 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 materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
 
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2002, the Group's businesses achieved sales of CHF 32.4 billion (USD 20.9 billion) and a net income of CHF 7.3 billion (USD 4.7 billion). The Group invested approximately CHF 4.3 billion (USD 2.8 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 78 200 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
 
 
References
1.)  Vitko S, Margreiter R, Weimar W et al. International, double-blind, parallel group study for the safety and efficacy of Certican(TM) (RAD) versus mycophenolate mofetil (MMF) in combination with Neoral® and steroids. Am J Transplant 2001 (Suppl 1):474. Abstract 1337.
2.)  Curtis J, Nashan B, Ponticelli C et al. One-year results of a multicenter, open-label trial on safety and efficacy of Certican(TM) (RAD) used in combination with Simulect®, corticosteroids and full or reduced dose Neoral® in renal transplantation. Am J Transplant 2001 (Suppl 1): 474. Abstract 1335.
3.)  Nishimura T et al. 40-0-(2-hydroxyethyl-) rapamycin attenuates pulmonary arterial hypertension and neointimal formation in rats. Am J Respir Crit Care Med 2001; 163:498-502.
4.)  Kaplan B, Srinivas TR, Meier-Kriesche HU. Factors associated with long-term renal allograft survival. The Drug Monitor 2002 Feb; 24 (1):36-9
 
 
 
NOTES TO EDITORS
  • Patients receiving organ transplants depend on immunosuppressive drugs to stop their immune systems from attacking and rejecting the transplanted organ (graft). The drug Neoral® (cyclosporin for microemulsion) is a mainstay of immunosuppression in transplant patients, permitting long-term survival, but the risk of acute and chronic graft rejection persists. Rates of chronic allograft dysfunction or late graft loss in particular have been barely influenced by standard regimens. Identifying additional immunosuppressive agents - which can act synergistically with Neoral® - is therefore an urgent priority in transplantation research.
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  • For further information, please access the Virtual Press Office on http://www.transplantsquare.com 
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