Basel, December 1, 2004 - Novartis Pharma AG announced today that the 10 new European Union Member States have completed the Mutual Recognition Procedure (MRP) for Certican® (everolimus) for the prophylaxis of organ rejection in adult kidney and cardiac transplant patients at low to moderate immunological risk.
The 10 new EU member states participating in the second wave of MRP included Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia and Slovenia. All of these countries agreed to issue a national marketing authorization based on the assessment of Sweden as the reference member state.
"The completion of the expanded MRP for Certican reinforces the value of Certican as a new agent in transplantation," said Tony Rosenberg, Head of the Novartis Transplantation and Immunology Business Unit, Novartis Pharma AG. "Certican could offer transplant patients and physicians a welcome new tool to improve long-term survival through its ability to reduce the incidence and severity of the primary causes of rejection."
Certican is a proliferation signal inhibitor that targets the primary causes of allograft dysfunction (also known as chronic rejection) following organ transplantation, including acute rejection and vascular remodelling. Certican is the first drug in its class to receive the indication for both heart and kidney transplant recipients. Preventing allograft dysfunction or late graft loss remains a major unmet medical need in transplantation.
The decision by these European countries is based on data from studies comprising 634 heart transplant patients over 24 months and more than 1,700 kidney transplant patients for up to 36 months. Results from these studies showed Certican effectively prevented graft rejection when given with low-dose Neoral® (ciclosporin for microemulsion) and corticosteroids.
At the completion of MRP in December 2003, the following 15 countries initially provided their endorsement: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain and Sweden. Certican received its first approval from the Swedish Medical Products Agency in July 2003 for the prevention of rejection in heart and kidney transplant patients in combination with Neoral and corticosteroids. Sweden served as the reference member state for MRP.
Since the completion of the initial MRP in the EU in December 2003, Certican is now available in Germany, Austria, Portugal, the Netherlands, Greece, the Nordic countries and most recently in several Latin American countries.
The Novartis Transplantation and Immunology Business Unit is committed to developing an 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 the role of Novartis 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 "could offer", "committed to developing", or similar expressions, or by express or implied discussions regarding potential additional marketing approvals or future sales of Certican. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause the actual results with Certican to be materially different from any future results, performance, or achievements expressed or implied by such statements. There can be no guarantee that Certican will receive any additional marketing approvals in any other countries, or that it will reach any particular sales levels. Any such results 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, competition in general, government, industry, and general public pricing 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 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.
About Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2003, the Novartis 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.
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