Transplant Pioneers and Patients Mark 50th Anniversary of First Successful Organ Transplant and 20 Years of Anti-Rejection Therapy

Novartis and National Kidney Foundation Honor Transplant Community at 2004 U.S. Transplant Games

Minneapolis /PRNewswire/ -- Nearly 7,000 transplant recipients, organ donors and family members gathered today at the Opening Ceremonies of the National Kidney Foundation's 2004 U.S. Transplant Games to honor the physicians and researchers who pioneered organ transplantation techniques and therapies. Held biennially, this year's Games run from July 27 through August 1st at the University of Minnesota in Minneapolis.

Novartis, the founding and title sponsor of the U.S. Transplant Games, is celebrating 20 years of providing transplant therapies that improve patients' lives. Novartis introduced Sandimmune(R) (cyclosporine, USP), the drug that revolutionized the field of organ transplantation in the early 1980s by helping to minimize the rejection of transplanted organs.

"While the first human organ transplant was performed 50 years ago, it was the arrival of the drug cyclosporine that vastly improved transplant survival rates and helped make transplantation the almost routine procedure it is today," said John Davis, Chief Executive Officer of the National Kidney Foundation, which is celebrating 50 years of transplantation. "That development offered hope to thousands of patients suffering from failing kidneys, livers, and hearts."

Over 1,500 transplant recipients, some transplanted as far back as 20 years ago, are participating as athletes at this year's Games. No one would have imagined that this medical technology would have made it possible for patients to have a second chance at life, let alone compete in an Olympic- style sports competition. In the past 20 years nearly 350,000 organ transplants have been performed in the United States and more than 200,000 transplant recipients are alive today because of advances in transplantation.¹

"As we commemorate these major milestones, we pay special tribute to all the athletes who showcase the success of transplantation and to the donor families who gave the gift of life," said Brian O'Callaghan, Vice President, Transplant and Immunology Business Unit at Novartis Pharmaceuticals Corporation. "Although transplantation has achieved great successes over the past 20 years, there are still advances that can be made to improve the patient's quality of life. It is Novartis' goal to provide treatment options that meet the needs of individual patients -- resulting in more successful transplants and healthier lives for the transplant recipient."

Today, Novartis provides physicians and patients with the largest selection of innovative transplant therapies of any pharmaceutical company, including the world's most widely prescribed anti-rejection product, Neoral® (cyclosporine, USP) MODIFIED, Simulect® (basiliximab) and the recently approved myfortic® (mycophenolic acid) delayed release tablets. The Novartis Transplantation and Immunology Business Unit is committed to ongoing research and developing new transplant therapies 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. For more information about Novartis and transplantation, see http://www.novartis-transplant.com.

Honoring Patients and Pioneers

At a special ceremony honoring transplant pioneers and patients, Novartis is presenting the National Kidney Foundation with two murals, "Triumph of Transplantation" and "Celebration of Transplantation." Both murals are by medical artist Scott T. Barrows, and they depict the Games in the context of scientific milestones of transplantation and ordinary people who perform extraordinary feats ( http://www.novartis-transplant.com/public/celebration.jsp ). Nobel Prize Laureate Joseph Murray, MD, the transplant pioneer who headed the team that performed the first successful kidney transplant between identical twins, will be in attendance.

The National Kidney Foundation (NKF) is presenting its eighth biennial U.S. Transplant Games. The Games showcase achievements of transplantation and also draw attention to the national organ shortage. More than 80,000 Americans are currently on the national transplant waiting list and 17 people die each day while waiting.² NKF is the world's largest organization dedicated to promoting organ and tissue donation. It provides education and offers programs for transplant recipients, donor families, living donors and the professionals who care for them. For more information about the Games, call the National Kidney Foundation at 1-800-622-9010 or visit http://www.kidney.org.

About Neoral®

Neoral® Soft Gelatin Capsules and Oral Solution are indicated for the prevention of organ rejection in kidney, liver, and heart allogenic transplant recipients. Neoral® (cyclosporine, USP) MODIFIED and Sandimmune® (cyclosporine, USP) are not bioequivalent and cannot be used interchangeably without careful monitoring of cyclosporine blood concentration. Blood level monitoring is not a replacement for clinical evaluation and routine monitoring of renal function and other laboratory tests are recommended. Dosage adjustments must be made based on individual response. The principal adverse reactions of cyclosporine therapy in transplantation are renal dysfunction, tremor, hirsutism, hypertension and gum hyperplasia. Neoral® and Sandimmune(R) are systemic immunosuppressants and may increase the susceptibility to infection and to the development of neoplasia.

Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe Neoral®. At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe Neoral®. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources.

The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient. Neoral®, a systemic immunosuppressant, may increase the susceptibility to infection and the development of neoplasia. In kidney, liver, and heart transplant patients Neoral® may be administered with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma and other neoplasms may result from the increase in the degree of immunosuppression in transplant patients.

Neoral® and Sandimmune® are contraindicated in patients with hypersensitivity to cyclosporine or to any of the ingredients of the formulations. Care should be taken in using cyclosporine with nephrotoxic drugs.

About myfortic®

WARNING: Increased susceptibility to infection and the possible development of lymphoma and other neoplasms may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should use myfortic® (mycophenolic acid). Patients receiving myfortic® should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

The common adverse reactions associated with myfortic® in clinical trials include constipation, nausea, and urinary tract infections in de novo patients, and nausea, diarrhea and nasopharyngitis in maintenance patients. Adverse events reported in >20% of patients receiving combination therapy with Neoral® (cyclosporine, USP) MODIFIED and corticosteroids in the 12-month de novo renal study and maintenance renal studies were similar between myfortic® and MMF in both patient groups.

myfortic® is contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, or to any of its excipients.

myfortic® should not be used in pregnant women unless the potential benefit justifies the potential risk of the fetus. For women of childbearing age, effective contraception must be used before beginning myfortic® therapy, during therapy, and for 6 weeks following discontinuation of therapy, even where there has been a history of infertility, unless due to hysterectomy. Two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method. If pregnancy does occur during treatment, the physician and patient should discuss the potential risk to the fetus.

Patients receiving myfortic® should be monitored for neutropenia. The development of neutropenia may be related to myfortic® itself, concomitant medications, viral infections, or some combination of these events. If neutropenia develops (ANC < 1.3x103 /uL), dosing with myfortic® should be interrupted or the dose reduced, appropriate diagnostic tests performed, and the patient managed appropriately.

Patients receiving immunosuppressive regimens involving combinations of drugs, including myfortic® (mycophenolic acid), as part of an immunosuppressive regimen are at increased risk of developing lymphomas or other malignancies, particularly of the skin. The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent. Oversuppression of the immune system can also increase susceptibility to infection, including opportunistic infections, fatal infections, and sepsis.

myfortic® has been administered in combination with the following agents in clinical trials: antithymocyte/lymphocyte immunoglobulin, muromonab-CD3, basiliximab, daclizumab, cyclosporine, and corticosteroids. The efficacy and safety of myfortic® in combination with other immunosuppression agents have not been determined.

myfortic® (mycophenolic acid) delayed-release tablets are indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids.

About Simulect®

Only physicians experienced in immunosuppression therapy and management of organ transplantation patients should prescribe Simulect. The physician responsible for Simulect administration should have complete information requisite for the follow-up of the patient. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. Severe acute (onset within 24 hours) hypersensitivity reactions including anaphylaxis have been observed both on initial exposure to Simulect and/or following re-exposure after several months. If a severe hypersensitivity reaction occurs, therapy with Simulect should be permanently discontinued. Simulect is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids. Please see full prescribing information for Simulect and Neoral, which include contraindications, warnings, precautions, and adverse events.

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 language describing Novartis' goals, or by express or implied discussions regarding the marketing of Sandimmune®, Simulect®, Neoral®, and myfortic®. Such statements reflect the current views of the Company with respect to future events. The commercial success of any product can be affected by, among other things, uncertainties relating to clinical trials, regulatory and legal actions and delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, 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.

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 .

For more information and for a copy of the complete prescribing information, please contact: Harry Rohme (862) 778-5151, or via email at harry.rohme@pharma.novartis.com.

Media Contacts:

Novartis Pharmaceuticals Corporation Harry Rohme (862) 778-5151
Novartis Corporation Jill Pozarek (Investor Relations) (212) 830-2445

SOURCE Novartis Pharmaceuticals Corporation Web Site:

This article posted August 14, 2004.