Healthcare Industry News:  organ transplant 

Biopharmaceuticals

 News Release - July 26, 2006

After Conversion to myfortic(R), Two-Thirds of Renal Transplant Recipients With Gastrointestinal Problems and Their Physicians Report a Significant Overall Reduction in Gastrointestinal Symptom Burden

In a three-month, prospective, open-label trial all 728 renal transplant recipients experiencing GI symptoms on mycophenolate mofetil (MMF) treatment were converted to myfortic

The data also suggest that overall efficacy and benefit of conversion are sustained after three months


BOSTON, July 26 (HSMN NewsFeed) -- In a new large-scale study, physicians and kidney transplant physicians reported a significant reduction in the incidence and symptom severity of gastrointestinal (GI) complications after conversion from MMF to enteric-coated myfortic® (all p<0.001). In addition, after conversion to myfortic more than two-thirds of patients and physicians reported an overall reduction in the gastrointestinal symptom burden. These improvements were first reported after one month and were sustained throughout the whole study period of three months. These findings were presented today at the World Transplant Congress in Boston.

"For many kidney transplant patients, GI side effects with current MPA (mycophenolate acid) therapies are commonplace and when serious enough, may require reducing the dose or withdrawing the drug altogether," said Stephen Tomlanovich, M.D., Medical Director of the University of California at San Francisco's Renal Transplant Service and the study author. "When combined with the growing body of patient-reported data about the impairment of quality of life following GI problems, this study further enhances the importance of the immunosuppressive choice for reducing GI symptom burden."

About the US02 trial

The US02 study, presented by Dr. Tomlanovich, was a three-month, prospective, open-label trial of 728 transplanted kidney recipients experiencing GI symptoms on MMF who were converted to myfortic in combination with the two leading immunosuppressant drugs, cyclosporine or tacrolimus. Starting with a baseline assessment, the study used questionnaires where both the patients and their treating physicians rated the complications and severity of five GI symptoms -- abdominal pain, gastric reflux, diarrhea, indigestion, and constipation -- at one month and three months after conversion to myfortic. According to the study's findings, 69% of the patients and 71% of the clinicians reported a significant reduction in GI symptom burden. These improvements occurred within four weeks of myfortic treatment and remained stable for the three-month study period. Moreover, patients and physicians reported significant reductions in GI symptom severity among African-American patients, who are at higher risk for adverse GI effects.(1,2)

The US02 study results confirm the findings of the exploratory PROGIS study, which demonstrated that patients with MMF-associated gastrointestinal side effects had a compromised health-related quality of life and impaired psychological well-being. Conversion to myfortic in these patients reduced their symptom burden and increased their GI-specific and general well- being.(3)

"The pivotal trials have already shown that myfortic when used in combination therapy gives patients and physicians a treatment alternative that offers the proven efficacy of mycophenolic acid therapy in an enteric-coated formulation," said Giacomo di Nepi, Global Head of Infectious Diseases, Transplantation and Immunology at Novartis Pharma AG. "This study underlines the possibility to reduce GI symptom burden and to leverage this reduction to enhance therapy. This makes myfortic a strong partner for de novo and maintenance renal transplant patients, and particularly for African-American patients."

Today, more than 16,000 Americans receive a kidney transplant each year and most require ongoing MPA therapy to prevent acute graft rejection.(4) However, studies find that up to 40% of patients on current MPA therapies experience debilitating GI side effects which is often managed by dose reductions leading to sub-therapeutic dosing of MPA.(5)

About myfortic

myfortic is an enteric-coated formulation of mycophenolate sodium -- an antimetabolite designed as a lifelong adjunctive immunosuppressive agent for transplanted patients. Approved in more than 80 countries for the prevention of acute rejection of kidney allografts in adult patients, myfortic is indicated in combination with cyclosporine and corticosteroids.

FDA's approval in 2004 of myfortic was based on two randomized, multi- center, double-blind pivotal clinical trials of more than 700 de novo (newly transplanted) and maintenance renal transplant patients, demonstrating effective graft protection together with a good safety profile.(6,7) In the de novo study, at both the six- and 12-month timepoints, therapeutic equivalence in terms of efficacy, safety and tolerability versus MMF was demonstrated. In the maintenance patient study, those who were converted from initial treatment with MMF to myfortic had comparable safety to patients who remained on MMF at six- and 12-month timepoints, without compromising efficacy. Results of these studies were published in the February 2004 issue of the American Journal of Transplantation.

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

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. 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.

Disclaimer

The foregoing release contains forward-looking statements regarding the long-term impact of a patient's use of myfortic. Such forward-looking statements involve known and unknown risks, uncertainties and other factors 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 guarantee regarding the long-term impact of a patient's use of myfortic. In particular, management's expectations regarding myfortic could be affected by, among other things, unexpected clinical trial results, including new clinical data and additional analysis of existing clinical data; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; and other risks and factors referred to in the Company's current Form 20-F on file with the U.S. 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 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 Pharmaceuticals Corporation develops, manufactures, markets and sells leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, gastrointestinal and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

Novartis has been a leader in the transplant area for more than 20 years, having pioneered early breakthrough treatments for organ protection with Neoral and Sandimmune®. Novartis markets the broadest immunosuppressant portfolio in the industry with three products [Neoral® (cyclosporine, USP) MODIFIED, Myfortic, and Simulect®] available throughout the world and the fourth product, Certican®, available in more than 55 countries outside of the U.S. Certican currently has an approvable status with the U.S. Food and Drug Administration (FDA). Novartis continues to be active in the research and development of new compounds. The company's goal is to build 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.

Novartis AG (NYSE: NVS ) is a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 96,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

Reference

1. Tomlanovich et al. A three month, prospective, open-label, two cohort study to investigate the efficacy, safety and tolerability of EC-MPS combination with cyclosporine or tacrolimus in renal transplant recipients with GI intolerance. Abstract # 1249, Presented as poster at the World Transplant Congress, July 24, 2006.

2. Bolin P et al. Significant improvement of GI-symptom burden in African-American transplant recipients after conversion to EC-MPS. Abstract #1328. Presented as poster at the World Transplant Congress, July 24, 2006.

3. Chan L, Mulgaonkar S, Walker W et al. Patient-reported gastrointestinal symptom burden and health-related quality of life following conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium. Transplantation 2006;81(9):1290-1297.

4. UNOS (United Network for Organ Sharing), 2005.

5. Behrend M. Adverse gastrointestinal effects of mycophenolate mofetil. Drug Safety 2001; 24 (9): 645-663.

6. 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. 2003;4:231-236.

7. 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;4:237-243.


Source: Novartis

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