Fujisawa GmbH

New Data Presented at the XX International Congress of the Transplantation Society in Vienna

Vienna, Austria (ots/PRNewswire) - - Prograf(R)-sirolimus Combination is Effective in Kidney Transplantation - Clinical Benefits With Prograf(R) for Heart Transplant Patients Six-month data from a new European study, presented today by Dr Stefan Vitko (IKEM, Prague, Czech Republic) at the XX International Congress of the Transplantation Society, demonstrated that cornerstone immunosuppressive therapy with Prograf(R) (tacrolimus) in combination with sirolimus is effective for the prevention of rejection following kidney transplantation.(1) This multicentre, randomised study compared the efficacy and safety of Prograf(R) in combination with either sirolimus at 0.5mg/day (n=325) or 2mg/day (n=325), or mycophenolate mofetil (MMF) 1g/day (n=327). All patients also received corticosteroids. The 6-month results revealed that Prograf(R) in combination with the higher dose of sirolimus (2mg) was associated with a significantly lower incidence of biopsy-proven acute rejection (15.7%) when compared with Prograf(R)/sirolimus 0.5mg (25.2%, p=0.003) and Prograf(R)/MMF (22.3%, p=0.036). There were also significant differences between groups (p<0.05) in terms of adverse events. Notably, the incidence of hyperlipidaemia, a key cardiovascular risk factor, was significantly (p<0.05) higher with sirolimus adjunctive therapy at both doses evaluated (2mg: 24.0%; 0.5mg: 19.4%) compared with MMF (11.0%). Adverse events were the main reason for premature study withdrawal in the sirolimus 2mg treatment arm. Although combination therapy with sirolimus was superior to MMF in preventing acute rejection, this increase in efficacy needs to be weighed against the dyslipidaemia and increased rate of adverse events associated with sirolimus. In addition to these data, Nizar A. Yonan of Wythenshawe Hospital, Manchester, UK, showed that cornerstone immunosuppression with Prograf(R) provides efficacy and safety benefits in heart transplant patients.(2) These data add to the growing body of evidence that supports the use of Prograf(R) as primary therapy in heart and other forms of solid-organ transplantation. This European, multicentre, phase III study randomly assigned 314 heart transplant patients to Prograf(R) or ciclosporin microemulsion. Patients in both treatment groups also received adjunctive therapy with azathioprine and corticosteroids in addition to antibody induction therapy. At 18 months post-transplantation, both treatment regimens were found to be associated with excellent patient/graft survival rates. Importantly, Prograf(R) treatment was associated with a significantly lower incidence of biopsy-proven acute rejection of ISHLT grades ³1B and ³3 compared with ciclosporin microemulsion (54.0% vs 66.4%, respectively, p=0.029; and 28.0% vs 42.0%, p=0.009). One of the most pertinent findings from this study concerned cardiovascular co-morbidity: significantly fewer patients receiving Prograf(R) versus ciclosporin microemulsion-based therapy experienced post-transplant arterial hypertension (65.6% vs. 77.7%, respectively) and hyperlipidaemia (28.7% vs. 40.1%), whereas tacrolimus patients experienced more new onset diabetes mellitus (20.3% vs 10.5%). These differences between the two treatment groups are important clinically because favourable rejection and cardiovascular risk profiles, as seen with the Prograf(R) based regimen, may translate into improved long-term outcomes. Notes to Editors: Prograf(R) is a cornerstone immunosuppressant for the prevention of graft rejection in kidney and liver transplantation. Prograf(R) is currently available in nearly 70 countries and currently forms the centrepiece of Fujisawa's continuing growth. Prograf(R) is approved for first-line use in the prevention of heart transplant rejection in Belgium and Luxembourg only. In a number of other European countries it is indicated for rescue therapy following heart transplantation. Acute rejection of the graft can occur at any time after transplantation, but the risk is highest in the first few months post-transplant. Immunosuppressants are used to suppress the immune system and thereby prevent acute rejection. Maximising patient health through minimising the risk of adverse events associated with immunosuppressive agents is an additional key challenge in transplantation. Events such as hyperlipidaemia increase the risk of cardiovascular disease, which is one of the main causes of late graft loss. Fujisawa GmbH is a subsidiary of Fujisawa Pharmaceutical Co., Ltd., based in Osaka, Japan. Fujisawa Pharmaceutical Co., Ltd. is among the world's top 30 pharmaceutical companies and employs over 8000 people in Japan, Europe, North America and Asia. Since its launch of Prograf(R) in Japan in 1993, the first in the world, Fujisawa has become one of the world's leading transplant and immunosuppression companies. Fujisawa plans to maintain its commitment to transplantation, and is dedicated both to improving the results of solid-organ transplantation and to ensuring the health and quality of life of patients. Prograf(R) is currently available in nearly 70 countries and forms the centerpiece of Fujisawa's continuing growth. Additional information on Fujisawa GmbH can be found on the Company's Web site at www.fujisawaeurope.com. References: 1. Vitko S, Wlodarczyk Z, Salmela K, Czajkowski Z, Margreiter R. Tacrolimus in combination with two different sirolimus doses versus a tacrolimus/MMF-based regimen: a large, randomised clinical study in renal transplantation. Abstract no. O286. 2. Yonan NA, Grimm M, Rinaldi M, et al. The advantage of tacrolimus versus ciclosporin-based therapy after heart transplantation - a large European phase III study. Abstract no.O410. Both abstracts presented at the XX International Congress of the Transplantation Society, 5-10 September 2004, Vienna, Austria. ots Originaltext: Fujisawa GmbH Im Internet recherchierbar: http://www.newsaktuell.ch Contact: Contact: Marite Ode, PR+Communications, T: +49-89-45442249, F: +49-89-45442030, media@fujisawa.de, www.fujisawaeurope.com

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