Roche Pharmaceuticals

IMPACT Study Shows Longer Valcyte Treatment Provides Better Protection Against Cytomegalovirus (CMV) Disease CMV is the Most Serious Viral Infection Affecting Transplant Patients

Basel, Switzerland (ots/PRNewswire) - - For Non-US Media Only

New Phase III study results presented for the first time today at the ninth annual American Transplant Congress 2009 (ATC) demonstrate that doubling the duration of preventive therapy ('prophylaxis') with Valcyte (oral valganciclovir), significantly reduces the incidence of CMV disease by 56% in high-risk kidney transplant patients within the first year post-transplant.(1)

CMV is a major cause of morbidity and mortality during the first six months after transplantation(2),(3) and is a key concern for transplant recipients and physicians. While 100-day Valcyte prophylaxis has been the standard for providing protection against CMV infection and disease, studies have shown that over 30% of patients can develop late onset CMV disease after treatment has ceased.1,(4),(5)

"As transplant physicians, we go to significant lengths to safeguard the health of the organ and patient post-transplant. We already recognise the terrible damage that CMV can cause to graft and patient," said Primary Investigator, Dr. Atul Humar, Director, Transplant Infectious Diseases and Associate Professor, Department of Medicine, University of Alberta, Canada. "Today's results show that continuing to treat with Valcyte for longer can help make a difference."

The IMproved Protection Against Cytomegalovirus in Transplant (IMPACT) study shows that 200-day Valcyte prophylaxis significantly reduces the proportion of patients with CMV disease within the first year post-transplant to 16%, compared to 37% with 100-day Valcyte prophylaxis (p<0.0001).1 No significant difference was detected in overall safety and tolerability, demonstrating that extended treatment poses no additional risk to patients.1

Roche has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMEA) for 200-day prophylaxis therapy based on the results of the IMPACT study. Further analyses will also be presented later this year at the European Society for Organ Transplantation (ESOT) in Paris, France, 30 August - 2 September.

About the IMPACT Study

IMPACT is a global, multi-centre (65 centres in 13 countries), double-blind study that randomised 326 high-risk (donor CMV seropositive/recipient CMV seronegative) kidney allograft recipients to one of two treatment groups:

    - 100 days of Valcyte (900 mg once daily) post-transplant followed by 100
      days placebo
    - 200 days of Valcyte (900 mg once daily) post-transplant 

The primary endpoint was the proportion of patients who developed CMV disease within the first 52 weeks (12 months) post-transplant. Secondary endpoints included safety and tolerability, time to CMV disease, time to CMV infection, acute rejection and graft loss.

The results demonstrated that 200-day Valcyte prevented CMV disease in 84% of patients and significantly reduced the incidence of CMV disease by 56%, compared to the current standard of care (100-day Valcyte therapy) (p<0.0001). In addition, extending Valcyte prophylaxis up to 200 days significantly reduced CMV viremia (spread of the CMV virus into the bloodstream and a known risk factor for developing CMV disease) from 51% with 100-day Valcyte prophylaxis to 37% with 200-day Valcyte prophylaxis (p=0.0149).

About CMV

CMV belongs to the family of herpes viruses(6) and is very common among the general population. It is estimated that 50-80% of all adults have been infected with the CMV virus.(7) In the majority of cases the virus lies dormant in the body throughout life, but can be reactivated at times when the immune system is weakened (for example, transplant patients and AIDS patients).(8) CMV is the most important serious infection complicating solid organ transplantation.(9),(10),(11) Transplant patients may already be infected with CMV prior to transplantation or receive a donor organ infected with CMV. CMV infection usually develops during the first few months after transplantation and may cause complications in the lungs, kidneys, nervous system, liver and gastrointestinal tract.11 If left untreated, the mortality rate can be as high as 90%.(12)

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: http://www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References

(1) Humar A, Lebranchu Y, Vincenti F et al. The IMPACT Study: Valganciclovir Prophylaxis for Until 200 Days Post-Transplant in High Risk Kidney Recipients Substantially Reduces the Incidence of CMV Disease. Presented at the American Transplant Congress 2009, Boston, USA. Monday 1 June. Abstract #201

(2) Hodson EM, Craig JC, Strippoli GFM et al. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients (Review). Cochrane Database of Systematic Reviews 2009;1:1-252

(3) Fishman JA, Rubin RH. Infection in Organ-Transplant Recipients. New Eng J Med 1998;338 (24):1741-1751

(4) Paya C, Humar A, Dominguez E et al. Efficacy and Safety of Valganciclovir vs. Oral Ganciclovir for Prevention of Cytomegalovirus in Solid Organ Transplant Recipients. Am J Transplantation 2004;4:611-620

(5) Limaye AP, Bakthavatsalam R, Kim HW et al. Impact of Cytomegalovirus in Organ Transplant Recipients in the Era of Antiviral Prophylaxis. Transplantation 2006;81(12):1645-52

(6) Centers for Disease Control and Prevention. Frequently Asked Questions About CMV. Available at: http://www.cdc.gov/cmv/faqs.htm (Last accessed on 27 March 2009)

(7) PatientUK. Cytomegalovirus (CMV). Available at: http://www.patient.co.uk/showdoc/40000377/ (Last accessed on 27 March 2009)

(8) Health Protection Agency North West. Cytomegalovirus Information Leaflet. Available at: http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1194947317758 (Last accessed on 27 March 2009)

(9) Leroy F, Sechet A, Abou Ayache R et al. Cytomegalovirus Prophylaxis With Intravenous Polyvalent Immunoglobin in High-Risk Renal Transplant Recipients. Trans Proceedings 2006;38:2324-2326

(10) van Son WJ, de Maar EF, van der Bij W et al. Overcoming the Problem of Cytomegalovirus Infection after Organ Transplantation: Calling for Heracles? Intervirology 1999;42:285-290

(11) Stitt NL 2003. Infection in the Transplant Recipient. Organ Transplant (Medscape Online). Available at: http://www.medscape.com/viewarticle/451788 (Last accessed on 27 March 2009)

(12) Pescovitz MD. Prevention and Treatment of Cytomegalovirus Disease in Solid Organ Transplant Recipients: The Clinical and Economic Impact of Evolving Strategies. Am J Health-Syst Pharm 2003;60(23):S3-S4.

Contact:

For further information, please contact: Julia Pipe, International
Communications Manager, Roche Transplant, Mobile tel:
+41-79-263-9715, Office tel: +41-61-687-4376, E-mail:
julia.pipe@roche.com; Helen Swift, Tonic Life Communications, Office
tel: +44-20-7798-9924, E-mail: helen.swift@toniclc.com

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