Study Proves Longer Prophylactic Therapy With Valcyte Increases Protection Against CMV - the Most Serious Viral Infection Affecting Transplant Patients

Basel, Switzerland (ots/PRNewswire) -

- Doubling Duration of Valcyte Therapy Provides Significant
Benefit to Patients Compared to Current Standard of Care

- For Non-US Media Only

Roche announced today that a Phase III study investigating the
efficacy and safety of extended preventative therapy ('prophylaxis')
with Valcyte (oral valganciclovir) met its primary endpoint of
reducing the number of kidney transplant patients who develop
cytomegalovirus (CMV) disease within the first year
post-transplant.[1]

Valcyte is currently licensed for the prevention of CMV disease
in high-risk kidney, heart, and kidney-pancreas transplant patients
and is administered for up to 100 days post-transplant. The
successful NT18435 study was designed to investigate whether
extending therapy with Valcyte to 200 days post-transplant will
further reduce the incidence of CMV disease. Previous studies have
shown that although Valcyte administered for up to 100 days provides
high protection against CMV infection and disease throughout therapy
duration, some patients may still develop CMV infection and disease
after stopping therapy.[2],[3] Valcyte for 200 days further reduced
the risk for CMV without increasing this risk after stopping therapy.
The efficacy and safety data will be presented at an upcoming major
medical meeting.

"Valcyte is considered the gold-standard anti-CMV medication for
transplant patients, and the fact that this study has shown improved
protection from CMV by extending the course of prophylaxis is
compelling news for both physicians and patients" said Primary
investigator Dr Atul Humar, Director, Transplant Infectious Diseases
and Associate Professor, Department of Medicine, University of
Alberta, Canada, he continued, "CMV is the most common viral
infection in transplant patients. It can 'lie dormant' leaving high
risk patients more vulnerable to infection for longer than was
previously thought, placing the new organ and patient at risk. We
expect this study to provide clinically important results about the
benefits of 200-day prophylaxis with Valcyte that will translate into
tangible improvements in patient care."

About CMV

CMV belongs to the family of herpes viruses[4] and, as such, is
very common among the general population. It is estimated that 50-80%
of all adults have been infected with the CMV virus.[5] 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
(e.g. transplant patients, AIDS patients and premature infants).[6]
CMV is the most important serious infection complicating solid organ
transplantation.[7] 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, stomach, liver, brain, and eyes.[8] If left
untreated, the mortality rate can be as high as 90%.[9]

About the NT18435 Study

NT18435 is a multi-centre (65 centres in 13 countries),
double-blind study that randomised 326 high-risk (donor
positive/recipient negative) kidney allograft recipients to one of
two treatment groups:

- 100 days valganciclovir (900 mg once daily) post-transplant
followed by 100 days placebo

- 200 days valganciclovir (900 mg once daily) post-transplant

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

Roche in Transplantation

Roche is strongly committed to improving the long-term outcomes
of transplantation and enhancing the quality of life of transplant
recipients. Roche, as leader in this field, has developed innovative
therapies that improve graft and post-transplant health: CellCept(R)
(mycophenolate mofetil) is the cornerstone of low toxicity
immunosuppressant therapies. CellCept, the largest selling branded
immunosuppressive in North America, offers both physicians and
patients the possibility of an effective long-term immunosuppressive
regimen with low toxicity. Valcyte was developed for the prevention
of cytomegalovirus (CMV), a dangerous viral infection associated with
transplantation. Oral Valcyte has displaced oral and intravenous
ganciclovir as the gold standard for the management of CMV in
immunocompromised patients. In addition, Roche supports basic
research in transplantation with its funding of the independent Roche
Organ Transplantation Research Foundation (ROTRF), which directly
supports innovative research projects attracting new researchers with
novel scientific ideas to meet unmet medical needs in solid organ
transplantation.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-focused healthcare groups in the fields of
pharmaceuticals and diagnostics. As the world's biggest biotech
company and an innovator of products and services for the early
detection, prevention, diagnosis and treatment of diseases, the Group
contributes on a broad range of fronts to improving people's health
and quality of life. Roche is the world leader in in-vitro
diagnostics and drugs for cancer and transplantation, and is a market
leader in virology. It is also active in other major therapeutic
areas such as autoimmune diseases, inflammatory and metabolic
disorders and diseases of the central nervous system. In 2008 sales
by the Pharmaceuticals Division totalled 36.0 billion Swiss francs,
and the Diagnostics Division posted sales of 9.7 billion francs.
Roche has R&D agreements and strategic alliances with numerous
partners, including majority ownership interests in Genentech and
Chugai, and invested nearly 9 billion Swiss francs in R&D in 2008.
Worldwide, the Group employs about 80,000 people. Additional
information is available on the Internet at http://www.roche.com.

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

References

[1] Roche data on file

[2] Paya C 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

[3] Limaya AP et al. Impact of Cytomegalovirus in Organ
Transplant Recipients in the Era of Antiviral Prophylaxis.
Transplantation 2006; 81:1645-52

[4] Centers for Disease Control and Prevention. Frequently Asked
Questions About CMV. Accessed on 9 February 2009 at:
http://www.cdc.gov/cmv/faqs.htm

[5] PatientPlus. Cytomegalovirus (CMV). Accessed on 10 February
2009 at: http://www.patient.co.uk/showdoc/40000377/

[6] Health Protection Agency North West. Cytomegalovirus
Information Leaflet. Accessed on 9 February 2009 at
http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1194947317758

[7] Weir MR. Medical Management of Kidney Transplantation. 2005
Chapter 28: Cytomegalovirus in Renal Transplantation. Lippincott
Williams and Wilkins

[8] Medscape. Infection in the Transplant Recipient: CMV.
Accessed on 9 February 2009 at:
http://www.medscape.com/viewarticle/451788_7

[9] 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

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

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