Roche Launches Another Large Study With PEGASYS Plus COPEGUS

Basel, Switzerland (ots/PRNewswire) -

- PROPHESYS Will Identify Factors That Influence Early Response to
Treatment

Roche announces the start of a large multinational observational
study, called PROPHESYS, in patients with hepatitis C (HCV). This
international cohort study will evaluate the important factors that
give hepatitis C patients the best chance of treatment success with
PEGASYS(R) (peginterferon alfa-2a (40 KD)) plus COPEGUS(R)
(ribavirin). PROPHESYS (PROspective observational study on Predictors
of early on-treatment response on sustained virological response in a
coHort of trEatment naïve HCV patientS treated with pegYlated
interferonS) is the largest study of its kind and will identify
factors that influence a patient's response to treatment. It is well
known that patients who respond early to treatment are more likely to
achieve a sustained virological response (SVR or cure) and have less
chance of relapse.

"For patients with hepatitis C, early response to treatment leads
to the best chance of a cure. The PROPHESYS study will establish what
factors help a patient to respond early and will give doctors a
better understanding of treatment success," said Mario Rizzetto,
Professor of Gastroenterology at the University of Torino, Italy, and
lead investigator of the study. "Large studies, such as PROPHESYS,
can define real-world clinical practice for hepatitis C."

PROPHESYS - Examining How Early Response to Treatment Influences
Overall Success

Over 5,000 patients with HCV will be treated with PEGASYS plus
COPEGUS in this large international observational study. Patients
will be monitored during treatment and for a further 24 weeks after
the end of treatment using Roche's highly sensitive COBAS(R)
TaqMan(R) real-time PCR tests to measure the amount of virus in the
patient's blood. Viral load levels will be recorded prior to
treatment, during treatment and at the end of treatment, as well as
at 12 and 24 weeks after treatment.

The study will examine whether it is possible to predict if a
patient will achieve a cure based on his or her response to treatment
at weeks 2, 4 or 12. The study will also examine how certain factors
can influence a patient's chance for an early response, sustained
virological response (SVR or cure) and relapse. Factors being
evaluated include:

- Age

- Pre-treatment viral load

- Alanine aminotransferase (ALT)

- Liver fibrosis stage

- Metabolic parameters

- Race

- Weight

- Gender

Five hundred centres within 18 countries will participate in the
study. Enrolment is ongoing and the study is expected to conclude in
2010.

"Roche recognises that there is a need to examine how on-treatment
response can influence the overall success for people with HCV, which
is why we are launching PROPHESYS," said Claire Steers, PEGASYS
Lifecycle Leader at Roche in Basel, Switzerland. "This ongoing
research underscores Roche's long-term commitment to curing more
people of hepatitis C."

About Hepatitis C

Hepatitis C, the most common chronic blood-borne infection, is
transmitted primarily through blood or blood products. Hepatitis C
chronically infects 180 million people worldwide, which makes it over
four times more prevalent than HIV.(1),(2) It is a leading cause of
cirrhosis, liver cancer and liver failure, despite the fact that
many patients can be cured.

Efficacy of PEGASYS plus COPEGUS Combination Therapy

PEGASYS plus COPEGUS is the only pegylated interferon combination
therapy to have demonstrated significantly superior benefits over
conventional interferon combination therapy across all HCV genotypes,
irrespective of viral load.(3),(4),(5) The combination of PEGASYS
plus COPEGUS consistently shows high cure rates - up to 66% overall
sustained virological response - across a number of large,
randomised clinical studies including in patients with
difficult-to-cure disease such as genotype 1 HCV, cirrhosis and
HIV-HCV co-infection.(3),(4-8)

About Roche COBAS(R) TaqMan(R) Tests

For more than a decade, Roche Diagnostics has been the world
leader in providing molecular diagnostic tests for Hepatitis C,
Hepatitis B, HIV, cytomegalovirus (CMV), and other infectious
diseases, and was the first to develop and commercialise real-time
PCR, the new gold standard in molecular testing. Roche's broad
portfolio of virology tests are designed to improve disease
management through diagnosis of active infections, quantification of
the amount of virus in the blood (viral-load monitoring) and
identification of treatment failure and disease recurrence. With a
focus on helping to improve answers for doctors and patients and
efficiency for labs, in 2005 Roche introduced the fully automated
COBAS(R) AmpliPrep/COBAS TaqMan(R) platform, the first system to
fully automate real-time PCR testing. It provides labs with flexible
configurations, true walk-away capabilities and improved test-result
integrity.

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, a market leader
in virology and active in other major therapeutic areas such as
autoimmune diseases, inflammation, metabolic disorders and diseases
of the central nervous system. In 2006 sales by the Pharmaceuticals
Division totalled 33.3 billion Swiss francs, and the Diagnostics
Division posted sales of 8.7 billion Swiss francs. Roche has R&D
agreements and strategic alliances with numerous partners, including
majority ownership interests in Genentech and Chugai, and invests
approximately 7 billion Swiss francs a year in R&D. Worldwide, the
Group employs about 75,000 people. Additional information is
available on the Internet at http://www.roche.com.

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References:

(1). Initiative for Vaccine Research, Viral Cancers, Hepatitis C.
World Health Organization, 2006. (Accessed July 24, 2006, at http://w
ww.who.int/vaccine_research/diseases/viral_cancers/en/index2.html.)

(2). AIDS Epidemic Update. 2006. (Accessed February 27, 2007, at
http://www.who.int/hiv/mediacentre/2006_EpiUpdate_en.pdf.)

(3). Hadziyannis SJ, Sette H, Jr., Morgan TR, et al.
Peginterferon- alpha2a and ribavirin combination therapy in chronic
hepatitis C: a randomized study of treatment duration and ribavirin
dose. Ann Intern Med 2004;140(5):346-55.

(4). Torriani FJ, Rodriguez-Torres M, Rockstroh JK, et al.
Peginterferon Alfa-2a plus ribavirin for chronic hepatitis C virus
infection in HIV-infected patients. N Engl J Med 2004;351(5):438-50.

(5). Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a
plus ribavirin for chronic hepatitis C virus infection. N Engl J Med
2002;347(13):975-82.

(6). Marcellin P, Brillanti S, Cheinquer H. Peginterferon alfa-2a
(40KD) (PEGASYS) plus ribavirin (COPEGUS) is an efficacious and safe
treatment for chronic hepatitis C (CHC) in patients with compensated
cirrhosis. In: 38th Annual Meeting of the European Association for
the Study of the Liver (EASL) July 3-6; 2003; Geneva, Switzerland;
2003.

(7). Heathcote EJ, Shiffman ML, Cooksley WG, et al. Peginterferon
alfa-2a in patients with chronic hepatitis C and cirrhosis. N Engl J
Med 2000;343(23):1673-80.

(8). Zeuzem S, Pawlotsky JM, Lukasiewicz E, et al. International,
multicenter, randomized, controlled study comparing dynamically
individualized versus standard treatment in patients with chronic
hepatitis C. J Hepatol 2005;43(2):250-57.

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

Contact:
Contact: Janet Kettels, Roche, +1-862-596-9084, or Natalie Henson,
Axon Communications, +44-(0)20-843-99-406


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