2007-09-13

Roche Launches Another Large Study With PEGASYS Plus COPEGUS


Basel, Switzerland (ots/PRNewswire) -

- PROPHESYS Will Identify Factors That Influence Early Response toTreatment

Roche announces the start of a large multinational observationalstudy, called PROPHESYS, in patients with hepatitis C (HCV). Thisinternational cohort study will evaluate the important factors thatgive hepatitis C patients the best chance of treatment success withPEGASYS(R) (peginterferon alfa-2a (40 KD)) plus COPEGUS(R)(ribavirin). PROPHESYS (PROspective observational study on Predictorsof early on-treatment response on sustained virological response in acoHort of trEatment naïve HCV patientS treated with pegYlatedinterferonS) is the largest study of its kind and will identifyfactors that influence a patient's response to treatment. It is wellknown that patients who respond early to treatment are more likely toachieve a sustained virological response (SVR or cure) and have lesschance of relapse.

"For patients with hepatitis C, early response to treatment leadsto the best chance of a cure. The PROPHESYS study will establish whatfactors help a patient to respond early and will give doctors abetter understanding of treatment success," said Mario Rizzetto,Professor of Gastroenterology at the University of Torino, Italy, andlead 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 InfluencesOverall Success

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

The study will examine whether it is possible to predict if apatient will achieve a cure based on his or her response to treatmentat weeks 2, 4 or 12. The study will also examine how certain factorscan influence a patient's chance for an early response, sustainedvirological response (SVR or cure) and relapse. Factors beingevaluated 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 thestudy. Enrolment is ongoing and the study is expected to conclude in2010.

"Roche recognises that there is a need to examine how on-treatmentresponse can influence the overall success for people with HCV, whichis why we are launching PROPHESYS," said Claire Steers, PEGASYSLifecycle Leader at Roche in Basel, Switzerland. "This ongoingresearch underscores Roche's long-term commitment to curing morepeople of hepatitis C."

About Hepatitis C

Hepatitis C, the most common chronic blood-borne infection, istransmitted primarily through blood or blood products. Hepatitis Cchronically infects 180 million people worldwide, which makes it overfour times more prevalent than HIV.(1),(2) It is a leading cause ofcirrhosis, liver cancer and liver failure, despite the fact thatmany patients can be cured.

Efficacy of PEGASYS plus COPEGUS Combination Therapy

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

About Roche COBAS(R) TaqMan(R) Tests

For more than a decade, Roche Diagnostics has been the worldleader in providing molecular diagnostic tests for Hepatitis C,Hepatitis B, HIV, cytomegalovirus (CMV), and other infectiousdiseases, and was the first to develop and commercialise real-timePCR, the new gold standard in molecular testing. Roche's broadportfolio of virology tests are designed to improve diseasemanagement through diagnosis of active infections, quantification ofthe amount of virus in the blood (viral-load monitoring) andidentification of treatment failure and disease recurrence. With afocus on helping to improve answers for doctors and patients andefficiency for labs, in 2005 Roche introduced the fully automatedCOBAS(R) AmpliPrep/COBAS TaqMan(R) platform, the first system tofully automate real-time PCR testing. It provides labs with flexibleconfigurations, true walk-away capabilities and improved test-resultintegrity.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world'sleading research-focused healthcare groups in the fields ofpharmaceuticals and diagnostics. As the world's biggest biotechcompany and an innovator of products and services for the earlydetection, prevention, diagnosis and treatment of diseases, the Groupcontributes on a broad range of fronts to improving people's healthand quality of life. Roche is the world leader in in-vitrodiagnostics and drugs for cancer and transplantation, a market leaderin virology and active in other major therapeutic areas such asautoimmune diseases, inflammation, metabolic disorders and diseasesof the central nervous system. In 2006 sales by the PharmaceuticalsDivision totalled 33.3 billion Swiss francs, and the DiagnosticsDivision posted sales of 8.7 billion Swiss francs. Roche has R&Dagreements and strategic alliances with numerous partners, includingmajority ownership interests in Genentech and Chugai, and investsapproximately 7 billion Swiss francs a year in R&D. Worldwide, theGroup employs about 75,000 people. Additional information isavailable 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://www.who.int/vaccine_research/diseases/viral_cancers/en/index2.html.)

(2). AIDS Epidemic Update. 2006. (Accessed February 27, 2007, athttp://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 chronichepatitis C: a randomized study of treatment duration and ribavirindose. 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 virusinfection in HIV-infected patients. N Engl J Med 2004;351(5):438-50.

(5). Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2aplus ribavirin for chronic hepatitis C virus infection. N Engl J Med2002;347(13):975-82.

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

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

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

ots Originaltext: Roche PharmaceuticalsIm 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

Roche Pharmaceuticals

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