Roche's Oral Polymerase Inhibitor Shows Robust Antiviral Efficacy in Treatment of Chronic Hepatitis C

Basel, Switzerland, November 2 (ots/PRNewswire) -

- Roche Progresses R1626 Into Phase IIb Study Called POLI 1

R1626, one of Roche's new investigational drugs for hepatitis C
(HCV), has shown promising antiviral efficacy when given in
combination with PEGASYS(R) (peginterferon alfa-2a (40KD)) and
COPEGUS(R) (ribavirin), according to results being presented at the
American Association for the Study of the Liver (AASLD) meeting in
Boston(1). After 4 weeks of treatment with the triple combination,
the hepatitis C virus could no longer be detected in up to 81% of the
HCV-infected patients. Patients receiving the triple combination had
a mean decrease in viral load of 5.2 log10 from baseline, indicating
a robust and rapid virological response.

R1626 belongs to a class of antivirals called polymerase
inhibitors, which are being investigated in combination with the
current standard of care, pegylated interferon and ribavirin. The
hope is that this potent combination will increase the number of
patients who manage to clear the hepatitis C virus from their system
and become cured of this disease.

Lack of Resistance Demonstrated

R1626 has also demonstrated a high barrier to the development of
resistance, according to a second abstract being presented at the
conference(2). Resistance to R1626 was not identified following
intensive testing for either 2 weeks of treatment with R1626 as
monotherapy or for 4 weeks in patients treated with R1626 in
combination with the standard of care.

"The results from this phase IIa study show that R1626 has a
profound effect when used in combination with PEGASYS plus COPEGUS,"
said Dr Paul Pockros (Scripps Clinic, San Diego, California), the
lead investigator of the study. "The synergistic antiviral effect of
R1626 along with the lack of resistance means that R1626 could be an
exciting antiviral treatment option for patients with hepatitis C if
a safe and acceptable dosage regimen can be determined in future
studies."

The study found(1):

- Up to 81% of patients treated with R1626 1500 mg BID + PEGASYS +
ribavirin had an undetectable HCV viral load by week 4 (mean
reduction of 5.2 log10 IU/ml)

- ALT, a liver enzyme, normalised in approximately 50% of patients
in R1626 treatment groups

- Most reported adverse events were mild to moderate. A higher
incidence of grade 4 neutropaenia was reported in R1626 treatment
arms (ie, 39% of patients receiving the R1626 1500 mg dose in
combination with PEGASYS and ribavirin), and it was the main reason
for dose reductions and discontinuations

Further phase II studies are underway to investigate R1626 in
combination with PEGASYS plus COPEGUS.

Start of the Phase IIb Trial

As a result of the robust antiviral effect seen in the phase IIa
study, R1626 is being progressed into a phase IIb study to further
investigate new treatment regimens, in combination with a standard or
lower dose of PEGASYS(R) plus a standard dose of COPEGUS(R). This
phase IIb trial, called POLI 1, is now open and about to enroll
patients in eight countries - Austria, Australia, Canada, France,
Germany, Italy, Spain and the US. More information about R1626 and
these clinical studies can be found on http://www.roche-trials.com.

"The strong synergistic antiviral effect seen among R1626, PEGASYS
and COPEGUS in the Phase IIa study together with the design of the
phase IIb study makes me confident that we will find the right
balance between the safety and efficacy," said Dr. Stefan Zeuzem,
Professor of Medicine at J.W.

Goethe University Hospital, Frankfurt, Germany, and a lead
investigator in this Phase IIb study.

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, with an additional
three to four million people newly infected each year(3). It is a
leading cause of cirrhosis, liver cancer and liver failure, despite
being potentially curable. The future of hepatitis C therapy is
likely to involve combinations of new small-molecule antiviral drugs
and pegylated interferon-based treatment, like PEGASYS.

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 largest 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, is a market
leader in virology and is 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.

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

References:

1. Pockros P. Robust synergistic antiviral effect of R1626 in
combination with Peginterferon alfa-2a (40KD), with or without
ribavirin - interim analysis results of phase 2a sudy. In: 58th
Annual Meeting of the American Association for the Study of Liver
Diseases; 2007 November 2-6; Boston, USA; 2007.

2. Le Pogam S. A high barrier to resistance may contribute to the
robust antiviral effect demonstrated by R1626 in HCV genotype
1-infected treatment-naive patients. In: 58th Annual Meeting of the
American Association for the Study of Liver Diseases; 2007 November
2-6, 2007; Boston, USA; 2007.

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

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

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


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