European Approval for Roche's Pegasys Personalises Treatment for a Subgroup of Hepatitis C Patients: Chance for Cure With Only Four Months of Treatment

Basel, Switzerland (ots/PRNewswire) -

- Roche Also Announces Start of NCORE Study to Determine Best
Length of Treatment in Patients who do not Experience a Rapid
Response

Roche announced today that the European Commission has approved a
shortened, 16-week course of treatment with Pegasys (peginterferon
alfa-2a (40 KD)) plus Copegus (ribavirin) for certain hepatitis C
patients.

The four-month treatment course will be for patients with
particular strains of chronic hepatitis C (genotype 2 or 3) who have
low virus levels before starting treatment, and who show a rapid
virological response by clearing the virus from the blood within the
first 4 weeks of treatment. This shorter treatment duration with
Pegasys/Copegus will provide patients with the full benefits of
therapy while reducing unnecessary drug exposure.

This is good news for eligible patients as previously, all
patients with genotype 2 or 3 hepatitis C (HCV) received 24 weeks of
Pegasys/Copegus therapy, regardless of their baseline virus levels
and response while on treatment.

The approval marks an important milestone in a new treatment
concept in hepatitis C, which is called "response-guided therapy" and
seeks to customise regimens for patients based on how well they
respond to treatment. Response-guided therapy is enabled by the use
of Roche's highly sensitive, real-time PCR diagnostic tests, which
accurately measure the levels of virus in the patient's blood. The
automated COBAS AmpliPrep/COBAS TaqMan HCV Test is the newest and
most advanced Roche product for measuring hepatitis C virus levels.
The test is widely used in many global markets, and is pending FDA
approval in the United States.

"Response-guided therapy in hepatitis C is an excellent example
of how Roche is uniquely positioned to individualise healthcare and
deliver real benefit to patients, physicians and healthcare payers by
combining the power of innovative pharmaceuticals and diagnostics,"
said William M. Burns, CEO, Roche Pharmaceuticals Division. "This
approval for 16 weeks of treatment in genotype 2 and 3 patients with
a rapid response demonstrates the value of using diagnostic tools to
determine an individual treatment regimen and hopefully will
encourage more eligible patients to come forward for treatment.
Together with the start of yet another large clinical study with
Pegasys, NCORE, these initiatives underscore Roche's commitment to
advancing the treatment of hepatitis and making personalised medicine
a reality."

Shortening the Treatment Duration for Many

This approval is based on data from several studies that show
shorter treatment duration in patients who have a rapid response to
Pegasys/Copegus results in high cure rates, similar to those achieved
with the currently-approved 24 weeks of therapy. (1-4) An analysis of
a major study (ACCELERATE) which evaluated the efficacy and safety of
16 weeks vs. 24 weeks of treatment with Pegasys/Copegus in patients
with genotype 2 or 3 HCV -- showed that a similar number of patients
achieved a cure (82% versus 90% respectively). In patients with low
virus levels before treatment and a rapid virological response
(undetectable virus 4 weeks after starting treatment), the cure rates
for 16 and 24 weeks of treatment were essentially identical (89% vs.
94%).(5)

"This EU approval is important, as it means that we can tailor a
patient's treatment with Pegasys based on an early marker of response
without a loss in the regimen's effectiveness," said Prof Stefan
Zeuzem, Chief of the Department of Medicine I at the Johann-Wolfgang
Goethe University Hospital in Frankfurt, Germany. "This is good news
for doctors, who now have the reassurance of offering a shorter
treatment regimen, and for patients themselves, who will have the
possibility to be cured with only 16 weeks of treatment."

NCORE Study Commenced to Determine If Genotype 2/3 Patients
Without a Rapid Virological Response Need Longer Treatment

Roche also announced the launch of the NCORE study (ENhancement
of Cure Through Treatment Extension Guided by On-Treatment ResponsE
in Patients Infected with G2/3 Hepatitis C; Roche study protocol
number MV21371). The study aims to further improve treatment outcomes
by examining whether genotype 2 and 3 patients who do not have a
rapid virological response at 4 weeks should have treatment with
Pegasys and Copegus extended to 48 weeks.(6) This global study will
enrol approximately 400 patients at 90 centres in seven countries.

About Hepatitis C

The hepatitis C virus (HCV) is transmitted primarily through
blood or blood products. HCV chronically affects 180 million people
worldwide, which makes it over four times more prevalent than
HIV.(7), (8) It is a leading cause of cirrhosis, liver cancer and
liver failure, despite the fact that many patients can be cured.

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 2007 sales by the Pharmaceuticals
Division totalled 36.8 billion Swiss francs, and the Diagnostics
Division posted sales of 9.3 billion Swiss francs. Roche has R&D
agreements and strategic alliances with numerous partners, including
majority ownership interests in Genentech and Chugai, and invested
over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group
employs about 79,000 people. Additional information is available on
the Internet at http:///www.roche.com .

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References

(1). Mangia A, Santoro R, Minerva N, et al. Peginterferon alfa-2b
and ribavirin for 12 vs. 24 weeks in HCV genotype 2 or 3. N Engl J
Med 2005;352:2609-17.

(2). Yu ML, Dai CY, Huang JF, et al. A randomised study of
peginterferon and ribavirin for 16 versus 24 weeks in patients with
genotype 2 chronic hepatitis C. Gut 2007;56:553-9.

(3). Dalgard O, Bjoro K, Ring-Larsen H, Verbaan H. Peginterferon
alfa-2b and ribavirin for 14 or 24 weeks in patients with HCV
genotype 2 or 3 and rapid virological response. The NORTH-C trial.
In: 42nd Annual Meeting of the European Association for the Study of
the Liver; 2007 11-16 April; Barcelona, Spain; 2007.

(4). von Wagner M, Huber M, Berg T, et al. Peginterferon-alpha-2a
(40KD) and ribavirin for 16 or 24 weeks in patients with genotype 2
or 3 chronic hepatitis C. Gastroenterology 2005;129:522-7.

(5). CHMP. CHMP Opinion for Pegasys on a Type II Variation; 2008.

(6). Roche. Clinical study protocol MV21371 (NCORE 2/3); 2007.

(7). AIDS Epidemic Update. 2006. (Accessed October 26, 2007, at
http://www.who.int/hiv/mediacentre/2006_EpiUpdate_en.pdf.)

(8). 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
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