European Commission Approval of New Indication for Roche's Pegasys(R) (peginterferon alfa-2a) Offers Hepatitis C Patients a Second Chance for a Cure

Basel (ots/PRNewswire) -

- Pegasys is the First and Only Pegylated Interferon to be
Approved for Treatment of up to 72 Weeks in Treatment-Experienced
Patients

Roche announced today that the European Commission has approved
Pegasys(R) (peginterferon alfa-2a (0 KD)) plus Copegus(R) (ribavirin)
for the retreatment of hepatitis C patients who were not successfully
treated with an initial course of interferon alpha (pegylated or
non-pegylated), either alone or in combination with ribavirin.

Although exciting advances in the treatment of hepatitis C have
been made in recent years, a significant number of patients do not
achieve treatment success (sustained virological response (SVR)
widely equated to cure(1)) with their first treatment. This results
in a large and growing population of patients who urgently need
alternative treatment solutions. Today's approval provides a
significantly broader indication for peginterferon alfa-2a and
establishes a new standard of care for treatment-experienced patients
with the most difficult-to-treat virus.

"This new indication for Pegasys plus Copegus is another
demonstration of Roche's commitment to extend the promise of a cure
to as many chronic hepatitis C patients as possible," said William M.
Burns, CEO, Roche Pharmaceuticals Division. "Our approach is to
optimise and individualise treatment to increase patients' chance of
success with Pegasys and Copegus, while establishing them as the
backbone for combination with novel agents in development, both by
Roche and through external partnerships and collaborations".

The new label for treatment-experienced patients contains several
aspects of Personalised Healthcare, a major focus for Roche which
seeks to tailor medicines for better disease management:

- The recommended length of peginterferon alfa-2a treatment for
patients is based on their virus genotype and type of prior
treatment. For patients with genotype 1 virus who did not respond to
initial treatment with pegylated interferon and ribavirin, it is
recommended that they be retreated with peginterferon alfa-2a for an
extended period of 72 weeks. Peginterferon alfa-2a is now the first
and only pegylated interferon to be approved for a 72-week treatment
duration in this patient population. For all other
treatment-experienced patients, the recommended treatment period is
48 weeks.

- The label recommends that after 12 weeks of treatment, a
patient's virus levels be measured to determine whether a full course
of treatment is likely to result in a cure.

A large, Roche-sponsored study called REPEAT demonstrated that 72
weeks of retreatment with peginterferon alfa-2a plus ribavirin
doubled the chance of a achieving a cure, compared to 48 weeks, in
patients who were prior non-responders to PegIntron(TM)
(peginterferon alfa-2b) and ribavirin. Furthermore, the study showed
that 57% of patients who responded by week 12 (defined as HCV RNA
levels of less than 50 IU/mL) went on to achieve a cure with 72 total
weeks of retreatment.

"The high predictability of response at week 12 with Pegasys plus
Copegus should be an important factor when considering whether to
retreat hepatitis C," said Prof Patrick Marcellin, Professor of
Hepatology at the University of Paris and Head of the Viral Hepatitis
Research Unit in Hôpital Beaujon, Clichy, France. "It means that
physicians and patients will be able to determine -- after only three
months -- whether treatment is likely to result in a cure".

The safety profile for peginterferon alfa-2a plus ribavirin in
prior non-responders was similar to that seen in patients being
treated for the first time. Further analyses of the 72-week treatment
in REPEAT showed a favourable benefit/risk ratio for the longer
duration, because more patients were able to achieve a cure than with
48 weeks of therapy.(2) The most common side effects of treatment are
flu-like symptoms, fatigue, depression and haematological
abnormalities.

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.(3-4) It is a leading cause of cirrhosis, liver cancer and liver
failure, despite the fact that many patients can be cured. In Europe
alone, HCV is estimated to cause more than 86,000 deaths every
year.(5)

A recent study examining the HCV-related burden of disease in 22
European countries estimated that 7.3-8.8 million people are infected
with HCV, representing 1.1-1.3% of the population. The report also
found that no uniform HCV surveillance exists at the European level,
and that authorities need to work on an EU-wide, consistent
surveillance system for HCV.6

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 80,000 people. Additional information is available on
the Internet at http://www.roche.com/ http://www.roche.com .

All trademarks used or mentioned are protected by law.

References
1. Swain M, Lai M, Shiffman M, Cooksley W et al. Sustained virologic
response (SVR) resulting from treatment with peginterferon alfa-2a
(40KD) (PEGASYS(R)) alone or in combination with ribavirin
(COPEGUS(R)) is durable and constitutes a cure: an ongoing 5-year
follow-up. Abstract presented at Digestive Disease Week; 21 May 2007;
Los Angeles, California, USA.
2. Marcellin P, Craxi A, Brandão-Mello C, Di Bisceglie A. A 72-week
treatment duration with peginterferon alfa-2a (40KD) (PEGASYS) plus
ribavirin (COPEGUS) has a favorable risk:benefit ratio in non-
responders to pegylated interferon alfa-2b (12KD) plus ribavirin:
findings of the multinational REPEAT study. Abstract presented at the
American Association for the Study of Liver Disease; 31 October 2008;
San Francisco, California, USA.
3. AIDS Epidemic Update. 2006. (Accessed October 26, 2007, at
http://www.who.int/hiv/mediacentre/2006_EpiUpdate_en.pdf.)
4. 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.)
5. Siebert U, Muhlberger N and Zeuzem S. Pan European Perspectives on
Hepatitis C. Volume 1: Burden of Disease. Pg. 10.
6. Siebert U, Muhlberger N and Zeuzem S. Pan European Perspectives on
Hepatitis C. Volume 1: Burden of Disease. Pgs. 6 and 8.

Roche Group Media Office:
Phone: +41-61-688-8888 / Email: basel.mediaoffice@roche.com
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- Claudia Schmitt

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