Roche Responds to Announcement of "IDEAL" Hepatitis C Study

Basel, Switzerland (ots/PRNewswire) - Following an announcement
from Schering-Plough, Roche today affirmed the value of PEGASYS(R)
(peginterferon alfa-2a) in combination with COPEGUS(R) (Roche's brand
of ribavirin) as the market-leading treatment for patients with
hepatitis C. Despite clear biases in the design of the "IDEAL" study
that potentially favoured patients taking PegIntron(TM)
(peginterferon alfa-2b) regimens - particularly the ribavirin dose
reduction protocol - the study results have shown that patients
treated with a PEGASYS regimen had a similar chance of being
successfully treated for hepatitis C.

"I do not expect that the results of the IDEAL study will
meaningfully impact clinical practice, except to inform physicians on
the appropriate dosing of PegIntron and to reinforce the already
widely-accepted view that optimising ribavirin dosing throughout
treatment is critical to achieving success and preventing treatment
relapse in hepatitis C," said Douglas Dieterich, M.D., Professor of
Medicine in the Division of Hepatology at Mt. Sinai School of
Medicine in New York, New York.

In 2001, the U.S. Food and Drug Administration (FDA) required
Schering-Plough to conduct a post-approval commitment trial to
determine if a lower dose of PegIntron (1.0 mcg/kg) was as effective
as the approved dose of 1.5 mcg/kg, both in combination with
identical ribavirin regimens.1 A third arm was added to the study in
which patients received PEGASYS 180 mcg with a different ribavirin
dosing schedule. This mismatch of ribavirin dosing introduces several
potential biases into the study because experts agree that an
optimised dose of ribavirin, with either pegylated interferon, is
critical to achieving success in hepatitis C treatment. In
particular, maintaining a full dose of ribavirin has shown an
important ability to reduce relapse following the end of treatment.

"PEGASYS quickly became the market leader after its launch, based
on robust clinical data and patient and physician preference. We are
convinced that physicians and patients will continue to choose the
PEGASYS plus COPEGUS combination therapy based on positive experience
and sound clinical evidence," said Rob Mitchell, Head of Viral
Diseases Strategic Marketing at Roche. "Our current focus at Roche is
on advancing the treatment of hepatitis C by optimising doses and
duration of PEGASYS and ribavirin in patients with unmet medical
need, while developing new compounds that have the potential to offer
a successful outcome to even more patients."

Roche believes that it is critical for patients and physicians to
receive complete information to fully understand the results of
"IDEAL" so that treatment decisions can be based on scientific data.

Please see below for additional information about the "IDEAL"
trial, Roche and PEGASYS including important safety information.

"IDEAL" Trial Design Issues

- Starting doses of ribavirin were different in the PegIntron and
PEGASYS arms of the study

- The design calls for a more drastic ribavirin dose reduction for
side effect management in most patients in the PEGASYS arm compared
to patients in the PegIntron arms; in some cases, ribavirin dose
reductions for patients in the PEGASYS arm were three times greater
than for patients in the PegIntron arms. This is important because a
substantial number of patients being treated for hepatitis C require
their ribavirin dose to be reduced to manage side effects, and this
could have an impact on the efficacy of the regimen

- The PEGASYS arm was not blinded, meaning that patients and
physicians knew which treatment was being administered. Many
comparative studies are blinded to ensure that bias does not
compromise the results

- Erythropoetin (EPO) is a medication that is often given to treat
ribavirin-related anemia and help patients maintain a higher
ribavirin dose. However, physicians could only prescribe EPO after
the first dose ribavirin reduction in the "IDEAL" trial. Since
patients in the PegIntron arms generally had smaller ribavirin dose
reductions, this introduces another potential bias and means those
PegIntron patients were potentially able to maintain a higher dose of
ribavirin compared to PEGASYS patients

Efficacy of PEGASYS plus COPEGUS Combination Therapy

PEGASYS was launched by Roche in 2002 and quickly became the
leading treatment for patients with hepatitis C. PEGASYS plus COPEGUS
is the only pegylated interferon combination regimen to have
demonstrated significantly superior benefits over conventional
interferon combination therapy across all HCV genotypes, irrespective
of viral load.2-4 The combination of PEGASYS and 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.2-7

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 diagnostics and
drugs for cancer and transplantation, a market leader in virology and
active in other major therapeutic areas such as autoimmune diseases,
inflammation, metabolism and 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 employs roughly 75,000 worldwide and has R&D agreements and
strategic alliances with numerous partners, including majority
ownership interests in Genentech and Chugai.

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

References:

1. FDA letter to Schering-Plough, August 7, 2001. Accessed Nov.
26, 2007 at:
http://www.fda.gov/cder/foi/appletter/2001/pegsche080701L.htm

2. Swan, T. Expediency, Cost-Cutting, Expediency Trump Science in
Clinical Development Plan for Peg-Intron: The head-to-head that
wasn't. TAGLine 2003: 10(10)1-4. Also available at:
http://www.aidsinfonyc.org/tag/taglines/0312.pdf

3. Raymond, D. The Real IDEAL: Peg-Intron vs. Pegasys. Hepatitis C
Harm Reduction Project Web site. Accessed Dec. 17, 2007 at: http://he
pcproject.typepad.com/hep_c_project/2004/05/the_real_ideal_.html

4. 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.

5. 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.

6. 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.

7. 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.

ots Originaltext: Roche Pharmaceuticals
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Contacts: Brad Jenkins, Roche, +41-61-68-86404, Michelle Marchione,
Axon Communications, +1-416-848-1419