Roche Progresses its Oral Polymerase Inhibitor Into Phase II Development Study in Patients With Hepatitis C

Basel, Switzerland (ots/PRNewswire) -

- FDA Grants Fast Track Status to R1626

Roche announced today the start of the first phase II development
study to evaluate R1626, their promising new polymerase inhibitor,
for the treatment of hepatitis C. The investigational drug has also
been granted Fast Track status by the US Food and Drug Administration
(FDA), a program designed to facilitate the development and to
expedite the review of new drugs with the potential to help treat
serious or life-threatening conditions.

R1626 has been shown in an earlier study to have a strong
antiviral effect against the hepatitis C virus. In the phase I
study[1] , the drug achieved significant reductions in viral load in
chronic hepatitis C patients infected with the difficult-to-cure
genotype 1 virus. By moving R1626 into phase II trials, Roche
signifies its commitment to finding more therapeutic solutions for
patients with hepatitis C. This trial will evaluate the safety and
antiviral effects of R1626 in combination with the current standard
of care for hepatitis C, Roche's PEGASYS (peginterferon alfa-2a
(40KD)) and COPEGUS (ribavirin).

"New medicines such as R1626 have strong antiviral activity and
could be very effective in helping patients to clear the virus,
especially when used in combination with current treatments," said
Dr. Paul Pockros, Head of the Division of Gastroenterology/Hepatology
at The Scripps Clinic and lead investigator of the study. "We know
that current hepatitis therapies cure about half of all patients
infected with the most common and difficult-to-treat genotype 1
virus, so a product that could potentially improve cure rates is much
needed."

About the phase II trial

This on-going multicenter phase II trial that is enrolling
patients with genotype 1 chronic hepatitis C who have not previously
received treatment.

Patients are randomised into four treatment groups. These
treatment groups are:

- Group A: R1626 1500mg twice a day + Pegasys 180mcg as a
subcutaneous injection every week for 4 weeks

- Group B: R1626 3000mg twice a day + Pegasys 180mcg as a
subcutaneous injection every week for 4 weeks

- Group C: R1626 1500mg twice a day + Pegasys 180mcg as a
subcutaneous injection every week + Copegus 1000-1200mg daily for 4
weeks

- Group D: Pegasys 180mcg as a subcutaneous injection every week +
Copegus 1000-1200mg daily (standard of care group) for 4 weeks

Following the first 4 weeks of treatment, all patients will
receive Pegasys 180mcg subcutaneously every week + Copegus
1000-1200mg daily for another 44 weeks, making the total treatment
duration of 48 weeks. The objectives of the study are to evaluate the
4 week safety and antiviral effect of combining R1626 with Pegasys
alone or R1626 with Pegasys plus Copegus.

The study is currently enrolling patients in the US. Patients and
healthcare providers interested in the trial can find more
information at www.roche-trials.com.

About Fast Track status

The criteria for Fast Track status are that the product's
indication represents a serious or life-threatening condition and the
product has the potential to meet an unmet medical need in treating
the condition. Fast Track allows for increased communication between
the sponsor and the FDA during the product's development and enables
a "rolling submission," which means Roche can submit materials on an
ongoing basis which can facilitate the eventual review process for
R1626.

"We are delighted to receive the Fast Track designation from the
FDA as this recognizes the potential important clinical role for
R1626 in reducing viral load and helping patients to clear hepatitis
C virus" said Nick Cammack, Head of Viral Diseases Research, Roche
"The development of this new treatment R1626 along with our extensive
partnerships with other companies and our ongoing research with
PEGASYS underscores our long-term commitment to finding effective
therapies to benefit patients with chronic hepatitis C."

About Hepatitis C

Hepatitis C, the most common chronic blood-borne infection, is
transmitted primarily through blood or blood products. Hepatitis C
chronically infects 170 million people worldwide[2], with an
additional three to four million people newly infected each year. It
is a leading cause of cirrhosis, liver cancer and liver failure.

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 a supplier of innovative products
and services for the early detection, prevention, diagnosis and
treatment of disease, the Group contributes on a broad range of
fronts to improving people's health and quality of life. Roche is a
world leader in diagnostics, the leading supplier of medicines for
cancer and transplantation and a market leader in virology. In 2005
sales by the Pharmaceuticals Division totalled 27.3 billion Swiss
francs, and the Diagnostics Division posted sales of 8.2 billion
Swiss francs. Roche employs roughly 70,000 people in 150 countries
and has R&D agreements and strategic alliances with numerous
partners, including majority ownership interests in Genentech and
Chugai. Additional information about the Roche Group is available on
the Internet (www.roche.com).

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References:

[1] Roberts S, Cooksley G, et al. Interim results of a multiple
ascending dose study of R1626, a novel nucleoside analog targeting
HCV polymerase in chronic HCV patients. Presented at the 41st
European Association for the Study of the Liver. April 29, 2006.

[2] Global surveillance and control of hepatitis C. Report of a
WHO Consultation organized in collaboration with the Viral Hepatitis
Prevention Board, Antwerp, Belgium. J Viral Hepat 1999;6(1):35-47.

ots Originaltext: Roche Pharmaceuticals
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Contact:
Contact: Janet Kettels, Roche, +41-79-597-82-85. Sarah Sheppard, Axon
Communications, +44-7876-618-321