For the First Time, Doctors can Predict Which Hepatitis B Patients Have the Highest Chance to Achieve Treatment Success With Pegasys(R)

Basel, Switzerland (ots/PRNewswire) -

- Immune-Boosting Effect of Pegasys Provides Patients With the
Chance for a Clinical Cure

FOR NON-UK MEDIA

New data presented today showed that, for the first time, doctors
can predict which hepatitis B patients treated with Pegasys(R)
(peginterferon alfa-2a) have the highest chance to achieve a positive
treatment outcome - and even a clinical cure.[i],[ii] The study
results represent an important step forward, as some patients will
now be able to feel confident during their Pegasys treatment about
the likelihood of beating the disease.

Several studies at the major Asia-Pacific liver disease meeting
(APASL) focused on measuring the decline in levels of a viral protein
called surface or 's'-antigen, to provide insight into the likelihood
of treatment success for patients treated with Pegasys. S-antigen
clearance, considered a clinical cure, is associated with greatly
reduced liver cancer, cirrhosis and an improved life
expectancy.[iii],[iv],[v]

'In treating hepatitis B, we need to change mindsets and raise
expectations so that patients and physicians are focused on achieving
the best possible outcome -- clearance of the s-antigen. These new
data show that measuring s-antigen decline throughout treatment can
help determine success in the long-term. Doctors can now therefore
make a strong case to certain patients that Pegasys treatment may
provide treatment success or even a clinical cure,' said Dr Patrick
Marcellin, Professor of Hepatology at the University of Paris and
Head of the Viral Hepatitis Research Unit in Hôpital Beaujon, Clichy,
France.

'Unlike anti-viral tablets for hepatitis B, which just reduce the
number of viral copies, Pegasys also boosts the body's immune system
and mobilises it to fight the disease,' commented William M. Burns,
CEO Roche Pharmaceuticals Division. 'Due to these immune-stimulating
effects, the number of patients treated with Pegasys who achieve a
clinical cure has been shown to continue increasing for years after
the end of treatment. This supports its use as a first-line therapy
for hepatitis B.'

Measuring success with Pegasys in the two types of hepatitis B

There are two types of patients with hepatitis B: those with
early disease who still have the envelope or 'e'-antigen in their
blood, and those who do not (called 'e-positive' and 'e-negative'
disease, respectively). Although some of the treatment endpoints are
different, s-antigen clearance is the ultimate goal of therapy in
both types of hepatitis B.

All patients start off with e-positive disease. For e-positive
patients, loss of the e-antigen after treatment, or
'e-seroconversion', signifies that therapy has worked well, and is a
first important indicator of treatment success. In a new study
looking at e-positive patients, the results showed that 50% of
patients whose s-antigen levels dropped significantly 24 weeks after
starting Pegasys treatment were able to achieve 'e-seroconversion',
an important treatment endpoint for these patients. Furthermore,
approximately 20% of the patients with e-seroconversion went on to
achieve s-antigen clearance, a so-called 'clinical cure', six months
after treatment had ended.[ii]

In some patients, after many years of infection, the virus
mutates and no longer produces the e-antigen; these patients are
considered e-negative. In this form of the disease, the virus evades
the body's immune system so that the infection and liver damage
return.

According to another new study presented at APASL, the number of
e-negative hepatitis B patients who achieved a clinical cure
continued to increase, even after the end of treatment with
Pegasys.[i] At year five, 12.2% of Pegasys-treated patients had
cleared s-antigen, compared with just 3.5% of lamivudine-treated
patients. Whilst modest, the number of patients who achieve s-antigen
clearance on Pegasys therapy is a breakthrough because such high
rates of s-clearance have never been shown with an oral anti-viral.
[i] Furthermore, researchers observed that s-antigen decline during
treatment was associated with the achievement of a clinical cure.[i]

The ability of a finite 48-week course of Pegasys to induce a
long-term response with increasing s-antigen clearance rates in some
patients makes it a cost-effective option compared with oral
anti-virals, which may need to be taken for life.[vi]

Measuring patients' response to therapy

New data were also presented at APASL on Roche's surface antigen
test, Elecsys HBsAg II assay.[vii],[viii],[ix] In line with Roche's
commitment to tailor treatment according to each patient's needs,
growing scientific evidence is showing that this test application for
quantitative detection of the s-antigen - currently available on a
research-only basis - represents a simple and reliable means of
testing s-antigen levels, allowing doctors to accurately assess a
patient's response to therapy and then to determine the most
appropriate treatment approach.

About chronic hepatitis B

Chronic hepatitis B is a serious global healthcare problem that
affects more than 350 million people worldwide. It is one of the
principal causes of chronic liver disease, cirrhosis, and primary
liver cancer. Approximately one million people die from chronic
hepatitis B annually, making it the tenth leading cause of death
worldwide. The ultimate objective of treatment in chronic hepatitis B
is to induce s-antigen clearance, which is associated with complete
and sustained remission of the liver disease, and improved life
expectancy and is generally equated to clinical cure.

Pegasys in hepatitis B

Pegasys is approved for the treatment of chronic hepatitis B in
over 60 countries. It is approved in the EU, the US and the People's
Republic of China, among others.

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, and is a market
leader in virology. It is also active in other major therapeutic
areas such as autoimmune diseases, inflammatory and metabolic
disorders and diseases of the central nervous system. In 2008 sales
by the Pharmaceuticals Division totalled 36.0 billion Swiss francs,
and the Diagnostics Division posted sales of 9.7 billion francs.
Roche has R&D agreements and strategic alliances with numerous
partners, including majority ownership interests in Genentech and
Chugai, and invested nearly 9 billion Swiss francs in R&D in 2008.
Worldwide, the Group employs about 80,000 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.

Additional information

-About Hepatitis, Roche Health Kiosk:
http://www.health-kiosk.ch/start_hepa.htm

-About Pegasys and Hepatitis:
http://www.roche.com/products/product-details.htm?type=product&id=86

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---------------------------------

[i] Marcellin P et al. HBsAg clearance continues to increase
after the end of treatment with PEGASYS plus or minus lamivudine:
5-year follow-up study in patients with HBeAg-negative disease.
Presented at: Asian Pacific Association for the Study of the Liver
(APASL); February 13-16, 2009; Hong Kong, China.

[ii] Lau GKK et al. HBsAg decline in patients treated with
PEGASYS and its association with post-treatment response in HBeAg
positive chronic hepatitis B. Presented at: Asian Pacific Association
for the Study of the Liver (APASL); February 13-16, 2009; Hong Kong,
China.

[iii] Marcellin P et al. Virological and biochemical response in
patients with HBeAg-negative chronic hepatitis B treated with
peginterferon alfa-2a (40KD) with or without lamivudine: results of
4-year follow-up. Presented at: 43rd Annual Meeting of the European
Association for the Study of the Liver (EASL); April 23-27, 2008;
Milan, Italy.

[iv] Fattovich G et al. Delayed clearance of serum HBsAg in
compensated cirrhosis B: relation to interferon alpha therapy and
disease prognosis. Am J Gastroenterol. 1998;93(6):896-900.

[v] Perrillo RP. Therapy of hepatitis B -- viral suppression or
eradication? Hepatology. 2006;43(2 suppl 1):S182-S193.

[vi] Hoofnagle JH et al. Management of hepatitis B: summary of a
clinical research group. Hepatology. 2007;45(4):1056-1075.

[vii] Ferruccio B et al. Use of the Elecsys(R) HBsAg II assay for
simple and accurate quantification of HBsAg levels in sera of
patients infected with HBV. Presented at: Asian Pacific Association
for the Study of the Liver (APASL); February 13-16, 2009; Hong Kong,
China.

[viii] Jidong J et al. Comparison of the sensitivity and
specificity of the Elecsys(R) HBsAg II assay with other available
assays in China for detection of HBsAg. Presented at: Asian Pacific
Association for the Study of the Liver (APASL); February 13-16, 2009;
Hong Kong, China.

[ix] Louisirirotchanakul S et al. Multiple sites for evaluation
of the performance of the Elecsys(R) HBsAg II assay. Presented at:
Asian Pacific Association for the Study of the Liver (APASL);
February 13-16, 2009; Hong Kong, China.

ots Originaltext: Roche Pharmaceuticals
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