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{\pard\sa900\fs50\f0\i Media Release\par}
{\pard\f0\li0\ri0\sa360\sl360\fs22 Basel, 21 January 2005\line \line {\b Pegasys 
receives positive opinion in the European Union for the treatment of chronic hepatitis B} \line First 
pegylated interferon to be indicated for treating chronic hepatitis B\line \line Roche 
announced today that the Committee for Medicinal Products for Human Use (CHMP) has granted a positive 
opinion for Pegasys (peginterferon alfa-2a (40KD)) for the treatment of chronic hepatitis B. The decision 
is granted for both types of the disease - HBeAg-positive and HBeAg-negative chronic hepatitis B (CHB). 
The recommendation will now go to the EU Commission for final approval. Hepatitis B is a major public 
health concern with data suggesting that globally, more than 350 million people are infected with the 
virus and approximately one million die each year from the disease.\line \line \u8220?Today 
marks another milestone in Pegasys\u8217? history as an effective antiviral agent,\u8221? said Ciro Caravaggio, 
Head of the Hepatitis Franchise at Roche. \u8220?We set out to explore the potential of Pegasys in treating 
chronic hepatitis B and demonstrated its effectiveness against both forms of the virus and against the 
two leading medications used to treat it today, lamivudine and conventional interferon,\u8221? he said. \u8220?It\u8217?s 
also an achievement for Pegasys in that it becomes the only pegylated interferon indicated for the treatment 
of chronic hepatitis B.\u8221? \line \line In contrast to lamivudine, Pegasys works with 
a dual mode of action: it stimulates the immune system as well as inhibits virus replication. This offers 
physicians a new option with the advantages of a finite treatment duration and lasting remission from 
the disease, avoiding the burden of putting their patients on a life-long therapy. \line \line \u8220?Studies 
have shown that Pegasys offers the best chance for a sustained response, in a defined treatment period, 
for chronic hepatitis B patients,\u8221? said Professor Patrick Marcellin, Hepatologist at H\u244?pital Beaujon, 
Clichy, France and one of the lead investigators of the Phase III global studies. \u8220?Pegasys is an effective 
pegylated interferon, and the only one that has been studied directly against lamivudine. Its response 
against this agent, as well as interferon, support its use as first line therapy for chronic hepatitis 
B.\u8221?\line \line {\b The studies on which the positive opinion has been 
granted} \line The CHMP positive opinion was based on one of the largest clinical development 
programmes in chronic hepatitis B, which included three global studies in more than 1,500 patients from 
19 countries. \line \line Pegasys has been proven twice as effective as conventional 
interferon for the treatment of the most common form of chronic hepatitis B, hepatitis B e antigen (HBeAg) 
-positive chronic hepatitis B, in a multinational phase II trial. These findings were published in the 
July 2003 {\i Journal of Viral Hepatitis} {\super 1} . \line \line Two 
large-scale multinational phase III trials, in patients with both the HBeAg-positive and HBeAg-negative 
forms of chronic hepatitis B, demonstrated that after 48 weeks of therapy, more patients achieved a 
sustained response with Pegasys than with lamivudine. Furthermore, these studies demonstrated that the 
addition of lamivudine to Pegasys did not improve response rates over Pegasys alone. \line The 
phase III study results in HBeAg-negative chronic hepatitis B, which is particularly prevalent in the 
Mediterranean areas and is the most difficult-to-treat form of the disease, were published in September 
2004 in the {\i New England Journal of Medicine} {\super 2} . The results 
of the phase III study in patients with HBeAg-positive chronic hepatitis B were presented at the 2004 
Annual Meeting of the American Association for the Study of Liver Diseases{\super 3} . 
Both lead investigators have stated that the results of these trials warrant Pegasys becoming the first-line 
treatment for HBeAg-positive or HBeAg-negative chronic hepatitis B.\line \line {\b About 
Pegasys } \line Pegasys, a new generation hepatitis therapy that is different by design, 
has already become the worldwide market leader in hepatitis C. Pegasys has a dual immunomodulatory and 
antiviral mode of action. The improved pharmacokinetic profile ensures drug plasma concentrations are 
maintained at constant levels throughout the one week dosing interval. Pegasys therapy in chronic hepatitis 
B is given once weekly as a 180 \u181?g subcutaneous injection for a 48-week period.\line Pegasys 
has recently been approved for the treatment of chronic hepatitis B in Switzerland, Taiwan and Thailand. 
Approval in the US is expected this year.\line \line {\b Roche in Hepatitis} \line Roche 
is committed to the viral hepatitis disease area, having introduced Roferon-A for hepatitis B and C, 
followed by Pegasys in hepatitis C and a full development program in hepatitis B. Roche has its own 
brand of ribavirin, Copegus, which is used in conjunction with Roferon A or Pegasys for HCV. In addition, 
Roche manufactures HBV and HCV diagnostic and monitoring systems: The COBAS AMPLICOR Test, and the AMPLICOR 
MONITOR Test, two testing systems used to detect the presence of, and quantity of, HBV DNA or HCV RNA 
in a person\u8217?s blood. Roche has received a positive opinion in the EU for a new indication for Pegasys 
and COPEGUS as a treatment for patients co-infected with HIV and HCV and it has also been filed in the 
United States. More than 40,000 patients worldwide continue to participate in trials with Pegasys and 
COPEGUS as Roche examines the unmet medical needs of hepatitis C patients. Roche\u8217?s commitment to viral 
hepatitis also extends to its pursuit of strategic alliances and partnerships to develop new compounds 
for the future.\line \line {\b About Roche} \line Headquartered 
in Basel, Switzerland, Roche is one of the world\u8217?s leading research-focused healthcare groups. Its core 
businesses are pharmaceuticals and diagnostics. As a supplier of innovative products and services for 
the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts 
to improving people\u8217?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 2003 the Pharmaceuticals 
Division generated 19.8 billion Swiss francs in prescription drug sales, while the Diagnostics Division 
posted sales of 7.4 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has 
R&D agreements and strategic alliances with numerous partners, including majority ownership interests 
in Genentech and Chugai.\line \line \line {\pard\f0\li0\ri0\sa360\sl360\fs18 All trademarks 
used or mentioned in this release are legally protected.\line \line References\line  
{\super 1}  Cooksley WG, Piratvisuth T, Lee SD, et al. Peginterferon alpha-2a (40 kDa): 
an advance in the 
treatment of hepatitis B e antigen-positive chronic hepatitis B. J Viral Hepat 2003; 10:298-305.\line  
{\super 2} Marcellin P, Lau GK, Bonino F, et al. Peginterferon alfa-2a alone, lamivudine 
alone, and the two 
in combination in patients with HBeAg-negative chronic hepatitis B. N Engl J Med 2004; 351:1206-17.\line  
{\super 3} Lau GK, et al. Peginterferon alfa-2a (40KD) ( Pegasys\u174?) monotherapy and 
in combination with lamivudine 
is more effective than lamivudine monotherapy in HBeAg-positive chronic hepatitis B: results from a 
large, multinational study. Hepatology, 2004; Vol. 40 (4); Suppl. 1:171A\par}\line \par}
{\pard \par}
{\pard\sb180\f1\fs22 {\b F. Hoffmann-La Roche Ltd}\line 4070 Basel\line Switzerland \par}
{\pard\sb180\f1\fs22 Corporate Communications\line Roche Group Media Relations \par}
{\pard\sb180\f1\fs22 Tel. +41 61 688 88 88\line Fax +41 61 688 27 75\line www.roche.com \par}
}