Basel, Switzerland

[Guest guest]

June 21, 2002:

Pegasys marketing authorisation granted by European Commision

5 million European

hepatitis sufferers get access to new hepatitis C treatment offering

improved efficacy against all forms of the disease

Basel, Switzerland –

21 June

2002 - Roche announced today that

Pegasys® (peginterferon alfa 2-a (40KD)), a new generation

pegylated interferon for the treatment of hepatitis C, has been granted

marketing authorization by the European Commission. The decision was based

on the unanimous positive opinion adopted by the Committee for Proprietary

Medicinal Products on March

21, 2002.

This license allows millions of

hepatitis C patients in the European Union to access a treatment with

increased efficacy, even for those with the more difficult-to-treat forms

of the disease.

" Today is a very important

day for Roche and for PEGASYS, " said M. Burns, head of the

pharmaceutical division at Roche. " Many European physicians and

patients have participated in our clinical trial program with Pegasys and

they have seen first-hand the excellent results. Now many more can benefit

from this treatment, which offers an excellent chance for a cure. "

Pegasys is indicated for the

treatment of histologically proven chronic hepatitis C in adult patients,

including patients with early stage cirrhosis. It is approved for use both

as a combination therapy with ribavirin and as monotherapy for those

intolerant to ribavirin. This license will also form the basis for approval

in Central and Eastern European countries later this year.

The authorization is based on

three pivotal monotherapy trials and one combination trial with ribavirin.

The Pegasys data shows that:

Pegasyscombination therapy shows

significant improvements over conventional therapy, in all disease types

regardless of the patient's viral load.

Of the patients demonstrating an

early virological response by week 12 (86% of total patients treated), 65%

went on to achieve a sustained virological response.

The European Commission noted

that the clinical benefit of Pegasys in monotherapy or combination therapy

appeared more pronounced in hard to treat forms of the disease, such as

patients with genotype 1 hepatitis C, high viral load or patients with

cirrhosis.

Copegus,

ribavirin from Roche

In order to provide combination

therapy which is the currently accepted standard of care, Roche has

developed its own anti-viral ribavirin product, Copegus. The Netherlands as the

first European country has already granted marketing authorization for

Copegus and the other European countries will follow within the coming

months.

New trial

results show even higher response rates

While the data that Roche has

submitted to the EMEA demonstrated Pegasys ' superior efficacy in

combination over interferon alfa 2-b and ribavirin, a new trial completed

recently demonstrated even higher response rates. This new landmark study

looking at duration of combination therapy and dose of ribavirin was

presented at the 37th Annual Meeting of the European Association

for the Study of the Liver held in April 2002.

The study found that PEGASYS

plus low dose ribavirin (800 mg) for just six months can cure 78% of

patients with genotype non-1 hepatitis C. Previously, patients needed a

higher dose of ribavirin or a year of therapy to achieve these results. For

the first time, patients with genotype 1(the most common form of the

disease yet also the most difficult to treat) achieved a sustained

virological response of 51% in the intent-to-treat analysis when they

received 48 weeks of treatment with a standard dose of ribavirin.

Earlier in June the US National

Institutes of Health (NIH) included the new generation of pegylated

interferons in their Consensus Statement on the management of hepatitis C.

These guidelines are generally accepted worldwide. The NIH Consensus

Conference Panel referenced clinical studies with Pegasys including the

results of two large-scale combination trials as well as the efficacy of

PEGASYS in patient populations with difficult-to-treat disease: cirrhosis

and those co-infected with HIV.

The consensus statement

acknowledged that important therapeutic advances have occurred since the

last consensus was held in 1997, particularly the introduction of pegylated

interferons and ribavirin therapy. The statement noted that the highest

response rates have been achieved with pegylated interferons in combination

with ribavirin and that genotype now influences treatment decisions. This

conclusion was based on the presentation of three large pivotal combination

therapy trials, two of which were with PEGASYS.

About PEGASYS

Pegasys, a new generation

hepatitis C therapy that is different by design, is unique in providing

benefit over conventional therapy in patients of all genotypes. The

benefits of Pegasys are derived from its new generation large 40 kilodalton

branched-chain polyethylene glycol (PEG) construction, which allows for

true seven-day viral suppression and is preferentially distributed to the

liver, the primary site of infection. PEGASYS is administered once weekly

in an easy-to-use pre-filled syringe with a fixed 180 mcg starting dose for

all patient types.

Pegasys has been approved in 24

countries since its first approval in Switzerland in

August 2001. Shortly Pegasys will be commercially available in all European

member states and it is already available in Argentina, Brazil, Bahrain,

Belarus, Cambodia, Columbia, Costa Rica, Dominican Republic, Ecuador,

Egypt, El Salvador, Guatemala, Israel, Kuwait, Mexico, Morocco, Panama,

Peru, Russia, Syria, United Arab Emirates, Uruguay and Venezuela. PEGASYS

has also been submitted for review by regulatory authorities in the United

States and Roche

expects approval there later this year.

About

Hepatitis C

Hepatitis C is a serious

blood-born viral infection that attacks the liver, and in many patients it

leads to liver disease, cirrhosis and cancer. It is the leading cause of

liver transplantation. Only identified in 1989, the HCV virus has infected

more than 170 million people world-wide, making it more common than the HIV

virus.

About Roche

Headquartered in Basel, Switzerland, Roche

is one of the world’s leading research-oriented healthcare groups in

the fields of pharmaceuticals, diagnostics and vitamins. Roche’s

innovative products and services address needs for the prevention,

diagnosis and treatment of disease, thus enhancing people’s

well-being and quality of life.

Roche is committed to the viral

hepatitis disease area, having introduced Roferon-A for hepatitis C,

followed by Pegasys in hepatitis C, with studies currently being conducted

on its efficacy in hepatitis B. Roche also manufactures The COBAS AMPLICORä

HCV Test, v2.0 and the AMPLICOR HCV MONITORä Test, v2.0 - two tests used to

detect the presence of, and quantify, HCV RNA in a person’s blood.

Roche's commitment to hepatitis has been further reinforced by the

in-licensing of Levovirin, an alternative antiviral. Levovirin will be

studied with the objective of demonstrating superior tolerability over the

current standard, ribavirin.

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