Cingles Info

Roche's ribavirin Copegus available in all EU Countries within months
Hepatitis C drug completes Mutual Recognition Procedure in the European Union
Roche announced today that it had received confirmation that the Mutual
Recognition Procedure has been completed for its proprietary ribavirin, Copegus.
This important milestone means that all EU member states have agreed to approve
Copegus for the treatment of chronic hepatitis C in combination with interferon
alfa-2a (Roferon A) or peginterferon alfa-2a (40 KD) (Pegasys).
"Today's approval of our stand-alone application means that we have satisfied
all European Union member states of the safety and efficacy of the Copegus/
Pegasys combination treatment in patients infected with the hepatitis C virus ,"
said William M. Burns, head of the pharmaceutical division at Roche, adding that
"this paves the way for the commercial availability of Copegus in all EU
countries within one to three months. This is very important news as combination
therapies are now standard for the treatment of hepatitis C."
The Dutch Medicines Evaluation Board, as the EU Reference Member State, first
approved Copegus on April 9th which started this two-step approval process.
National approvals will follow swiftly as Copegus is now an approved drug.
Copegus is manufactured by Roche as a light pink, oval shaped, film-coated
tablet containing 200 mg of ribavirin.
Copegus is indicated for the treatment of adult patients with chronic hepatitis
C who have not previously been treated, including patients with fibrosis or
compensated cirrhosis. It is also indicated for the treatment of adult patients
who have responded to interferon alpha monotherapy but have since relapsed.
Copegus is always prescribed as a combination regimen with interferon alfa-2a
(Roferon A) or peginterferon alfa-2a (40 KD) (Pegasys).
About Pegasys
Pegasys, a new generation hepatitis C therapy that is different by design,
provides significant benefit over conventional interferon therapy in patients
infected with HCV 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 now been approved in 47 countries, including the European Union. In
the EU, it is indicated for the treatment of histologically proven chronic
hepatitis C in adult patients, including patients with early stage cirrhosis. It
is approved both as a combination therapy with ribavirin and as monotherapy. In
the United States, Pegasys in combination with Copegus was granted a priority
review by the FDA and its approval is anticipated 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-orientated healthcare groups. The company's two core businesses in
pharmaceuticals and diagnostics provide innovative products and services, that
address prevention, diagnosis and treatment of diseases, thus enhancing people's
health and quality of life. The two core businesses achieved a turnover of 13,1
billion Swiss Francs in the 1st half of 2002 and employed about 57'000 employees
worldwide.
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.
All trademarks used or mentioned in this release are legally protected.
Your IR contacts:
Dr. Karl Mahler Dr. Mathias Dick Dianne Young
Tel: +41 (61) 687 85 03 Tel: +41 (61) 688 80 27 Tel: +41 (61) 688 93 56
email: karl.mahler@... email: mathias.dick@... email:
dianne.young@...
US investors please contact:
Richard Simpson
Tel: +41 (61) 688 48 66
email: richard.simpson@...
With best regards,
Your Roche Investor Relations Team
F. Hoffmann-La Roche Ltd
Investor Relations
Grenzacherstrasse 68 / Postfach
4070 Basel
http://ir.roche.com/
email: investor.relations@...
phone: ++41 61 688 88 80
fax: ++41 61 691 00 14