MIRCERA Receives Positive Opinion in Europe for the Treatment of Anaemia due to Chronic Kidney Disease

Basel, Switzerland (ots/PRNewswire) - Roche announced today that
it has received a positive opinion from the European Committee for
Medicinal Products for Human Use (CHMP) recommending a marketing
authorisation be granted for MIRCERA for the treatment of anaemia
associated with chronic kidney disease. MIRCERA is a new long-acting
chemically synthesized erythropoiesis-stimulating agent (ESA).

The positive opinion recommends the following use of MIRCERA in
the treatment of anaemia associated with chronic kidney disease:

- once every two weeks as a single intravenous or subcutaneous
injection to increase haemoglobin levels (the oxygen-transporting
protein housed in red blood cells) for the initial correction of
anaemia in patients not currently treated with an ESA;

- once monthly as a single intravenous or subcutaneous injection
to maintain target haemoglobin levels for patients currently being
treated with an ESA (epoetin alfa, epoetin beta and darbepoetin alfa)
who are converted to treatment with MIRCERA.

The safety and efficacy of MIRCERA therapy in other indications
has not been established.

When approved by the European Commission, MIRCERA will become the
first and only ESA to have such a dosing schedule in the EU. This
represents a significant step forward in improving patient
management.

MIRCERA has been designed to overcome the shortcomings of
currently used ESAs. It has been shown to provide stable maintenance
of haemoglobin with only 12 injections a year (i),(ii),
(iii),(iv),(v) which may allow overworked renal units to devote more
time to other patient needs.

"As one of the largest biotechnology companies in the world, it is
Roche's ambition to create clinically differentiated medicines that
meet unmet medical needs and this positive opinion for MIRCERA marks
another milestone in this effort," said William M. Burns, CEO of the
Pharma Division at Roche. "We have been the leader in anaemia
management for many years now and we look forward to providing this
newest innovation to physicians and patients in Europe in the near
future."

The positive opinion is based on a submission which included data
from the largest Phase II-III program ever carried out for a drug
treating anaemia associated with chronic kidney disease comprising 10
global studies involving more than 2,700 patients from 29 countries.
The phase III program consisted of six pivotal studies that explored
the use of MIRCERA to correct anaemia in untreated patients and to
maintain haemoglobin after conversion from treatment regimens using
existing agents. This program consisted of two correction and four
maintenance studies of both intravenous and subcutaneous MIRCERA
given at longer dosing intervals of up to once every four weeks.

About MIRCERA

MIRCERA, is a continuous erythropoietin receptor activator that
shows a different activity at the receptor level characterized by a
slower association to and faster dissociation from the receptor, a
reduced specific activity in vitro with an increased activity in
vivo, as well as an increased half-life, in contrast to
erythropoietin. MIRCERA is the only drug to have compared itself in
its registration program to three ESAs: epoetin alfa, beta and
darbepoetin alfa.

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, a market leader in virology and active in
other major therapeutic areas such as autoimmune diseases,
inflammation, metabolism and central nervous system. In 2006 sales by
the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and
the Diagnostics Division posted sales of 8.7 billion Swiss francs.
Roche employs roughly 75,000 worldwide 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 at www.roche.com.

All trademarks used or mentioned in this release are protected by
law.

Notes to the Editor:

The Phase III study program consisted of two correction and four
maintenance studies. Correction is a term that is used to describe
the initial phase of treatment for patients with chronic kidney
disease (CKD) who have been diagnosed with anaemia but who are not
currently receiving treatment with an agent to increase their Hb
level. Maintenance refers to keeping Hb levels in a defined range
over time in patients whose Hb levels have been corrected and are
currently treated with an agent.

In correction, the primary endpoint was the haemoglobin (Hb)
response rate during the correction period. The criteria for response
was Hb increase>1 g/dL above baseline and Hb >11 g/dL during
correction period without RBC transfusion.

- The first study (AMICUS) was designed to evaluate anaemia
correction with IV MIRCERA once every 2 weeks in naïve patients with
CKD on dialysis vs. epoetin.

- The second study (ARCTOS) was designed to evaluate anaemia
correction with SC MIRCERA once every 2 weeks in naïve patients with
CKD not on dialysis vs. darbepoetin alfa

In maintenance, the primary endpoint was the change in Hb
concentration between baseline and the evaluation period:

- The first study (MAXIMA) was designed to evaluate IV CERA in the
maintenance of Hb levels in CKD patients on dialysis previously
maintained on IV epoetin. IV epoetin was dosed up to three times
weekly compared to CERA dosed once every two weeks or once every four
weeks.

- The second study (PROTOS) was designed to evaluate SC MIRCERA in
the maintenance of Hb levels in CKD patients on dialysis previously
maintained on SC epoetin. SC epoetin was administered up to three
times weekly, compared to CERA dosed either once every two weeks or
once every four weeks.

- The third study (STRIATA) was designed to evaluate IV MIRCERA in
the maintenance of Hb levels in CKD patients on dialysis previously
maintained on IV darbepoetin alfa. Darbepoetin alfa was dosed once a
week or once every two weeks compared to CERA dosed once every two
weeks.

- The fourth study (RUBRA) was designed to evaluate SC or IV
MIRCERA in a pre-filled syringe in the maintenance of Hb levels in
patients on dialysis previously maintained on epoetin. Epoetin was
administered up to three times weekly compared to CERA administered
once every two weeks.

(i) Levin N et al. Poster SO23, 43rd European Renal
Association-European Dialysis and Transplant Association (ERA-EDTA)
Glasgow, Scotland, 2006.

(ii) Sulowicz W et al. Poster: SP424, 43rd European Renal
Association-European Dialysis and Transplant Association (ERA-EDTA)
Glasgow, Scotland, 2006.

(iii) Canaud B et al. Poster: SP425, 43rd European Renal
Association-European Dialysis and Transplant Association (ERA-EDTA)
Glasgow, Scotland, 2006.

(iv) Macdougall I et al. Poster SAPO208, 39th annual meeting of
the American Society of Nephrology, San Diego, USA, 2006.

(v) Klinger M et al. Poster SAPO212, 39th annual meeting of the
American Society of Nephrology, San Diego, USA, 2006.

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

Contact:
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