Investor Update
Basel, 17 July 2006 1,2 3 1,2 1,2,4 1,2,4 1,2,4 1,2,4 1,2,4 1,2,4
Mircera
(C.E.R.A.) first
drug to directly convert dialysis patients to once-monthly dosing schedule
First
public presentation of Phase III data from largest ever renal anaemia clinical development program
For
the first time, clinical studies show that dialysis patients treated with short-acting and frequently
administered epoetin anti-anaemia drugs can be directly switched to a once-monthly treatment resulting
in stable haemoglobin (Hb) levels.
Dialysis patients can receive existing anti-anaemia treatments as frequently
as several times a week, depending on the drug and patient status.
The
results of three Phase III ‘maintenance’ studies – part of the largest clinical development program
ever undertaken for a drug treating renal anaemia – were presented at the annual meeting of the European
Renal Association - European Dialysis and Transplant Association (ERA-EDTA) in Glasgow, Scotland. These
included two studies using epoetin alfa/beta as a comparator and one study using darbepoetin alfa.
“This
was the first Phase III registration study that examined a once-monthly dosing interval. We were gratified
to see that C.E.R.A. maintained stable haemoglobin levels during the evaluation and extended phases
in these dialysis patients,” said Dr. Nathan Levin, Medical and Research Director of the Renal Research
Institute, New York and one of the lead investigators who presented the results of the first study.
“Haemoglobin plays an important role in improving physical function and reducing the likelihood of heart
disease, but maintaining stable haemoglobin levels can be a clinical challenge. These results with this
C.E.R.A. indicate the therapy may be a major step forward in the practical treatment of anaemia”.
Roche
filed applications with the regulatory authorities in the United States and the European Union in April
for the treatment of anaemia associated with chronic kidney disease including patients on dialysis and
not, based in part on this data. Results from the remaining Phase III correction studies will be announced
later this year.
About the Phase III Maintenance Studies
The primary objective of the studies was to demonstrate that intravenous (IV)
or subcutaneous (SC) C.E.R.A. can maintain Hb concentrations in dialysis patients on prior epoetin alfa/beta
or darbepoetin alfa therapy.
In
these maintenance
studies, which aim to keep Hb levels in a defined range over time in dialysis patients whose Hb levels
have been corrected, patients were randomized to continue their frequent treatment or convert directly
to C.E.R.A. given once every two weeks or once-monthly.
- The first study was designed to evaluate
IV
C.E.R.A dosed once every two weeks or once-monthly in the maintenance of Hb levels in dialysis
patients
previously maintained on IV epoetin alfa/beta dosed up to three times weekly.
1
Close to 90 percent of patients were receiving a three-time weekly dose of epoetins at the time they were converted.1
The difference between once-monthly IV C.E.R.A. and epoetin at short dosing intervals in the mean change in Hb was negligible (0.05g/dL), which shows a steady maintenance of Hb. According to the study protocol, these results demonstrate that IV C.E.R.A. once monthly is as effective as IV epoetin in maintaining Hb levels. (p<0.0001).1
- The
second study mirrored the first and evaluated
SC C.E.R.A at the same dosing intervals and patient population previously maintained
on SC epoetin alfa/beta.
2
The difference between once-monthly SC C.E.R.A. and epoetin in the mean change in Hb was negligible (-0.02g/dL) demonstrating a steady maintenance of Hb. According to the study protocol, these results demonstrate that SC C.E.R.A. once monthly is as effective as SC epoetin in maintaining Hb levels. (p<0.0001).2
- The third study evaluated IV C.E.R.A dosed
once every two weeks
in the maintenance of Hb levels in dialysis patients previously maintained on IV darbepoetin alfa.
3
Darbepoetin alfa was dosed once a week or once every two weeks.3
The difference between IV C.E.R.A. and darbepoetin in the mean change in Hb was negligible (0.18g/dL) demonstrating a steady maintenance of Hb. According to the study protocol, these results demonstrate that IV C.E.R.A. twice monthly is as effective as IV darbepoetin alfa in maintaining Hb levels. (p<0.0001).3
- The
data from these three multi-centre, Phase III maintenance studies showed that both IV and SC administration
of this C.E.R.A. twice a month or once monthly maintained haemoglobin levels in a seamless fashion in
dialysis patients.
1,2,4
C.E.R.A. was well-tolerated, with a safety profile characteristic of the patient population.1,2,4
About
C.E.R.A.
Roche’s
innovative investigational anti-anaemia agent is the first continuous erythropoietin receptor activator
(C.E.R.A.), which is a new class of drugs. Its activity at the receptor sites involved in stimulating
red blood cell production is different from that observed with traditional epoetin drugs. The distinct
molecular interaction of this C.E.R.A. is believed to play an important role in providing targeted,
stable and sustained control of anaemia.
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 a supplier of innovative products and services for the
early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range
of fronts to improving people’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
2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division
posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries 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 (www.roche.com).
All
trademarks used or mentioned in this release are protected by law.
References:
1.
N. Levin, S. Fishbane, S. Zieg, G. Nassar, J. Moran, G. Villa, F. Dougherty. Poster Submitted to EDTA.
Intravenous (IV) C.E.R.A. (Continuous Erythropoietin Receptor Activaor) Administered Once Every 2 Weeks
Or Once Monthly Maintains Haemoglobin (Hb) Levels in Patients With Chronic Kidney Disease, 2006, Glasgow,
Scotland.
2. W. Sulowicz, F. Locatelli, J. Balla, B. Csiky, C. Rikker, J. Aldigier, F.
Dougherty. Poster Submitted to EDTA. Subcutaneous (SC) C.E.R.A. (Continuous ErythropoietinReceptor Activator)
Administered Once Every 2 Weeks or Once Monthly Maintains Haemoglobin (Hb) Levels in Patients with Chronic
Kidney Disease (CKD) on Dialysis, 2006, Glasgow, Scotland.
3. National Kidney Foundation:
K/DOQI Clinical Practice Guidelines: 2000 Update.
4. B. Canaud, J. Braun, F. Locatelli,
G. Villa, B. Vlem, D. Guajardo, F. Dougherty. Intravenous (IV) C.E.R.A. (Continuous Erythropoietin Receptor
Activator) administered once every 2 weeks maintains stable haemoglobin (Hb) levels in patients with
chronic kidney disease (CKD) on dialysis, 2006, Glasgow, Scotland.