Investor Update
Basel, 3 June 2005 1,2 .3 4 5
NeoRecormon
offers patients maximum anaemia control with minimum injection discomfort compared to Aranesp
Comparative
new French data show that subcutaneous injection of NeoRecormon is significantly less painful than Aranesp
New
data from a comparative study show that people experience significantly less pain and discomfort when
given subcutaneous injections of the anaemia treatment NeoRecormon (epoetin beta) compared to Aranesp
(darbepoetin alfa).
Commenting
on the new data Professor François Berthoux of the CHU Saint Etienne, France and scientific committee
member of the study said, “Our findings demonstrated that subcutaneous administration of NeoRecormon
causes less pain and discomfort and was better tolerated than Aranesp."
ESAs
can either be given via intravenous or subcutaneous injections. Injection into the skin of ESAs has
a number of advantages, as it allows individuals to self-administer at their convenience, treatment
can therefore continue without the need for clinic visits. In addition, the subcutaneous route of administration
is recommended in treatment guidelines for patients with chronic kidney disease (CKD) not undergoing
dialysis, for both economic and practical reasons. Subcutaneous NeoRecormon achieves the same therapeutic
effect as intravenous administration with a lower dose requirement when used in the treatment of renal
disease
The new data will be presented simultaneously at the Congress of the
European Hematology Association (EHA) in Stockholm and the European Renal Association – European Dialysis
and Transplant Association (ERA-EDTA) congress in Istanbul.
These results
are in line with those reported from a study in paediatric patients where subcutaneous injections of
Aranesp were found to be more painful that those of NeoRecormon in the majority of patients.
Study
design and results
Study design
The study was a
comparative, single centre, randomised cross-over trial involving 40 healthy volunteers. After subcutaneous
administration of saline (placebo), subjects were randomized to receive identical volumes (0.3ml) and
doses (6000 IU or 30µg respectively) of either NeoRecormon or Aranesp over 2 consecutive study
periods according to a cross-over design. For pain evaluations, a qualitative verbal scale ranging from
no pain (0) to extremely painful (5) and a 10cm un-graduated Visual Analogue Scale (VAS) (0 = no pain,
10 = maximal pain) were used.
Intent to treat (ITT) Results
Median
verbal pain score immediately after injection was 0 for placebo (0.0-1.5), 0 (0.0-1.0) for NeoRecormon
and 2 (1.0-3.0) for Aranesp (p < 0.0001, NeoRecormon vs. Aranesp). The median VAS immediately
after injections were 0.4 (0.0-2.3) for placebo, 0.5 (0.0-1.5) for NeoRecormon and 2.0 (1.4-4.2)
for Aranesp (p < 0.0001, NeoRecormon vs. Aranesp). Pain was considered moderate to severe immediately
after injection for 12.5 % of subjects on placebo, 5.4% on NeoRecormon and 37.5 % on Aranesp.
Roche in anaemia
In the field of
anaemia therapy, NeoRecormon (epoetin beta)
is Roche’s leading treatment for anaemic patients with kidney disease and cancer with over 15 years
of experience. Patients who are anaemic and who have renal disease or cancer benefit from treatment
with NeoRecormon because it helps give back the energy they need to live the lives they are used to.
Roche is developing the first Continuous Erythropoietin Receptor Activator
(CERA) for global commercialisation in renal and cancer related anaemia. CERA is the first of a new
class of continuous erythropoietin receptor activators. CERA has a different activity at the receptor
which, based on current results, promises to deliver rapid, stable and sustained correction of anemia.
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 2004 sales by the Pharmaceuticals
Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 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. Additional
information about the Roche Group is available on the Internet (www.roche.com).
References
1.
B. Coiffier, F. Berthoux, P. Fiorentini, F. Montestruc. Pain at the injection site; results of a cross-over
study comparing epoetin beat and darbepoetin alfa administered subcutaneously in healthy volunteers.
Poster 0281. Congress of the European Hematology Association (EHA) Stockholm, 2005
2.
G Choukroun, S Gelu-Mantoulet, S Rouanet, A de Chasteigner, F Montestruc, F Berthoux. Pain at the Injection
Site: Results of the first cross-over study comparing Epoetin beta and Darbepoetin alfa administered
subcutaneously in healthy volunteers. Poster, June 6, European Renal Association – European Dialysis
and Transplant Association (ERA-EDTA), Istanbul, 2005.
3. Besarab A, Reyes CM and Hornberger
J Am J Kidney Dis 2002 40:3 439-46.
4. Locatelli F, et al: European Best Practice Guidelines
Working Group. Revised European best practice guidelines for the management of anaemia in patients with
chronic renal failure. Nephrol Dial Transplant 19 (Suppl 2) : 1-47, 2004
5. Schmitt CP,
Brummer C, Rosenkranz J et al. Increased injection pain with darbepoetin alpha compared to epoetin beta:
a double-blind study in pediatric patients. Poster SU-PO068, 37th Annual Meeting of the American Society
of Nephrology; October 29-November 1 2004.