Theresa Catharina de Góes Campos

  De: PR Newswire Brasil
Assunto: Innovative Technology for Treatment of Renal Anaemia Unveiled Today
16 de junho de 2006 08:07 HORALOCAL

Innovative Technology for Treatment of Renal Anaemia Unveiled Today

- First Human Cell Line-Derived Erythropoietin Research Reported

- Abstract Numbers: 562 and 576

BASINGSTOKE, England, June 16 /PRNewswire/ -- Effective treatment of
anaemia in patients suffering from chronic kidney disease (CKD)(i) is
possible with the first erythropoietin product produced in a human
cell line.(1)
DYNEPO(R) (epoetin delta), developed using innovative gene activation
technology in a human cell line, corrects and maintains haemoglobin
levels in patients suffering from anaemia and CKD who are on
dialysis, according to the results of a study presented for the first
time today at the 11th Congress of the European Hematology
Association (EHA).(1) A second study, also presented for the first
time today, highlighted a key difference between DYNEPO and other
erythropoietin treatments - na unquantifiably low amount of a
specific carbohydrate residue compared to those treatments produced in
Chinese Hamster Ovary cell lines. This carbohydrate residue is known
to produce immune responses in humans.(2,3) Potential differences in
immunogenicity between DYNEPO and other erythropoietin treatments
have not been investigated in clinical practice.

Dr Iain MacDougall, Consultant Nephrologist and Honorary Senior
Lecturer from the Renal Unit in King's College Hospital, London
commented, "There is a pressing need for further research into the
differences between DYNEPO and conventional erythropoietin treatments
that are not produced in human cell lines. It will be fascinating to
see whether these differences will ultimately translate into specific
benefits for patients with CKD who are suffering from anaemia." By
stimulating red blood cell production in the bone marrow, DYNEPO
performs the same role as naturally occurring human erythropoietin.
The prevalence of anaemia in patients with CKD rises as kidney
function Declines(4) and in Europe, the prevalence of end stage renal
disease is estimated at 225,000, growing at 6 per cent per annum,
with more than 80 per cent of these patients on dialysis.(5)

Dr Raymond Pratt, Vice President Global Medical Affairs, Shire,
added, "Shire is proud to be involved in products produced by this
ground-breaking gene activation technology. We are committed to
bringing innovative products, like DYNEPO, to market to meet
patients' needs. DYNEPO will be another addition to our renal
therapeutics area, focusing on patients with anaemia and CKD."

The primary cause of anaemia in CKD is a deficiency in
erythropoietin, a protein produced by the kidneys responsible for red
blood cell production.(6) As renal function declines, so does the
capacity for producing erythropoietin and consequently red blood
cells. Additionally, anaemia in patients with CKD may be aggravated
by a loss of red blood cells during haemodialysis. Consequences can be
serious with increased risk of cardiovascular disease, the main cause
of death amongst dialysis patients, along with a major impact on the
quality of life through fatigue and a reduction in life-expectancy
due to cardiovascular complications.

If the kidney starts to fail, patients require an increase in
erythropoietin from a treatment such as DYNEPO in order to increase
red blood cell production. Red blood cells (erythrocytes) contain
haemoglobin and are vital for oxygen transportation around the body.
Erythropoietin is produced in the kidneys and stimulates the bone
marrow to produce more red blood cells by promoting the development
of stem cells into mature red blood cells. These cells are then
released into the blood stream. DYNEPO works in exactly the same way.

Notes to Editors:

Shire Plc
Shire's strategic goal is to become the leading specialty
pharmaceutical company that focuses on meeting the needs of the
specialist physician. Shire (LSE: SHP, Nasdaq: SHPGY, TSX: SHQ),
focuses its business on central nervous system, gastrointestinal,
general products with an emphasis on renal, and human genetic
therapies -- all being areas in which Shire has a commercial
presence. The structure is sufficiently flexible to allow Shire to
target new therapeutic areas to the extent opportunities arise
through acquisitions. Shire believes that a carefully selected
portfolio of products with strategically aligned and relatively
small-scale sales forces will deliver strong results. Shire's
strategy is to develop and market products for specialty physicians.
Shire's in-licensing and merger and acquisition efforts are focused
on products in niche markets with strong intellectual property
protection either in the US or Europe. For further information on
Shire, please visit the Company's website: .

1. R Pratt. Epoetin delta, erythropoietin produced by a human cell
line, is effective in the treatment of renal anaemia. Poster
presented at 11th Congress of European Hematology, 15-18 June,
Amsterdam, Holland, 2006, organized by the European Hematology
Association (EHA).

2. Varki A. Loss of N-glycolylneuraminic acid in humans: Mechanisms,
consequences, and implications for hominid evolution. Yrbk Phys
Anthropol 2001; 44: 54-69.

3. Z Shahrokh, S Flatman, M Davies, A Baycroft, M Heartlein.
Erythropoietin produced by a human cell line has only trace levels of
potentially immunogenic N-glycolylneuraminic acid residues. Poster
presented at 11th Congress of European Hematology, 15-18 June 2006,
Amsterdam, Holland, organized by the European Hematology Association

4. Locatelli F, Alijama P, Barany P et al. Revised European Best
Practice Guidelines for the management of anaemia in patients with
chronic renal failure. Section 1: Anaemia evaluation. Nephrol Dial
Transplant 2004a; 19 Suppl 2: ii2-ii5.

5. Molowa DT. First annual nephrology survey. With a focus on Aranesp
and Renagel. J.P.Morgan Securities Inc. Equity Research. 13 February

6. Eschbach JW. Current concepts of anemia management in chronic
renal failure: impact of NKF-DOQI. Semin Nephrol 2000; 24(4): 320-329.

(i) CKD is sometimes referred to as chronic renal failure (CRF).

SOURCE Shire Plc
CONTACT: Media Shire, Jessica Mann, +44-1256-894-280; Media PR agents
for Resolute Communications, +44-7921-489-607, DYNEPO, Dr Diane Ross;
Media PR agents for Resolute Communications, DYNEPO, Lizzy Ray,
Web site:


TELS: USA:1-305-507-2550/BRASIL:55-21-2132-8461
FAXES: USA:1-305-461-8670/BRASIL:55-21-2132-8469


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