Innovative Technology for Treatment of Renal Anaemia Unveiled Today

BASINGSTOKE, England, June 16 /PRNewswire/ --

-- First Human Cell Line-Derived Erythropoietin Research Reported

BASINGSTOKE, England, June 16 /PRNewswire/ --

-- Abstract Numbers: 562 and 576

Effective treatment of anaemia in patients suffering from chronic kidney disease (CKD)(x) 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 - an 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.

ABOUT DYNEPO

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: www.shire.com.

References

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 (EHA).

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 2002.

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

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

For further information please 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, +44-20-7357-8187