omniture

Shire Launches New Trial for First Renal Anaemia Treatment Produced in Human Cell Lines

Shire PLC
2006-10-31 18:59 12592

BASINGSTOKE, England, Oct. 31 /Xinhua-PRNewswire/ -- Shire today

announced the start of a new Phase IIIb clinical trial to evaluate two new

dosing schedules of DYNEPO(R) (epoetin delta), the first commercial

erythropoiesis-stimulating agent produced in a human cell line. DYNEPO is

used in the treatment of anaemia in patients with chronic kidney disease (CKD

[*]). Anaemia becomes more common and severe as a patient’s kidney function

declines.(1)

Patients with anaemia have reduced haemoglobin levels. DYNEPO has

previously been shown to be as effective as epoetin alfa in increasing and

then maintaining haemoglobin levels in the target range (10-12 g/dL) in

patients with anaemia associated with CKD when initially given three times

per week by the intravenous route.(2,3) It is also effective when given twice

per week via the subcutaneous route.(3,4) This open-label, randomised study

will investigate the efficacy and safety profiles of different starting doses

of DYNEPO administered by subcutaneous injection, which are at a lower

frequency (once weekly and once every two weeks) than those currently

approved for subcutaneous administration.

The study is planned to enroll over 400 patients with anaemia and CKD,

who are either not on dialysis, who require peritoneal dialysis or who

require haemodialysis, at over 50 centres across Europe. It will include

patients suffering from kidney disease as a result of diabetes (diabetic

nephropathy).

The primary endpoints of the study are to:

-- assess whether DYNEPO administered once per week is as effective as

when administered twice per week for patients who have not previously been

treated with an erythropoiesis-stimulating agent (this will be assessed by

measuring haemoglobin levels at Week 24).

-- assess whether DYNEPO administered once every two weeks is as

effective as when administered once per week for patients who have been

previously treated with another erythropoiesis-stimulating agent (this will

be assessed by measuring haemoglobin levels over Weeks 16 to 24).

Dr Iain Macdougall, lead investigator of the study and Consultant

Nephrologist and Honorary Senior Lecturer from the Renal Unit in King’s

College Hospital, London commented, "If the study demonstrates the efficacy

of the different dosing schedules of DYNEPO, it will allow future flexibility

in the frequency of subcutaneous administration of the product. An

interesting secondary endpoint of this study is to also monitor diabetic

retinopathy, the progressive damage to the eye’s retina, in those patients

with anaemia, diabetes and CKD."

CKD is a progressive condition that results in end stage renal disease

(ESRD). Approximately 1.8 million people worldwide are undergoing treatment

for ESRD, of whom approximately 77% are on dialysis.(5) In Europe, the

prevalence of ESRD is estimated at 225,000, growing at 6 per cent per annum.

(6)

"This new trial demonstrates Shire’s continuing commitment to the care

of people suffering from CKD and ESRD," commented David Milton, Senior Vice

President, Renal Business Unit Leader, Shire.

ABOUT DYNEPO

Erythropoietin is normally 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. Red blood cells (erythrocytes)

contain haemoglobin and are vital for oxygen transportation around the body.

If the kidney starts to fail, natural production of erythropoietin declines

leading to lower levels of haemoglobin (anaemia). DYNEPO is the first

erythropoiesis-stimulating agent produced by gene-activation technology in a

human cell line; all others are produced in animal cell lines -- either

Chinese Hamster Ovary Cells or baby hamster kidney cells. Anaemic patients

with CKD require treatment with an erythropoiesis-stimulating agent such as

DYNEPO in order to increase red blood cell production. Currently DYNEPO is

given twice weekly if administered via the subcutaneous route, and three

times per week if administered intravenously.

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

focuses its business on attention deficit and hyperactivity disorder (ADHD),

human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. 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 a strategically aligned

and relatively small-scale sales force will deliver strong results.

Shire’s focused 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:

http://www.shire.com .

References

(1) 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.

(2) M Smyth, KJ Martin, RP Pratt. Epoetin delta (Dynepo(R)),

erythropoietin produced by a human cell line, is as

effective as epoetin alfa in patients with renal

anaemia, including those with diabetic nephropathy.

Poster presented at the 42nd Annual Meeting of

the European Association for the Study of Diabetes

(EASD), 14-17 September 2006, Copenhagen-Malmoe,

Denmark-Sweden.

(3) DYNEPO Summary of Product Characteristics (SPC). 8 June

2006. Shire plc. Available at URL:

http://www.emea.eu.int/humandocs/PDFs/EPAR/dynepo/H-372-PI-en.pdf .

(4) JTC Kwan, M Smyth, RD Pratt. Human cell line derived

erythropoietin (epoetin delta, Dynepo(R)) administered

subcutaneously is effective in the management of anaemia

associated with chronic kidney disease. Poster presented

at the 42nd Annual Meeting of the European Association

for the Study of Diabetes (EASD), 14-17 September 2006,

Copenhagen-Malmoe, Denmark-Sweden.

(5) Grassmann A, Gioberge S, et al. ESRD patients in 2004:

global overview of patient numbers, treatment modalities

and associated trends. Nephrol Dial Transplant 2005; 20:

2587-2593.

(6) Molowa DT. First annual nephrology survey. With a focus

on Aranesp and Renagel. J.P.Morgan Securities Inc.

Equity Research. 13 February 2002.

[*] CKD is sometimes referred to as chronic renal failure

Source: Shire PLC
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