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

Geschrieben am 31-10-2006

Basingstoke, England (ots/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[i]). 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 enrol 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.


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'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: www.shire.com.


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:

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. ---------------------------------

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

ots Originaltext: Shire Pharmaceuticals Group Plc
Im Internet recherchierbar: http://www.presseportal.de

For further information please contact: Media Shire, Jessica Mann,
+44-1256-894-280; Media PR agents for DYNEPO, Resolute
Communications, Claire Woods , +44-207-357-8187; Media PR agents for
DYNEPO , Resolute Communications, Marilyn Ewan, +44-207-357-8187


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