New Treatment a Success for Anaemia Associated With Chronic Kidney Disease

New Treatment a Success for Anaemia Associated With Chronic Kidney Disease

September 14, 2006

-- Not for distribution in the United States

    BASINGSTOKE, England, Sept. 14 /Xinhua-PRNewswire/ --
The first anti-anaemia treatment produced in a human cell
line, DYNEPO(R) (epoetin delta), can effectively control
anaemia in patients with chronic kidney disease (CKD[x])
according to two Phase III studies presented for the first
time today.(1),(2)

    Patients with kidney disease as a result of diabetes
(diabetic nephropathy) were amongst the population
effectively treated with this new treatment. The data were
presented today at the 42nd Annual Meeting of the European
Association for the Study of Diabetes (EASD).

    DYNEPO is the first erythropoiesis-stimulating agent
(ESA) to be produced by gene-activation technology in a
human cell line and accordingly differs from all other
available ESAs, which are all recombinant proteins produced
in Chinese Hamster Ovary cells. The two large-scale Phase
III studies have shown that treatment with DYNEPO can
effectively maintain haemoglobin at target levels (10-12
g/dL) over a long period of time (up to 52 weeks) when
administered by either intravenous or subcutaneous
administration, with the data demonstrating overall
efficacy when DYNEPO was used in various types of patients
with anaemia associated with CKD -- whether they require
dialysis or not.

    "Using a human cell line to produce DYNEPO through
activation of the erythropoietin gene is a highly innovative
method," commented Dr. Jonathan Kwan, South West Thames
Renal & Transplantation Unit, St. Helier Hospital, UK.
"Also, because of the increasing trend for less
frequent dosing intervals with ESAs, Shire is initiating a
study to investigate a reduction in the dosing frequency of
DYNEPO. The study will also evaluate the impact of treatment
with DYNEPO on diabetic retinopathy which, together with
diabetic nephropathy, is a serious complication in diabetes
patients."

    Diabetic nephropathy is kidney disease that occurs as a
result of diabetes and is the leading cause of kidney
failure in the western world.(3) Approximately two million
people worldwide are undergoing treatment for end stage
renal disease, of which approximately 77% are on
dialysis.(4) In  patients with diabetic nephropathy,
anaemia occurs at an earlier stage and is often more severe
than in patients with CKD due to other causes.(5) Anaemia is
also implicated in the development of other microvascular 
complications of diabetes.(6)

    Dr. Raymond Pratt, Vice President Global Medical
Affairs, Shire said, "The studies underscore the
emerging clinical interest in patients who are not only
suffering from diabetes but also from the many
complications, such as nephropathy, that it can cause.
Shire is committed to meeting the needs of these patients,
and to further investigate DYNEPO's potential for distinct
benefits in these patients."

    ABOUT DYNEPO

    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. 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.
   
    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 (LSE: SHP), please
visit the Company's website: http://www.shire.com .

    References

    1. 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.

    2. 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.

    3. Russell TA. Diabetic nephropathy in patients with
type 1 diabetes mellitus. Nephrol Nurs J 2006; 33(1):
15-28.

    4. 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.

    5. Stevens PE, O'Donoghue DJ, Lameire NR. Anaemia in
patients with diabetes: unrecognised, undetected and
untreated? Curr Med Res Opin 2003; 19 (5): 395-401.

    6. Thomas MC, Cooper ME, Rossing K, Parving HH. Anaemia
in diabetes: is there a rationale to TREAT? Diabetologia
2006 Jun; 49(6):1151-1157.

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

    For more information, please contact:

     Media Shire, Jessica Mann, [phone]; Media
PR agents for DYNEPO, Resolute Communications,
[phone], Lizzy Ray; Media PR agents for Resolute
Communications; DYNEPO, Dr Marilyn Ewan, [phone]

SOURCE  Shire plc