Basingstoke, England (ots/PRNewswire) -
- Not for Distribution in the United States
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
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.
BASINGSTOKE, England, September 14 /PRNewswire/ --
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 (LSE: SHP), please visit the
Company's website: www.shire.com.
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;
[x] CKD is sometimes referred to as chronic renal failure (CRF).
ots Originaltext: Shire Pharmaceuticals Group Plc
Im Internet recherchierbar: http://www.presseportal.ch
For further information please contact: Media Shire, Jessica Mann,
+44(0)1256-894-280; Media PR agents for DYNEPO, Resolute
Communications, +44(0)20-7357-8187, Lizzy Ray; Media PR agents for
Resolute Communications; DYNEPO, Dr Marilyn Ewan, +44(0)20-7357-8187