BASINGSTOKE and COLOGNE--16 Mar--PRNewswire-AsiaNet/InfoQuest Shire's Launch of DYNEPO(R) (epoetin delta) Begins Across Europe Today, Shire plc (LSE: SHP), (Nasdaq: SHPGY), (TSX: SHQ) launched DYNEPO(R) (epoetin delta) in Germany, completing the initial step of a launch programme planned for Europe over the coming months. DYNEPO is a unique erythropoiesis-stimulating agent (ESA), as it is the only ESA produced in human cells. ESAs are agents used in the treatment of anaemia to increase the production of red blood cells. DYNEPO is produced by activating the erythropoietin (EPO) gene in human cells. All other commercially available ESAs are presently made in animal cells. DYNEPO's entry to the market provides a new, effective and well-tolerated choice for both physicians and a wide range of patients who suffer from anaemia as a result of chronic renal failure (CRF).(i) It is approved for use in patients not yet requiring dialysis as well as those with end-stage renal disease (ESRD) on dialysis.(1) DYNEPO will be available in other European markets in the coming months. DYNEPO is supported by a comprehensive clinical efficacy and safety programme and competitive pricing structures designed to reduce the existing economic burden of healthcare to providers treating renal anaemia with ESAs. "This new and different treatment with its proven efficacy and tolerability is a welcome addition to the options available for physicians treating anaemia in chronic kidney disease (CKD) patients," commented Dr Markus Ketteler, Division of Nephrology, Academic Teaching Hospital, Coburg, Germany. "Anaemia can be a very compromising condition for patients suffering with CKD andsuccessfully treating it can improve their quality of life and may reduce the risk of further complications. With the growing numbers of patients with kidney failure, we face a significant challenge to detect, diagnose and treat CKD across Europe," he added. Anaemia is a common and serious complication in patients with CKD, estimated to affect over 180,000 people in Germany alone.(2,3) Research has shown that anaemia correction improves patients' quality of life by reducing fatigue and increasing both appetite and work capacity.(4) In addition, a study has shown that treatment with an ESA can reduce the crude relative risk ofmortality by up to 30%.(4) International and national medical guidelines clearly emphasise the need for correcting haemoglobin levels in patients with anaemia and then maintaining them within a pre-specified range.(5,6,7) Two large-scale Phase III studies have shown that treatment with DYNEPO can effectively increase and maintain mean average haemoglobin at target levels (10-12 g/dL) over a period of up to 52 weeks by either subcutaneous or intravenous administration.(8,9,10) DYNEPO offers flexibility and ease of use for both healthcare practitioners and patients. DYNEPO may be administered intravenously or subcutaneously. It is packaged in pre-filled syringes for subcutaneous, self administration injection and is currently available in five presentations. The syringe is designed for ease of use by patients after training by a medical professional and features a needle safety guard to reduce needle stick injury. DYNEPO should be kept in a refrigerator, but it can be used after a single period of un-refrigerated storage at 25 degrees C or less for up to five days, after which it should be discarded. "The launch of DYNEPO is another milestone in Shire's continuing efforts to focus on improving health outcomes for patients with renal disease and servicing renal units with speciality pharmaceuticals," said Mike Cola, President of Shire's Specialty Pharmaceuticals Business. "DYNEPO's unique human gene activation origin and comprehensive clinical efficacy and safety programmeprovide physicians with an alternative choice in the management of anaemia. To continue building on these efforts and supporting DYNEPO's entry into the market, we have developed pricing structures that are intended to reduce the economic burden of treating renal anaemia by reducing the total renal healthcare costs currently consumed by ESA treatments," he added. About ERYTHROPOIETIN Erythropoietin is a glycoprotein hormone; the protein core is a sequence of 165 amino acids with four attached carbohydrate residues that make up approximately 40% of the molecular mass.(11) These carbohydrate residues are important for its biological activity within the body.(12) Erythropoietin is normally produced in the kidneys and stimulates the bone marrow to produce redblood cells. Red blood cells 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). About DYNEPO DYNEPO is the first ESA produced in human cells. This is accomplished by activating the endogenous human erythropoietin gene in a human cell line using specialised gene-activating DNA sequences. All other commercially available ESAs are produced in animal cell lines derived from Chinese Hamster Ovary cells or Baby Hamster Kidney cells. Anaemic patients with CKD require treatment with an ESA such as DYNEPO in order to increase red blood cell production. DYNEPO is a registered trademark of Sanofi-Aventis. i) While common terminology is now chronic kidney disease (CKD), some regulatory agencies have not adopted this terminology, instead they refer to chronic renal failure (CRF); these terms are essentially interchangeable. DYNEPO (epoetin delta) is indicated for the treatment of anaemia in patients with CRF and may be used in patients on dialysis and in patients not on dialysis. Notes to editors SHIRE plc Shire's strategic goal is to become the leading specialty pharmaceuticalcompany 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 "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization; the impact of competitive products, including, but not limited to the impact of those on Shire's Attention Deficit and Hyperactivity Disorder (ADHD) franchise; patents, including but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including but not limited to the expected product approval dates of SPD503 (guanfacine extended release) (ADHD),SPD465 (extended release triple-bead mixed amphetamine salts) (ADHD); Shire's ability to secure new products for commercialization and/or development; Shire's planned acquisition of New River Pharmaceuticals announced February 20, 2007; and other risks and uncertainties detailed from time to time in Shire's and its predecessor registrant Shire Pharmaceuticals Group plc's filings withthe Securities and Exchange Commission, particularly Shire plc's Annual Report on Form 10-K for the year ended December 31, 2006. References (1) DYNEPO, Summary of Product Characteristics, December 2006. (2) The World Factbook. http://www.cia.gov/cia/publications/factbook/print/gm.html Accessed 14 March 2007. (3) National Institute for Health and Clinical Excellence. Anaemia management in people with chronic kidney disease. Costing report. Implementing NICE guidance in England. September 2006. p15. (4) JFE Mann. What are the short-term and long-term consequences of anaemia in CRF patients? Nephrol Dial Transplant 1999; 14 (Suppl 2): 29-36. (5) Kidney Disease Outcomes Quality Initiative. KDOQI Clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease. Am J Kid Dis 2006: 47(5): Suppl 3. (6) F Locatelli, P Aljama, P Barany, et al. Revised European best practice guidelines for the management of anaemia in patients with chronic renal failure. Nephrol Dial Transplant 2004; 19 Suppl 2: 6-15. (7) National Collaborating Centre for Chronic Conditions. Published by RCP. Anaemia management in chronic kidney disease. National clinical guideline for management in adults and children. 2006. p19. (8) M Smyth, KJ Martin, RD Pratt. Epoetin delta (Dynepo(R)), erythropoietin produced in 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. (9) JTC Kwan, RD Pratt on behalf of the Epoetin Delta 3002 Study Group. Epoetin delta, erythropoietin produced in a human cell line, in the management of anaemia in predialysis chronic kidney disease patients. Curr Med Res Opin 2007; 23(2): 307-311. (10) JTC Kwan. Subcutaneous epoetin delta for the management of anaemia in patients with CKD: safety and efficacy in a one-year study. Poster presented at the American Society of Nephrology (ASN) Renal Week, 14- 19 November 2006, San Diego, CA. (11) R Deicher and W Horl. Differentiating factors between erythropoiesis- stimulating agents. Drugs 2004; 64(5): 499-509. (12) V Skibeli, G Nissen-Lie, P Torjesen. Sugar profiling proves that human serum erythropoietin differs from recombinant human erythropoietin. Blood 2001; 98(13): 3626-3634. SOURCE: Shire PLC CONTACT: Investor Relations, Clea Rosenfeld, +44-1256-894-160, Media Shire, Jessica Mann, +44-1256-894-280, Media PR agents for DYNEPO, Resolute Communications, Laura Musgrave, +44-207-357-8187, Media PR agents for DYNEPO, Resolute Communications, Ane Tobro, +44-207-357-8187 Web site: http://www.shire.com --Distributed by AsiaNet ( www.asianetnews.net )--