Healthcare Industry News: End Stage Renal Disease
News Release - January 17, 2008
Shire Completes Fosrenol(R) Roll-Out in Major European Markets With Launch in SpainNon-Calcium Phosphate Binder for the Management of Hyperphosphataemia Now Available in 24 Countries
NOT FOR DISTRIBUTION IN THE UNITED STATES
BASINGSTOKE, England, January 17 (HSMN NewsFeed) -- Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that with the launch today in Spain of FOSRENOL (lanthanum carbonate), a non-calcium phosphate binder, Shire is celebrating the completion of the launch roll-out in the major European markets. FOSRENOL is the first of the company's medicines developed in-house from research molecule to market.
FOSRENOL is an effective monotherapy treatment for the management of hyperphosphataemia(1) (excess phosphate, which the body cannot excrete(2)) in patients with End Stage Renal Disease (ESRD). Hyperphosphataemia is a problem which affects more than 70% of the 1.5 million people worldwide who require kidney dialysis.(3), (4)
Chronic Kidney Disease (CKD) is a progressive condition classified in five stages culminating in Stage 5 (or ESRD), a condition typified by a complete loss of kidney function, usually requiring the patient to undergo dialysis or kidney transplantation.
CKD is recognized as a growing 'silent epidemic' affecting up to 1 in 10 people(5), due in part to rising obesity rates and an increasing number of people with diabetes.(6) CKD can cause numerous serious health consequences for patients, including hyperphosphataemia.
Effective phosphate control is critical for these patients because, if not managed successfully, hyperphosphataemia can lead to significant health problems. These include CKD-related mineral and bone disorder, resulting in painful, brittle bones that may fracture or become deformed and cardiovascular disease, which accounts for almost half of all deaths in dialysis patients. (7), (8)
"As CKD progresses, its management becomes increasingly challenging for patients as dietary restrictions and fluid limitations become paramount," said David Milton, Senior Vice President, Shire Renal Business Unit. "By the time they reach CKD stage 5, patients are not only likely to be on dialysis, but are often taking as many as 10 to 12 different medications(9), which can amount to 25 tablets a day or more, for the different complications of CKD including hyperphosphataemia.
"Shire is proud to have developed FOSRENOL from research molecule to the healthcare market as an effective non-calcium monotherapy treatment option for ESRD patients with hyperphosphataemia. FOSRENOL is provided as a simple one tablet per meal dose for the majority of patients," added Milton.
"Shire participated with the other phosphate binder manufacturers at a recent Shire requested US Food and Drug Administration Cardiovascular and Renal Drugs Division Advisory Committee. The majority of the members on the Advisory Committee voted to recommend the use of phosphate binders to treat hyperphosphataemia in CKD Stage 4 patients. As a result Shire is working to identify the regulatory pathway forward for the use of FOSRENOL in this group of patients," he added.
To date, over 5,200 patients have been treated with FOSRENOL during an extensive clinical development program.(10) Globally over 100,000 patients have been prescribed FOSRENOL since it was launched in 2005.(10) FOSRENOL has an extensive long-term safety data package extending out to six years.
Following its launch in Spain, FOSRENOL is now available in 24 countries worldwide.
Notes to editors:
Phosphate, which is found in nearly all foods, is absorbed from the gastrointestinal (GI) tract into the blood stream. When the kidneys fail, they no longer effectively filter out phosphate, even with the help of blood-cleansing dialysis. While the normal adult range for phosphate is 0.8mmol/L (2.5 mg/dL) to 1.4mmol/L (4.5 mg/dL), the blood phosphorus levels of many patients on dialysis can exceed 2.1mmol/L (6.5 mg/dL ). Such levels have been linked to a significantly higher complications and death risk for patients who have undergone at least one year of dialysis(11) with over 70 per cent of these patients developing hyperphosphataemia.(3)
Chronic Kidney Disease disrupts the delicate interplay between the body's levels of calcium, parathyroid hormone (PTH) and vitamin D, leading to hyperphosphataemia. Over time, hyperphosphataemia can ultimately lead to calcification in the heart, lung and some arteries.(12) Accumulating evidence shows that hyperphosphataemia contributes to cardiovascular disease, which accounts for almost half of all deaths among dialysis patients.(13) Studies have shown that cardiovascular mortality in dialysis patients aged 25-34 years is more than 5 times greater than that in people aged 65-74 in the general population.(14)
Since dialysis and diet restrictions alone generally cannot control phosphate levels, patients traditionally manage hyperphosphataemia by taking phosphate binding agents with every meal and snack. Such binders "soak up" phosphate in the gastrointestinal tract, before it can be absorbed into the blood.
About FOSRENOLŽ (lanthanum carbonate)
FOSRENOL is indicated to reduce serum phosphate in adult patients with ESRD.(1)
FOSRENOL works by binding to dietary phosphate in the GI tract; once bound, the lanthanum/phosphate complex cannot pass through the intestinal lining into the blood stream and is eliminated from the body. As a consequence, overall phosphate absorption from the diet is decreased significantly.
FOSRENOL is available in a broad range of dosage strengths including 500-milligram (mg), 750-mg, and 1000-mg tablets.(1) Patients taking FOSRENOL can achieve serum phosphate target levels with as little as one tablet per meal.
FOSRENOL was approved by the FDA in October 2004. In March 2005 regulatory authorities in the EU granted marketing authorization for FOSRENOL in sixteen member states, thus completing the first step in securing marketing approval throughout Europe. Later, the European process was completed resulting in recommendation for approval in the remaining eleven member states. FOSRENOL is now available in 24 countries, including Italy, France, Germany, UK and the US and continues to be launched in new markets around the world. The company has out-licensed the rights to develop, market and sell FOSRENOL in Japan to Bayer Yakuhin Ltd.
Patients with renal insufficiency may develop hypocalcaemia. Serum calcium levels should therefore be monitored at regular time intervals for this patient population and appropriate supplements given.
No data are available in patients with severe hepatic impairment. Caution should, therefore, be exercised in these patients, as elimination of absorbed lanthanum may be reduced.
FOSRENOL should not be used during pregnancy.
Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease or bowel obstruction were not included in clinical studies with Fosrenol.
The most commonly reported Adverse Drug Reactions (ADRs) are gastrointestinal reactions such as abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, nausea and vomiting. These are minimized by taking FOSRENOL with food and generally abate with time with continued dosing. Hypocalcaemia was the only other commonly reported adverse reaction.
Full prescribing information is available on request.
Shire's strategic goal is to become the leading specialty biopharmaceutical 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's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe. Shire believes that a carefully selected portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company's website: http://www.shire.com.
Shire is a proud partner of World Kidney Day (WKD); Thursday 13th March 2008. For further information on WKD visit http://www.worldkidneyday.org
"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 including, but not limited to, the successful development of JUVISTAŽ (Human TGFbeta3) and GA-GCB (velaglucerase alfa); manufacturing and commercialization including, but not limited to, the launch and establishment in the market of VYVANSE(TM)(lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder ("ADHD")); the impact of competitive products including, but not limited to, the impact of those on Shire's 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 date of INTUNIV(TM) (guanfacine extended release) (ADHD); Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire plc's filings with the Securities and Exchange Commission, particularly Shire plc's Annual Report on Form 10-K for the year ended December 31, 2006.
(1) FOSRENOL EU SmPC
(2) Venes D and CL Thomas (eds). Taber's Cyclopedic Medical Dictionary. 20th ed. Philadelphia, Pa: FA Davis Company. 2001; 1037, 1173, 1543. Available at http://www.tabers.com (15 January 2008)
(3) Kim J et al. Achievement of proposed NKF-K/DOQI Bone Metabolism and Disease Guidelines: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). J Am Soc Nephrol 2003; 14: 269A
(4) Global dialysis. Global dialysis: dialysis standards and statistics. Available at http://www.globaldialysis.com/stats.asp (18 May 2007)
(5) World Kidney Day, available at http://www.worldkidneyday.org (15 Jan 2008)
(6) Pezarella MA. Chronic Kidney Disease: The Silent Epidemic. Hospital Medicine 2003
(7) National Kidney Foundation (NKF). K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Disease 2004; 42: 24-45, 55-63, 69-71
(8) Vanholder R, et al. (2005) Chronic kidney disease as cause of cardiovascular morbidity and mortality. Dial Transplant; 20: 1048-1056
(9) Manley et al. Nephrol Dial Transplant. 2004; 19: 1842 - 1848
(10) Data on file, Shire Pharmaceuticals Group Limited
(11) Block GA et al. Association of serum phosphorus and calcium x phosphate product with mortality risk in chronic hemodialysis patients: A national study. Am J Kidney Dis 1998; 31: 607-617
(12) Norris KC. Toward a new treatment paradigm for hyperphosphataemia in chronic renal disease. Dial Transplant 1998; 27 (12): 767-773
(13) Block G, Port FK. Re-evaluation of risks associated with hyperphosphataemia and hyperparathyroidism in dialysis patients: recommendations for a change in management. Am J Kidney Dis 2000; 35 (6): 1226-1237
(14) Foley R et al. Clinical epidemiology of cardiovascular disease in chronic renal disease. Am J Kidney Dis 1998; 32 (5) Suppl 3:112-119
Source: Shire PLC
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