Bayer Yakuhin Ltd. has Filed Fosrenol(R) for the Treatment of Hyperphosphatemia in Japan.Tokyo, Japan, Dec 20, 2006 - (JCN JCN Japan Corporate News JCN Journal of Cognitive Neuroscience JCN Journal of Cardiovascular Nursing JCN Journal of Christian Nursing JCN Job Control Number JCN Journal of Child Neurology JCN joint communications network (US DoD) Newswire) - Bayer Yakuhin Ltd. has submitted a marketing application for Fosrenol(R) (lanthanum carbonate lanthanum carbonate Fosrenol Pharmacologic class: Phosphate binder Therapeutic class: Renal and genitourinary agent Pregnancy risk category C Action) for the treatment of hyperphosphatemia in end stage renal disease Renal diseaseKidney disease. Mentioned in: Glycogen Storage Diseases hypertension High blood pressure Cardiovascular disease An abnormal ↑ systemic arterial pressure, corresponding to a systolic BP of > 160 mm Hg (ESRD ESRD end-stage renal disease. ESRD End-stage renal disease; chronic or permanent kidney failure. Mentioned in: Dialysis, Kidney ESRD End-stage renal disease, see there ) patients in Japan. Bayer Yakuhin received an exclusive license from Shire International Licensing BV in December, 2003 to develop and sell Fosrenol(R) in Japan and completed Phase II and Phase III clinical trials in Japan. Fosrenol(R) is a non-aluminium, non-calciumbased phosphate binder and is sold around the world in 15 countries, including the US, Taiwan, Korea, Germany Sweden, Denmark, Austria and Ireland. Launches are ongoing across the world. About Hyperphosphatemia Guidelines for the management of secondary hyperparathyroidism secondary hyperparathyroidism Endocrinology ↑ Parathyroid activity with overproduction of PTH due to parathyroid hyperplasia in response to an extraparathyroid defect that results in ↓ Ca2+ Etiology Rickets, vitamin D deficiency, chronic renal failure in chronic dialysis patients recommend that patients' serum phosphorus level in the blood should be controlled within the phosphorus range of 3.5 to 6.0 mg/dL. Phosphorus, an element found in nearly all foods, is absorbed from the gastrointestinal tract gastrointestinal tract n. The part of the digestive system consisting of the stomach, small intestine, and large intestine. Gastrointestinal tract into the blood stream. In ESRD, phosphates (phosphorus) are accumulated as the kidneys no longer effectively filter them out. Patients are advised to follow a low phosphate low phosphate Hypophosphatemia, see there diet, but even with the help of blood-cleansing dialysis machines, most dialysis patients will develop hyperphosphataemia. Chronic hyperphosphatemia is associated with serious health risks including renal osteodystrophy (resulting in bone pain, brittle bones, skeletal deformities and fractures), and heart failure caused by cardiovascular calcification calcification /cal·ci·fi·ca·tion/ (kal?si-fi-ka´shun) the deposit of calcium salts in a tissue. dystrophic calcification . The number of dialysis patients in Japan is estimated at approximately 260 thousand, and is increasing by 10 thousand per year. Approximately 70% of dialysis patients are estimated to be on phosphate-binders. ESRD patients with hyperphosphataemia are prescribed phosphate binders to reduce the amount of phosphorus absorbed by the body. Current treatments are predominantly with calcium salts which can exacerbate hypercalcaemia (high calcium levels in the blood), which is another mineral disorder associated with ESRD. About Fosrenol(R) Fosrenol(R) is a non-aluminium, non calcium phosphate binder that has a very high affinity for dietary phosphate, forming lanthanum lanthanum (lăn`thənəm) [Gr.,=to lie hidden], metallic chemical element; symbol La; at. no. 57; at. wt. 138.9055; m.p. about 920°C;; b.p. about 3,460°C;; sp. gr. 6.19 at 25°C;; valence +3. phosphate, which passes through the intestines and is eliminated from the body, leading to effective reduction in serum phosphorus levels. Fosrenol(R) is formulated as a chewable tablet that does not need water to be swallowed, an important benefit for dialysis patients who have severely restricted fluid intake. About Bayer Yakuhin Bayer Yakuhin is in charge of Pharmaceuticals, Biological Products, and Consumer Care in the Japanese market as a part of the global operations of Bayer Healthcare AG. In addition to the three key fields of cardiovascular diseases, urological diseases, and infectious diseases, in recent years we have been aggressive in developing cancer treatments. Bayer Yakuhin is a healthcare company striving to contribute to improved health and quality of life for Japanese through innovation and creativity based on the science and technology developed by Bayer worldwide. About 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 Attention-Deficit/Hyperactivity Disorder (ADHD) Definition Attention-deficit/hyperactivity disorder (ADHD) is a developmental disorder characterized by distractibility, hyperactivity, impulsive behaviors, and the inability to remain focused on tasks or ), human genetic therapies (HGT HGT Height HGT Harlem Globetrotters HGT Harmonic Greedy Triplets HGT Hudson Guild Theatre (New York, NY) HGT Hand Geometry Technology HGT High Grand Touring ), gastrointestinal (GI) and renal diseases. 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, 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. Source: Bayer Yakuhin Contact: Bayer Yakuhin, Ltd Corporate Communications Hiroaki Nishihara TEL. +81-3-6398-1036 FAX. +81-3-6398-1033 E-mail: hiroaki.nishihara.hn@bayer.co.jp Home Page: http://www.bayer.co.JP/byl/ Copyright [c] 2006 JCN Newswire. All rights reserved. A division of Japan Corporate News Network K.K. |
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