First Approval for FOSRENOL(R); New Medication for Patients with End Stage Renal Disease Approved in Europe.AnorMED Inc. (TSX TSX Toronto Stock Exchange (TSE before April, 2002)
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AOM America on the Move ) announced today that the Swedish authorities have granted the first European regulatory approval for FOSRENOL(R) (lanthanum carbonate lanthanum carbonate
Pharmacologic class: Phosphate binder
Therapeutic class: Renal and genitourinary agent
Pregnancy risk category C
Action). FOSRENOL is a new medicine that helps control phosphate levels in patients who require dialysis for severe kidney disease Kidney Disease Definition
Kidney disease is a general term for any damage that reduces the functioning of the kidney. Kidney disease is also called renal disease. . Sweden will be the reference member state in the EU Mutual Recognition Procedure for FOSRENOL. AnorMED's worldwide exclusive licensee Shire Pharmaceuticals Group plc expects FOSRENOL should be available in other countries in the European Union during the second half of the year, assuming a positive response from other regulatory authorities. Submissions have also been made by Shire to gain marketing approvals for FOSRENOL in the United States.
FOSRENOL is a treatment for high phosphate levels in the blood (hyperphosphataemia) that occurs as a result of chronic kidney failure Chronic Kidney Failure Definition
Chronic kidney failure occurs when disease or disorder damages the kidneys so that they are no longer capable of adequately removing fluids and wastes from the body or of maintaining the proper level of certain . Estimates show there are approximately 225,000 dialysis patients in Europe(1). Even with a low-phosphate diet, as many as 80% of dialysis patients develop hyperphosphataemia(1) and need treatment with a phosphate binder, such as FOSRENOL. Without effective treatment, hyperphosphataemia can lead to renal osteodystrophy renal osteodystrophy
A bone disease characterized by softening and fibrous degeneration of bone and the formation of cysts in bone tissue, caused by chronic renal failure. , a bone disease that can cause pain, skeletal deformities, and bone fractures. Recent research also suggests that hyperphosphataemia is associated with the development of cardiovascular disease, which accounts for nearly 50% of all deaths in dialysis patients(2).
"This approval is the first step toward establishing FOSRENOL as an effective and well-tolerated alternative to current therapies for patients with end-stage renal disease. We look forward to Shire's launch of FOSRENOL throughout Europe, which is expected by year end, and also steady progress with the FDA toward gaining marketing approval in the US," said Dr. Michael Abrams, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of AnorMED Inc.
AnorMED recently sold the global patents for FOSRENOL(R) to Shire Pharmaceuticals Group plc, and one of its wholly owned subsidiaries, for up to US$31 million in milestone payments to be made upon regulatory approval in the United States, the European Union, and Japan. AnorMED will receive a US$1M milestone payment for this first approval of FOSRENOL in the EU and an additional US$6M upon approval in the relevant EU countries. Shire will pay AnorMED US$18 million in additional milestones upon approval in the United States. The agreement also provides Shire with a 12 month option to purchase the Japanese patents for US$6 million to be paid upon approval in Japan. If the option is not exercised, AnorMED will continue to be entitled to FOSRENOL royalties in Japan. The title to the patents will be transferred from AnorMED to Shire upon payment of milestones.
AnorMED is a biopharmaceutical company focused on the discovery and development of new small molecule therapeutics for the treatment of cancer and HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. among others. Over the course of 2004, the Company plans to hold an end of Phase II meeting with the FDA for AMD (Advanced Micro Devices, Inc., Sunnyvale, CA, www.amd.com) A major manufacturer of semiconductor devices including x86-compatible CPUs, embedded processors, flash memories, programmable logic devices and networking chips. 3100, a potential new agent for stem cell transplantation Stem Cell Transplantation Definition
Stem cells are basic human cells that reproduce (replicate) easily, providing a continuous source of new, sometimes different types of cells. , and will initiate a Phase II trial for AMD070, a new HIV entry inhibitor. Additional information on AnorMED Inc. is available on the Company's website: http://www.anormed.com/.
Note: Certain of the statements contained in this press release contain forward-looking statements which involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. The Company does not expect to update forward-looking statements continually as conditions change. Investors are referred to the full discussion of risk factors associated with the Company's business contained in the Company's Short Form Prospectus filed with securities regulatory authorities dated December 17, 2003.
Notes to editors:
Shire was granted an exclusive agreement to develop, manufacture, use and sell FOSRENOL worldwide by the patent holder, AnorMED Inc. Shire has assumed all responsibility and costs for the development and commercialization of FOSRENOL. Shire filed for regulatory review and approval in the European Union, Canada and with the U.S. Food and Drug Administration (FDA) for FOSRENOL as a treatment for high phosphate levels in the blood, which occurs in patients undergoing dialysis as a result of chronic kidney failure. On February 28, 2003, Shire received an approvable letter from the FDA. The approvable letter asked Shire for additional data and analysis to address a number of remaining questions. The requested data and analysis has been provided to the FDA and Shire expects the FDA's review to be completed in 2004. Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing projects and marketing products in the areas of central nervous system (CNS See Continuous net settlement.
See continuous net settlement (CNS). ), gastrointestinal (GI), and renal diseases. Shire has operations in the world's key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US.
Hyperphosphataemia and its consequences
Chronic kidney failure is complicated by hyperphosphataemia - high phosphate levels in the blood - caused by the inability of the kidneys (and dialysis) to filter out excess phosphate from food. Even with a low-phosphate diet as many as 80% of Europe's 225,000 and the United States' 269,000 dialysis patients develop hyperphosphataemia(1,3) and need treatment with a phosphate-binder. The most well-known consequences of hyperphosphataemia are a range of bone diseases which can cause bone pain, skeletal deformities and fractures. Hyperphosphataemia is also associated with the development of cardiovascular disease, which accounts for nearly 50% of all deaths in dialysis patients(2). Ironically, currently available phosphate binders - although they help control phosphate levels - can worsen these complications. Aluminium-based phosphate binders are associated with severe bone toxicity while calcium-based binders contribute to cardiovascular disease by promoting the deposition of hard calcium deposits (calcification calcification /cal·ci·fi·ca·tion/ (kal?si-fi-ka´shun) the deposit of calcium salts in a tissue.
dystrophic calcification ) in the heart and blood vessels.
References: Numbers of patients on dialysis broadly equates to patients with end stage kidney disease. Source: Market Research, Insight International, Dec 01/Jan 02 2. Davies MR, Hruska K. Pathophysiological mechanisms of vascular calcification in end-stage renal disease. Kidney Int. 2001 Aug; 60(2): 472-9 1.3. USRDS 2002 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2002, page 44.
Lanthanum carbonate (FOSRENOL(R)) FOSRENOL works by binding to dietary phosphate in the GI tract; once bound, the FOSRENOL/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. Shire has conducted an extensive clinical research program for FOSRENOL involving almost 1750 patients, some of whom have been treated for 36 months or more. This program has demonstrated that FOSRENOL is an effective phosphate binder with a proven safety profile for long-term use.
CONTACT: Elisabeth Whiting, M.Sc., Senior Director, Corporate Development & Communications, Office: (604) 532-4667, Direct: (604) 763-4682, e-mail: firstname.lastname@example.org