Shire plc Secures European Wide Label Extension for FOSRENOL(R) in Chronic Kidney Disease
DUBLIN, October 28 /PRNewswire-FirstCall/ --
- FOSRENOL(R) (lanthanum carbonate) Now Approved in the EU to Treat hyperphosphataemia >1.78mmol/L in Chronic Kidney Disease Patients Not on Dialysis
Shire plc , the global specialty biopharmaceutical company, today announced it has received approval through the European Mutual Recognition Procedure for an extension to the current indication for FOSRENOL(R) (lanthanum carbonate), paving the way to make the non-calcium, non-resin phosphate binder available throughout the EU to control hyperphosphataemia in chronic kidney disease (CKD) patients who are not on dialysis with a serum phosphorus level greather than or equal to 1.78mmol/L (5.5mg/dL).
The extension was sanctioned by the Swedish Medicines Products Agency as reference member state. Submissions for national marketing authorizations have been made to Sweden and the other 28 European markets with first national approvals anticipated in Q4 2009.
"Failure to control phosphate in the earlier stages of chronic kidney disease carries well documented risks, and is associated with reduced bone health and poor cardiovascular outcomes," said Dr. Alastair Hutchison, Manchester Royal Infirmary, UK. "The extension to the existing indication for FOSRENOL provides nephrologists in the EU with an important additional option to help tackle the challenge of uncontrolled phosphate at an earlier stage in the progression of kidney disease, before the need for dialysis treatment."
"This is an important development in helping CKD patients better manage their elevated phosphate and we are pleased that FOSRENOL is now approved as a treatment option for these patients in the EU," said Gian Piero Reverberi, Senior Vice President, International Specialty Pharmaceuticals, Shire. "We are firmly committed to serving the needs of renal patients and ensuring that FOSRENOL is available to the prescribers and patients who can benefit from it."
In relation to the US, Shire continues to evaluate its options for securing a label extension to include CKD patients not on dialysis.
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 hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced 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.
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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, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.
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