More Choice for CKD Patients in Europe as FOSRENOL® is Approved in a New Oral Powder Formulation

NYON, Switzerland, March 8, 2012 /PRNewswire/ --

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced it has received approval through the European Decentralised Procedure for an oral powder formulation of FOSRENOL (lanthanum carbonate).

FOSRENOL is a non-calcium, non-resin phosphate binder indicated as a phosphate binding agent for use in the control of hyperphosphataemia in chronic renal failure patients on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).  FOSRENOL is also indicated in adult patients with chronic kidney disease not on dialysis with serum phosphate levels ≥1.78 mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels.

The oral powder formulation was developed by Shire to give patients more choice in how they take their phosphate binder.

The approval of FOSRENOL oral powder was granted by the Swedish Medical Products Agency acting as reference member state. Submissions for national marketing authorisations of FOSRENOL in oral powder form have been made to Sweden and the other 27 European markets, with the first national approvals anticipated in Q2 2012.  

"Shire is delighted to receive European approval for the oral powder formulation of FOSRENOL," said Angus Hogg, Product General Manager at Shire. "Shire has developed this new formulation so that patients have an additional choice and that patients who may find it easier to take their treatment in powder form are able to do so. We believe the new oral powder formulation of FOSRENOL demonstrates our commitment to enabling people with life-altering conditions to lead better lives."

The challenge of uncontrolled phosphate in CKD patients

Although poor serum phosphate control is associated with negative outcomes, reducing phosphate levels continues to be a significant challenge for clinicians. According to the Dialysis Outcomes and Practice Patterns Study (DOPPS), a prospective, longitudinal, observational study of haemodialysis patients in twelve countries, approximately 50-70% of CKD patients on dialysis have phosphate levels above the normal range ^* . This is despite the use of diet, dialysis and phosphate binders.^[1,2]

"Even with dietary intervention and dialysis, reducing phosphate in patients with chronic kidney disease is an ongoing struggle," said Professor Mario Cozzolino, Assistant Professor of Nephrology at the Department of Medicine, Surgery, and Dentistry, at the University of Milan, Italy. "Nephrologists need to ensure they have an efficacious binder like FOSRENOL that can remove excess phosphate, however binders will only work if a patient takes them as prescribed. FOSRENOLoral powder provides an important additional option that gives patients more choice in how they take their binder."

Another challenge for patients with CKD is they are often prescribed multiple medications (on average between 9-12 different medications) and therefore need to take a large number of pills each day.^[3,4] In one study, patients on dialysis took a median of 19 tablets every day, whilst for a quarter of those studied, the number of tablets exceeded 25 per day.^[3]

"We see quite high levels of non-adherence in CKD patients on phosphate binders^[5], partly because of the high pill burden," said Professor Rob Horne, an expert on adherence at the UCL School of Pharmacy, London, UK. "To help patients get the best from medicines, healthcare practitioners need to tailor their support to address the perceptual and practical barriers that reduce patients' motivation and their ability to start and continue with treatment."

"This involves communicating why the medicine is necessary and addressing concerns about potential adverse effects. It also involves making the regimen as convenient and easy to take as possible. Having a range of formulations can help with this process by offering practical alternatives if the pill burden is an issue."

The efficacy and safety of FOSRENOL in adults has been investigated in clinical studies that included over 6,000 subjects. The estimated total patient exposure to FOSRENOL from launch to 31 December 2010 is estimated to be in excess of 225,200 patient years.^[6]

ABOUT FOSRENOL^® (lanthanum carbonate)

FOSRENOL is indicated as a phosphate binding agent for use in the control of hyperphosphataemia in chronic renal failure patients on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Fosrenol is also indicated in adult patients with chronic kidney disease not on dialysis with serum phosphate levels ≥1.78 mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels. ^[7]

FOSRENOL is not available in all countries and prescribing information may differ between countries.  Please consult your local prescribing information.

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.^[7] As a consequence, overall phosphate absorption from the diet is decreased significantly.

FOSRENOL is available in a broad range of dosage strengths including 500mg, 750mg, and 1000mg^[7] which facilitates an effective dosing regimen of one tablet per meal for the majority of patients.  

FOSRENOL was first approved in Sweden in March 2004, and by the US FDA in October 2004. FOSRENOL was subsequently approved in 28 EU markets by the European Mutual Recognition Procedure and is now launched in 41 markets worldwide.

Important Safety Information

Please consult the Summary of Product Characteristics (SPC) before prescribing, particularly in relation to warnings and precautions for use and undesirable effects.

FOSRENOL is contraindicated in patients with hypersensitivity to lanthanum carbonate hydrate or to any of the excipients, and in patients with hypophosphataemia.  Fosrenol is not recommended in children, adolescents or pregnancy.  The risk/benefit for continuing/discontinuing either Fosrenol or breast feeding should be carefully considered.

The use of FOSRENOL in clinical studies beyond 2 years is currently limited. However, treatment of subjects with Fosrenol for up to 6 years has not demonstrated a change in the benefit/risk profile.  Rising levels of lanthanum in bone have been noted in patients treated with FOSRENOL.  Paired bone biopsies have showed no differences in the development of mineralisation defects between patients treated with lanthanum carbonate versus calcium carbonate or alternative therapy.  FOSRENOL should be used with caution in patients with acute peptic ulcer, ulcerative colitis, Crohn's disease, bowel obstruction (e.g. previous abdominal surgery, peritonitis) and hepatic impairment.  Monitoring of liver function and calcium levels is recommended.  Abdominal x-rays of patients taking Fosrenol may have a radio-opaque appearance typical of an imaging agent.

Very common reactions (≥1/10):

Headache, abdominal pain, diarrhoea, nausea, vomiting, allergic skin reactions (including skin rashes, urticaria and pruritus)

Common reactions (≥1/100 to <1/10):

Hypocalcaemia, constipation, dyspepsia, flatulence

Notes to editors

SHIRE PLC

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, human genetic therapies, gastrointestinal diseases and regenerative medicine 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.

"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, 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 Pharmaceuticals, Human Genetic Therapies and Regenerative Medicine products, as well as the ability to secure 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.

References:

1. KDIGO. Kidney Int 2009; 76 (suppl 113): S1-130.

2. DOPPS 2010.

3. Chiu YW et al. Clin J Am Soc Nephrol 2009; 4(6): 1089-1096.

4. Manley HJ et al. Nephrol Dial Transplant 2004; 19(7): 1842-1848.

5. Riley S et al. British Journal of Renal Med 2007; 12: 19-21.

6. Shire Data on File SPD405-20, 2011.

7. Shire plc. FOSRENOL EU SmPC. http://www.medicines.org.uk/emc/medicine/19617

For further information please contact:

Investor Relations      
Eric Rojas erojas@shire.com +1-781-482-0999
Sarah Elton-Farr seltonfarr@shire.com +44-1256-894157
Media      
Jessica Mann (Corporate) jmann@shire.com +44-1256-894-280
Gwen Fisher (Specialty Pharma) gfisher@shire.com +1-484-595-9836
Nicole Barraud-Estoppey (Corporate) nbarraud@shire.com +41-79-961-99-12

* As defined by the Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Guidelines