The most common adverse events were gastrointestinal, such as nausea and vomiting, and generally abated over time with continued dosing. The most common side effects leading to discontinuation in clinical trials were gastrointestinal events (nausea, vomiting, and diarrhea). Other side effects reported in trials included dialysis graft complications, headache, abdominal pain, and hypotension. Although studies were not designed to detect differences in risk of fracture and mortality, there were no differences demonstrated in patients treated with FOSRENOL compared to alternative therapy for up to three years. The duration of treatment exposure and time of observation in the clinical program were too short to conclude that FOSRENOL does not affect the risk of fracture or mortality beyond three years. While lanthanum has been shown to accumulate in the GI tract, liver, and bone in animals, the clinical significance in humans is unknown. Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease, or bowel obstruction were not included in FOSRENOL clinical studies. Caution should be used in patients with these conditions. FOSRENOL should not be taken by patients who are nursing or pregnant. FOSRENOL should not be taken by patients who are under 18 years of age.
For Full US Prescribing Information on FOSRENOL, please visit http://www.fosrenol.com.
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 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.
"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 JUVISTA (Human TGF beta 3) 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.
References:
(1). SM Sprague, WF Finn, and P Qiu (2007) Hyperphosphatemia in Chronic Kidney Disease Stages 3 and 4: Findings from a Randomized, Multi-Center Trial. Abstract for ASN Renal Week 2007, Filename: 555494
(2). FOSRENOL(R) U.S. PI.
(3). Venes D and CL Thomas, eds. (2001) Cyclopedic Medical Dictionary. 20th ed. Philadelphia, Pa: FA Davis Company. 1037, 1173, 1543.
(4). U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee. Federal Register / Vol. 72, No. 176 / Wednesday, September 12, 2007 / Notices.
(5). Data on file, Shire U.S., Inc.
(6). National Kidney Foundation. 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.
(7). Vanholder R, et al. (2005) Chronic kidney disease as cause of cardiovascular morbidity and mortality. Dial Transplant; 20: 1048-1056.
(8). Hutchison AJ and R Pratt. (2005) Evidence for the long-term safety and tolerability of lanthanum carbonate. Poster presented at 38th annual meeting of the American Society of Nephrology, Philadelphia, PA. November 8-13.
(9). Verispan's Total Patient Tracker: January 2005-August 2007.
(10). Moe SM. Calcium, phosphorus and vitamin d metabolism in renal disease and chronic renal failure. In: Kopple JD and SG Massry, eds. Nutritional Management of Renal Disease. Philadelphia, PA: Lippincott Williams & Wilkins; 2004: 261.
(11). Block GA, Hulbert-Shearon TE, Levin NW and FK Port. (1998) Association of serum phosphorus and calcium x phosphate product with mortality risk in chronic hemodialysis patients: A national study. Am J Kidney Dis; 31: 607-617.
(12). Block GA. (2000) Prevalence and clinical consequences of elevated Ca x P product in haemodialysis patients. Clin Nephrol; 54(4): 318-24.
Ann Blumenstock, Resolute (ex-US.), Phone: +44-207-357-8187, Cell: +44-7788-543-537, Email: Ann.blumenstock@resolutecommunications.com; Carrie Fernandez, Porter Novelli (US), Phone: +1-212-601-8336, Cell: +1-917-202-5553, Email: carrie.fernandez@porternovelli.com.