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Friday, September 01, 2006

Katie Lee Joel Joins Kidney Friendly Comfort Foods Program to Support Chronic Kidney Disease Patients on Dialysis

Katie Lee Joel Joins Kidney Friendly Comfort Foods Program to Support Chronic Kidney Disease Patients on Dialysis

Celebrity Chef Demonstrates 'Kidney Friendly' Recipes at 33rd Annual American Association of Kidney Patients Meeting

ORLANDO, Fla., Sept. 1 /PRNewswire/ -- Katie Lee Joel, the first season host of Bravo's hit, "Top Chef" and Shire Pharmaceuticals today announced Katie's participation in the company's Kidney Friendly Comfort Foods program, including her contribution of six recipes for the 2006 edition of the Kidney Friendly Comfort Foods: A Collection of Recipes for People with Chronic Kidney Disease. Attendees of the 33rd Annual American Association of Kidney Patients (AAKP) Convention in Orlando, Florida, will be able to sample some of the recipes Katie developed for the cookbook at an event this afternoon.

Kidney disease is an issue close to Katie's heart. Katie's grandfather was diagnosed with it some years back, and, although the family was worried about his health, her grandfather was more concerned with the restrictions it put on his diet. Katie began to research kidney disease diet restrictions and eventually adapted her family's traditional recipes, so that her grandfather and family could still eat the meals that they loved together, while maintaining a diet that would support his health.

"When Shire approached me about getting involved with their Kidney Friendly Comfort Foods program, I was thrilled to have the opportunity to share my recipes. My grandfather has since passed and sharing these recipes with kidney patients and caregivers is a way to honor his memory. I want patients to know that cooking kidney friendly foods is not a sentence to boring food, it just means being creative," said Katie Lee Joel.

The 2006 edition of the Kidney Friendly Comfort Foods cookbook focuses on preparing meals low in phosphorus, while offering healthy tips, and delicious and easy-to-make recipes for patients and their families to enjoy. Patients can enjoy these six new recipes from Katie, including:

- Spiced Zucchini Pineapple Bread
- Breakfast Burritos
- Turkey Meatloaf
- Crispy Cornflake-Crusted Fish
- Apple Cobbler
- Strawberry Pie

Katie is conducting a low phosphorus cooking demonstration of her recipes at the AAKP meeting today from 3:30 p.m. - 5:30 p.m. EDT, where she will be joined by William Finn, MD, a nephrologist (a doctor specializing in treating diseases of the kidney) and Professor of Medicine at the University of North Carolina at Chapel Hill, and, Cathi J. Martin, RD, CSR, LDN, a dietitian who specializes in caring for patients with kidney disease at NutrePletion Resources. Through the cooking demonstration and educational program, Katie and these experts will show people with chronic kidney disease on dialysis, and their caregivers, that they can still enjoy delicious foods, even on a modified diet.

It is important for people with chronic kidney disease on dialysis to follow a low phosphorus diet, because most dialysis patients will develop hyperphosphatemia (high serum phosphorus levels in the blood). Excess phosphorus in the blood can lead to serious long-term health problems for these patients, such as mineral deposits in the heart and blood vessels, bone disease and even death. Because phosphorus is found in so many foods, patients often cannot reach target blood phosphorus levels through dietary restriction and dialysis alone, and they generally treat hyperphosphatemia by taking phosphate binders at meals and snacks. Phosphate binders "soak up" phosphorus in the gastrointestinal tract before it can be absorbed into the blood, thereby helping patients maintain target blood phosphorus levels.

"Hyperphosphatemia is a difficult condition to treat because it requires patients to follow a special diet and comply with a prescribed binder therapy regimen that may be comprised of up to nine pills a day," explained Dr. William F. Finn, Professor of Medicine, University of North Carolina. "But with newer treatments such as Shire's FOSRENOL(R), patients with hyperphosphatemia may be able to considerably reduce their pill burden to as few as one tablet with each meal, which could help improve binder therapy compliance."

The Kidney Friendly Comfort Foods cookbook is available for free by visiting http://www.fosrenol.com/, or by calling 866-896-6152. For more information about the AAKP annual meeting in Orlando, FL, visit http://www.aakp.org/.

About Katie Lee Joel:

Most recently, Katie was the first season host of Bravo's hit "Top Chef," a reality competition series for the culinary arts. In July 2005, Katie co- created the website http://www.oliveandpeach.com/ with partner Aleishall Girard. The site focuses on food and aims to provoke readers to think more deeply about the origins of the food they eat. It seeks to heighten awareness about the importance of "conscious consumption." She resides in the New York area with her husband, musician Billy Joel.

Scope of Chronic Kidney Disease (CKD) Stage 5

Approximately 20 million Americans have some form of kidney disease and more than 530,000 have developed chronic kidney disease (CKD) Stage 5. In 2003, a little over 100,000 Americans started treatment for CKD Stage 5, approximately 320,000 were on dialysis and more than 128,000 had functioning kidney transplants. Nearly $27.3 billion was spent to treat CKD Stage 5 patients in 2003, and Medicare projects that costs for its program to treat kidney failure will more than double by 2010. In Europe, an estimated 225,000 people have CKD Stage 5 and more than 80 percent are on dialysis, whereas in Japan, some 230,000 people have CKD Stage 5. In the United States, males, the elderly and members of the Native American, African American and Asian/Pacific Islander population groups are at greatest risk of developing CKD Stage 5.

FOSRENOL(R)

FOSRENOL(R) is indicated to reduce serum phosphate in patients with end stage renal disease (ESRD).

FOSRENOL(R) (lanthanum carbonate) is an effective, non-calcium, phosphate binder that reduces high phosphorus levels in ESRD patients. FOSRENOL(R) is formulated as an easy-to-use, unflavored, chewable-only tablet that can be taken without water, an important consideration for ESRD patients who must restrict their fluid intake.

FOSRENOL(R) is available in a broad range of dosage strengths, including the newly formulated higher strengths of 750 milligrams (mg) and 1.0 gram (g), as well as the original 250-mg and 500- mg strengths. With the reformulated doses, patients may need to take as few as three tablets a day to reach target levels of mean serum phosphorus. (Dosing based on as few as three tablets per day. Number of meals per day may vary. To achieve certain doses, additional tablets may be required.)

FOSRENOL(R) works by binding to dietary phosphorus in the gastrointestinal tract. Once bound, the FOSRENOL(R)/phosphorus complex cannot pass into the bloodstream and is eliminated from the body, thereby decreasing mean serum phosphorus levels.

FOSRENOL(R) has been clinically tested in more than 5,500 patients. Nearly 1,000 patients have been treated with lanthanum carbonate for more than one year. Long-term safety was demonstrated in patients treated for six years (n=17). Trials involving patients treated with FOSRENOL(R) showed sustained mean serum phosphorus reduction in a majority of patients.

Important Safety Information

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(R) 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(R) 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(R) clinical studies. Caution should be used in patients with these conditions. FOSRENOL(R) should not be taken by patients who are nursing or pregnant. FOSRENOL(R) should not be taken by patients who are under 18 years of age.

For Full Prescribing Information on FOSRENOL(R), please visit http://www.fosrenol.com/.

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), 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 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: 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 forwarding- 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 plc'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, manufacturing and commercialization; the impact of competitive products, including, but not limited to, the impact of those on Shire plc's Attention Deficit and Hyperactivity Disorder ("ADHD") franchise; patents, including but not limited to, legal challenges relating to Shire plc's ADHD franchise; government regulation and approval, including but not limited to the expected product approval dates of CONNEXYN(TM) (SPD503) (ADHD), SPD465 (ADHD), MESAVANCE(TM) (SPD476) (ulcerative colitis), and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; Shire plc'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 and its predecessor registrant Shire Pharmaceuticals Group plc's filings with the US Securities and Exchange Commission, particularly Shire plc's Annual Report on Form 10-K for the year ended December 31, 2005.

Source: Shire Pharmaceuticals plc

CONTACT: Carrie Fernandez of Porter Novelli, +1-212-601-8336, cell
+1-917-202-5553

Web site: http://www.shire.com/
http://www.fosrenol.com/

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