PHILADELPHIA, Feb. 26 /PRNewswire/ -. With new reports showing almost half of Medicare beneficiaries enrolled in prescription drug plans in 2006 were impacted by the Medicare Part D coverage gap known as the “donut hole,” Shire is pleased to announce the launch of a new Medicare Part D component under the FOSRENOL(R)| at hand program.
Through this program addition, Shire will now provide FOSRENOL(R) (lanthanum carbonate) -- a therapy used to treat hyperphosphatemia (high phosphorus levels in the blood) -- free of charge to qualifying patients who are enrolled in a Medicare prescription drug plan.
Through the FOSRENOL(R) | at hand Patient Assistance Program (the original at hand offering) Shire provides help to patients who have no coverage for FOSRENOL(R) under prescription drug benefits, Medicare, Medicaid, or other state-funded programs, by providing FOSRENOL(R) free of charge or at a shared (reduced) cost. With the addition of the new Medicare Part D Assistance component, qualifying patients enrolled in a Medicare Part D program who cannot afford their co-payments or co-insurance, along with those facing the Medicare Part D “donut hole,” may now receive FOSRENOL(R) free of charge. Patients will receive monthly quantities of FOSRENOL(R) through the end of the calendar year in which they enroll in the program.
“Shire believes cost should not be a barrier to the effective treatment of hyperphosphatemia in chronic kidney disease (CKD) Stage 5 patients,” said Matt Handel, Shire, product general manager, FOSRENOL(R) U.S. “Through the FOSRENOL(R) | at hand program, qualifying CKD Stage 5 patients can now gain access to this effective, non-calcium phosphate binder therapy.”
Patients and health care providers can contact the FOSRENOL(R) | at hand program by calling the toll free hotline at (866) 325-8223. Trained representatives are available to answer questions and help enroll patients Monday through Friday, 9:00 a.m. to 5:00 p.m. (EST).
Managing Hyperphosphatemia
Of the approximately 20 million Americans who have some form of kidney disease, more than 530,000 have developed CKD Stage 5. Even with dialysis and a low-phosphorus diet, most CKD Stage 5 patients in the United States will develop hyperphosphatemia (high phosphorus levels in the blood). Without effective treatment, hyperphosphatemia may lead to renal osteodystrophy, a collection of bone diseases characterized by bone pain, brittle bones, skeletal deformities and fractures. Evidence also shows that hyperphosphatemia may contribute to cardiovascular disease, which accounts for almost half of all deaths among dialysis patients. FOSRENOL(R) is not indicated for the treatment of secondary hyperparathyroidism, vascular and nonvascular calcification, or cardiovascular or renal disease.
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 reformulated strengths of 500 milligrams (mg), 750 mg and 1.0 gram (g), as well as the original 250 mg. With the reformulated doses, patients may achieve serum phosphorus target levels with as few as three tablets per day. (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 of these patients have been treated with lanthanum carbonate for more than one year. Over 53,000 patients have been treated with FOSRENOL(R). The long-term safety profile of FOSRENOL(R) shows no evidence of toxicity at clinical doses. 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 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, manufacturing and commercialization; the impact of competitive products, including, but not limited to the impact of those on Shire’s Attention Deficit and Hyperactivity Disorder (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 dates of SPD503 (guanfacine extended release) (ADHD), SPD465 (extended release triple-bead mixed amphetamine salts) (ADHD); Shire’s ability to secure new products for commercialization and/or development; Shire’s planned acquisition of New River Pharmaceuticals announced February 20, 2007; and other risks and uncertainties detailed from time to time in Shire’s and its predecessor registrant Shire Pharmaceuticals Group 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, 2005.
Shire plc
CONTACT: Carrie Fernandez of Porter Novelli, +1-212-601-8336, for Shireplc
