'On Track' Initiative Provides Broader Access to FOSRENOL(R) and Resources
for Enhanced Hyperphosphatemia Management
PHILADELPHIA, April 3, 2008 /PRNewswire/ -- Shire Pharmaceuticals, the global biopharmaceutical company, today announced the launch of On Track, an innovative program designed to improve adherence to disease management regimens among chronic kidney disease (CKD) Stage 5 patients with hyperphosphatemia (elevated levels of phosphorus in the blood). In addition to offering the highly effective phosphate binder, FOSRENOL (lanthanum carbonate), Shire has created On Track, a program designed to provide resources to patients, health care professionals (HCPs) and renal care teams that can help them collectively identify "real world" solutions to adherence- related challenges.
Approximately half of all CKD Stage 5 patients fail to attain serum phosphorus control, and poor adherence is a primary barrier preventing them from achieving success. In fact, up to 73 percent of patients are repeatedly non-compliant to phosphate binder therapy. Specifically, 30 percent of patients have decided not to fill one or more prescriptions due to medication costs and/or lack of transportation to the pharmacy, while 21 percent of CKD Stage 5 patients admit to not taking medications as prescribed due to side effects, cost, and the belief that they already take "too many" medications. This is not surprising, since CKD Stage 5 patients are prescribed an average of 12 different medications for concurrent medical conditions.
"Nonadherence to phosphate binder therapy is a serious problem and has become a growing issue among CKD Stage 5 patients due to the complexity of managing the condition," said William Finn, MD, professor of Medicine, University of North Carolina School of Medicine at Chapel Hill. "It is vital for patients to work with their renal care teams to identify successful adherence strategies, as well as to utilize programs and resources available, to address the myriad of reasons that contribute to nonadherence, in order to realize the full benefit of their medications."
Through On Track, Shire is providing resources and services developed
with insights from experts in the nephrology and behavior modification
fields to help renal care teams and patients take a multifaceted approach
to hyperphosphatemia control. Shire also is offering additional support
specifically for FOSRENOL patients through its comprehensive offerings in
FOSRENOL On Track - a first of its kind program for the renal community
that offers an array of unique services to help renal care teams and
patients improve adherence.
-- Shire developed tools for HCPs and renal care teams to help enhance
their communication with patients in clinical settings. These tools
will facilitate the development of individualized plans that address
patients' specific barriers to managing their hyperphosphatemia
through diet, dialysis, and phosphate binder therapy.
-- Shire established the FOSRENOL On Track hotline to provide a simple,
single point of access to a comprehensive range of support services
and tools for all FOSRENOL patients and their renal care teams.
- FOSRENOL patients also can elect to receive regular lifestyle and
medication "reminders" through FOSRENOL On Track.
-- Knowing that high and rising out-of-pocket expenses for medications
often decrease patient adherence, Shire also is providing several
resources for FOSRENOL patients who face financial burdens to
- Shire will provide a discount card for patients with private
insurance that will help them with financial assistance for their
medication. This is the first offering of its kind for
- Qualified dialysis patients can receive grants to help with
phosphate binder costs through Shire's partnerships with the
American Kidney Fund(R) and HealthWell Foundation(R).
- Eligible patients who fall into the Medicare Part D coverage gap and
who are in need of Medicaid assistance may receive FOSRENOL free of
As an additional component of the On Track initiative, Shire assembled an Adherence Task Force composed of renal dietitians and other HCPs with expertise in improving patient adherence. Recognizing the complexities of effectively managing hyperphosphatemia over the long term, Shire is working with these experts to evaluate the many factors impacting adherence to hyperphosphatemia management and develop effective, "real world" solutions.
"Nonadherence is an everyday issue that hinders our collective efforts to help patients remain on track," said Marianne Hutton, RD, CDE, instructor, Northern California Center for Well-Being. "By examining the wealth of techniques currently used to promote adherence among patients, the Adherence Task Force will develop resources and establish best practices to reduce our patients' difficulties following hyperphosphatemia treatment regimens and help them achieve success more easily."
One tool the Adherence Task Force believes can be useful to renal care teams as they work with their patients to develop individualized plans is the phosphate binding ratio (PBR). PBR signifies the number of grams of phosphorus bound by each gram of a particular medication. By knowing the PBR of the binder a patient is taking, HCPs can help patients make informed decisions about what they eat and the extent to which they can balance their diet and binder to achieve good phosphate balance. There are a variety of phosphate binders available for patients with hyperphosphatemia, and these medications have a range of PBRs based on their active ingredients. FOSRENOL is powered by lanthanum, which has a high PBR.
Phosphate binders are a major source of pill burden for CKD Stage 5 patients. With treatments, such as FOSRENOL, patients with hyperphosphatemia may be able to reduce their pill burden to as few as one tablet with each meal.* In fact, FOSRENOL has the lowest pill burden of all phosphate binders, which may aid in adherence and reduce treatment costs.
"Shire is committed to offering its effective, noncalcium, nonresin
phosphate binder, FOSRENOL, to CKD Stage 5 patients who need assistance
with the complications of elevated serum phosphorus," said Joseph Schlitz,
vice president, US Renal Business, Shire Pharmaceuticals. "Knowing the
evolving needs of the CKD community, we are continuing to improve the
product through new formulations and more user-friendly packaging. We hope
the combination of these efforts and the On Track program will provide
patients with the resources they require to help them adhere to their
hyperphosphatemia management regimens."
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Phosphorus, an element found in nearly all foods, is absorbed from the gastrointestinal tract into the bloodstream. When the kidneys fail, they no longer effectively remove phosphorus. While the normal adult range for phosphorus is 2.5 to 4.5 mg/dL, the blood phosphorus levels of many patients on dialysis often exceed 6.5 mg/dL. Such levels have been linked to a significantly higher morbidity and mortality risk for patients who have undergone at least one year of dialysis. Research has shown that for each mg/dL increase in mean serum phosphorus, the relative risk of death increases by 6 percent.
Hyperphosphatemia is managed with a combination of dialysis, diet restriction, and phosphorus-binding agents, because diet and dialysis alone generally cannot adequately control phosphorus levels. Such binders "soak up" phosphorus in the gastrointestinal tract, before it can be absorbed into the blood, and aid patients in maintaining acceptable levels of mean serum phosphorus.
FOSRENOL is indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD).
FOSRENOL is an effective, noncalcium, nonresin phosphate binder that reduces high phosphorus levels in CKD Stage 5 patients. FOSRENOL is formulated as an easy-to-use, unflavored, chewable tablet that can be taken without water, an important consideration for CKD Stage 5 patients who must restrict their fluid intake.
FOSRENOL is available in a broad range of dosage strengths, including 500- mg, 750-mg and 1-g tablets. Patients taking FOSRENOL can achieve serum phosphorus target levels with as few as three tablets per day.*
FOSRENOL has the lowest pill burden of all phosphate binders, which may aid in adherence and reduce treatment costs.
The active ingredient in FOSRENOL is lanthanum, which has a high PBR. In addition, the binding power of FOSRENOL, in vitro, was not compromised by pH variations throughout the gastrointestinal tract.
FOSRENOL has a high affinity for phosphate and works by binding to dietary phosphorus in the gastrointestinal tract. Once bound, the FOSRENOL/phosphorus complex cannot pass into the bloodstream and is eliminated from the body, thereby decreasing mean serum phosphorus levels.
The safety of FOSRENOL has been studied in over 5,500 patients. Despite the challenge of CKD Stage 5 mortality for long-term data, a number of patients (N=22) taking FOSRENOL have been followed for more than 5 years. In addition, more than 87,000 patients have been prescribed FOSRENOL in the US alone.
FOSRENOL has the most extensive long-term safety data package of any phosphate binder and is generally well tolerated. Trials involving patients treated with FOSRENOL showed sustained serum phosphorus reduction in a majority of patients, with some patients being followed over a six-year duration.
FOSRENOL is now available in 25 countries, including Spain, Canada,
France, Germany, Italy, and the UK, and continues to be launched in new
markets around the world.
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 compared to alternative therapy for up
to 3 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 3 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
For Full Prescribing Information on FOSRENOL, please visit http://www.fosrenol.com.
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 Web site: 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(R) (Human TGF.3) and veleglucerase alfa (GA-GCB); manufacturing and commercialization including, but not limited to, the 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, 2007.
*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.
|SOURCE Shire Pharmaceuticals|
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