- New Option for Effective Control of Phosphate Levels and Potential to
Lower Pill Burden Now Available for Patients With End Stage Renal Disease
BASINGSTOKE, England, March 5 /CNW/ - Shire plc (LSE: SHP, NASDAQ: SHPGY,
TSX: SHQ). Shire recently announced the launch of FOSRENOL (lanthanum
carbonate) in the United Kingdom (UK) following the product's successful
approval for the control of hyperphosphataemia in patients with chronic kidney
disease (CKD) on haemodialysis or continuous ambulatory peritoneal dialysis
FOSRENOL provides a new simplified treatment option to the estimated
1.4 million people on dialysis worldwide(1) who are at risk from the serious
consequences of hyperphosphataemia.
FOSRENOL is an effective treatment for the control of hyperphosphataemia
in patients with CKD on dialysis.(2) FOSRENOL has a high affinity for
phosphate (in vitro data)(3), and therefore in the patients with CKD FOSRENOL
binds to dietary phosphate to effectively reduce serum phosphorus levels.
FOSRENOL is well tolerated and the majority of patients require just one
chewable tablet taken during each meal.(4)
Dr David Goldsmith, Consultant Nephrologist at Guy's and St Thomas'
Hospitals in London welcomed news of this launch and explained, "Effective
control of hyperphosphataemia remains a difficult problem for many patients on
dialysis, with many patients still having phosphate levels above the
recommended upper limit of 1.78 mmol/L. The introduction of FOSRENOL in the UK
offers patients a new, effective therapy with the added potential benefit of a
reduced pill burden, which may help to simplify the management of their
Over 5,000 patients have been treated with FOSRENOL during an extensive
clinical development programme,(5) with a small number having now received
treatment for up to six years.(6) This launch extends the availability of
FOSRENOL which is now available in Australia, Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Iceland, Ireland, Korea, The
Netherlands, Sweden, Taiwan and the US.
"Shire is delighted with the introduction of FOSRENOL in the UK adding to
recent successful launches into Germany and France, which have helped to
extend the availability of this important new product across Europe," said
David Milton, Senior Vice President, Shire Renal Business Unit. "Effective
control of serum phosphate levels is seen as complex and challenging for
patients with CKD who are already taking a number of different therapies for
their condition. FOSRENOL provides an effective new treatment option helping
to make control of phosphate levels simpler and easier. We hope the UK launch
will continue to build on the success FOSRENOL has achieved in the US, where
it has already benefited thousands of CKD patients."
Hyperphosphataemia is an almost inevitable consequence of CKD due to the
inability of failing kidneys to effectively rid the body of excess phosphate
that enters the body during daily dietary intake.
If not managed successfully, hyperphosphataemia can cause unpleasant
symptoms such as intense itching and in the long-term patients face serious
health risks including renal osteodystrophy, a bone disorder resulting in
painful, brittle bones that may fracture or lead to deformities.(7) Surveys of
medical records have shown that high phosphate levels are also linked with
cardiovascular disease, which accounts for almost half of all deaths among
To help manage their phosphate levels, dialysis patients are restricted
to a low phosphate diet, which can be unpalatable and difficult to
maintain.(9) Whilst dialysis can remove some of the ingested phosphate, it is
insufficient alone for the majority of patients. Indeed, up to 75 per cent of
dialysis patients exceed the Kidney Disease Outcomes Quality Initiative
(K/DOQI) guidelines for phosphate of 1.78 mmol/L (5.5 mg/dL).(10) Phosphate
binder therapy is therefore an important and necessary part of achieving
Despite the availability of existing therapies, effective phosphate
management remains a challenge. FOSRENOL provides physicians with an
alternative treatment option to help effectively manage hyperphosphataemia in
their dialysis patients.
1. Grassman A et al. ESRD patients in 2004: global overview of patient
numbers, treatment modalities and associated trends. Nephrol Dial Transplant
2005; 20: 2587-2593.
2. Hutchison AJ et al. Long-term efficacy and tolerability of lanthanum
carbonate: results from a 3-Year Study. Nephron Clinical Practice 2006; 102:
3. Damment SJP, Webster I. The pharmacology of lanthanum carbonate
(FOSRENOL(R)): a novel non-aluminum, non-calcium phosphate binder. Poster
presented at 36th Annual Meeting of the American Society of Nephrology, San
Diego, 14-17 November 2003.
4. Vemuri N et al. Lanthanum carbonate provides serum phosphorus control
with a reduced tablet burden. Poster presented at ERA/EDTA, Glasgow, 15-18
5. Shire Data on File 08.2644.
6. Hutchison A et al on behalf of the SPD405-309 Lanthanum Study Group.
Evidence for the long-term safety and tolerability of lanthanum carbonate.
Poster presented at 38th Annual Meeting of the American Society of Nephrology,
Philadelphia, 8-13 November 2005.
7. Martin K, Gonzalez A. Strategies to minimize bone disease in renal
failure. Am J Kidney Dis 2001; 38: 1430-36.
8. Block G et al. Re-evaluation of risks associated with
hyperphosphataemia and hyperparathyroidism in dialysis patients:
recommendations for a change in management. Am J Kidney Dis 2000; 35 (6):
9. Malluche HH, Monier-Fugere M-C. Hyperphosphataemia: pharmacologic
intervention yesterday, today and tomorrow. Clin Nephrol 2000; 54(4): 309-17.
10. Kim J et al. Achievement of proposed NKF-K/DOQI Bone Metabolism and
Disease Guidelines: results from the Dialysis Outcomes and Practice Patterns
Study (DOPPS). J Am Soc Nephrol 2003; 14: 269A.
Notes to Editors:
Phosphorus, an element found in nearly all foods, is absorbed from the
gastrointestinal tract into the blood stream. When the kidneys fail, they no
longer effectively filter out phosphates, even with the help of
blood-cleansing dialysis machines. While the normal adult range for phosphorus
is 2.5 (0.8mmol/L) to 4.5 mg/dL (1.4mmol/L), the blood phosphorus levels of
many patients on dialysis exceed 6.5 mg/dL (2.1mmol/L). Such levels have been
linked to a significantly higher illness and death risk for patients who have
undergone at least one year of dialysis(i) with up to 75 per cent of patients
Hyperphosphataemia disrupts the delicate interplay between the body's
levels of calcium, parathyroid hormone (PTH) and vitamin D. Over time,
hyperphosphataemia can ultimately lead to calcification of the heart, lung and
some arteries(iii). Accumulating evidence shows that hyperphosphataemia
contributes to cardiovascular disease, which accounts for almost half of all
deaths among dialysis patients(iv). Studies have shown that cardiovascular
mortality in dialysis patients aged 25-34 years is more than 5 times greater
than that in people aged 65-74 in the general population(v).
Since dialysis and diet restrictions alone generally cannot control
phosphate levels, patients traditionally manage hyperphosphataemia by taking
phosphate binding agents with every meal and snack. Such binders "soak up"
phosphate in the gastrointestinal tract, before it can be absorbed into the
FOSRENOL(R) (lanthanum carbonate)
FOSRENOL(R) 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. As a
consequence, overall phosphate absorption from the diet is decreased
significantly. Shire has conducted an extensive worldwide clinical research
programme for FOSRENOL involving over 5000 patients(vi), with a small number
followed for up to 6 years.(vii) This programme has demonstrated that FOSRENOL
is an effective phosphate binder with a good tolerability profile for
long-term use. FOSRENOL was approved by the FDA in October 2004. In March 2005
regulatory authorities in the EU granted marketing authorization for FOSRENOL
in sixteen member states, thus completing the first step in securing marketing
approval throughout Europe. FOSRENOL has since been launched in Austria,
Belgium, Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland,
The Netherlands, Poland and Sweden. The final step in the European process was
recently completed resulting in recommendation for approval in the remaining
11 member states. Further roll-outs are underway across the rest of Europe and
other countries around the world. The company has out-licensed the rights to
develop, market and sell FOSRENOL in Japan to Bayer Yakuhin Ltd.
Patients with renal insufficiency may develop hypocalcaemia. Serum
calcium levels should therefore be monitored at regular time intervals for
this patient population and appropriate supplements given.
No data are available in patients with severe hepatic impairment. Caution
should, therefore, be exercised in these patients, as elimination of absorbed
lanthanum may be reduced.
FOSRENOL should not be used during pregnancy.
Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease or
bowel obstruction were not included in clinical studies with Fosrenol.
The most commonly reported Adverse Drug Reactions (ADRs) ((greater
than)1/100, 1/10) are gastrointestinal reactions such as abdominal pain,
constipation, diarrhoea, dyspepsia, flatulence, nausea and vomiting. These are
minimized by taking FOSRENOL with food and generally abated with time with
continued dosing. Hypocalcaemia was the only other commonly reported adverse
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:
"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),
MEZAVANT(TM) (SPD476) (mesalazine) in Europe, and VYVANSE(TM) (NRP104)
(lisdexamfetamine dimesylate) (ADHD), including its scheduling classification
by the Drug Enforcement Administration in the United States; Shire's ability
to secure new products for commercialization and/or development; 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.
For further information:
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