15-Mar-2001 - Shire plc

First filing for FOZNOL* (lanthanum carbonate) in Europe

Shire Pharmaceuticals Group plc (Nasdaq: SHPGY, LSE: SHP.L) announces that the first regulatory submission for Foznol* (lanthanum carbonate, Project Lambda) was delivered to a Reference Member State in the EU Mutual Recognition Procedure yesterday.

Foznol* is being developed for the treatment of hyperphosphataemia in patients with chronic renal failure. Hyperphosphataemia (high levels of phosphate in the blood), results from the inability of damaged kidneys to excrete any excess phosphate that enters the body in food. Adequate control of serum phosphate is essential to reduce the risk of death from cardiovascular disease and to manage secondary hyperparathyroidism and the multifactorial disorders of bone and mineral metabolism that can result in renal osteodystrophy. Conventional dialysis and a phosphate restricted diet are generally unable to reduce these levels sufficiently without the addition of phosphate binding agents.

Administration of Foznol* with food results in the formation of lanthanum phosphate, a compound of low aqueous solubility which cannot pass easily through the gut lining. As a consequence, phosphate absorption from the diet is decreased and the insoluble phosphate salt is not absorbed into the blood stream. As Foznol* does not contain calcium it enables the physician to separate the control of serum calcium from serum phosphate and reduces the risk of hypercalcaemia.

It is estimated that there are 650,000 patients worldwide with end stage renal disease. These patients tend to be treated within specialised renal units, which will allow Shire to effectively target the key prescribers, without the need for a large sales force. This is consistent with Shire’s strategy of marketing specialty products.

Shire was granted an exclusive agreement to develop, manufacture, use and sell Foznol worldwide by the patent holder, AnorMed Inc. A royalty on net sales and a milestone payment will be due once the product is successfully launched.

Dr. Wilson Totten, Group R&D Director of Shire, said: “Foznol* will hopefully play an important role in building Shire’s international specialty marketing presence. If approved, this will help to grow our recently established marketing subsidiaries in Continental Europe, at the same time providing further growth for our more mature marketing operations in the US, Canada, the UK and Ireland and an additional product for sale by relevant distributors elsewhere.”

Facts, background information, dossiers
  • milestone payments
  • metabolism
  • kidneys
  • dialysis
  • chronic renal failure
  • cardiovascular diseases
  • AnorMED
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