BY OUR PHARMA CORRESPONDENT
19th August, 2005: The Swiss drug major Novartis has acquired the global rights for a novel oral phosphate binder in development for the treatment of elevated serum phosphate levels (hyperphosphatemia) in late- or end-stage renal disease patients. The company has signed an agreement with SeBo GmbH of Germany recently, A Novartis release said.
Under the terms of the agreement, which were not disclosed, Novartis has obtained the rights to develop, manufacture and commercialize this compound for patients with chronic kidney disease or patients already on dialysis. The compound is currently in phase I clinical development.
This novel compound complements the expertise in kidney disease that we have established through our leadership in transplantation and has the potential to offer dialysis patients a new, more potent and convenient oral treatment option to help them manage the effects of dialysis and chronic kidney disease, the release noted.
Patients with chronic kidney disease, as well as those already on dialysis, have reduced phosphate excretion, which leads to elevated serum phosphate levels (hyperphoshatemia). This condition may lead to increased calcium-phosphate deposits that cause arteriosclerosis, which in turn raises the risk for coronary heart disease and stroke as well as bone disease.
The treatments available today for hyperphosphatemia do not reliably achieve treatment standards set by kidney specialists to help patients effectively manage their disease. As a result, a need remains for novel, more efficient, convenient and tolerable treatment options that lower phosphate without raising calcium levels in the serum to values that are accepted by physicians in order to improve patient well being and possibly survival.
At least 90% of dialysis patients receive chronic treatment for hyperphoshatemia, while an estimated 80% of patients with chronic kidney disease are also treated for this condition. Approximately 800,000 patients are estimated to have end-stage renal disease in Europe and the US, with the vast majority of them requiring dialysis. An equal number of patients are estimated to have late-stage chronic kidney disease and could eventually require dialysis.
Phosphate is primarily derived from dietary sources and is absorbed in the intestine. Hyperphosphatemia is generally caused by renal insufficiency when the kidneys are no longer able to filter excessive amounts of phosphate out of the blood. Elevated phosphate levels in the blood can lead to several serious conditions that include soft tissue calcification, kidney failure and heart disease. Another potential condition is hyperplasia of parathyroid glands with secondary hyperparathyroidism (HPT), which leads to bone disease. Acute hyperphosphatemia can also lead to hypocalcemia with tetany, seizures and arrhythmias.
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 83,700 people and operate in over 140 countries around the world. The company introduced Sandimmune (cyclosporin) for organ transplantation over two decades ago.
BY OUR PHARMA CORRESPONDENT
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