Agreement to develop fourth generation active d therapies for renal disease
"This agreement reflects Abbott's continuing commitment to cutting-edge science that helps patients with kidney disease," said Eugene Sun, M.D., divisional vice president, global pharmaceutical development, Abbott Laboratories. "Abbott pioneered the clinical development and commercialization of therapies targeting vitamin D receptor activation for the treatment of secondary hyperparathyroidism in patients with chronic kidney failure, which were discovered by Hector F. DeLuca, Ph.D., DSc, professor and chair of the Department of Biochemistry at the University of Wisconsin - Madison. These therapies have now become the standard of care."
The new agreement continues a 20-year partnership between Abbott, Dr. DeLuca (now president and chief executive officer of Deltanoid), and the University of Wisconsin to discover, develop, and commercialize innovative vitamin D therapies for patients with kidney disease. A growing body of research is beginning to establish the fundamental role of vitamin D receptor biology in human health and disease.
The agreement provides Abbott with rights to license, develop and commercialize a new generation of VDRAs. Preclinical studies conducted by Deltanoid suggest that these investigational compounds, developed by Dr. DeLuca, may have an optimal profile to help address the future needs of the growing population of patients with kidney disease.
"The agreement between Deltanoid and Abbott reinforces the value of Deltanoid's active vitamin D therapies in treating disease. Vitamin D Receptor Activation is a primary method of treating secondary hyperparathyroidism associated with chronic kidney failure, and Abbott is the pioneer and market leader in this area," said Dr. DeLuca. "This collaboration will allow Deltanoid to move these new compounds forward with one of the most experienced and effective partners in the field of renal disease. Abbott's extensive resources and world-class expertise in this field make them an ideal partner for this effort, and we look forward to continuing to work with them."
Under the terms of the agreement, Abbott will make an undisclosed upfront payment to Deltanoid. The agreement also includes milestone payments contingent upon meeting specified objectives, as well as royalties on future sales of marketed compounds.
About Renal Disease
Healthy kidneys are essential for the conversion of vitamin D into its active form, known as calcitriol. Calcitriol is required for the normal function of many organs and systems throughout the body. As kidney disease progresses, patients lose the ability to produce calcitriol, which leads to many metabolic imbalances and complications, including elevated parathyroid hormone levels (a condition known as secondary hyperparathyroidism), abnormal calcium and phosphorus levels, and bone disease (renal osteodystrophy).
Approximately 300,000 patients have end-stage renal disease and require dialysis (Stage 5 kidney disease). More than 20 million Americans suffer from early to late-stage kidney disease, according to the National Kidney Foundation. That figure is rising with increased incidences of diabetes and hypertension, the major diseases leading to kidney disease. New scientific evidence and treatment guidelines recently published by the National Kidney Foundation are changing the way doctors approach early stage kidney disease and emphasize the importance of identification and treatment earlier in the progression of the disease. As a result, the global market for vitamin D compounds used in renal patients is expected to grow to more than $2 billion by the end of the decade.
About Deltanoid
Deltanoid Pharmaceuticals Inc. is a biopharmaceutical company engaged in research, development and commercialization of novel therapies for the treatment of human diseases. The company was founded to advance the development of select, patented vitamin D and other compounds developed at the University of Wisconsin - Madison and licensed from the Wisconsin Alumni Research Foundation. Deltanoid's focus is to develop selected therapies through early phases of the drug-development process and seek partners for later-stage development and commercialization. The agreement with Abbott is the third such partnership between Deltanoid and a pharmaceutical company since Deltanoid began operations in 2001. Two compounds developed by Deltanoid are currently in clinical testing.
Deltanoid founder, Hector F. DeLuca was named Ernst and Young Wisconsin Entrepreneur of the Year® for 2004, in recognition of the success of Deltanoid Pharmaceuticals.
About Abbott Renal Care
Abbott Laboratories has been involved in the treatment of certain complications associated with renal disease for more than 25 years. Abbott currently markets Zemplar® (paricalcitol injection) for the prevention and treatment of secondary hyperparathyroidism in patients with chronic kidney failure. Initially introduced in 1998, Zemplar is currently used to treat a majority of dialysis patients with secondary hyperparathyroidism in the United States. Abbott is currently investigating the use of an oral formulation of Zemplar in patients with earlier stages of chronic kidney disease.
Product Indication and Important Safety Information
Zemplar is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal failure.
As observed in Phase II and III clinical trials, adverse effects with greater than 5 percent frequency with Zemplar versus placebo, regardless of causality, were nausea (13 percent versus 8 percent), vomiting (8 percent versus 4 percent), and edema (7 percent versus 0 percent). Zemplar is contraindicated in patients with vitamin D toxicity, hypercalcemia, or hypersensitivity to product ingredients. Administration may place patients at risk for hypercalcemia, elevated Ca x P product, and metastatic calcification.
For full prescribing information on Zemplar visit http://www.abbottrenalcare.com.
About Abbott Laboratories
Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 55,000 people and markets its products in more than 130 countries.
View drug information on Zemplar.
Acordul de a dezvolta patra generaþie activã d terapii pentru boalã renalã - Agreement to develop fourth generation active d therapies for renal disease - articole medicale engleza - startsanatate