MIDDLETON, Wis., April 26 /PRNewswire-FirstCall/ -- Bone Care International, Inc. today announced that the U.S. Food and Drug Administration approved a new indication and strength for Hectorol(R) (doxercalciferol) Capsules. Hectorol(R), a novel pro-hormone vitamin D2 analog, currently approved for the treatment of secondary hyperparathyroidism (SHPT) in dialysis patients in the United States, is now approved for the treatment of SHPT that develops in the earlier stages (Stages 3 and 4) of chronic kidney disease (CKD) prior to dialysis.
Current therapies for SHPT are primarily targeted for, or limited to, use in the more than 300,000 dialysis (Stage 5 CKD) patients in the United States. However, this disease frequently develops in the earlier stages of CKD before patients require dialysis, and it is estimated that there are more than eight million Stage 3 and 4 CKD pre-dialysis patients in the United States, many of whom have developed SHPT. "The approval of our supplemental new drug application (sNDA) for Hectorol(R) 0.5 mcg Capsules in pre-dialysis CKD patients reflects the outstanding efforts of our employees and their commitment to developing therapeutic products to serve patients," said Paul L. Berns, president and chief executive officer at Bone Care International. "We are enthusiastic about this new indication for Hectorol(R) Capsules as it provides physicians and patients with the first oral pro-hormone vitamin D2 analog therapy for early treatment of SHPT in pre-dialysis patients, a large population with significant unmet medical needs."
The National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines recommend the treatment of SHPT before CKD patients progress to dialysis. "The new indication for Hectorol(R) 0.5 mcg Capsules provides the nephrology community with a safe and effective way to treat SHPT in pre-dialysis patients (Stages 3 and 4) in a manner consistent with the NKF K/DOQI clinical practice guidelines for bone metabolism and disease in CKD," said Jeffrey J. Freitag, M.D., vice president of research and development at Bone Care International.
Secondary Hyperparathyroidism
SHPT initially develops due to the CKD patient's inability to produce adequate levels of active vitamin D hormone. As CKD progresses, vitamin D hormone levels decline with SHPT typically characterized by a subsequent decrease in calcium levels along with elevated parathyroid hormone (PTH) and phosphorus levels. If left untreated, SHPT can eventually result in cardiovascular disease, reduced immune system function, muscle weakness and bone mineral loss and fractures. "Hectorol(R) 0.5 mcg Capsules address the CKD-related active vitamin D hormone deficiency that triggers the onset of SHPT. This was demonstrated in the clinical setting through the effective and safe management of SHPT in Stages 3 and 4 CKD patients; Hectorol(R) significantly reduced PTH while maintaining calcium and phosphorus targets," said Freitag.
"It is important to recognize that depletion of vitamin D hormone in CKD patients is a significant disorder that can lead to serious clinical consequences," said Jill Lindberg, M.D., a lead investigator for the Hectorol(R) Phase III clinical trials and director of the Metabolic Bone and Stone Clinic, New Orleans Nephrology Associates, and associate clinical professor of medicine at Tulane University. "Up until now, the only available vitamin D treatment for SHPT in pre-dialysis patients was calcitriol; a first generation vitamin D3 sterol often associated with elevations in serum calcium and calcium-phosphorus product."
Correcting vitamin D hormone deficiency due to kidney disease is a vital component of the treatment strategy for SHPT in Stages 3, 4 and 5 CKD. According to Shaul G. Massry, M.D., professor of medicine at KECK School of Medicine, University of Southern California, and Work Group Chair, K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in CKD, "Vitamin D hormone therapy is an important aspect of our K/DOQI clinical practice guidelines. Innovative therapies that improve the treatment of kidney disease complications related to bone and mineral metabolism, such as the harmful effects caused by vitamin D hormone deficiency, are important for maintaining the health and well-being of these patients."
Hectorol(R) is a useful tool to help practitioners and patients meet recommended target treatment goals. "Hectorol(R) is an important addition to our armamentarium of therapeutic solutions to help clinicians achieve the NKF K/DOQI guideline treatment goals designed to protect the long-term health of CKD patients," said Mark Williams, M.D., a lead investigator for the Hectorol(R) Phase III clinical trials and director of dialysis at Beth Israel Deaconess Medical Center in Boston and associate clinical professor of medicine at Harvard University. "Hectorol(R) Capsules effectively lowered PTH in Stages 3 and 4 CKD patients with no increase in the incidence of hypercalcemia or hyperphosphatemia compared to placebo treatment. Hectorol(R) is an effective treatment option safe enough to use when SHPT really begins."
Regarding Hectorol
In clinical trials in pre-dialysis CKD patients with SHPT, Hectorol(R) 0.5 mcg Capsules were safe and effective in reducing PTH while maintaining calcium, phosphorus and calcium-phosphorus product in men and women with Stages 3 and 4 CKD.
Importantly, 74 percent of pre-dialysis CKD patients treated with Hectorol(R) 0.5 mcg Capsules achieved a greater than or equal to 30 percent reduction in PTH and the average reduction in PTH was 46 percent. These results were statistically significant compared to placebo results. In terms of safety data, the incidences of hypercalcemia and hyperphosphatemia were similar to placebo therapy, and no episodes of hypercalciuria were observed.
Vitamin D therapies such as Hectorol(R) regulate blood calcium at levels required for essential body functions. Based on the mechanism of action, vitamin D should not be given to patients with a tendency towards hypercalcemia or evidence of vitamin D toxicity. Oversuppression of PTH, increases in serum calcium, serum phosphorus and urinary calcium can occur with vitamin D therapy. These potential adverse effects should be managed by regular patient monitoring and appropriate dosage adjustments.
Regarding Bone Care International, Inc.
Bone Care International (http://www.bonecare.com/) is a pharmaceutical company engaged in discovery, development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. Our current commercial and therapeutic focus is in nephrology utilizing Hectorol(R), our novel Vitamin D hormone therapy, to treat secondary hyperparathyroidism in patients with CKD. In addition to chronic kidney disease, the Company is developing vitamin D hormone therapies to treat hyperproliferative disorders such as cancer and psoriasis.
Contacts:
Rx Communications Group, LLC Bone Care International, Inc.
Melody A. Carey (Investors) Brian J. Hayden
(917) 322-2571 Chief Financial Officer
Pete Holmberg (Media) (608) 662-7800
(917) 322-2164
This press release contains forward-looking statements. Statements relating to future sales, costs of sales, other expenses, profitability, financial resources, or products and production schedules, or statements that predict or indicate future events and trends and which do not relate solely to historical matters identify forward-looking statements. Forward-looking statements are made in reliance on to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on management's current plans and expectations as well as assumptions made by and information currently available to management. Accordingly, the Company's actual results may differ materially from those expressed or implied in such forward-looking statements due to known and unknown risks and uncertainties that exist in the Company's operations and business environment, including, among other factors, the ability of the Company and each of its suppliers of doxercalciferol, Hectorol(R) Injection and Hectorol(R) Capsules to meet the Company's anticipated production schedules, technical risks associated with the development of new products, regulatory policies in the United States and other countries, risks associated with our ability to avoid or minimize delays in/or interruption of the manufacture and supply of our products, including the approvals of regulatory authorities in connection therewith, reimbursement policies of public and private health care payors, introduction and acceptance of new drug therapies, competition from existing products and from new products or technologies, the failure by the Company to produce anticipated cost savings or improve productivity, the timing and magnitude of capital expenditures and acquisitions, economic and market conditions in the United States, Europe and the rest of the world, and other risks associated with the Company's operations, including those identified from time to time in our public filings. The Company disclaims any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future events or developments.
Bone Care International, Inc.