ST. LOUIS, Oct. 31 /PRNewswire-FirstCall/ -- Bone Care International, Inc. today announced new data from two Hectorol(R) (doxercalciferol) Injection studies. In a retrospective study, Hectorol(R) showed higher attainment than paricalcitol regarding compliance to several Kidney Disease Outcomes Quality Initiative (K/DOQI) Bone Guidelines in dialysis patients with secondary hyperparathyroidism (SHPT). "These findings provide continuing evidence that Hectorol(R) is a safe and effective treatment for lowering parathyroid hormone (PTH) levels in dialysis patients with SHPT," stated Jeffrey J. Freitag, M.D., Vice President of Research and Development for Bone Care International.
In an animal model of SHPT, Hectorol(R), unlike calcitriol, reduced elevated levels of PTH and normalized serum calcium without causing hypercalcemia. The findings were presented today during Renal Week 2004 (TM) at the 37th annual meeting of the American Society of Nephrology (ASN) in St. Louis.
Data was also presented on Bone Care's investigational vitamin D drug, LR-103, suggesting advantages versus calcitriol in lowering PTH and bone histology in an animal model of SHPT. LR-103 is our novel vitamin D analog being studied for the treatment of SHPT and several types of cancers.
Hectorol(R) Studies Overview
In a retrospective study, 1,047 patients treated with Hectorol(R) Injection were matched with 1,047 patients treated with paricalcitol injection on baseline PTH values, race and prior vitamin D use. In patients treated for at least six months, Hectorol(R) treated patients had a higher attainment than paricalcitol treated patients regarding compliance to several K/DOQI Bone Guidelines by PTH group and for the total population at six months. There were trends favoring Hectorol(R), but no significant differences between the two groups with respect to serum calcium, phosphorus or PTH. (ASN Abstract No. PUB468)
In a second study comparing the effect of Hectorol(R) and calcitriol on PTH and serum calcium levels in a transgenic mouse model of SHPT, Hectorol(R) dose-dependently reduced PTH and normalized serum calcium without causing hypercalcemia. In contrast, while calcitriol reduced PTH levels, its use dose-dependently increased serum calcium, resulting in significant hypercalcemia at the highest dose tested. Increased serum calcium may be associated with soft tissue calcification, vascular calcification and cardiovascular complications. (ASN Abstract No. PUB467)
Hectorol(R) should not be given to patients with a tendency towards hypercalcemia or evidence of vitamin D toxicity. Overdosage of any form of vitamin D, including Hectorol(R), is dangerous. Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate the action of digitalis drugs. Chronic hypercalcemia can lead to generalized vascular calcification and other soft-tissue calcification. The principle adverse effects of treatment with Hectorol(R) are hypercalcemia, hyperphosphatemia, hypercalciuria, and oversuppression of iPTH. Oversuppression of iPTH may lead to adynamic bone syndrome.
LR-103 Study Overview
A follow-up study on the effects of LR-103 presented at last year's meeting (ASN 2003 Abstract No. F-PO625) further investigates the effect of LR-103 on bone parameters using a transgenic mouse model of SHPT. LR-103 is effective in normalizing serum calcium and PTH levels without causing hypercalcemia. Importantly, LR-103 also normalized bone abnormalities consequent to SHPT and active vitamin D deficiency. In contrast, calcitriol caused PTH over suppression and bone abnormalities at the dose tested. (ASN Poster SU-PO942)
"The ongoing LR-103 Phase II study and active pre-clinical research program is an example of our commitment to move our pipeline forward," stated Paul L. Berns, President and Chief Executive Officer of Bone Care International. "Our expectations are to complete the initial Phase II trial which is being held at the University of Wisconsin in calendar year 2005."
About Bone Care International
Bone Care International (http://www.bonecare.com/) is a specialty pharmaceutical company engaged in the 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), a novel vitamin D hormone therapy, to treat secondary hyperparathyroidism in patients with moderate to severe chronic kidney disease and end-stage renal disease. In addition to chronic kidney disease, the Company is developing vitamin D hormone therapies to treat hyperproliferative disorders such as cancer and psoriasis.
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 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.
Contacts:
Rx Communications Group, LLC Bone Care International, Inc.
Melody A. Carey (Investors) Jeffrey J. Freitag, M.D.
(917) 322-2571 Vice President, Research & Development
mcarey@rxir.com (608) 662-7800
Alison Minaglia (Media)
(917) 322-2575
aminaglia@rxir.com
Tony Ho Loke (Media)
(917) 322-2164
tloke@rxir.com
Bone Care International, Inc.
CONTACT: Investors, Melody A. Carey, +1-917-322-2571, ormcarey@rxir.com, or Media, Alison Minaglia, +1-917-322-2575, oraminaglia@rxir.com, or Tony Ho Loke, +1-917-322-2164, or tloke@rxir.com, allof Rx Communications Group, LLC, all for Bone Care International, Inc.; orJeffrey J. Freitag, M.D., Vice President, Research & Development, of Bone CareInternational, Inc., +1-608-662-7800