FOR IMMEDIATE RELEASE
— New Vitamin D Hormone Replacement Therapy for Chronic Kidney Disease —
Washington, DC, May 5, 2005 – Following the successful filing of the Investigational New Drug (IND) Application in March, 2005, Bone Care International announces plans to move the novel Vitamin D hormone, LR-103, into human subjects with Chronic Kidney Disease (CKD).
The recently accepted IND focuses on the use of LR-103 to treat secondary
hyperparathyroidism in patients with CKD. Data available from pre-clinical research indicate that LR-103 has the same potency as calcitriol, but much lower toxicity. “Early safety data from an ongoing Phase I clinical study with LR-103 in cancer patients support the expanded testing of LR-103 in patients with chronic kidney disease,” said Charles W. Bishop Ph.D., Chief Scientific Officer at Bone Care International. The initial study with LR-103 in CKD will be a Phase I/II dose-ranging efficacy and safety study in patients with Stage 5 CKD or end-stage renal disease. Additionally, a separate study is being planned to study LR-103 in earlier stages of CKD.
According to the National Kidney Foundation, more than 20 million Americans have CKD and an additional 20 million are at risk.
About Bone Care International
Bone Care International (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®, 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.
Bone Care International, Inc.
Brian J. Hayden
Chief Financial Officer
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 pursuant 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 beliefs 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® Injection and Hectorol® 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, currency exchange risks, economic and market conditions in the United States, Europe and the rest of the world, and other risks associated with the Company’s operations. 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.