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.
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.
Mazess, Acting President and Chairman of the Board, indicated "This change in reimbursement status should markedly improve the competitiveness of Hectorol in the $500 million market for intravenous vitamin D hormone
replacement therapy for patients with end stage renal disease".
The Company will use its net proceeds from the offering to: (1) commercialize Hectorol Injection to manage secondary hyperparathyroidism in patients with end-stage renal disease; (2) complete FDA post-approval Phase IV commitments for Hectorol Injection; (3) seek FDA approval and commercialize Hectorol Capsules in the pre-dialysis market; (4) develop additional clinical indications for Hectorol Capsules by conducting Phase II, and possibly Phase III, trials in patients with senile osteoporosis, psoriasis and prostate cancer; (5) continue research and development activities on new vitamin D hormone
therapies; and (6) provide working capital for general corporate purposes.
Bone Care is an emerging pharmaceutical company with a platform of improved vitamin D-hormone therapies for the treatment of diverse diseases involving the vitamin D hormone
It is now well accepted that the vitamin D hormone
is a pleotropic hormone that regulates a wide spectrum of biological processes beyond calcium and skeletal homeostasis.
Activated vitamin D hormone
therapy is problematic in CKD patients with secondary hyperparathyroidism arising primarily from vitamin D insufficiency since it further stimulates catabolism of the available vitamin D stores and is often associated with hypercalcemia, a side effect linked to vascular calcification.
The product is designed to reliably correct vitamin D insufficiency by raising serum vitamin D pro-hormone concentrations to adequate levels (30 ng/mL or higher), thereby lowering elevated plasma parathyroid hormone (PTH) without the side effects often associated with vitamin D hormone
The new molecular entity (NME) being developed, APH-M109, is an analog of the naturally occurring Vitamin D hormone
that is very toxic at therapeutic concentrations.
Further, they highlight the potential benefit of CTA018, the Company's novel vitamin D hormone
analog designed to simultaneously activate the vitamin D signaling pathway and inhibit CYP24.
Our current commercial and therapeutic focus is in nephrology, utilizing Hectorol(R) (doxercalciferol), our novel vitamin D hormone
therapy, to treat secondary hyperparathyroidism in patients with moderate to severe chronic kidney disease and end-stage renal disease.
Patients with kidney failure do not produce enough vitamin D hormones
and lose the ability to control critical metabolic processes.