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.
Our subsequent studies demonstrated that the vitamin D hormone downregulates renin gene expression by targeting the cAMP-PKA-CREB (cAMP-protein kinase A-cAMP-responsive element binding protein) signaling pathway that promotes renin transcription (4).
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.
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.
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
Patients with kidney failure do not produce enough vitamin D hormones
and lose the ability to control critical metabolic processes.