OPKO Health, Inc. (NYSE: OPK) has entered into a definitive agreement to acquire Cytochroma Inc. (Markham, Canada) whose lead products, both in phase 3 clinical trials, are Replidea™ (coded CTAP101 Capsules), a vitamin D prohormone to treat secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency, and Alpharen™, a non-absorbed phosphate binder to treat hyperphosphatemia in dialysis patients.
Replidea™ has been shown in a phase 2b clinical trial to effectively and safely treat SHPT and the underlying vitamin D insufficiency in pre-dialysis patients. Vitamin D insufficiency arises in CKD due to the abnormal upregulation of CYP24, an enzyme which destroys vitamin D and its metabolites. Studies in CKD patients have demonstrated that currently available over-the-counter and prescription vitamin D products cannot reliably raise blood vitamin D prohormone levels or effectively treat SHPT.
“OPKO intends to market Replidea™ along with our proprietary point-of-care vitamin D diagnostic test currently in development,” stated Phillip Frost, MD, CEO and Chairman. “We envision these remarkable products as part of the foundation for a new and markedly improved standard of care for chronic kidney disease patients having SHPT and/or hyperphosphatemia.”
Alpharen™ has been shown safe and effective in treating hyperphosphatemia in the phase 2 and 3 clinical trials undertaken to date in dialysis patients. Hyperphosphatemia (elevated serum phosphorus) exacerbates SHPT and promotes bone disease, soft tissue mineralization and progression of kidney disease. Approximately 90% of dialysis patients in the United States require regular treatment.Cytochroma’s officers, including Charles W. Bishop, PhD, CEO, an authority on developing and commercializing successful new vitamin D therapies, and Eric J. Messner, MBA, having a noteworthy track record in pharmaceutical business development and in marketing and sales in the CKD arena, will join the OPKO management team. Prior to Cytochroma, Dr. Bishop and Mr. Messner held key positions at Bone Care International, Inc., a leader in vitamin D therapeutics acquired by Genzyme Corporation, now a division of Sanofi.