OPKO will acquire worldwide rights to Cytochroma's two lead product candidates: 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 (fermagate tablets), a non-absorbed phosphate binder to treat hyperphosphatemia in dialysis patients. Both products are in phase III development in the U.S.
"We are pleased that OPKO and Cytochroma have joined forces to improve the care of kidney patients," said Alan J. Lewis, PhD, chairman of Cytochroma. "The combined companies are well positioned to become a major new global player in the chronic kidney disease space."
Replidea has been shown in a phase IIb 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 OPKO's proprietary point-of-care vitamin D diagnostic test currently in development," ssid Phillip Frost, MD, CEO and chairman of OPKO. "We envision these remarkable products as part of the foundation for a new and markedly improved standard of care for chronic kidney disease patients."
Alpharen has been shown safe and effective in treating hyperphosphatemia in the phase II and III clinical trials undertaken to date in dialysis patients. Hyperphosphatemia exacerbates SHPT and promotes bone disease, soft tissue mineralization and progression of kidney disease. Approximately 90% of dialysis patients in the U.S. require regular treatment. Cytochroma acquired global rights to Alpharen from INEOS Healthcare in 2010.
In addition, Cytochroma's officers will join the OPKO management team, and all other Cytochroma employees will be retained by OPKO.