Acquisition Includes Replidea TM and Alpharen TM, Both in Phase 3 Clinical Trials with Kidney Disease Patients
Jan. 8, 2013
/PRNewswire/ - Cytochroma today announced that it has entered into a definitive agreement with OPKO Health, Inc. (NYSE:
) under which Cytochroma, a privately held pharmaceutical company with operations in
, will be acquired by OPKO. Through this transaction, 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 3 development in
the United States
. Cytochroma's officers will join the OPKO management team, and all other Cytochroma employees will be retained by OPKO.
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
, 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," stated
, MD, OPKO's 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."
"We are pleased that OPKO and Cytochroma have joined forces to improve the care of kidney patients," commented
Alan J. Lewis
, PhD, Cytochroma's Chairman. "The combined companies are well positioned to become a major new global player in the chronic kidney disease space."
Alpharen™ has been shown safe and effective in treating hyperphosphatemia (elevated serum phosphorus) in the phase 2 and 3 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 United States
require regular treatment. Cytochroma acquired global rights to Alpharen
from INEOS Healthcare in 2010.
About Chronic Kidney Disease
CKD is a condition characterized by a progressive decline in kidney function. The kidney is normally responsible for excreting waste and excess water from the body, and for regulating various hormones. CKD is classified in five different stages - mild (stage 1) to severe (stage 5) disease - as measured by the kidney's glomerular filtration rate. According to the National Kidney Foundation, CKD afflicts over 26 million people in the US, including more than eight million patients with moderate (stages 3 and 4) and severe (stage 5) forms of CKD. In stage 5 CKD, kidney function is minimal to absent and patients require regular dialysis or a kidney transplant for survival.