OPKO Health Agrees to Buy Cytochroma

OPKO Health, Inc. (NYSE: OPK) has entered into a definitive agreement toacquire Cytochroma Inc. (Markham, Canada) whose lead products, both in phase 3clinical trials, are Replidea™ (coded CTAP101 Capsules), a vitamin Dprohormone to treat secondary hyperparathyroidism (SHPT) in patients withstage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency, andAlpharen™, a non-absorbed phosphate binder to treat hyperphosphatemia indialysis patients.Replidea™ has been shown in a phase 2b clinical trial to effectively andsafely treat SHPT and the underlying vitamin D insufficiency in pre-dialysispatients. Vitamin D insufficiency arises in CKD due to the abnormalupregulation of CYP24, an enzyme which destroys vitamin D and its metabolites.Studies in CKD patients have demonstrated that currently availableover-the-counter and prescription vitamin D products cannot reliably raiseblood vitamin D prohormone levels or effectively treat SHPT.“OPKO intends to market Replidea™ along with our proprietary point-of-carevitamin D diagnostic test currently in development,” stated Phillip Frost, MD,CEO and Chairman. “We envision these remarkable products as part of thefoundation for a new and markedly improved standard of care for chronic kidneydisease patients having SHPT and/or hyperphosphatemia.”Alpharen™ has been shown safe and effective in treating hyperphosphatemia inthe phase 2 and 3 clinical trials undertaken to date in dialysis patients.Hyperphosphatemia (elevated serum phosphorus) exacerbates SHPT and promotesbone disease, soft tissue mineralization and progression of kidney disease.Approximately 90% of dialysis patients in the United States require regulartreatment.