OPKO Health inks deal to acquire Cytochroma and two Ph III products

Privately-held Canadian company Cytochroma says that it has entered into a definitive agreement to be acquired by USA-based OPKO Health (NYSE: OPK). Cytochroma has operations in Markham, Ontario, and Bannockburn, Illinois, USA. Financial terms were not revealed.

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 III development in the USA. 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 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.

Foundation for improved standard of care for chronic kidney disease patients