Nephoxil^®: A Best in Class Phosphate Binder
Nephoxil^® is a new generation phosphate binder for the treatment of hyperphosphatemia in ESRD (end stage renal disease) patients. The disease, hyperphosphatemia, is highly prevalent in ESRD patients and has been known to result in bone disorder (renal osteodystrophy), heart disease and vascular calcifications and linked to increase the morbidity and mortality rate. The multi-nation Phase II trials under the scrutiny of US FDA & Taiwan FDA has successfully proven Nephoxil^® is able to significantly lower serum phosphorus, calcium-phosphorus by product in dialysis patients with good safety and tolerability. In addition, Nephoxil^® has the potential to ameliorate metabolic acidosis and reduce use of EPO & IV iron in dialysis patients.
The worldwide market for phosphate binders is around US$1 Billion currently and continues to increase at a rapid pace. We are in a joint development effort with our licensees in the US and Japan to seek market approval for Nephoxil^®. This product is currently in global Phase III clinical studies and is positioned to launch from 2013 onward.

PB1612:
PB1612 is to combat soft tissue calcification in renal failure patients. In these patients, calcification can be developed all over the body system including arteries, eye, joints, skin and subcutaneous tissues, and also in internal organs such as the lungs, kidney, stomach and heart. It has been reported that cardiovascular disease, particularly coronary artery disease and chronic heart failure, substantially increases morbidity and mortality in ESRD patients. Chronic kidney disease patients have 2 to 5 times more coronary artery calcification than healthy age-matched individuals. In ESRD patients, it has been reported that on average of 83% of dialysis patients have some degree of coronary artery calcification. Vascular calcification is a strong prognostic marker of cardiovascular disease mortality in CKD patients. The USRDS has reported cardiac causes of death account for approximately 50% of all deaths of ESRD patients. Currently, there is no product available on the market to effectively manage the disease. Success of PB1612 would be a significant therapeutic advance in improving the quality of life of CKD patients.



PB1603:
PB1603 is to combat the progression of Chronic Kidney Disease (“CKD”). CKD is a gradual and progressive loss of the ability of the kidneys to excrete wastes, concentrate urine, and conserve electrolytes. Unlike acute kidney failure with its abrupt but reversible of kidney function, the kidney function in CKD progresses irreversibly and slowly gets worse toward end stage renal disease (ESRD). Patients suffering from ESRD can not survive without dialysis or kidney transplantation. CKD usually occurs over a number of years as the internal structures of the kidney are damage.