3SBio and Panacor Bioscience Enter Collaboration and License Agreement to
Develop and Commercialize NephoxilÂ® for Hyperphosphatemia
3SBio Inc, a
leading China-based biotechnology company focused on researching, developing, manufacturing and marketing
biopharmaceutical products, today announced a collaboration and license agreement with Panacor Bioscience Ltd. to
develop and commercialize its NephoxilÂ® pharmaceutical product for the treatment of hyperphosphatemia in China.
Nephoxil (ferric citrate) is a differentiated, iron-based phosphate binder for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end stage renal disease (ESRD). Nephoxil is free of aluminum, lanthanum and calcium, and is not polymer-based. Due to the deterioration of kidney function, ESRD patients are unable to excrete phosphorus effectively even through frequent dialysis, and almost all patients require daily phosphate binder intake to control body phosphate levels. If not treated, hyperphosphatemia could lead to serious or fatal complications such as bone deformation (renal osteodystrophy), coronary calcification, heart disease, stroke and cardiovascular diseases which account for about half of the causes of death in the ESRD population. China represents a large and rapidly growing market with approximately 12 million Stage 3 and 4 chronic kidney disease (CKD) patients, and over 91,000 dialysis patients.
Nephoxil has completed Phase II clinical development programs, including a dose-ranging study, a high dose safety and tolerability study and an open-label extension study, with compelling clinical data. Nephoxil is developed globally and is entering Phase III clinical development in the United States, Japan and Taiwan.
Under the terms of the agreement, Panacor Bioscience will grant 3SBio exclusive commercialization rights to Nephoxil in China. Panacor Bioscience will receive an upfront equity investment of US$1 million and royalties on future product sales. 3SBio will be responsible for the cost of clinical development, registration, manufacturing and commercialization of Nephoxil in China. The agreement is subject to final approval by Taiwanâ€™s regulatory authorities, including the Investment Commission of the Taiwan Ministry of Economic Affairs.
â€śWe are excited to extend the franchise of Nephoxil into one of the most important markets for chronic kidney disease. We are very pleased to enter the relationship with 3SBio which has a proven track record of developing and marketing innovative pharmaceutical products in China,â€ť said Winston Town, Chief Executive Officer of Panacor Bioscience Ltd.
â€śGiven the limitation of existing phosphate binders in China, Nephoxil has the potential to improve the phosphate management of the growing number of CKD patients in China. We are optimistic about this new addition to our nephrology franchise and look forward to working with Panacor Bioscience as we start the SFDA approval process,â€ť said Dr. Jing Lou, Chief Executive Officer of 3SBio Inc.