3SBio to Commercialize Iron Deficiency Agent in China

3SBio, Inc. (NSDQ: SSRX) has signed a development-commercialization deal with AMAG Pharmaceuticals, Inc. (NSDQ: AMAG) to obtain SFDA approval and then market ferumoxytol, an intravenous iron replacement therapeutic agent being developed to treat iron deficiency anemia in chronic kidney disease [CKD] patients.

3SBio’s flagship drugs, EPIAO, an injectable recombinant human erythropoietin, and TPIAO, a protein-based therapeutic recombinant human thrombopoietin, are sold largely to dialysis patients with chronic kidney disease.

3SBio paid $1 million upfront and will make milestone payments as ferumoxytol achieves regulatory goals for chronic kidney disease and other indications. AMAG will also receive tiered, double-digit royalties, up to 25%, based on sales of ferumoxytol. 3SBio will assume complete financial responsibility for the approval process of ferumoxytol in China, which will be administered by a joint 3SBio-AMAG steering committee. Under the agreement, 3SBio will have rights to the drug for 13 years. If minimum levels of sales are met, the agreement will be automatically renewed. AMAG will manufacture ferumoxytol and sell it to 3SBio at a set supply price.

Ferumoxytol has completed its clinical trials in the US, and AMAG submitted its request for FDA approval of the drug in December 2007.

According to AMAG, there are 12 million Stage 3 and 4 CKD patients and over 91,000 patients on dialysis in China. AMAG used a proprietary nanoparticle technology to develop the drug.

3SBio is based in Shenyang and AMAG is headquartered in Cambridge, MA.

Disclosure: none.