3SBio Inc. (Nasdaq: SSRX), a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, today announced that it has submitted its application for a registrational clinical trial to the Chinese State Food and Drug Administration ("SFDA") for Feraheme (ferumoxytol) Injection for intravenous use.
Feraheme is an intravenous iron therapy that 3SBio licensed from AMAG Pharmaceuticals, Inc. (Nasdaq: AMAG) for development in China for the treatment of iron deficiency anemia in adult patients with chronic kidney disease ("CKD").
Feraheme was approved on June 30, 2009 by the U.S. Food and Drug Administration for the same indication for which 3SBio is seeking approval in China and launched commercially in the U.S. by AMAG in July 2009. As previously announced, 3SBio has exclusive rights to develop and commercialize Feraheme in China. Once approved by the SFDA, 3SBio will commence a multi-center randomized efficacy and safety study in China with approximately 200 CKD patients, measuring the mean change in hemoglobin from baseline at Day 35 after first dose.
Dr. Jing Lou, Chief Executive Officer of 3SBio comments: "We are pleased with the timely submission of the Feraheme clinical trial application to the SFDA in China, representing a major milestone and our commitment to bringing this innovative therapy to Chinese CKD patients in need. We look forward to working with the SFDA to ensure an efficient review process."
Brian J.G. Pereira, MD, President and Chief Executive Officer of AMAG Pharmaceuticals comments: "3SBio is the ideal partner to bring Feraheme to iron deficiency anemia patients with chronic kidney disease in China. This step represents an important milestone in our efforts to broaden the global reach of Feraheme."
Important Safety Information about Feraheme
Feraheme is contraindicated in patients with evidence of iron overload, known hypersensitivity to Feraheme or any of its components, and patients with anemia not caused by iron deficiency.
In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects receiving Feraheme, including three patients with serious hypotensive reactions. Serious hypersensitivity reactions were reported in 0.2% (3/1726) of patients. Patients should be observed for signs and symptoms of hypersensitivity for at least 30 minutes following Feraheme injection and the drug should only be administered when treatment of hypersensitivity reactions is readily available. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy. As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging but will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.
In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients were diarrhea, nausea, dizziness, hypotension, constipation and peripheral edema.