Ferumoxytol
Our technology and expertise enable us to synthesize, sterilize and stabilize iron oxide nanoparticles
Products of AMAG Pharmaceuticals, Inc.
Our core technology is based on the characteristic properties of extremely small, coated superparamagnetic iron oxide nanoparticles. Our core competencies include the ability to design such nanoparticles for particular applications, to manufacture the nanoparticles in controlled sizes and to cover the nanoparticles with different coatings depending upon the application for which they will be used. Our technology and expertise enable us to synthesize, sterilize and stabilize these iron oxide nanoparticles in a manner necessary for use in pharmaceutical products such as iron replacement therapeutics and magnetic resonance imaging (MRI) contrast agents.
Our iron oxide nanoparticles are composed of bioavailable iron that is easily absorbed by the body and incorporated into the body's iron stores. As a result, products using our core technology are well suited for use in intravenous (IV) iron replacement therapy. Additionally, the superparamagnetic characteristic of our products results in nanoparticles that become strongly magnetic when placed in a magnetic field, but lose their magnetism once the field is removed. Therefore, use of our nanoparticles results in magnetic resonance images that increase the information available to the reviewing physicians.
“Our nanoparticles result in magnetic resonance images that increase information available to reviewing physicians.”
Feridex®
Feridex I.V.® (generic name: ferumoxides) is AMAG Pharmaceuticals' contrast agent for use with magnetic resonance imaging (MRI) for the detection of liver lesions...
GastroMARK®
GastroMARK® is AMAG Pharmaceuticals' oral gastrointestinal imaging agent used to distinguish the loops of the bowel from other abdominal structures and physiology...
Combidex®
Combidex® is an investigational functional molecular imaging agent consisting of iron oxide nanoparticles for use in conjunction with magnetic resonance imaging (MRI) to aid in the differentiation of cancerous from normal lymph nodes...
Ferumoxytol
Ferumoxytol, the company's key product candidate, is being developed for use as an intravenous iron replacement therapeutic for the treatment of iron deficiency anemia in chronic kidney disease. The Company has released data on all four planned Phase III clinical trials of ferumoxytol as an intravenous iron replacement therapeutic in chronic kidney disease patients...
Product Development
The Company has two product candidates, Ferumoxytol and Combidex®. Ferumoxytol, the company's key product candidate, is being developed for use as an intravenous iron replacement therapeutic for the treatment of iron deficiency anemia in chronic kidney disease patients. The company has released data on all four of the Phase III clinical trials with ferumoxytol. The company submitted an NDA for marketing approval of ferumoxytol with the FDA in December of 2007. Combidex®, our other product under development, is an investigational functional molecular imaging agent consisting of iron oxide nanoparticles for use in conjunction with MRI to aid in the differentiation of cancerous from normal lymph nodes. In March 2005, we received an approvable letter from the FDA with respect to Combidex®, subject to certain conditions.