Amag Pharmaceuticals, Inc. and 3SBio, Inc., a leading Chinese biotechnology company, announced the signing of a development and commercialization agreement for ferumoxytol, an intravenous iron replacement therapeutic agent being developed to treat iron deficiency anaemia in chronic kidney disease (CKD) patients.
"This is an exciting first step towards expanding the potential use of ferumoxytol outside the United States. China represents a large and rapidly growing market opportunity as there are approximately 12 million Stage 3 and 4 CKD patients, and over 91,000 patients on dialysis in China," stated Brian J.G. Pereira, MD, president and CEO of Amag Pharmaceuticals, Inc. "With their leading position in the nephrology therapeutic market, nationwide specialty sales force, and strong marketing capabilities, 3SBio is an ideal partner to develop and commercialize ferumoxytol in China."
Under the terms of the agreement, Amag will grant 3SBio exclusive rights to develop and commercialize ferumoxytol in China, initially for CKD, and with an option to expand into additional indications. 3SBio will be responsible for the clinical development, registration, and commercialization of ferumoxytol in China. Amag and 3SBio will form a joint steering committee, with equal representation from both parties, to oversee and guide the development and commercialization of ferumoxytol in China. The agreement has an initial duration of thirteen years and will be automatically renewed for a set term if minimum sales thresholds are achieved. Amag will retain all manufacturing rights for ferumoxytol and will provide, under a separate agreement, commercial supply to 3SBio at a predetermined supply price.
Amag will receive an upfront payment of $1 million from 3SBio and is eligible to receive additional milestone payments upon regulatory approval of ferumoxytol in China for CKD and other specified indications. Amag is also entitled to receive tiered, double-digit royalties, of up to 25 per cent, based on sales of ferumoxytol by 3SBio.
"We are very pleased that Amag Pharmaceuticals has entrusted 3SBio to develop and commercialize ferumoxytol in China," said Dr. Jing Lou, chief executive officer of 3SBio. "Along with Amag, we are committed to bringing this innovative medicine to millions of patients in China. This partnership represents a key milestone towards our goal of establishing 3SBio as the partner of choice in China for biotechnology companies around the world."
Amag Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes its proprietary nanoparticle technology for the development and commercialization of therapeutic iron compounds to treat anaemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease.
3SBio Inc. is a leading, fully integrated biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, primarily in China.