SHENYANG, China, May 28 /Xinhua-PRNewswire-FirstCall/ -- AMAG Pharmaceuticals, Inc. (Nasdaq: AMAG) and 3SBio, Inc. (Nasdaq: SSRX), a leading Chinese biotechnology company, today announced the signing of a development and commercialization agreement for ferumoxytol, an intravenous iron replacement therapeutic agent being developed to treat iron deficiency anemia 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(1), and over 91,000 patients on dialysis in China(2)," 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%, 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."
About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes its proprietary nanoparticle technology for the development and commercialization of therapeutic iron compounds to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease.
Ferumoxytol, the Company's key product candidate, is being developed for use as an intravenous iron replacement therapeutic agent for the treatment of iron deficiency anemia in chronic kidney disease patients. The Company has released data on all four planned Phase III clinical trials of ferumoxytol as an intravenous iron replacement therapeutic agent in chronic kidney disease patients. The Company submitted a New Drug Application for marketing approval of ferumoxytol with the U.S. Food and Drug Administration (FDA) in December 2007, which was accepted for filing by the FDA in February 2008.
About 3SBio, Inc.
3SBio Inc. is a leading, fully integrated biotechnology company focused
on researching, developing, manufacturing and marketing biopharmaceutical
products, primarily in China. The Company's corporate headquarters and
manufacturing facilities are located in Shenyang with sales headquarters in
(1) Kidney International, (2005) 68; 2837-2845
(2) Nephrology Dialysis Transplantation (2005) 20: 2587-2593
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AMAG Pharmaceuticals, Inc.
|SOURCE 3SBio, Inc.|
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