SHANGHAI - China's 3SBio Pharmaceutical and U.S.-based AMAG Pharmaceuticals have entered into a strategic partnership to develop and commercialize AMAG's nanoparticle agent Ferumoxytol in China, the two companies announced May 27.

Ferumoxytol is an intravenous iron replacement drug to treat iron deficiency anemia in chronic kidney disease.

The Cambridge, Massachusetts-based AMAG is licensing ferumoxytol to 3SBio while awaiting U.S. FDA approval, Kristen Galfetti, AMAG's senior director for investor relations, told PharmAsia News.

"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," Galfetti, said. 3SBio will be responsible for the clinical development, registration and commercialization of ferumoxytol in China.

AMAG expects to receive FDA approval for ferumoxytol in October, she said, and once approved, 3SBio will file a new drug application with China's State FDA.

The agreement has an initial duration of 13 years and will be automatically renewed for a set term if minimum sales thresholds are achieved, according to Galfetti. AMAG has patent protection on ferumoxytol until 2020, she said.

Under the terms of the agreement, AMAG will receive an upfront payment of $1 million 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 percent, based on sales of ferumoxytol.

AMAG and 3SBio will also form a joint steering committee, with equal representation from both parties, to oversee and guide the development and commercialization of ferumoxytol in China, according to Galfetti.

"China represents a large and rapidly growing market opportunity as there are approximately 12 million stage III and IV CKD patients, and over 91,000 patients on dialysis," said Galfetti. "This is AMAG's first presence in China, and this is an exciting first step towards expanding the potential use of ferumoxytol outside the United States."

"We seek to work with companies [that] maintain a leading position, preferably in the nephrology therapeutic market, and [that] have a nationwide specialty sales force, and strong marketing capabilities," she added.

Shenyang-based 3SBio is the first Chinese biotech company to list on NASDAQ when it began trading on the exchange Feb. 12 (Also see "Chinese Biosimilars Firm 3SBio Reports Positive Second Quarter" - Scrip, 10 August, 2007.).

Products in 3SBio's research and development pipeline feature a number of next-generation protein-based therapeutics, including new high-dosage EPIAO product for chemo-induced anemia.

3SBio's CEO Lou Jing told PharmAsia News in April in an exclusive interview that 3SBio would speed up development over the next few years, because of the market in China for nephrology products, which has grown annually by 20 percent, compared to the international EPO market growth rate of less than 10 percent (Also see "3SBio CEO Jing Lou On Building An Integrated Biopharma Company In China: An Interview With PharmAsia News" - Scrip, 28 April, 2008.).

3SBio executives said earlier this year that Phase III trials of TPIAO, an injectable recombinant human thrombopoietin, for the treatment of ITP, and of Nuleusin, a second-generation IL-2 for renal cell carcinoma, should be completed in the second half of 2008.

- Ying Huang and Kevin Holden ( pharmasia@elsevier.com )

3SBio And AMAG Ink Deal To Develop Ferumoxytol In China

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