Businessweek

AMAG Pharmaceuticals, Inc., a biopharmaceutical company, engages in the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia (IDA). Products Feraheme The company’s principal product includes Feraheme (ferumoxytol) Injection for Intravenous (IV) use, which was approved for marketing in the United States in 2009 by the U.S. Food and Drug Administration (FDA) for use as an IV iron replacement therapy for the treatment of IDA in adult patients with chronic kidney disease (CKD). In December 2011, Feraheme was also granted marketing approval in Canada for use as an IV iron replacement therapy for the treatment of IDA in adult patients with CKD. The company is in the process of pursuing marketing applications for Feraheme in the European Union (EU), and Switzerland for the treatment of IDA in CKD patients. Licensing, Marketing and Supply Arrangements Takeda Pharmaceutical Company Limited (Takeda): In 2010, the company entered into a collaboration agreement with Takeda, under which it granted exclusive rights to Takeda to develop and commercialize Feraheme as a therapeutic agent in the Licensed Territory. In December 2011, Feraheme was granted marketing approval in Canada for use as an IV iron replacement therapy for the treatment of IDA in adult patients with CKD. 3SBio Inc. (3SBio): In 2008, the company entered into collaboration and exclusive license agreement (the 3SBio License Agreement, and a Supply Agreement, or the 3SBio Supply Agreement), with 3SBio for the development and commercialization of Feraheme as an IV iron replacement therapeutic agent in China. The 3SBio License Agreement grants 3SBio a license for an initial term of 13 years to develop and commercialize Feraheme as a therapeutic agent in China for an initial indication for the treatment of IDA in patients with CKD. Guerbet S.A. (Guerbet): The company has a supply and distribution agreement with Guerbet granting Guerbet a right to manufacture and sell Lumirem in western Europe and Brazil. This agreement was subsequently amended to expand Guerbet's exclusive rights to manufacture and sell Lumirem in various other areas, including South America, the Middle East, southeast Asia, and eastern Europe. Covidien, Ltd. (Covidien): Covidien has rights to GastroMARK in the U.S. only. Under the terms of the agreement, the company receives royalties based on GastroMARK net sales by Covidien as well as a percentage of sales for supplying the active ingredient. Distribution The company sells Feraheme primarily through authorized wholesalers and specialty distributors who, in turn, sell Feraheme to nephrologists, hematologists/oncologists, hospitals and dialysis centers who treat patients with CKD. Patents The company holds various U.S. and foreign patents, which expire at various times through 2020. Its primary U.S. patent for Feraheme may be subject to an extension to 2023 under U.S. patent law and FDA regulations. Research and Development The company incurred research and development expenses of $58.1 million, as of December 31, 2011. Regulations The company’s activities in the United States are subject to the jurisdiction of various other federal regulatory and enforcement departments and agencies, such as the Department of Health and Human Services, the Federal Trade Commission, and the Department of Justice. Its general operations, and the research, development, manufacture, sale and marketing of products, are subject to federal and state regulation, including FDA regulations, the Federal Anti-Kickback Statute, the Federal False Claims Act, and the Foreign Corrupt Practices Act Other U.S. Regulatory Requirements: The company is subject to regulation under local, state and federal law regarding occupational safety, laboratory practices, handling of chemicals, environmental protection and hazardous substances control. It possesses a Byproduct Materials License from the Commonwealth of Massachusetts for receipt, possession, manufacturing and distribution of radioactive materials and Registration Certificates from the federal Drug Enforcement Agency and the Commonwealth of Massachusetts Department of Public Health for handling controlled substances. The company is also registered with the federal Environmental Protection Agency (EPA), as a generator of hazardous waste. The company is subject to the regulations of the Occupational Safety and Health Act and has a safety program in effect to assure compliance with all of these regulations. Significant Events In September 2012, AMAG Pharmaceuticals, Inc. announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization in Switzerland for ferumoxytol, an intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD). History AMAG Pharmaceuticals, Inc. was founded in 1981.