AMAG Pharmaceuticals, Takeda Pharmaceutical announce Feraheme collaboration

Apr 1 2010

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) and Takeda Pharmaceutical Company Limited (TSE: 4502) today jointly announced that the companies have entered into a license, development and commercialization agreement related to Feraheme® (ferumoxytol) Injection for intravenous (IV) use in all therapeutic indications.

“One of our primary goals is to expand the reach of Feraheme to patients around the world with iron deficiency anemia”

Agreement Highlights

• Takeda receives an exclusive license to Feraheme for all therapeutic applications in 5 regions, including Europe, Canada, Turkey, the Commonwealth of Independent States and Asia Pacific countries, excluding Japan, China and Taiwan.
• AMAG receives a $60 million upfront payment and is eligible to receive up to $220 million in development and commercial milestones. Additionally, AMAG will receive tiered, double-digit royalties based on net sales of Feraheme in the licensed territories.
• AMAG will execute and fund the global clinical development of Feraheme in all potential therapeutic indications. AMAG will also be initially responsible for the filing of regulatory applications for Feraheme in Europe and Canada, with Takeda responsible for the regulatory filings in all other regions covered by the agreement. Takeda will eventually hold all marketing authorizations in the licensed territories.
• Takeda will be responsible for commercializing Feraheme in all regions included in the licensed territories.

"One of our primary goals is to expand the reach of Feraheme to patients around the world with iron deficiency anemia," said Brian J.G. Pereira, MD, President and Chief Executive Officer of AMAG Pharmaceuticals, Inc. "Takeda's global presence, their pipeline that includes complementary products to Feraheme and their strength in the marketing and commercialization of therapeutics across many specialties where iron deficiency anemia is present makes them the ideal partner for Feraheme."

"This partnership provides an exciting opportunity to combine AMAG's unique development abilities with Takeda's global commercialization capabilities," said Alan MacKenzie, Executive Vice President, International Operations & CEO, Takeda Pharmaceuticals International, Inc. "Takeda is poised to maximize Feraheme's entry into the selected countries following approval."

Currently, Feraheme is approved in the United States for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease. AMAG plans to submit a marketing authorization application to the European Medicines Agency (EMA) for Feraheme for the treatment of IDA in adult patients with chronic kidney disease in Europe in mid-2010. Additionally, AMAG plans to initiate a broad global registrational program for Feraheme for the treatment of IDA regardless of the underlying cause in mid-2010.