Highlights of the license, development andcommercialization agreement include:
- Takeda receives an exclusive license to Ferahemefor all therapeutic applications in five regions, including Europe, Canada, Turkey, theCommonwealth of Independent States, and Asia-Pacific countries, excludingJapan, China and Taiwan.
- In addition to the $280 million in upfront andpotential milestones, AMAG will receive tiered, double-digit royalties based onnet sales of Feraheme in the licensed territories.
- AMAG will execute and fund the global clinicaldevelopment of Feraheme in all potential therapeutic indications. AMAG willalso be initially responsible for the filing of regulatory applications forFeraheme in Europe and Canada, with Takeda responsible for the regulatoryfilings in all other regions covered by the agreement. Takeda will eventuallyhold all marketing authorizations in the licensed territories.
- Takeda will be responsible for commercializingFeraheme in all regions included in the licensed territories.
"One of our primary goals is to expand the reachof Feraheme to patients around the world with iron deficiency anemia," says Dr.Brian J.G. Pereira, president and CEO of AMAG Pharmaceuticals. "Takeda's globalpresence, their pipeline that includes complementary products to Feraheme andtheir strength in the marketing and commercialization of therapeutics acrossmany specialties where iron deficiency anemia is present makes them the idealpartner for Feraheme."
"This partnership provides an exciting opportunityto combine AMAG's unique development abilities with Takeda's globalcommercialization capabilities," says Alan MacKenzie, executive vice presidentof international operations and CEO, Takeda Pharmaceuticals International Inc."Takeda is poised to maximize Feraheme's entry into the selected countriesfollowing approval."
Currently, Feraheme is approved in the UnitedStates for the treatment of iron deficiency anemia (IDA) in adult patients withchronic kidney disease. AMAG plans to submit a marketing authorizationapplication to the European Medicines Agency for Feraheme for the treatment ofIDA in adult patients with chronic kidney disease in Europe in mid-2010.Additionally, AMAG plans to initiate a broad global registrational program forFeraheme for the treatment of IDA regardless of the underlying cause inmid-2010.