Takeda Pharmaceutical negotiated exclusive rights in five territories to AMAG Pharmaceuticals' FDA-approved intravenous iron replacement therapy, Feraheme®, with $60 million up front. The agreement, which covers all potential indications for the drug, includes Europe, Canada, Turkey, the Commonwealth of Independent States, and Asia Pacific (excluding Japan, China, and Taiwan).
AMAG could receive another $220 million in development and commercial milestones plus tiered double-digit royalties on net sales. The deal will involve AMAG carrying out and funding global clinical development of Feraheme in all potential therapeutic indications. The firm will also be responsible for filing regulatory applications in Europe and Canada. Takeda will undertake regulatory submissions in the remaining territories covered in the agreement as well as commercialization in all its licensed countries.
Feraheme comprises bioavailable iron oxide surrounded by a carbohydrate shell composed of polyglucose sorbitol carboxymethylether. The drug was granted FDA clearance in June 2009 for use as an iron-replacement therapy in the treatment of iron deficiency anemia in adult patients with chronic kidney disease.
“Takeda’s global presence, their pipeline that includes complementary products to Feraheme, and their strength in the marketing and commercialization across many specialties where iron deficiency anemia is present makes them the ideal partner for Feraheme,” comments Brian J. G. Pereira, M.D., president and CEO at AMAG.
“We expected an ex-US partnership sometime his year,” notes Adam Cutler, Canaccord Adams' life sciences analyst, “We note that Takeda is an established partner in the anemia space; the company already has a global partnership with Affymax for Hematide (for the treatment of anemia).
“We view the EU opportunity to be very attractive. The current EU IV iron market is estimated to be about $150 million and growing, with a trend toward greater usage of IV irons (rather than ESAs) compared to the U.S.”
AMAG says that it hopes to submit a Feraheme MAA to the European regulatory authorities for the iron deficiency anemia in chronic kidney disease indication during mid-2010. The firm is also planning to start a global program later this year in iron deficiency anemia regardless of the underlying cause. Potential patient populations include women with abnormal uterine bleeding, patients undergoing various surgical procedures, and those with cancer and gastrointestinal diseases.
AMAG is separately carrying out Phase II trials with Feraheme as a diagnostic agent for vascular-enhanced MRI to assess peripheral arterial disease. The firm claims that there are currently no iron-based vascular contrast agents approved for MRI in the U.S. Those MRI contrast agents that are approved, according to AMAG, are all gadolinium-based and associated with rare but severe adverse events in patients with chronic kidney disease.