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An ironclad partnership
May 2010
by Jeffrey Bouley  |  Email the author
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LEXINGTON, Mass.—AMAG Pharmaceuticals Inc. and Osaka, Japan-based Takeda Pharmaceutical Co. have entered into a license, development and commercialization agreement related to Feraheme (ferumoxytol) injection for intravenous (IV) use in all therapeutic indications.

Feraheme is already indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. But looking to the rest of this year, AMAG is keen to advance its clinical development programs for the treatment of iron deficiency anemia in other indications as well. For example, Feraheme shows promise for treating iron deficiency anemia in women with abnormal uterine bleeding and in patients with cancer and gastrointestinal diseases.

Feraheme is also being developed as a diagnostic agent for vascular-enhanced magnetic resonance imaging. AMAG notes that there are currently no iron-based vascular contrast agents approved for MRI in the United States, and the currently approved contrast agents used for MRI in the United States are all gadolinium-based—and thus associated with rare but severe adverse events in patients with chronic kidney disease. The initial focus of AMAG's clinical development of Feraheme as an imaging agent is in assessing patients with peripheral arterial disease.

"One of our primary goals is to expand the reach of Feraheme to patients around the world with iron deficiency anemia," says Dr. Brian J.G. Pereira, president and CEO of AMAG Pharmaceuticals. "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."

Under the deal struck April 1, Takeda receives an exclusive license to Feraheme for all therapeutic applications in five regions: Europe, Canada, Turkey, the Commonwealth of Independent States and Asia Pacific countries—excluding Japan, China and Taiwan.
For this consideration, AMAG receives a $60 million upfront payment and is eligible to receive s much as $220 million in development and commercial milestones. In addition, AMAG will receive tiered, double-digit royalties based on net sales of Feraheme in the licensed territories.

The terms of the deal call for AMAG to 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.

Finally, Takeda will be responsible for commercializing Feraheme in all regions included in the licensed territories.

"This partnership provides an exciting opportunity to combine AMAG's unique development abilities with Takeda's global commercialization capabilities," says Alan MacKenzie, executive vice president of international operations and CEO of Takeda Pharmaceuticals International Inc. "Takeda is poised to maximize Feraheme's entry into the selected countries following approval."

From a governance standpoint, the companies will establish two joint committees to oversee the relationship, says David A. Arkowitz, executive vice president, chief financial officer and chief business officer of AMAG.

"The Joint Steering Committee, consisting of equal representation from each company, is responsible for overall coordination and oversight of the activities covered by the agreement," he explains. "Also, a Joint Development Committee, also consisting of equal representation from both companies, will coordinate all elements of the development and approval of Feraheme in the territories covered by the agreement."

In terms of AMAG's $60 million upfront payment, the company is still working with auditors to determine exactly how to represent and characterize it in the company's profit and loss statements, Arkowitz says, but he doesn't expect it to show up in the first quarter profit and loss; rather, in some way after that quarter.

With a Japanese company partner, why was Japan excluded from the terms of this deal? Arkowitz says that Japan and probably other territories will be part of future discussions with Takeda, but adds, "Takeda's interest in Feraheme is in part based on the fit with their late-stage pipeline. Given the early stage of development of Feraheme as it relates to Japan we have not prioritized—and Takeda is not prioritizing—Japan in the same way as the EU and the other territories that are covered by this agreement. So this is something that's not included in the agreement and we haven't reached a final decision yet as it relates to Japanese rights."

"The two dominant areas are the U.S. and the EU," notes Pereira, though he notes AMAG is enrolling patients for studies in countries that are beyond the United States and the European Union. "[But] our emphasis at this point in time is to get the EU done … At the end of the day, the additional territories—we have language about the cost sharing for those, but we haven't released details yet."

Currently, Feraheme is approved with the U.S. Food and Drug Administration for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease, and AMAG plans to submit a marketing authorization application to the European Medicines Agency 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 registration program for Feraheme for the treatment of IDA regardless of the underlying cause in mid-2010.

"In the EU alone, more than a million people have chronic kidney disease and iron deficiency anemia. Outside of chronic kidney disease, an additional 4 million in the EU are estimated to have iron deficiency anemia," Pereira says, "With a strong presence in gastroenterology and primary care, Takeda is poised to maximize Feraheme's entry into the licensed territories following approval."

 
Code: E051002

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