December 29, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Waltham, Mass.-based AMAG Pharmaceuticals and Osaka, Japan-based Takeda Pharmaceutical Company Limited announced today that they will mutually end a four-year-old agreement to market anemia drug ferumoxytol. Originally inked in March 2010, the agreement gave Takeda exclusive rights to market ferumoxytol in Canada, the European Union (EU) and Switzerland, as well as other territories under the trade name Rienso.
By terminating this agreement, AMAG regains all worldwide development and commercialization rights for Feraheme/Rienso. Feraheme was marketed in Canada and Rienso in Europe for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CDK).
AMAG has benefited from the sale of Feraheme. In the second quarter of 2014, net sales hit about $22.2 million, an increase of 26.9 percent from 2013.
The drug received approval from the FDA on June 30, 2009 and launched shortly afterwards. The compound has five U.S. patents, which are listed in the FDA’s Orange Book. The last patient will not expire until June 2023.
Various plans AMAG has to expand Feraheme’s label for broader use has had its ups and downs. Earlier in 2014 the FDA turned down the company’s supplemental new drug application (sNDA) for the compound in its present form, asking the company to perform extra clinical trials. The company is working closely with the FDA.
Takeda had filed a similar application for expanding use of Rienso in the EU. The EU’s Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA recommended a revision of the drug’s label in July 2014. The PRAC also indicated Rienso was contraindicated for patients with drug allergies.
Feraheme has been AMAG’s primary source of revenue. It provided revenue guidance for 2014, with total revenue projected from $93 million to $102 million. Feraheme was expected to account for $80 million to $87 million of that. About $13 million to $15 million were projected from other sources.
In November 2014 AMAG announced it had acquired Lumara Health Inc., a specialty drug company focused on maternal health. The deal was for $600 million in cash up front and 3,209,971 shares of AMAG common stock, as well as up to $350 million based on sales milestones.
“The acquisition of Lumara Health accelerates AMAG’s transformation into a profitable specialty biopharmaceutical company and provides a strong operating and financial platform for future growth,” said AMAG executive VP and COO in a statement. “Our integration plans are well underway, and we are already hard at work preparing to issue our combined 2015 financial guidance in early January.”
