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Attorney General J.B. Van Hollen Announces Astellas Pharma to Resolve Allegations of Improper Marketing of Mycamine

MADISON — Attorney General J.B. Van Hollen announced today that Wisconsin has joined with other states and the federal government to settle allegations that Astellas Pharma US Inc. (Astellas) caused false claims to be submitted to federal and state health care programs in connection with its marketing and promotion of the drug Mycamine for pediatric use.  Mycamine is a sterile, lyophilized antifungal agent.  Astellas Pharma US Inc., located in Northbrook, IL, manufactures and sells pharmaceutical drugs, including Mycamine.  As part of the settlement, the state received $208,788.05 in restitution to Wisconsin Medicaid.


The settlement resolves allegations that, between 2005 and 2010, Astellas knowingly marketed and promoted the sale of Mycamine for pediatric use, which was not a medically accepted indication and, therefore, not covered by federal health care programs.  During this time period, the FDA approved Mycamine to treat adult patients suffering from serious and invasive infections caused by the fungus Candida, including infections in the esophagus, the blood and the abdomen, and to prevent Candida infections in adults undergoing stem cell transplants. From 2005 through June 2013, however, Mycamine was not approved to treat pediatric patients for any use.


The allegations resolved by this settlement were originally raised in a lawsuit filed against Astellas  in the United  States District  Court for the Eastern District of Pennsylvania  under the qui tam, or whistle blower, provisions of the False Claims Act and analogous state false claims statutes, including Wisconsin’s, which allow  private  citizens  with  knowledge  of  false  claims  to  bring  civil  actions  on  behalf  of  the government and to share in any recovery.