(The Center Square) – Iowa has reached an agreement in principle with Endo International plc and its lenders that would provide up to $450 million over 10 years to participating states and local governments, Iowa Attorney General Tom Miller’s office announced Wednesday.
Under the agreement in principle, specialty pharmaceutical company Endo could not promote its opioids and must turn over millions of documents related to its role in the opioid crisis and pay $2.75 million for expenses involved in publishing them in a public online archive, according to the news release from Miller’s office. The resolution with Endo is contingent upon final documentation and Bankruptcy Court approval, the release said. Endo filed Chapter 11 bankruptcy protection Tuesday in the Southern District of New York, the company announced.
Endo President and Chief Executive Officer Blaise Coleman said addressing the company’s more than $8 billion of debt and establishing a pathway to closure regarding thousands of opioid-related and other lawsuits it has been defending at an unsustainable cost will allow the company to move forward and prosper.
In June 2017, the U.S. Food and Drug Administration asked Endo Pharmaceuticals to remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market, based on the administration’s concern that the benefits of the drug may no longer outweigh its risks.
“This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse,” the FDA’s news release said.
Endo said in a news release in July 2017 that while it continued to believe in the safety and benefits of its extended release painkiller when used as intended and significant steps taken by the company over the years to combat misuse and abuse, it would voluntarily remove OPANA® ER from the market.
“Endo reiterates that neither the FDA’s withdrawal request nor Endo’s decision to voluntarily remove OPANA® ER from the market reflect a finding that the product is not safe or effective when taken as prescribed,” the release said. “To the contrary, Endo remains confident in the clinical research and other data demonstrating OPANA® ER’s safety and efficacy, as well as its favorable risk-benefit profile when used as intended in appropriate patients.”
The states in the agreement say that Endo falsely promoted Opana ER’s abuse-deterrent formulation and that formulation did not deter oral abuse that led to deadly outbreaks of hepatitis and HIV through widespread abuse via injection. Miller added the settlement will help fund opioid abuse prevention and treatment efforts. Details of each state’s share of the settlement have not yet been determined, the release said.
Iowa is joined by more than 30 other states’ attorneys general.
Endo’s global headquarters are in Dublin, Ireland. Its U.S. headquarters are in Malvern, Pa. Its products include PERCOCET®, FORTESTA® and VALSTAR®.
Endo was not immediately available for comment.