Oxymorphone Hydrochloride

After four-plus years as CEO at Endo, Blaise Coleman will depart Aug. 29. The company gave no reason for his exit, and he will be replaced by new board member Scott Hirsch. Four months after emerging from bankruptcy, Endo is in transition again with the sudden departure of CEO Blaise Coleman.Tuesday, without providing a reason, the Dublin-based company revealed Coleman’s eventful four-year tenure will end Thursday. Scott Hirsch, formerly the CEO of Solta Medical, will take over as Endo's interim CEO. Hirsch joined the company’s board in April. Endo has brought on executive search firm Spencer Stuart to assist in finding a new CEO.Coleman leaves after navigating Endo through a challenging period in which it faced a mountain of litigation over marketing of its opioid products. The company filed for bankruptcy in August 2022.“We thank Blaise for his successful leadership of Endo over the last four years, which were integral to establishing our strong foundational footing following our restructuring,” Endo’s chairman, Paul Herendeen, said in a release.After stints at AstraZeneca and Johnson & Johnson, Coleman served as the chief financial officer at Endo for three-plus years before taking over the troubled company as CEO in March 2020.Two years later, when Endo filed for Chapter 11, it agreed to pay a $450 million settlement to 36 states to resolve allegations that it falsely marketed opioids. That deal came on top of the company paying a combined $204 million to settle individual lawsuits with four other states.Around the same time, the company drew much criticism for paying lucrative pre-bankruptcy bonuses to its top execs, including $11.85 million to Coleman.Later in the year, Endo laid off 90 staffers as it pulled the plug on its innovative cellulite treatment Qwo (collagenase clostridium histolyticum-aaes), which was plagued by skin discoloration and injection-site bruising. In February of this year, Endo agreed to a $465 million bankruptcy settlement with the federal government that superseded deals to resolve civil and criminal lawsuits for its marketing of Opana ER (oxymorphone).Four months ago, Endo revealed the completion of its reorganization and exit from Chapter 11.“Endo is strategically well-positioned to become a vibrant growth company with a strong balance sheet, a broad, diversified portfolio of on-market medicines, and a pipeline of innovative and differentiated product candidates,” Herendeen added in the release. “As we work toward our goal of re-listing on a national stock exchange, the board is focused on identifying a new chief executive with the experience, skill set and strategic vision to guide Endo through its next phase of development.” In also reporting its second-quarter financials Tuesday, Endo is showing signs of recovery as it bumped up its 2024 revenue projection from a window of $1.68 billion to $1.77 billion to a new range of $1.72 billion to $1.78 billion.Endo also provided guidance for 2025, saying it expects revenue to increase by a low single-digit percentage over its new expected sales figure for 2024. “In the near term, our priority will be continued focus on execution across our branded, sterile injectables and generics portfolios as we position the company for long-term growth,” Hirsch said.

The U.S. government had contested parts of Endo's restructuring efforts in bankruptcy court. Editor's note: This story was updated to note that Endo's criminal and civil opioid settlement payments will be satisfied by the bankruptcy resolution, according to an Endo spokesperson. As Endo looks to emerge from bankruptcy, the company has agreed to fork over up to $464.9 million to the federal government, which had been investigating its marketing of opioid painkiller Opana ER. On Thursday, the U.S. Department of Justice (DOJ) said Endo has reached settlements in civil and criminal cases over its prior marketing of Opana ER. In addition, Endo inked a bankruptcy settlement worth up to $464.9 million, which essentially supersedes the civil and criminal deals for financial purposes. In the bankruptcy case, Endo agreed to pay $364.9 million over 10 years, plus up to $100 million depending on its performance after emerging from bankruptcy. Alternatively, Endo could resolve the bankruptcy case for $200 million upfront, plus the contingent payment worth up to $100 million depending on its future performance. The bankruptcy case stems from the U.S. government's "monetary claims" in the bankrupt Endo, according to a separate DOJ release. Among those claims are monetary payments stemming from Endo's new federal opioid deals. In the criminal settlement, Endo agreed to plead guilty to a misdemeanor charge of violating the Federal Food, Drug and Cosmetic Act with its prior opioid marketing. The deal proposes a whopping $1.086 billion criminal fine and a $450 million criminal forfeiture, according to the DOJ. In the civil case, a proposed payment of $475.6 million would resolve Endo's potential liabilities under the False Claims Act, the DOJ said. In its own release, Endo noted that the civil deal does not include an admission of liability. Endo stopped selling Opana ER in 2017, the company noted. While the DOJ touted the federal government's civil and criminal deals, the financial figures from those agreements are not actually relevant. That's because the "the criminal and civil fines are essentially claims that are being satisfied by the settlement payments" in Endo's bankruptcy case, according to a company spokesperson. Since Endo's bankruptcy filing in August 2022, the company has been undergoing a restructuring in the U.S. Bankruptcy Court in the Southern District of New York. That court must sign off on all of the deals, the DOJ said. Under Endo's restructuring plan, the company aims to sell itself to certain lenders. A court hearing to consider the proposal is scheduled for March 19. The bankruptcy case with the government is Endo's largest hurdle to completing its planned restructuring, Reuters reports.