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Will gain OPNT003, an investigational opioid overdose reversal agent that has received FDA Fast Track designation.
November 14, 2022
By: Kristin Brooks
Managing Editor, Contract Pharma
Indivior PLC and Opiant Pharmaceuticals, Inc. entered a definitive agreement, under which Indivior will acquire Opiant for approximately $145 million in cash, plus potential milestones for achievements during the relevant seven-year period by OPNT003 after its approval and launch. The transaction has been approved by the boards of directors of each company. Opiant is a biopharmaceutical company developing treatments for addiction and drug overdose leveraging intranasal and injectable delivery technologies. Opiant contributed to the development of the formulation of NARCAN Nasal Spray, a treatment to reverse opioid overdose. In addition to OPNT003, nasal nalmefene, the pipeline includes OPNT002, nasal naltrexone, which is currently in a Phase II trial to assess its potential as a treatment for alcohol drinking and cravings, and OPNT004, a CB-1 antagonist in preclinical development as a potential injectable treatment for acute cannabinoid overdose (ACO). OPNT003 is an investigational opioid overdose reversal agent that Opiant has been developing alongside a worsening opioid crisis, driven by the increased prevalence of synthetic opioids, such as illicit fentanyl. These powerful drugs are responsible for the surge of overdose deaths in the United States (103,000-plus overdose deaths reported in the latest annual period, of which over 75% were driven by opioids, mainly fentanyl and synthetic opioids). OPNT003 is designed to be used by non-healthcare individuals and delivered intranasally. Opiant received FDA Fast Track Designation for OPNT003 in November 2021 and is expected to complete its NDA submission for OPNT003 with the FDA in 4Q22. “Our work in combatting addiction has never been more critical, with overdose deaths in the United States occurring at near record numbers1,” said Mark Crossley, Chief Executive Officer of Indivior. “Opiant’s portfolio of product candidates is an excellent strategic fit that diversifies and strengthens our offerings, while Indivior’s strong commercial capabilities are expected to propel a combined product pipeline with the potential to help patients along a continuum from substance use disorder and rescue to recovery. The combination with Opiant will provide Indivior with one of the most comprehensive and relevant treatment platforms to address the ongoing U.S. opioid and overdose epidemic and extends our leadership position in addiction treatments. We look forward to working with Opiant’s talented team as we undertake our shared mission of changing patients’ lives through access to life-transforming treatment for substance use disorders.” “We are pleased to have reached an agreement that reflects the great potential Opiant has created with OPNT003 and our pipeline of medicines,” said Roger Crystal, M.D., Opiant’s President and Chief Executive Officer. “This transaction combines Opiant with an organization that shares our patient-focused mindset, and we believe creates immediate value for patients, our employees and our stockholders. It will enable us to leverage Indivior’s global scale, commercial strength and scientific expertise to accelerate our mission to create best-in-class medicines for the treatment of substance use disorders and drug overdose.”
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