Friday, March 03, 2023
Indivior PLC announced that it has completed the acquisition of Opiant Pharmaceuticals, Inc. ("Opiant"). The transaction strengthens Indivior's addiction treatment and science portfolio by adding Opiant's late-stage assets, notably OPNT003, an investigational opioid overdose treatment designed to offer an important treatment option to address the current wave of US opioid overdoses from powerful synthetic opioids, such as fentanyl.
"We are pleased to close our combination with Opiant, which provides us with a comprehensive and relevant treatment platform to address the ongoing U.S. opioid and overdose epidemic," said Mark Crossley, Chief Executive Officer of Indivior. "We look forward to bringing on Opiant's talented team and undertaking our shared mission to change patients' lives through access to life-transforming treatment for substance use disorders."
On November 13, 2022, Indivior and Opiant entered into a definitive agreement under which Indivior would acquire Opiant for an upfront consideration of $20.00 per share, in cash (approximately $145 million in aggregate), plus up to $8.00 per share in contingent value rights ("CVRs") that may become payable in the event that certain net revenue milestones are achieved during the relevant seven-year period by OPNT003 after its approval and launch. Following the closing of all customary conditions, the acquisition was completed today. As previously announced, Indivior has funded the upfront consideration of approximately $145 million with existing cash. Opiant's common stock ceased trading on Nasdaq following the close of business yesterday in anticipation of the completion of the acquisition this morning.
As previously announced, Indivior expects OPNT003 to generate peak net revenue of $150 million to $250 million and the acquisition of Opiant to be earnings accretive after the second full year of launch of OPNT003. Indivior intends to provide updated FY 2023 guidance to include the expected impact from the Opiant acquisition with its first quarter results announcement scheduled for April 27, 2023.
OPNT003 is a patented intranasal nalmefene formulation that utilizes an absorption-enhancing technology to enhance its pharmacokinetic and pharmacodynamic profile leading to fast and long-acting duration of action that supports OPNT003 as a potential new treatment option for opioid overdose. Opiant announced the completion of its rolling NDA (New Drug Application) submission for OPNT003 on December 22, 2022. A PDUFA (Prescription Drug User Fee Action) date for OPNT003 has been set by the FDA for May 22, 2023. OPNT003 is covered by one issued patent covering formulation (expiry 2038), along with five other patent applications that are directed to various aspects of the drug, including methods of treatment. Development of the OPNT003 program was partially funded by a grant from the National Institute on Drug Abuse (NIDA), an institute of the National Institutes of Health, and a contract from the Biological Advanced Research and Development Authority (BARDA).