Narcan naloxone nasal spray developer Opiant Pharmaceuticals has agreed to be acquired by Indivior for $20 per share at closing, plus up to $8 contingent value rights (CVRs) per share based on achievement of revenue goals for Opiant’s OPNT003 intranasal nalmefene over a 7-year period, the company said. Both boards of directors have approved the deal, and the transaction is expected to be completed in early 2023.
In June 2022, Opiant announced that it had initiated a rolling 505(b)(2) NDA submission for OPNT003 and said that it was investing €2 million to increase manufacturing capacity for Aptar Pharma’s UDS device, which is used for delivery of the nalmefene nasal spray. Development of OPNT003 has received support from the US Biomedical Advanced Research and Development Authority (BARDA). In addition to OPNT003, Opiant is developing OPNT002 intranasal naloxone for the treatment of alcohol use disorder.
Adapt Pharma, later part of Emergent BioSolutions, acquired rights to Narcan naloxone nasal spray for the treatment of opioid overdose from Lightlake Therapeutics (later Opiant Pharmaceuticals) in 2014, and the FDA approved the nasal spray in 2015. Adapt launched Narcan in the US in 2016.
In July 2015, Indivior announced that it had submitted an NDA for its naloxone nasal spray for the treatment of opioid overdose to the FDA. The agency issued a complete response letter to that NDA a few months later.
Opiant President and CEO Roger Crystal said, “We are pleased to have reached an agreement that reflects the great potential Opiant has created with OPNT003 and our pipeline of medicines. This transaction provides Opiant shareholders with immediate value in addition to the potential future upside from the CVRs. This transaction will also enable us to leverage Indivior’s commercial strength and resources to maximize the value of OPNT003 and our pipeline assets. Importantly, I want to thank our talented team, who have worked tirelessly to progress our company to this point and look forward to the achievements still to come.”
Indivior CEO Mark Crossley commented, “Our work has never been more critical, with reported overdose deaths in the United States occurring at near record numbers. Opiant’s portfolio of product candidates is an excellent strategic fit that diversifies and strengthens our offerings, while Indivior’s strong commercial capabilities will propel a combined product pipeline with the potential to help patients along a continuum from addiction and rescue to recovery. We look forward to working with Opiant’s talented team as we undertake our shared mission of helping people with substance use disorders.”
Read the Opiant Pharmaceuticals press release.