お知らせ • May 23
Indivior PLC Announces U.S. Food and Drug Administration Approval of OPVEE® (nalmefene) Nasal Spray, An Opioid Overdose Rescue Medicine for Natural and Synthetic Opioids Like Fentanyl Indivior PLC announced that the U.S. Food and Drug Administration (FDA) approved OPVEE® (nalmefene) nasal spray for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression. OPVEE contains nalmefene, an opioid receptor antagonist that provides fast onset and long duration reversal of opioid-induced respiratory depression, which is the primary cause of opioid overdose injury and death. OPVEE was designed to address the challenges of today's opioid crisis. OPVEE was approved via the 505(b)(2) pathway. In a first of its kind pharmacodynamic study (NCT04828005) in 61 opioid-experienced, non-dependent subjects, the effect of 2.7 mg OPVEE was assessed on remifentanil-induced respiratory depression. Following OPVEE administration, the time to onset of reversal of respiratory depression was observed between 2.5 to 5 minutes and full recovery of respiratory drive was manifested as early as 5 minutes after OPVEE administration. The duration of action of nalmefene is as long as most opioids, including fentanyl. These attributes are well-suited to address the challenges of today's opioid overdose crisis. The speed of action, long duration, and high potency of fentanyl and other synthetic opioids are driving unprecedented overdose deaths across a broader range of ages, and they are now a leading cause of death for people ages 18 to 45.5 For each opioid-induced fatality, it has been estimated that there are an additional 6.4-8.4 non-fatal overdoses that can lead to long-term physical and mental disability. A federally funded contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services, for up to $10.8 million, combined with a $7.4 million U01 "grand opportunities in medications development" grant received from the National Institute on Drug Abuse (NIDA), supported the development of OPVEE. The contract (number HHSO100201800029C) with BARDA was intended to develop OPVEE for reversal of opioid overdoses in the community and as a medical countermeasure and reversal agent in the event of a chemical attack using synthetic opioids. OPVEE is expected to be in the market in Fourth Quarter of 2023. Indivior added OPVEE to its portfolio with the acquisition of Opiant Pharmaceuticals Inc., which closed March 2, 2023. As previously indicated, Indivior believes the clinical profile of OPVEE supports the potential for this treatment to deliver annual net revenue of $150 million to $250 million, with expected earnings accretion from the Opiant acquisition after the second full year of launch of OPVEE. お知らせ • Feb 17
Indivior PLC Announces Board and Committee Changes Indivior PLC announced that Juliet Thompson has been appointed as Senior Independent Director with effect from October 1, 2023. Juliet has been a Non-Executive Director since March 2021 and is the Chair of the Audit Committee and a member of the Nomination & Governance Committee. The Company further announces that Jo Le Couilliard has been appointed as Chair of the Remuneration Committee also with effect from October 1, 2023. Jo has been a Non-Executive Director since March 2021 and is a member of the Audit and Remuneration Committees. This announcement follows the Company's previous announcement on October 13, 2022 that Daniel J. Phelan, current Senior Independent Director and Chair of the Remuneration Committee, will stand down from the Board on September 30, 2022 having served as a Director for nine years. お知らせ • Jan 12
Indivior PLC to Report Q4, 2022 Results on Feb 16, 2023 Indivior PLC announced that they will report Q4, 2022 results at 2:00 AM, US Eastern Standard Time on Feb 16, 2023 お知らせ • Nov 28
Reckitt Benckiser Group Submits Claim against Indivior PLC Indivior PLC announced it has been made aware that a claim was submitted to the Commercial Court in London by Reckitt Benckiser Group plc ('RB') against the company on November 13, 2020 pursuant to an indemnity contained in the Demerger Agreement entered into between RB and the Company on November 17, 2014. The amount claimed under the submission is £1,073,622.580.51. The claim has not been served on the company and the company does not have any further details at this time. The company will assess with its advisors the background and merits to the case and will provide an update in due course. お知らせ • Nov 19
Indivior PLC Announces Executive Changes Indivior PLC announced the appointment of Graham Hetherington as Chair of the Board with immediate effect. Graham's appointment was approved by the Board and follows a succession process undertaken by the Nomination & Governance Committee and led by Lorna Parker, Chair of the Nomination & Governance Committee. Graham will step down as Chair of the Audit Committee. Daniel Tassé will remain the Senior Independent Director and will be appointed Chair of the Audit Committee, effective immediately. Daniel has been a member of the Audit Committee since the Company listed in 2014 and served as Chair of the Audit Committee between July 2019 and March 2020. Graham will be appointed as a member of the Nomination & Governance Committee and will remain a member of the Audit and Remuneration Committees. The Board also intends to undertake a search to identify an additional independent Non-Executive Director with recent and relevant financial experience. 
