Indivior Announces BARDA's First Order of OPVEE® to Combat Opioids and Aid in National Preparedness

Rhea-AI Summary

Indivior PLC (LSE/Nasdaq: INDV) announced the first order of OPVEE® (nalmefene) nasal spray from the Biomedical Advanced Research and Development Authority (BARDA). This order, worth $8.7 million, is part of BARDA's national preparedness efforts against synthetic opioid overdose emergencies. OPVEE is the first and only nasal rescue medicine specifically indicated for synthetic opioids like fentanyl.

The order comes as opioid overdose deaths in the U.S. reached 76,922 in the year ending January 2024. BARDA will use OPVEE to supplement local supplies for emergency rooms, ambulances, and other sites in case of medical countermeasure shortages during emergencies. This is the first option exercised under an agreement announced in December 2023, with BARDA having the option to purchase additional OPVEE annually for the next nine years.

Positive

• First order of OPVEE® from BARDA worth $8.7 million
• OPVEE is the first and only nasal rescue medicine for synthetic opioids
• Potential for additional annual purchases from BARDA over the next nine years
• Supports national preparedness against synthetic opioid overdose emergencies

Negative

• Opioid overdose deaths in the U.S. reached 76,922 in the year ending January 2024

Financial Analyst

The $8.7 million initial procurement of OPVEE® by BARDA represents a significant milestone for Indivior. This deal not only provides immediate revenue but also establishes a potential long-term revenue stream with options for annual purchases over the next nine years. The contract's structure suggests a stable, government-backed income source, which could enhance Indivior's financial stability and appeal to investors.

However, it's important to note that while this order is positive, its impact on Indivior's overall financial health needs context. In 2022, Indivior reported total net revenue of $901 million. Thus, this initial order represents ~1% of annual revenue. The long-term potential is more significant if BARDA continues to exercise its purchase options. Investors should monitor future orders and their frequency to gauge the contract's full impact on Indivior's financials.

Medical Research Analyst

OPVEE's unique position as the first and only nasal rescue medicine specifically indicated for synthetic opioids like fentanyl gives Indivior a significant competitive advantage in the opioid overdose reversal market. This is particularly important given the alarming statistic of 76,922 fatal overdoses in the year ending January 2024.

The product's potential to address the evolving threat landscape of synthetic opioids could lead to increased adoption beyond government contracts. Healthcare systems and first responders might view OPVEE as a superior alternative to existing treatments, potentially driving broader market penetration. However, it's important to note that the effectiveness of OPVEE in real-world, large-scale emergency situations remains to be seen and its performance will be critical for future orders and market expansion.

Market Research Analyst

This BARDA contract positions Indivior favorably in the growing market for opioid overdose reversal medications. The agreement not only provides a guaranteed customer in the U.S. government but also serves as a strong endorsement of OPVEE's efficacy, potentially influencing other large-scale buyers like state health departments or major hospital systems.

Moreover, the contract's nine-year duration aligns with long-term market projections for sustained demand in combating the opioid crisis. This could provide Indivior with a stable foundation to invest in further research and development or expand its product line. However, investors should be aware of potential risks, such as the emergence of competing products or changes in government policy regarding opioid crisis management, which could impact future orders or market dynamics.

• BARDA purchased OPVEE, a nalmefene opioid overdose reversal nasal spray
• Through BARDA's contract with Indivior, communities will be better equipped to respond to mass poisoning emergencies and address biosecurity threats involving synthetic opioids

RICHMOND, Va., Aug. 26, 2024 /PRNewswire/ -- Indivior PLC (LSE/Nasdaq: INDV) today announced the first order of OPVEE^® (nalmefene) nasal spray from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, to support its ongoing national preparedness efforts and help save lives during potential synthetic opioid overdose emergencies. OPVEE is the first and only nasal rescue medicine specifically indicated for synthetic opioids like fentanyl.

Opioid overdose deaths continue to claim lives in the U.S. with over 76,922 fatal overdoses in the one-year period ending in January 2024.¹ Access to effective opioid overdose reversal treatments is essential to reducing preventable deaths and helping communities against the evolving threat landscape. With its first order of OPVEE, BARDA will be able to supplement local supplies of emergency opioid overdose medications for emergency rooms, ambulances, and other sites in the United States if medical countermeasure shortages occurred during an emergency response.

"Providing communities with effective tools to address the fentanyl crisis is essential," said Richard Simkin, Chief Commercial Officer and Head of Government Affairs, Indivior. "This order of OPVEE has the potential to support the nation's preparedness against potential biothreats and response efforts to reduce overdose deaths from fentanyl and other synthetic opioid poisonings."

BARDA will use $8.7 million in Project BioShield designated funding for the initial procurement. The first option was exercised under the agreement with Indivior that was announced in December 2023. BARDA has the option to purchase additional OPVEE annually under Indivior vendor managed inventory over the next nine years.

OPVEE would be used in the prehospital setting (first responder/EMS) in accidental or intentional mass casualty situations.^2,3 The need for this product is pressing given the increase in fentanyl overdoses in the US.

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A50123C00068.

About OPVEE^® 
OPVEE (nalmefene) nasal spray

INDICATION
OPVEE nasal spray is an opioid antagonist indicated for the emergency treatment of known or suspected 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 nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present.

OPVEE nasal spray is not a substitute for emergency medical care.

HIGHLIGHTED SAFETY INFORMATION
CONTRAINDICATIONS
Hypersensitivity to nalmefene or to any of the other ingredients.

WARNINGS AND PRECAUTIONS
Risk of Recurrent Respiratory and Central Nervous System Depression: While the duration of action of nalmefene is as long as most opioids, a recurrence of respiratory depression is possible, therefore, keep patient under continued surveillance and administer repeat doses of OPVEE using a new nasal spray with each dose, as necessary, while awaiting emergency medical assistance.

Limited Efficacy with Partial Agonists or Mixed Agonist/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.

Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid dependent may precipitate opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal.

Risk of Cardiovascular (CV) Effects: Abrupt postoperative reversal of opioid depression may result in adverse CV effects. These events have primarily occurred in patients who had preexisting CV disorders or received other drugs that may have similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting after use of nalmefene hydrochloride.

Risk of Opioid Overdose from Attempts to Overcome the Blockade: Attempts to overcome opioid withdrawal symptoms caused by opioid antagonists with high or repeated doses of exogenous opioids may lead to opioid intoxication and death.

ADVERSE REACTIONS
Most common adverse reactions (incidence at least 2%) are nasal discomfort, headache, nausea, dizziness, hot flush, vomiting, anxiety, fatigue, nasal congestion, throat irritation, rhinalgia, decreased appetite, dysgeusia, erythema, and hyperhidrosis.

For more information about OPVEE and the full Prescribing Information visit www.opvee.com

About Indivior

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD), overdose and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.

References

1. Ahmad FB, C. J., Rossen LM, Sutton P. (2024). Provisional drug overdose death counts. National Center for Health Statistics, https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm. Accessed April 26, 2024.
2. Karila, L., Marillier, M., Chaumette, B., Billieux, J., Franchitto, N., & Benyamina, A. (2019). New synthetic opioids: Part of a new addiction landscape. Neuroscience & Biobehavioral Reviews/Neuroscience and Biobehavioral Reviews, 106, 133–140. https://doi.org/10.1016/j.neubiorev.2018.06.010
3. Skolnick, P. (2022). Treatment of overdose in the synthetic opioid era. Pharmacology & Therapeutics, 233, 108019. https://doi.org/10.1016/j.pharmthera.2021.108019

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SOURCE Indivior PLC

FAQ

What is the value of BARDA's first order of OPVEE® from Indivior (INDV)?

BARDA's first order of OPVEE® from Indivior (INDV) is valued at $8.7 million, using Project BioShield designated funding.

How long is BARDA's agreement with Indivior (INDV) for OPVEE® purchases?

BARDA has the option to purchase additional OPVEE® annually from Indivior (INDV) over the next nine years under a vendor managed inventory agreement.

What makes OPVEE® unique in treating opioid overdoses?

OPVEE® is the first and only nasal rescue medicine specifically indicated for synthetic opioids like fentanyl, making it unique in treating opioid overdoses.

How many opioid overdose deaths occurred in the U.S. according to Indivior's (INDV) press release?

According to Indivior's (INDV) press release, there were 76,922 fatal opioid overdoses in the U.S. in the one-year period ending in January 2024.