Indivior Applauds New U.S. Opioid Legislation

RNS Number : 1098F

Indivior PLC

25 October 2018

 

Indivior Applauds Enactment of the SUPPORT for Patients and Communities Act of 2018

Act Broadens Access to Medication-Assisted Treatment

for People Affected by Opioid Addiction

Slough, UK, and Richmond VA, October 25, 2018 - Indivior PLC (LON: INDV) ("Indivior" or the "Company") commends Congress and the Administration for passing and enacting H.R. 6, the SUPPORT for Patients and Communities Act of 2018. We further thank the Administration for its leadership in declaring the opioid epidemic a public health emergency and supporting this comprehensive new legislation, which includes many provisions critical to addressing opioid and substance use disorders.

"This bipartisan effort will improve the ability of patients with opioid use disorder (OUD) to access treatment and begin their path to recovery. This is critical in the fight against the increasing number of human lives lost to opioid overdose in the United States every year," said Indivior Chief Executive Officer Shaun Thaxter. "We know from our decades-long commitment to helping patients with this complex and stigmatized disease that there is a small window of time when a person is emotionally and physically able to pursue treatment. H.R. 6 will make treatment more immediately accessible and allow healthcare professionals to care for more patients when they decide to seek help."

Specifically, this legislation expands access to buprenorphine medication-assisted treatment (BMAT) by:

·     Making the buprenorphine prescribing authority permanent for nurse practitioners and physician assistants;

·     Specifically allowing for specialty pharmacy distribution of injectable medications to treat OUD;

·     Allowing for administration of OUD injectable treatments by non-waivered healthcare practitioners;

·     Allowing waivered practitioners to immediately treat 100 patients at a time if the practitioner is board certified in addiction medicine or addiction psychiatry, or in a qualified practice setting;

·     Putting into law the regulation expanding the patient limit to 275 for certain qualified physicians;

·     Authorizing additional funding for State Targeted Response Grants to support programs that help reduce opioid-related overdoses and addiction; and

·     Embedding substance use disorder training into medical school curricula with a goal of expanding the number of physicians able to treat OUD.

The opioid addiction epidemic in the United States is a national public health emergency, with more than 11 million people impacted nationwide and an average of nearly five people dying from opioid overdose every hour of every day.^1,2,3 OUD, commonly referred to as opioid addiction,⁴ is a chronic disease that changes the brain.⁵ The patient journey to treatment and recovery is complex, with many barriers, such as social stigma, challenges accessing treatment and prescribers, and difficulty adhering to treatment plans, which can lead to relapse.^5,6 More than 2.5 million patients have OUD, the majority of whom do not receive medication-assisted treatment (MAT).⁷

"We are pleased that the SUPPORT for Patients and Communities Act expands treatment authorization and ensures increased access to new, innovative FDA-approved buprenorphine formulations for OUD treatment. This, in addition to allowing certain qualified waivered practitioners to immediately treat up to 100 patients at a time, is imperative in combatting the current opioid crisis," said Indivior Chief Medical Officer Ponni Subbiah, M.D. "As each patient's journey towards recovery is different, access to all evidence-based treatment options is essential. We look forward to working together with the Administration on the implementation of these critical provisions."

For Further Information

Investor Enquiries	Jason Thompson	VP Investor Relations, Indivior PLC	[phone] [e-mail]
Media Enquiries	Jonathan Sibun	Tulchan Communications US Media Enquiries	[phone] [phone] [e-mail]

Corporate Website         www.indivior.com

This announcement does not constitute an offer to sell, or the solicitation of an offer to subscribe for or otherwise acquire or dispose of shares in the Company to any person in any jurisdiction to whom it is unlawful to make such offer or solicitation.

About Indivior

Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy and health policy while providing education on evidence-based treatment models that have revolutionized modern addiction treatment. The name is the fusion of the words individual and endeavour, and the tagline "Focus on you" makes the Company's commitment clear. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of opioid dependence treatments, Indivior has a strong pipeline of product candidates designed to both expand on its heritage in this category and address other chronic conditions and co-occurring disorders of addiction, including alcohol use disorder and schizophrenia. Headquartered in the United States in Richmond, VA, Indivior employs more than 900 individuals globally and its portfolio of products is available in over 40 countries worldwide. Visit www.indivior.com to learn more.

Forward-Looking Statements

This announcement contains certain statements that are forward-looking and which should be considered, amongst other statutory provisions, in light of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. By their nature, forward-looking statements involve risk and uncertainty as they relate to events or circumstances that may or may not occur in the future. Actual results may differ materially from those expressed or implied in such statements because they relate to future events. Forward-looking statements include, among other things, statements regarding the Indivior Group's financial guidance for 2018 and its medium- and long-term growth outlook, its operational goals, its product development pipeline and statements regarding ongoing litigation.

Various factors may cause differences between Indivior's expectations and actual results, including: factors affecting sales of Indivior Group's products; the outcome of research and development activities; decisions by regulatory authorities regarding the Indivior Group's drug applications; the speed with which regulatory authorizations, pricing approvals and product launches may be achieved; the outcome of post-approval clinical trials; competitive developments; difficulties or delays in manufacturing; the impact of existing and future legislation and regulatory provisions on product exclusivity; trends toward managed care and healthcare cost containment; legislation or regulatory action affecting pharmaceutical product pricing, reimbursement or access; claims and concerns that may arise regarding the safety or efficacy of the Indivior Group's products and product candidates; risks related to legal proceedings, including the ongoing investigative and antitrust litigation matters; the Indivior Group's ability to protect its patents and other intellectual property; the outcome of patent infringement litigation relating to Indivior Group's products, including the ongoing ANDA lawsuits; changes in governmental laws and regulations; issues related to the outsourcing of certain operational and staff functions to third parties; uncertainties related to general economic, political, business, industry, regulatory and market conditions; and the impact of acquisitions, divestitures, restructurings, internal reorganizations, product recalls and withdrawals and other unusual items.

1.      The White House Office of the Press Secretary. (October 26, 2017). President Donald Trump is Taking Action on Drug Addiction and the Opioid Crisis. Retrieved from https://www.whitehouse.gov/the-press-office/2017/10/26/president-donald-j-trump-taking-action-drug-addiction-and-opioid-crisis. Accessed October 30, 2017.

2.      Substance Abuse and Mental Health Services Administration. (2018). Key Substance Use and Mental Health Indicators in the United States: Results from the 2017 National Survey on Drug Use and Health (HHS Publication No. SMA 18-5068, NSDUH Series H-53). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Retrieved from hhttps://www.samhsa.gov/data/report/2017-nsduh-annual-national-report. Accessed October 19, 2018.

3.      National Institute on Drug Abuse (2018). Opioid Overdose Crisis. Retrieved from https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis#one. Accessed October 19, 2018.

4.      Murthy VH. Ending the Opioid Epidemic - A Call to Action. N Engl J Med 2016; 375:2413-2415.

5.      National Institute on Drug Abuse. (2007). Drugs, Brains, and Behavior: The Science of Addiction. Retrieved from https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/soa_2014.pdf. Accessed October 23, 2017.

6.      American Society of Addiction Medicine (2013). Advancing Access to Addiction Medications. Retrieved from https://www.asam.org/docs/default-source/advocacy/aaam_implications-for-opioid-addiction-treatment_final. Accessed October 19, 2018.

7.      National Institute on Drug Abuse (2016). Effective Treatments for Opioid Addiction. Retrieved from https://www.drugabuse.gov/publications/effective-treatments-opioid-addiction/effective-treatments-opioid-addiction. Accessed October 19, 2018.

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