RBP-6000 Investor Event Reminder

RNS Number : 5703J

Indivior PLC

29 June 2017

 

Indivior to Host Investor Event Today on RBP-6000 at 12:00 Noon EDT US (5:00 P.M. UK Time)

Slough, UK, and Richmond, VA, June 29th, 2017 - Indivior PLC (LON: INDV) today will host an investor presentation on RBP-6000, its once monthly injectable buprenorphine which is being developed for the treatment of moderate-to-severe opioid use disorder (OUD) as part of a complete treatment plan to include counselling and psychosocial support. Indivior submitted a new drug application (NDA) for RBP-6000 to the U.S. Food & Drug Administration (FDA) on May 30th, 2017.

The presentation, to be led by Christian Heidbreder, Ph.D., Chief Scientific Officer of Indivior, will focus on data submitted to FDA that demonstrate RBP-6000's statistically significant differences in the rate of abstinence and other clinical endpoints versus placebo. Dr. Heidbreder's team will also provide insights into submitted safety data.

Shaun Thaxter, CEO of Indivior said:

"Indivior has been a pioneer in buprenorphine medication-assisted treatment (BMAT), educating and working with physicians, advocacy groups, medical societies, payors, policy makers and other key stakeholders to help address opioid addiction and we remain the leader today. Our leadership position stems from our clear focus on developing treatments that deliver on the unmet needs of patients, along with our relentless advocacy for evidenced-based medication-assisted treatment (MAT) as a key part of the addiction recovery equation. It is this focus on serving the needs of the patient that has led us to develop RBP-6000 as a potential new standard of care, and I am delighted that you will get the opportunity to hear more about this investigational product today.

"I am also very pleased with our commercial execution in the first half of 2017. Despite having lost some share in Managed Medicaid, our overall base film business remains resilient - with a current share in the U.S. market of about 57%. This continues to provide us the resources and strong foundation we will leverage as we look to launch RBP-6000 in the early part of 2018, if granted priority review by the FDA."

Event Access Details

The event will take place today at 12:00 p.m. Eastern Daylight Time US (5:00 p.m. UK Time). The webcast and presentation will be available on the "Investors" section of the company's website at www.indivior.com shortly before the event begins. The webcast link is http://edge.media-server.com/m/p/inwa9aui

Members of the investment community also may access the event telephonically: US participants 1-212-444-0412; international participants 44-(0)20-3427-1916. Please reference confirmation number 9276504. A replay of the call will be available at www.indivior.com.

About RBP-6000

RBP-6000 IS AN INVESTIGATIONAL PRODUCT THAT HAS NOT BEEN APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION OR ANY OTHER REGULATORY AGENCY FOR SAFETY AND EFFICACY.

RBP-6000 is an investigational buprenorphine sustained-release formulation using our ATRIGEL® delivery system, which consists of a polymeric solution of a biodegradable poly-(DL-lactide-co-glycolide) co-polymer dissolved in N-methyl pyrrolidone (NMP), a water-miscible biocompatible solvent. After subcutaneous injection, NMP diffuses out of the polymer matrix and the polymer precipitates, trapping the drug inside and forming an amorphous solid depot in situ. The depot releases buprenorphine over a one-month period by diffusion as the polymer biodegrades.

Available safety findings suggest that 2.7% of subjects on RBP-6000 (both dosage regimens combined) experienced a serious treatment-emergent adverse event (TEAE) compared with 5.0% of subjects on placebo. There were no related serious TEAEs across groups. 6.9% of subjects on RBP-6000 (both dosage regimens combined) experienced a severe TEAE compared with 4.0% of subjects on placebo. 4.2 % of subjects on RBP-6000 (both dosage regimens combined) discontinued treatment due to TEAEs compared with 2.0% of subjects on placebo. The most common (reported in ≥ 5% of subjects) TEAEs reported in the active total group were headache, constipation, nausea, injection site pruritus, vomiting, insomnia and upper respiratory tract infection.

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.

Contact:

Jason Thompson

Vice President, Investor Relations

Tel: [phone] or [e-mail]

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