RBP-6000 Investor Event Announcement| June 29, 2017 |
Indivior to Host Investor Event on RBP-6000 on June 29th at 12:00 Noon EDT US (5:00 P.M. UK Time)
Slough, UK, and Richmond, VA, 16 June 2017 – Indivior PLC (LON: INDV) today announced that it 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 psychological 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.
The presentation will be followed by a question and answer session, during which other members of the Indivior leadership team, including CEO Shaun Thaxter and CFO Mark Crossley, will be available to address questions from the investment community.
Event Access Details
The event will take place on June 29th, 2017, 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.
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.
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.