Indivior PLC RBP-6000 Investor Event (2638I)
June 16 2017 - 9:00AM
UK Regulatory
TIDMINDV
RNS Number : 2638I
Indivior PLC
16 June 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, June 16th, 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.
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(R) 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: 804-423-8916 or jason.thompson@indivior.com
This information is provided by RNS
The company news service from the London Stock Exchange
END
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