TIDMINDV
RNS Number : 1582B
Indivior PLC
08 June 2021
INDIVIOR EXTS LEADERSHIP POSITION IN SUBSTANCE USE DISORDER
TREATMENT WITH EXCLUSIVE AGREEMENT FOR LEADING ASSET TARGETING
CANNABIS-RELATED DISORDERS
AEF0117 is a leading compound targeting the CB1 receptor;
potentially represents the first treatment for cannabis-related
disorders; executing on a key Strategic Priority to build
Indivior's pipeline
Richmond, VA, June 8, 2021 - Indivior PLC (LON: INDV) today
announced that it is extending its leadership position in substance
use disorder ("SUD") treatment by expanding into the under treated
cannabis-related disorders, including cannabis use disorder ("CUD")
and cannabis-induced psychosis ("CIP"). Indivior has entered into a
strategic collaboration with Aelis Farma ("Aelis"), a private
biotechnology company based in Bordeaux, France, that includes an
exclusive option and license agreement (the "Agreement") for the
global rights to AEF0117, Aelis' first-in-class synthetic Signaling
Specific inhibitor ("SSi") engineered to inhibit the cannabinoid
type 1 ("CB1") receptor ("CB1-SSi").
Under the Agreement, Indivior will pay an initial $30 million to
secure an exclusive global option for AEF0117. In clinical Phase 1
studies, AEF0117 has shown promising safety and tolerability
signals. Furthermore, in a recently completed Phase 2a study,
AEF0117 has shown positive signals of efficacy in subjects with CUD
(1) . The option gives Indivior the right to assume all development
and commercialization activities for AEF0117 upon successful
completion of a planned Phase 2b study by Aelis in return for an
exercise fee of an additional $100 million and a series of
potential milestone payments and sales-based royalties. The
Agreement also includes exclusive global rights on a patent
covering AEF0117 and related compounds and on a methods of use
patent for treating cannabis-related disorders, including CUD and
CIP.
"Our heritage and focus is helping address unmet needs for
people struggling with substance use disorders," said Mark
Crossley, Chief Executive Officer. "Increasing prevalence of
cannabis from the growing movement to legalize medical and
recreational marijuana use is leading to greater concern for the
potential of adverse outcomes, including elevated addiction risk(2)
. Cannabis is the most commonly used substance of abuse in the US
after alcohol and tobacco(3) ; however, we have no FDA-approved
medications for cannabis-related disorders, which are complex and
concerning. AEF0117 is the most advanced new chemical entity under
investigation in the clinic and potentially represents a unique
opportunity to address a growing unmet public health need."
Over 48 million(4) people used marijuana in the U.S. in 2019 and
4.8 million(4) people had a CUD during the same period. The United
Nations also recently estimated that 192 million people globally
used cannabis in 2018(5) , making it the most used drug in the
world. The most recent global burden of disease study including 195
countries over the 1990-2016 period estimated that 22.1 million
people met the diagnostic criteria for CUD (289.7 cases per 100,000
people)(6) .
"We are excited about the potential for our partnership with
Aelis," said Christian Heidbreder, Chief Scientific Officer. "Our
collaboration to advance the clinical development of AEF0117
reflects the success of our Connect and Develop R&D strategy
that seeks to marry our drug discovery and development capabilities
with innovators targeting the most promising pharmacological
mechanisms in substance use disorders and related CNS diseases.
Favorable data in support of Aelis' new CB1-SSis have the potential
to yield the necessary clinical proof of concept to advance AEF0117
closer to regulatory approval as the first medication to treat
CUD."
Background on lead compound AEF0117 & milestones
Aelis' lead CB1-SSi compound AEF0117 is a new chemical entity
("NCE") with U.S. composition of matter patent expiry in 2033 and a
method of use patent extending to 2039.
Completed Phase 1 clinical (single and multiple ascending dose)
studies for AEF0117 have suggested good safety and tolerability and
a recently-completed 29-patient Phase 2a study in subjects with CUD
demonstrated positive signals of efficacy ("Effect of AEF0117 on
Subjective Effects of Cannabis in CUD Subjects"; ClinicalTrials.gov
Identifier: NCT03717272).
Under the Agreement, Aelis will fund and manage a Phase 2b proof
of concept study of AEF0117. This will be a multi-center study
evaluating efficacy of the compound as a treatment of CUD and will
be coordinated by Prof. Frances Levin at Columbia University, USA.
Assuming successful completion of the Phase 2b study, the exclusive
option gives Indivior the right to assume full control of clinical
development and commercialization of AEF0117 in return for a
payment to Aelis of $100 million. Phase 3 studies and
commercialization would then be at Indivior's direction and
expense. Aelis would also be entitled to certain other development
and sales milestones, including payments linked to U.S. NDA filing
acceptance and NDA approval, as well as royalties in the mid-teen
percentage range on global net sales.
About Indivior
Indivior is a global pharmaceutical company working to help
change patients' lives by developing medicines to treat addiction
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 addiction.
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
pipeline of product candidates designed to both expand on its
heritage in this category and potentially address other chronic
conditions and cooccurring disorders of addiction, including
alcohol use disorder. Headquartered in the United States in
Richmond, VA, Indivior employs more than 700 individuals globally
and its portfolio of products is available in over 40 countries
worldwide. Visit www.indivior.com to learn more. Connect with
Indivior on LinkedIn by visiting www.linkedin.com/company/indivior
.
Forward-Looking Statements
This announcement contains certain statements that are
forward-looking. By their nature, forward-looking statements
involve risks and uncertainties 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 2021 and its
medium- and long-term growth outlook, its operational goals, its
product development pipeline and statements regarding ongoing
litigation and other statements containing the words "subject to",
"believe", "anticipate", "plan", "expect", "intend", "estimate",
"project", "may", "will", "should", "would", "could", "can", the
negatives thereof, variations thereon and similar expressions.
Various factors may cause differences between Indivior's
expectations and actual results, including, among others (including
those described in the risk factors described in the most recent
Indivior PLC Annual Report and in subsequent releases): factors
affecting sales of Indivior Group's products and financial
position; the outcome of research and development activities;
decisions by regulatory authorities regarding the Indivior Group's
drug applications or authorizations; the speed with which
regulatory authorizations, pricing approvals and product launches
may be achieved, if at all; the outcome of post-approval clinical
trials; competitive developments; difficulties or delays in
manufacturing and in the supply chain; disruptions in or failure of
information technology systems; 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; challenges in the commercial
execution; 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
compliance with the U.S. Department of Justice Resolution and
Settlement Agreements, noncompliance with which could result in
potential exclusion from participating in U.S. Federal health care
programs; the ongoing investigative and antitrust litigation
matters; the opioid national multi-district litigation and
securities class action litigation; 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; risks related to the evolving COVID-19 pandemic and the
potential impact of COVID-19 on the Indivior Group's operations and
financial condition, which cannot be predicted with confidence;
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.
Consequently, forward-looking statements speak only as of the
date that they are made and should be regarded solely as our
current plans, estimates and beliefs. You should not place undue
reliance on forward-looking statements. We cannot guarantee future
results, events, levels of activity, performance or achievements.
Except as required by law, we do not undertake and specifically
decline any obligation to update, republish or revise
forward-looking statements to reflect future events or
circumstances or to reflect the occurrences of unanticipated
events.
Investor Contact:
Jason Thompson
Vice President, Investor Relations
+1 804-402-7123
Media Contacts:
Tulchan Communications
+44 207-353-4200
or
IndiviorMediaContacts@indivior.com
+1 804-594-0836
Citations :
1. ClinicalTrials.gov Identifier: NCT03717272.
2. https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2464591 , page 1
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6223748/ , page 1
4. Substance Abuse and Mental Health Services Administration.
(2020). Key substance use and mental health indicators in the
United States: Results from the 2019 National Survey on Drug Use
and Health (HHS Publication No. PEP20-07-01-001, NSDUH Series
H-55). Rockville, MD: Center for Behavioral Health Statistics and
Quality, Substance Abuse and Mental Health Services Administration.
Retrieved from https://www.samhsa.gov/data/
5. United Nations. World Drug Report 2020 (2020)
6. Degenhardt L et al. The global burden of disease attributable
to alcohol and drug use in 195 countries and territories,
1990-2016: a systematic analysis for the Global Burden of Disease
Study 2016. Lancet Psychiatry 5, 987-1012 (2018).
-ends-
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