SLOUGH, England and
RICHMOND, Va., March 29, 2018 /PRNewswire/ -- Indivior PLC
("Indivior") (LON: INDV) today announced that its subsidiary
Indivior UK Limited ("Indivior UK") and C4X Discovery Holdings PLC
("C4X") (AIM: C4XD) entered into a license agreement whereby
Indivior UK obtained exclusive global rights to develop and
commercialize C4X's oral orexin-1 receptor antagonist program. The
orexin-1 ("OX1") molecular pathway has been identified by Indivior
as a priority pathway for the treatment of addiction. Selective
blockade of the OX1 system has been shown to decrease drug-seeking
behaviour related to psychomotor stimulants1,
opiates2 and alcohol3, and to prevent relapse
or reinstatement of drug-seeking behaviour during
abstinence4. Indivior believes that further development
of the OX1 pathway may lead to significant advances in
medication-assisted treatment for opioid and other substance use
disorders.
The agreement with C4X includes lead candidate C4X3256, a novel,
first-in-class, oral, small molecule that has demonstrated
preclinical efficacy and tolerability in animal models. The
collaboration also includes a library of additional OX1 compounds
in the same chemical family.
Under the terms of the agreement, Indivior UK will make an
upfront payment to C4X of $10 million
with potential milestone payments to C4X that could total
$284 million over time if all
development, regulatory and commercial goals are achieved.
"We are continuing to extensively review and invest in targeted
new treatments that extend our understanding of and leadership in
addiction," said Shaun Thaxter,
Chief Executive Officer of Indivior. "The OX1 pathway is a key
molecular pathway we are targeting for development and is
particularly attractive to us for its potential as a non-narcotic
mechanism for treating and preventing relapse across a broad range
of substance use disorders. Our development of the OX1 pathway will
leverage the current efforts we have already underway internally
and through other collaborations as we pursue novel treatments for
addiction."
"We believe C4X's OX1 program is one of the most promising early
stage programs to potentially treat addiction and look forward to
rapidly advancing lead compound C4X3256 into the clinic," said
Christian Heidbreder, Chief
Scientific Officer of Indivior. "Further, we believe there is great
potential for additional compounds to be discovered and developed
with respect to this important mechanism that will contribute to
the continued elucidation of the neurobiological underpinnings of
withdrawal symptoms, drug intake, craving, relapse, and co-morbid
psychiatric associations."
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 AUD and
schizophrenia. Headquartered in the
United States in Richmond,
VA, Indivior employs more than 1,000 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 press
release contains certain statements that are forward-looking and
which should be considered, amongst other statutory provisions, in
light of the safe harbour 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 will or may 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 our financial guidance for 2017 and our medium- and
long-term growth outlook, our operational goals, our 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; 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.
This press release 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.
References
- Hutcheson et al. Behav Pharmacol. 2011
Apr;22(2):173-81.
- Baimel et al. Br J Pharmacol. 2015 Jan;
172(2):334-48
- Moorman et al. Psychopharmacology (Berl). 2018
Mar 6.
- James et al. Curr Top Behav Neurosci. 2017;
33:247-281.
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SOURCE Indivior PLC