SLOUGH, England and RICHMOND, Va., Jan.
3, 2018 /PRNewswire/ -- Indivior PLC (LON:
INDV) ("Indivior") today announced that Indivior UK Limited has
entered into a strategic collaboration with Addex Pharma S.A., a
wholly-owned subsidiary of Addex Therapeutics Ltd. (SIX: ADXN)
("Addex"), in the field of GABAB positive allosteric
modulators (PAMs). GABAB PAMs have demonstrated
preclinical efficacy and tolerability in animal models for alcohol
use disorder (AUD) and cocaine use disorder (CUD)1,2.
The collaboration includes an exclusive global license to lead
candidate ADX71441, which is a novel, first-in-class, oral, small
molecule and is expected to enter Phase 1 trials in 2018. The
collaboration also includes exclusive global license to backup
GABAB PAM compounds, as well as a research collaboration
focused on discovering additional GABAB PAMs. The Addex
GABAB program was recently awarded a $5.3 million grant by the National Institute on
Drug Abuse ("NIDA") to support the development of ADX71441 in
CUD3.
Under the terms of the agreement, Indivior is making an
upfront payment to Addex of $5
million, and will also invest in research funding over the
next two years to discover additional GABAB PAM
compounds commercially-viable to treat addiction. Potential
milestone payments to Addex could total $330
million over time if all development, regulatory and sales
goals are achieved.
"As part of our leadership position in addiction, among
the key priorities we are pursuing is continuing to review and
invest in promising new treatments for this chronic and
relapsing disease," said Shaun
Thaxter, CEO of Indivior. "Modulation of the
GABAB receptor pathway is an attractive mechanism,
particularly for the potential it holds in advancing treatments for
AUD and CUD. Further, we are excited about this new strategic
collaboration with Addex to discover additional compounds targeting
the GABAB receptor pathway, which will complement
the current pipeline efforts we have underway to develop novel
treatments for addiction."
"We believe Addex has the most advanced science in the
area of GABAB allosteric modulation and look forward to
rapidly advancing lead compound, ADX71441, into Phase 1 trials,"
said Christian Heidbreder, Chief
Scientific Officer of Indivior. "As we continue to collaborate with
the Addex team, we believe there is great potential for additional
compounds to be discovered and developed related to this important
mechanism for addiction science."
Addex's GABAB PAMs Program Focused on
Addiction
Long-term exposure to drugs of abuse causes
adaptive changes in several neurotransmitter systems, including
gamma-aminobutyric acid (GABA) receptors. Research has shown
that exposure to psychostimulants depresses the normal function of
the GABAB receptor signaling in the mesolimbic
dopaminergic system4, which plays a role in the
positive reinforcing properties of several drugs of
abuse and may also contribute to the negative reinforcing effects
associated with their withdrawal5. Therefore, full
agonists aimed at the orthosteric site on the GABAB
receptor have been the target for the development of
pharmacotherapies for AUD and CUD2.
The efficacy of these full agonists at the orthosteric
site on the GABAB receptor, however, are limited due to
tolerance and undesired side effects, including sedation,
myorelaxing activity and hypothermia. Unlike orthosteric agonists,
positive allosteric modulators (PAMs) work by only enhancing the
activity of GABAB receptors when and where needed
physiologically. As such, GABAB PAMs are expected to
have significantly less undesired side effects than full
GABAB receptor agonists and to be suitable for long-term
treatment without challenges related to
tolerance6.
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 900 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
- Hwa LS et al. 2014. Reduction of excessive alcohol
drinking by a novel GABAB receptor positive allosteric modulator
ADX71441 in mice. Psychopharmacology 231(2):333-43; Augier E et al.
2017. The GABAB Positive Allosteric Modulator ADX71441 Attenuates
Alcohol Self-Administration and Relapse to Alcohol Seeking in Rats.
Neuropsychopharmacology. 42(9):1789-1799.
- Phillips & Reed 2014.
Targeting GABAB receptors for
anti-abuse drug discovery. Expert
Opin Drug Discov. 9(11):1307-17.
-
https://www.addextherapeutics.com/en/news-and-events/press-releases/
- Padgett CL et al. 2012. Methamphetamine-evoked
depression of GABA(B) receptor signaling in GABA neurons of the
VTA. Neuron 73, 978–989.
- Wise RA 2004. Dopamine, learning and motivation. Nat Rev
Neurosci 5:483-494
- Filip et al. 2015. GABAB receptors as a therapeutic
strategy in substance use disorders: focus on positive
allosteric modulators. Neuropharmacology.
88:36-47.
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SOURCE Indivior PLC