Indivior and C4X Enter Licensing Agreement

RNS Number : 3297J

Indivior PLC

29 March 2018

 

Indivior Enters Into an Exclusive Global License Agreement for C4X Discovery's Orexin-1 (OX1) Antagonist Program

Slough, UK and Richmond, VA, 29 March 2018 - 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 stimulants ¹, 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, CEO 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

1.     Hutcheson et al. Behav Pharmacol. 2011 Apr;22(2):173-81.

2.     Baimel et al. Br J Pharmacol. 2015 Jan; 172(2):334-48

3.     Moorman et al. Psychopharmacology (Berl). 2018 Mar 6.

4.     James et al. Curr Top Behav Neurosci. 2017; 33:247-281.

Media Contacts:

US
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UK
Tulchan Communications
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Investor Contact:

Jason Thompson, Indivior
Vice President, Investor Relations
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[e-mail]

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