Indivior Receives Complete Response Letter from FDA Not Approving
`Naloxone Nasal Spray New Drug Application for Opioid Overdose
`
`Slough, UK, [November 24, 2015] – Indivior Inc., a subsidiary of Indivior PLC (LON: INDV), today
`announced that it has received a Complete Response Letter from the U.S. Food and Drug
`Administration (FDA) regarding its New Drug Application for naloxone nasal spray, an intranasal
`naloxone product candidate for the emergency treatment of known or suspected opioid
`overdose.
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`The FDA’s response was principally focused on clinical pharmacology that found the early stage
`uptake of naloxone nasal spray did not fully meet the FDA’s threshold as determined by the
`reference product (0.4 mg naloxone by intramuscular injection).
`
`Indivior is evaluating the FDA’s comments to determine our next steps to address FDA’s findings.
`
`“We are closely reviewing the FDA’s response,” said Shaun Thaxter, Chief Executive Officer,
`Indivior PLC. “Our commitment to improving patient outcomes remains steadfast, and as part of
`this, our work with stakeholders across communities will continue.”
`
`As the rate of opioid prescription painkiller and heroin abuse and dependence has escalated in
`recent years, so has the number of overdose deaths. Between 1999 and 2013, the total deaths
`involving opioid pain relievers per year increased fourfold. More than 24,000 people in the United
`States succumbed to opioid prescription painkiller or heroin overdose in 2013.
`
`About Indivior
`Indivior is a global specialty pharmaceutical company with a 20-year legacy in patient advocacy,
`health policy and evidence-based best practice models that have helped to advance modern
`addiction treatment. The name is the fusion of the words individual and endeavor, and the tagline
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`Adapt & Opiant Exhibit 2012
`Nalox-1 Pharmaceuticals, LLC v. Adapt Pharma Limited et al.
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`“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 opioid dependence portfolio, Indivior has a pipeline of product candidates designed to
`both expand on its heritage in this category and address other chronic diseases of addiction –
`including opiate overdose, alcohol use disorders and cocaine intoxication. It also is pursuing novel
`product candidates in related mental health disorders such as schizophrenia. Headquartered in
`the United States in Richmond, Va., Indivior employs more than 700 individuals globally and its
`portfolio is available in over 40 countries worldwide. Visit www.Indivior.com to learn more.
`
`Forward-Looking Statements
`This press release contains forward-looking statements. We may, in some cases, use terms such
`as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates,"
`"expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that
`convey uncertainty of future events or outcomes to identify these forward-looking statements.
`Forward-looking statements include statements regarding our intentions, beliefs, projections,
`outlook, analyses or current expectations.
`
`Various factors may cause differences between Indivior's expectations and actual results,
`including: factors affecting sales of Indivior products and any future 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 litigation relating to 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.
`
`Any forward-looking statements that we make in this press release speak only as of the date of
`this press release. We assume no obligation to update our forward-looking statements whether
`as a result of new information, future events or otherwise, after the date of this press release.
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`Media Contacts
`
`Amir Khan
`Biosector 2
`+1 212-845-5656
`amir.khan@inventivhealth.com
`
`
`Andria Arena
`Biosector 2
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`Adapt & Opiant Exhibit 2012
`Nalox-1 Pharmaceuticals, LLC v. Adapt Pharma Limited et al.
`IPR2019-00693
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`+1 212-845-5620
`Andria.arena@inventivhealth.com
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`Investor Contact
`
`Tom Corran
`Indivior, Director, Investor Relations
`+44(0)175 321 780
`
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`Adapt & Opiant Exhibit 2012
`Nalox-1 Pharmaceuticals, LLC v. Adapt Pharma Limited et al.
`IPR2019-00693
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