Indivior’s Temporary Restraining Order is Extended

Indivior’s Temporary Restraining Order is Extended

Slough, UK, 28 June 2018 – Indivior PLC (LON: INDV) (“Indivior” or the “Company”) today announced that the U.S. District Court for the District of New Jersey heard Indivior’s application for a preliminary injunction (PI) against Dr. Reddy’s Laboratories (DRL). This PI motion was filed to extend the cessation of launch activities by DRL during the pendency of the outcome of the recently filed litigation against DRL related to U.S. Patent No. 9,931,305. At today’s hearing, Judge McNulty reserved judgment on Indivior’s motion, and has extended Indivior’s temporary restraining order (TRO) issued on June 15, 2018 for an additional 14-days, during which time the Court will consider Indivior’s application and ultimately issue a ruling on the PI.

Indivior will not make further statements on this matter until the U.S. District Court for the District of New Jersey makes its final ruling on the Company’s PI.

 

For Further Information 

Investor Enquiries

Jason Thompson

VP Investor Relations, Indivior PLC

+1 804 423 8916

jason.thompson@indivior.com

Media Enquiries

Jonathan Sibun

Tulchan Communications

US Media Enquiries

+44 207 353 4200

+1 804 594 0836

Indiviormediacontacts@indivior.com

Corporate Website www.indivior.com

This announcement 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.

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 alcohol use disorder 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 announcement contains certain statements that are forward-looking and which should be considered, amongst other statutory provisions, in light of the safe harbor 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 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 2018 and its medium- and long-term growth outlook, its operational goals, its 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, including the ongoing investigative and antitrust litigation matters; 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.

 

 

 

(2) Batlivala & Karani Dr. Reddy’s Event Update, June 15, 2018, Page 1