IntelGenx Technologies Corp.
TSX VENTURE : IGX
OTCQX : IGXT

IntelGenx Technologies Corp.

September 06, 2017 08:00 ET

IntelGenx Announces Decisions in Suboxone® Patent Litigation

SAINT-LAURENT, QUEBEC--(Marketwired - Sept. 6, 2017) - IntelGenx Corp. (TSX VENTURE:IGX)(OTCQX:IGXT) ("IntelGenx" or the "Company") today announced that the U.S. District Court for the District of Delaware (the "Delaware Court"), in a decision rendered August 31, 2017, determined that the process used to manufacture IntelGenx' and Par Pharmaceutical, Inc.'s ("Par") buprenorphine/naloxone sublingual film product for the treatment of opiate addiction does not infringe MonoSol Rx U.S. Patent No. 8,900,497 (the "497 patent").

"This is a great outcome for IntelGenx, confirming that our process for making generic Suboxone® film does not infringe the process covered by the '497 patent'," said Dr. Horst G. Zerbe, President and CEO of IntelGenx.

Also on August 31, 2017, the Delaware Court rendered a decision in a separate case, which previously resulted in a finding infringement of the MonoSol Rx U.S. Patent No 8,603,514 (the "514 patent"), denying IntelGenx' and Par's motion to reopen the case.

Dr. Zerbe further commented, "According to IMS data, the oral film market for opioid dependence in the United States was worth more than $1.4 billion in 2014. We are working with Par on the appeal process."

About Opioid Addiction

Opioid addiction is one of the fastest growing public health epidemics in North America. In the U.S. alone, 2.5 million people struggle with opioid addiction and, according to the U.S. Centers for Disease Control, 78 people die each day from the disease. The Drug Addiction Treatment Act of 2000 allowed medical office-based treatment of opioid dependence and greatly expanded patient access to medication-assisted treatments. In 2015, the U.S. Health and Human Services Department announced it would move to expand access to medication-assisted-treatment even further by revising regulations that cap the number of patients who can be treated with buprenorphine products by physicians.

About Suboxone®

The U.S. Food and Drug Administration approved Suboxone® film in October of 2002 for use in the treatment of opioid dependence. Suboxone® is a registered trademark of Indivior UK Limited and Suboxone® film is manufactured by MonoSol Rx. Suboxone® film is composed of the two active ingredients: buprenorphine and naloxone.

About IntelGenx:

Established in 2003, IntelGenx is a leading oral drug delivery company primarily focused on the development and manufacturing of innovative pharmaceutical films based on its proprietary VersaFilm™ technology platform.

IntelGenx' highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx' state-of-the-art manufacturing facility, established for the VersaFilm™ technology platform, supports lab-scale to pilot and commercial-scale production, offering full service capabilities to its clients. More information about the company can be found at www.intelgenx.com.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange), nor the OTCQX accepts responsibility for the adequacy or accuracy of this release.

Source: IntelGenx Technologies Corp.

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