SAINT LAURENT, Quebec, Jan. 13, 2020 — IntelGenx Corp. (IGX.V) (IGXT) (“IntelGenx”), a leader in pharmaceutical films, today provided a commercial update on its two lead product candidates, cannabis-infused VersaFilm® and RIZAPORT®. IntelGenx is providing this information ahead of its planned participation in investment community meetings to be held in connection with, among other investor events, the 38th Annual J.P. Morgan Healthcare Conference in San Francisco.
Cannabis-Infused VersaFilm® Remains on Track for Commercial Launch in Q1-2020
IntelGenx announced that a cannabis-infused VersaFilm® product has been finalized with its co-development partner, Tilray®, and all manufacturing scale-up work has been successfully completed.
“Because we believe this is an exciting product that will meet, if not exceed, consumer expectations, we think that we’re well positioned to become a significant player in this expanding market as new product formats come online,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “We continue to work with Health Canada in the pursuit of our requisite micro-processing license – the last step before commercial production can commence.”
Specific details of the cannabis-infused VersaFilm® product will be unveiled closer to its commercial launch.
IntelGenx and Orivas Sign Binding Term Sheet for Commercialization of RIZAPORT® in Select European Countries
IntelGenx also announced the signing of a binding term sheet with Orivas for the commercialization of RIZAPORT®, a unique oral thin film for the treatment of acute migraines, pursuant to which Orivas will obtain exclusive rights to market and sell RIZAPORT® in Lithuania, Latvia, Estonia and Poland, with the right of first refusal for a predefined term to include the Republic of Belarus and/or Republic of Ukraine, as well as any of the Scandinavian countries (Finland, Denmark, Sweden and Norway). Financial terms of the agreement were not disclosed.
Established in 2001, Orivas is a private pharmaceutical company based in Lithuania. The company cooperates with drug manufacturers to market innovative prescription and over-the-counter medicines, and medical and oral care products, in the Baltic States.
“We are excited to enter into a binding agreement with Orivas to market RIZAPORT® in these, and potentially additional European territories,” said Dr. Zerbe. “RIZAPORT®, based on IntelGenx’s proprietary VersaFilm® technology, will provide patients suffering from migraines with an innovative solution, and we view this collaboration as an important milestone toward expanding the distribution of this product to new markets.”
IntelGenx Continues to Make Preparations Ahead of RIZAPORT® PDUFA Goal Date of March 26, 2020
Finally, IntelGenx confirmed that it is continuing to make launch preparations with Gensco® Pharma, its U.S. commercialization partner for RIZAPORT® VersaFilm®, ahead of the U.S. Food and Drug Administration’s (“FDA”)-assigned Prescription Drug User Fee Act (“PDUFA”) goal date of March 26, 2020 for completion of its review of the product’s 505(b)(2) New Drug Application (“NDA”).
“Receipt of the FDA’s PDUFA goal date for completion of the its review of the RIZAPORT® NDA marked an important milestone and we are looking forward to continuing to work with the Agency to make this innovative migraine treatment available to patients,” commented Dr. Zerbe.
IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.
IntelGenx’s superior film technologies, including VersaFilm®, VetaFilm™ and transdermal, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offer significant benefits to patients and physicians for many therapeutic conditions.
IntelGenx’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.
Forward Looking Statements:
This document may contain forward-looking information about IntelGenx’ operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx’ plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words “may,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “could,” “would,” and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx’ actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading “Risk Factors” in IntelGenx’ annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.
Each of the TSX Venture Exchange and OTCQX has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Source: IntelGenx Technologies Corp.
(514) 331-7440 ext 232
Andre Godin, CPA, CA
President and CFO
(514) 331-7440 ext 203