IntelGenx Corp., an innovator in pharmaceutical films, 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.