IntelGenx Corp., a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems, has received a No Objection Letter (NOL) from Health Canada for the commencement of a pivotal clinical trial to be conducted with IntelGenx' proprietary VersaFilm oral thin film technology for the rapid relief of migraine.
IntelGenx filed a Clinical Trial Application (CTA) with Health Canada and received the NOL for a phase 1 study, the objective of which is to determine if IntelGenx' product is safe and bioequivalent with the FDA approved reference product. In the pivotal study, bioequivalence will be determined by pharmacokinetic parameters measuring maximum or "peak" concentration (Cmax) of the drug observed after its administration, and the Area Under the Curve (AUC),
IntelGenx is developing its VersaFilm anti-migraine product in accordance with the co-development and commercialisation agreement with RedHill Biopharma Ltd. (RedHill), an Israeli corporation, which was executed in August of 2010.
"With the NOL from Health Canada now in place, we plan to initiate and complete the pivotal bioequivalence study for the anti-migraine film in 2012," commented Dr. Horst Zerbe, President and CEO of IntelGenx. "With the recent FDA approval of our anti-depressant Forfivo (CPI-300) and expectations of consummating a commercial license agreement for this product early in the New Year, our clinical focus turns towards thin films, where the anti-migraine product is the most advanced of our 6 VersaFilm products in development."
In addition, and further to IntelGenx' announcement on June 14, 2011 regarding the execution of a term-sheet with RedHill for the acquisition of rights from IntelGenx for an anti-psychotic VersaFilm product, both parties have mutually agreed to terminate the term sheet and not pursue a detailed agreement. Neither party will be required to pay the other any amount on account of the termination of the term sheet. As a result, IntelGenx has re-acquired full rights to the anti-psychotic product and looks forward to working on its future development.