IntelGenx (OTCQX:IGXT; TSX-V:IGX) has signed a binding term sheet to license Eli Lilly's tadalafil dosing patent. Any exclusivity associated with the tadalafil compound patent is not affected by the agreement.
Subject to FDA approval, the license allows IntelGenx to commercialize its Tadalafil ED VersaFilm product in the U.S. prior to the expiration of the '166 dosing patent.
The license terminates all current tadalafil-related litigation activities for IntelGenx and IntelGenx will be actively seeking a partner for the commercialization of Tadalafil ED VersaFilm.
IntelGenx has developed a proprietary process and formulation for manufacturing the Tadalafil ED VersaFilm product and plans to manufacture the product for markets around the world.
The latest formulation successfully demonstrated bioequivalence to Cialis tablet in a pilot study. Cialis is a registered trademark of Eli Lilly. With the license in hand, IntelGenx may now target launch readiness ahead of Cialis’ patent expiry. Tadalafil VersaFilm has the potential to be the first generic competitor to the Cialis tablet and the only film delivery product of the blockbuster ED drug.
IntelGenx plans to file a Tadalafil VersaFilm 505(b)(2) NDA with the FDA in the second quarter of 2017 and if approved, expects a U.S. launch of the ED product in the second quarter of 2018.
"Securing the license with Lilly is a significant achievement for IntelGenx,” president and CEO, Horst Zerbe, said in a statement. “It will substantially alleviate any legal concern regarding the launch of our Tadalafil VersaFilm product ahead of the expiry of the '166 dosing patent," he added.
Dr. Zerbe said the license also opens IntelGenx to the lucrative U.S. ED market and accelerates its partnering of and commercialization of Tadalafil VersaFilm.