- IntelGenx Technologies (TSXV:IGX) is implementing new strategies, after the US FDA rejected its Rizaport VersaFilm drug application a second time
- The company is now actively pursuing the drug’s distribution in Spain to improve revenue
- Furthermore, IntelGenx is developing a cannabis-infused version of the VersaFilm technology, with its partner company Tilray
- Due to the FDA’s decision and COVID-19, the company has implemented cost-saving measures, including laying off 10 per cent of employees
- IntelGenx Technologies (IGX) is up 4.76 per cent, with shares trading at C$0.22 and a market cap of $24.26 million
IntelGenx Technologies (TSXV:IGX) has been forced to change strategies, after the FDA failed to approve the company’s new drug application.
Last week, the US Food and Drug Administration issued a response letter to IntelGenx. The letter described the FDA’s issues with the company’s Rizaport Versafilm drug.
The drug uses IntelGenx’s patented drug delivery technology, which dissolves on the tongue, quickly administering migraine medication to the patient.
This is the second time that the FDA has failed to approve the drug, creating many challenges for IntelGenx.
IntelGenx’s CEO, Dr. Horst G. Zerbe, outlined the challenges facing the company in the coming months.
“The decision by the FDA to issue a CRL for our RIZAPORT NDA significantly reduces our internal revenue expectations for 2020.
“Additionally, the current COVID-19 crisis and its potential effect on the capital markets may make it more difficult to secure additional capital and the long-term financial stability of the company,” he said.
As a result, IntelGenz has outlined a number of initiatives moving forward, to help navigate the unforeseen challenges facing it.
To this end, the company is overhauling its team, with all projects now being led directly by Dr Zerbe. IntelGenx is also laying off around 10 per cent of its staff, to help retain liquidity.
As for the VersaFilm project, the company is now accelerating the drug’s launch in Spain, to help sure up revenue outside of the US.
Furthermore, IntelGenx is pursuing applications for VersaFilm that do not require FDA approval. These applications include a cannabis-infused version, which the company is developing with Tilray.
Dr Zerbe stated that the company is still working closely with the FDA, and has requested a meeting to evaluate the next steps for Rizaport VersaFilm.
IntelGenx Technologies (IGX) is up 4.76 per cent, with shares trading for C$0.22 at 9:34am EST.