IntelGenx Site Obtains GMP Compliant Rating From Health Canada for Manufacturing and Packaging Activities
SAINT-LAURENT, QUEBEC–(Marketwired – Dec. 18, 2017) - IntelGenx Corp. (TSX VENTURE:IGX)(OTCQX:IGXT) (the “Company” or “IntelGenx”) is pleased to announce that, following a Good Manufacturing Practices (“GMP”) inspection performed by Health Canada, its site has obtained an amended Drug Establishment License (“DEL”) for manufacturing activities. The Company successfully achieved a GMP compliant rating, allowing the site to conduct licensable commercial manufacturing and packaging activities of finished dosage forms.
The Health Canada GMP audit included a thorough review of the existing quality management systems, supplier management, controls of raw materials, documentation, equipment, processes and engineering. No critical deficiencies preventing a GMP Compliant rating were identified. IntelGenx intends to respond with a plan to address Health Canada’s initial inspection observations within the next 30 days.
“Health Canada’s amended DEL represents a major achievement for our Company and, as it was the last milestone before we could initiate manufacturing at our new state-of-the-art facility,” said Dr. Horst G. Zerbe, President and CEO of IntelGenx. “It also marks a key step towards the commercialization of our products. For example, the amended DEL will support applications to transfer the manufacturing of RIZAPORT®, our proprietary oral thin-film formulation of rizatriptan for the treatment of acute migraines, from Europe to IntelGenx’ site.”
Established in 2003, IntelGenx is a leading oral drug delivery company primarily focused on the development and manufacturing of innovative pharmaceutical oral films based on its proprietary VersaFilm™ technology platform.
IntelGenx’ highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’ state-of-the-art manufacturing facility, established for the VersaFilm™ technology platform, supports lab-scale to pilot and commercial-scale production, offering full service capabilities to its clients. More information about the company can be found at www.intelgenx.com.
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 and 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.
Source: IntelGenx Technologies Corp.
(514) 331-7440 ext 232
Andre Godin, CPA, CA
Executive Vice-President and CFO
(514) 331-7440 ext 203