IntelGenx Partner Insud Pharma Submits ANDA for Co-Developed Generic Buccal Film Product
SAINT LAURENT, Quebec, Oct. 04, 2018 (GLOBE NEWSWIRE) — IntelGenx Corp. (IGX.V) (IGXT) (the “Company” or “IntelGenx”) today announced that an Abbreviated New Drug Application (“ANDA”) for a generic buccal film product has been submitted to the U.S. Food and Drug Administration (“FDA”) by its partner, Insud Pharma (formerly Chemo Group).
“The filing of an ANDA for this product, one of several products being co-developed in a partnership between IntelGenx and Insud Pharma, marks the achievement of a major milestone and serves to help demonstrate the strength of our collaboration,” commented Dr. Horst Zerbe, IntelGenx’s President and CEO.
Under the terms of the agreement with Insud Pharma, Insud Pharma has obtained certain exclusive rights to market and sell the IntelGenx generic buccal film product (which comprises a novel formulation based on IntelGenx’s VersaFilm™ technology) in exchange for upfront and milestone payments, together with a share of the profits of commercialization once the product is authorised.
About Insud Pharma:
With more than 40 years of experience, Insud Pharma (before Chemo Group) has become an established, global group in the pharmaceutical industry, with continuous growth and diversification.
Insud Pharma operates across the entire pharmaceutical value chain, delivering specialized expertise in scientific research, development, manufacturing, sales and marketing of a wide range of value-adding APIs, finished dosage forms (FDFs) and branded pharmaceuticals, for human and animal health.
While the main offices are located in Spain, Switzerland and Argentina, Insud Pharma has a truly global footprint and has built a broad and balanced manufacturing and commercial network across Europe, North and South America, Asia and Africa, to address global opportunities and customers’ needs in all major pharmaceutical markets.
Insud Pharma’s activity is organized in three synergistic business areas: Industrial, Branded and Biotech, with over 6,000 professionals in more than 40 countries, 17 state-of-the-art facilities, more than 15 specialized R&D centers and more than 40 pharmaceutical affiliates, serving 1,150 customers in 96 countries around the world.
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’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s 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.
Forward Looking Statements:
This document may contain forward-looking information about IntelGenx’s 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’s 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’s 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’s 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 at 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. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Source: IntelGenx Technologies Corp.