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pharmaceutical investing

IntelGenx Partner Insud Pharma Submits ANDA for Co-Developed Generic Buccal Film Product

Written by Gabrielle Lakusta
|
Oct. 04, 2018 09:38AM PST

IntelGenx (TSXV: IGX) (OTCQX: IGXT) 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 by its partner, Insud Pharma (formerly Chemo Group). As quoted in the press release: “The filing of an ANDA for this product, one of several products …

IntelGenx (TSXV: IGX) (OTCQX: IGXT) 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 by its partner, Insud Pharma (formerly Chemo Group).

As quoted in the press release:

“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.

Click here to read the full press release.

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