IntelGenx partner, Insud Pharma, submits ANDA for generic buccal product


IntelGenx’s (TSXV:IGX; OTCQX:IGXT) partner, Insud Pharma (formerly Chemo Group), submitted an abbreviated new drug application (ANDA) with the FDA for a generic buccal film product.

“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,” Dr. Horst Zerbe, IntelGenx’s president and CEO, said in a statement.

Under the accord, 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 after the product is approved.

Closely-held Insud Pharma’s is a global pharmaceutical company, with more than 6,000 professionals in more than 40 countries.

Sydney Stewart