Nov 17 2009
IntelGenx Corp. (TSX VENTURE:IGX)(OTCBB:IGXT) ("IntelGenx") is pleased to announce the results of a clinical pilot study that suggests IntelGenx has successfully developed a product that is bioequivalent to a leading branded anti-migraine therapy. The product (INT008) has been developed using IntelGenx's proprietary immediate release film "VersaFilm" drug delivery technology. VersaFilm provides a patent-protected method of formulating in a convenient and discrete dosage form.
"The achievement of bioequivalence in this pilot study puts IntelGenx at the forefront of immediate release film development, as we believe this to be the first successful human study of an anti-migraine film," commented Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "The data and the lessons learned from this initial bioequivalence study will be valuable in our development of other film medicines, most notably our erectile dysfunction film which is another priority product we are currently working on."
With the completion of the pilot study, scale-up and manufacturing of the pivotal INT008 batches will now commence. It is anticipated that the pivotal bioequivalence study will be conducted in early 2010 and the Company will endeavor to file the NDA in the fourth quarter of the same year.
Dr. Zerbe added, "We believe that film delivery offers a discreet and convenient alternative to other oral delivery systems, which should also improve patient compliance. These attributes should allow INT008 to not only compete against the existing branded anti-migraine product but also other drugs within the anti-migraine segment."
Audited 2008 sales of the branded anti-migraine product in the United States were several hundred million dollars. IntelGenx currently is seeking a development and marketing partner for INT008.
Source IntelGenx Corp.
High diastolic blood pressure linked to increased migraine risk in women