Here's what's in store for us.
Forfivo™ - indicated for Major Depressive Disorder
Forfivo™ (Bupropion extended-release) is a new product opportunity formulated using VersaTab™, IntelGenx’ proprietary controlled release tablet technology. Bupropion is approved by the FDA up to 450 mg for the treatment of major depressive disorder but was, until now, only available in 150 mg and 300 mg tablets. Forfivo™ completes the dosing options for physicians who currently prescribe multiples of lower strengths to provide patients with 450 mg of bupropion in a single tablet. Forfivo™ was developed to decrease the risk of dosing errors, improve patient compliance and therefore efficacy. Forfivo™ extended-release of bupropion blunts peak plasma concentrations compared to the instant release formulations, which should decrease the risk of seizures. Forfivo™ was approved by the FDA in 2011 and is currently licensed and marketed in the US through a partnership with Edgemont Pharmaceuticals LLC. IntelGenx is currently looking for a partnership or alliance opportunity to commercialize Forfivo™ in markets other than the US.
Rizatriptan film – indicated for Migraine
IntelGenx’ rizatriptan film is a new product opportunity co-developed in partnership with RedHill Biopharma (“RedHill”) and formulated using VersaFilm™, IntelGenx’ proprietary thin film technology. Rizatriptan is a selective 5-HT1B/1D receptor agonist indicated for the treatment of migraine. Compared to other triptan-based medications, rizatriptan demonstrates the highest efficacy and exhibits the shortest Tmax providing a quick onset of action for migraine sufferers. Rizatriptan is also indicated for the treatment of migraine attacks in children and elderly who could both benefit from the ease of administration of the film formulation. The rizatriptan film demonstrated bioequivalence in a successful pivotal clinical trial compared to the reference listed drug Maxalt MLT®. IntelGenx submitted a 505(b)(2) New Drug Application for regulatory approval to the U.S. Food and Drug Administration in Q1 2013. According to Merck's most recent annual report, sales of Maxalt® were $638 million in 2012. IntelGenx and RedHill are currently looking for a partnership or alliance opportunity to commercialize the rizatriptan film.
Tadalafil film – indicated for Erectile Dysfunction
IntelGenx’ tadalafil film is a new product opportunity formulated using VersaFilm™, IntelGenx’ proprietary thin film technology. Tadalafil is one of the three major PDE5 inhibitors in the erectile dysfunction market. Compared with the competitors, tadalafil shows longer duration of action and less food effect. IntelGenx’ tadalafil film offers an improved discrete dosage form that does not require water intake. IntelGenx tadalafil film formulations have been tested in various clinical trials to improve the pharmacokinetics and optimize the formulation. The latest formulation is planned to be tested in a pilot study in Q4 2012. IntelGenx is currently looking for a partnership or alliance opportunity to complete development and commercialize the tadalafil film.
INT0028 – indicated for Neuropathic Pain Management
INT0028 is a new product opportunity formulated using AdVersa™, IntelGenx’ proprietary muco-adhesive tablet technology. INT0028 is an improved product containing dronabinol (THC) for the symptomatic management of neuropathic pain. Marinol® is currently approved as an antiemetic but the analgesic properties of its active ingredient, dronabinol, is vastly recognized. When compared with Marinol® in a pilot clinical trial, INT0028 doubled the bioavailability of the active dronabinol while decreasing the plasma levels of the unwanted psychoactive metabolites. Therefore, INT0028 is designed to increase efficacy, avoid undesired psychotropic side effects, reduce degradation and decrease metabolisation compared with currently marketed formulations of dronabinol. INT0028 is formulated using patented and patent pending technology. IntelGenx is currently looking for a partnership or alliance opportunity to complete development and commercialize INT0028.
Animal health products
VetaFilm is designed to facilitate the administration of medication and promote compliance and the acceptability of medication regimes. VetaFilm has the potential to replace invasive administration procedures, improve animal compliance and avoid the tendency of animals to spit medications. VetaFilm is formulated to rapidly hydrate upon contact with the tongue and cannot be spat out due to its adhesive formulation. VetaFilm administration does not require water or chewing and offers enticing flavour options and appealing scents for increased acceptability. We are currently combining our VetaFilm technology with various active ingredients but remain interested in partnerships or alliances opportunities to complete development and commercialization of animal health products based on VetaFilm technology.
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