IntelGenX Technologies Corp

account_balanceDiversified Industries

  About Us
IntelGenx is a leading oral drug delivery company focused on the development and manufacturing of innovative pharmaceutical oral films based on its proprietary VersaFilmTM technology platform. Established in 2003, the Montreal-based company is listed on the TSX-V and OTC-QX.
Website

http://www.intelgenx.com/

http://www.intelgenx.com/

Headquarters

6420 Abrams Ville Saint-Laurent, Quebec H4S 1Y2

Public Issuance

1999

Shares Outstanding

Corporate Filings

SEDAR

Stock Symbol

IGX:CA

location_on6420 Abrams Ville Saint-Laurent, Quebec H4S 1Y2
 3 Reasons to invest
  1. Montelukast VersaFilm™ is a unique drug opportunity for the treatment of neurodegenerative diseases of the brain, such as mild cognitive impairment, Alzheimer’s disease and dementia. IntelGenx is working to repurpose Montelukast as a therapeutic to treat neurodegenerative diseases by re-formulating the drug using VersaFilm™, IntelGenx’ proprietary thin film technology.
  2. INT0007 is a tadalafil film is a new product opportunity formulated using VersaFilm™, IntelGenx’s 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.
  3. Rizaport® is the first rizatriptan oral disintegrating film for the treatment of migraine to achieve E.U. marketing approval. Rizaport® is a new product opportunity formulated using VersaFilm™, IntelGenx proprietary oral 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.

If you are interested in investing in us, please join management, shareholders and other interested investors in our Investor Group. We want to ensure all investors are well informed and have access to important investor information.

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Rizaport (Rizatriptan)












INDICATED FOR MIGRAINE
Rizaport® is the first rizatriptan oral disintegrating film for the treatment of migraine to achieve E.U. marketing approval. Rizaport® is a new product opportunity formulated using VersaFilm™, IntelGenx proprietary oral 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.

The administration method of the Rizaport® oral soluble film, which does not require the patient to swallow a pill or consume water, along with its neutral flavor, presents a potentially attractive therapeutic alternative for migraine patients, specifically for patients who suffer from migraine-related nausea, estimated to be approximately 80% of the total migraine patient population and patients suffering from dysphagia (difficulty swallowing)1. 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 Rizaport® film formulation.

Rizaport® demonstrated bioequivalence in a successful pivotal clinical trial compared to the reference listed drug Maxalt-MLT® (Merck & Co.). IntelGenx submitted a 505(b)(2) New Drug Application for regulatory approval to the U.S. Food and Drug Administration in Q1 2013. In addition, in November 2015, the German Federal Institute for Drugs and Medical Devices (BfArM) has granted national marketing approval for Rizaport® for the treatment of acute migraines under the European Decentralized Procedure (DCP).

According to Merck’s annual report, sales of Maxalt® were $638 million in 2012. Global migraine sales are expected to grow to $8.7 billion by 2026, at a Compound Annual Growth Rate (CAGR) of 10.3%2. Commercialization agreements for Rizaport® were signed with Grupo JUSTE S.A.Q.F (now Exeltis Healthcare, S.L.) for Spain and Pharmatronic Co. for South Korea.
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Tadalafil 








INDICATED FOR ERECTILE DYSFUNCTION
INT0007 is a tadalafil film is a new product opportunity formulated using VersaFilm™, IntelGenx’s 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’s 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 successfully demonstrated bioequivalence to Cialis® tablet in a pilot study. Tadalafil film’s development program targets launch readiness ahead of Cialis® patent expiry, which could lead to tadalafil VersaFilm™ being the first competitor to Cialis® tablets. IntelGenx is currently looking for a partnership or alliance opportunity to complete development and commercialize tadalafil VersaFilmTM.
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Loxapine








INDICATED FOR SCHIZOPHRENIA & BIPOLAR 1 DISORDER

Loxapine VersaFilm™ is the first innovative oral thin film of loxapine for use in patients with agitation associated with schizophrenia and bipolar 1 disorder. Loxapine VersaFilm™ utilizes IntelGenx' proprietary VersaFilm™ technology, allowing for an improved drug product which addresses unmet medicals needs in schizophrenia and bipolar 1 disorder.

Agitation associated with schizophrenia or bipolar mania can, if left untreated, rapidly escalate into physically aggressive behavior that can be potentially dangerous to the agitated individual and others. In a clinical setting agitation associated with schizophrenia and bipolar mania are often managed with loxapine, a well-known antipsychotic medication.

Loxapine is currently available in two dosage forms: (1) An inhaled version of vaporized loxapine for direct administration to the lungs, approved by the U.S. Food and Drug Administration in 2012, is indicated for the treatment of acute agitation associated with schizophrenia or bipolar 1 disorder in adults. The inhaled loxapine powder is associated with potentially life-threatening bronchospasms, limiting its administration in the U.S. to clinical settings associated with a Risk Evaluation and Mitigation Strategy (REMS) program. Under such program, the inhaled loxapine must be administered only in an enrolled healthcare facility, and to patients that have been pre-screened to ensure they are not susceptible to pulmonary issues. (2) An oral dosage form of loxapine is available since 1975 and indicated for the treatment of schizophrenia. The loxapine capsules are unsuitable for treating acute agitation associated with schizophrenia or bipolar 1 disorder because the delayed onset of relief, which occurs approximately 20-30 minutes after administration, would significantly increase the risk of injury to a person being treated and those administering treatment.

IntelGenx has demonstrated in a successful pilot study that buccal absorption of the drug using loxapine VersaFilm™ results in a significantly higher bioavailability compared to oral capsules. Additionally, orally disintegrating film, without need for water, packaged in a carry-on-the-go pocket size pouch provides unprecedented convenience for patients suffering from agitation

IntelGenx has already submitted a U.S. patent application for an oral film dosage form containing loxapine for the treatment of anxiety and aggression in patients suffering from schizophrenia or bipolar 1 disorder, potentially offering 20 years intellectual property protection.

Sales of schizophrenia drugs across the major markets were estimated at $5.2 billion in 2012 and by 2021, the market is forecast to grow to $6.9 billion.1

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Montelukast








FOR TREATMENT OF DEGENERATIVE DISEASES OF THE BRAIN
Montelukast VersaFilm™ is a unique drug opportunity for the treatment of neurodegenerative diseases of the brain, such as mild cognitive impairment, Alzheimer’s disease and dementia.

IntelGenx is working to repurpose Montelukast as a therapeutic to treat neurodegenerative diseases by re-formulating the drug using VersaFilm™, IntelGenx’ proprietary thin film technology.

Currently, Montelukast is marketed as Singulair® (Merck & Co.), a once daily tablet for the chronic treatment of asthma and seasonal allergic rhinitis. The drug was first approved by the U.S. Food and Drug Administration in 1997 and has a very good safety profile. Montelukast is a leukotriene receptor antagonist used for the maintenance treatment of asthma and to relieve symptoms of seasonal allergies. Montelukast is a CysLT1antagonist; it blocks the action of leukotriene D4 (and secondary ligands LTC4 and LTE4) on the cysteinyl leukotriene receptor CysLT1 in the lungs and bronchial tubes by binding to it. This reduces the bronchoconstriction otherwise caused by the leukotriene and results in less inflammation. 

IntelGenx' proprietary VersaFilm™ technology offers several potential advantages over the tablet form of Montelukast, including the avoidance and minimization of first-pass-effects, improved API bioavailability, lower dosing and toxicity, easier swallowing and better patience compliance.

In a recent Phase I study, IntelGenx demonstrated that an oral film formulation of Montelukast is safe and tolerable in healthy subjects, reduces the first-pass-effect and has a 52% higher bioavailability compared to the regular Montelukast tablet, demonstrating a clear advantage of delivering Montelukast via film. IntelGenx' Montelukast VersaFilm™ also crossed the blood-brain barrier, an essential feature for treating degenerative brain diseases.

IntelGenx is currently preparing for a Phase 2a proof of concept study to assess the safety, feasibility, tolerability, and efficacy of Montelukast VersaFilm™ in patients with mild to moderate Alzheimer's Disease.
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