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