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`NEWS
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`CONTACT US
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`(cid:1)
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`FILMS
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`INTELGENX > PRODUCT > FILMS
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`PRODUCT
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`(cid:2) Overview
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`(cid:2) Films
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`(cid:2) Tablets
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`RIZAPORTTM – INDICATED FOR MIGRAINE
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`RizaportTM is the first rizatriptan oral disintegrating film for the treatment of
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`migraine to achieve EU marketing approval. RizaportTM is a new product
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`opportunity co-developed in partnership with RedHill Biopharma and formulated
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`using VersaFilm™, IntelGenx’s proprietary thin film technology. Rizatriptan is a
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`selective 5-HT1B/1D receptor agonist indicated for the treatment of migraine.
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`Compared to other triptan-based medications, rizatriptan demonstrates the
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`highest efficacy and exhibits the shortest Tmax providing a quick onset of action
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`for migraine sufferers. Rizatriptan is also indicated for the treatment of migraine
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`attacks in children and elderly who could both benefit from the ease of
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`administration of the film formulation. RizaportTM demonstrated bioequivalence
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`in a successful pivotal clinical trial compared to the reference listed drug Maxalt
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`MLT®. IntelGenx submitted a 505(b)(2) New Drug Application for regulatory
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`approval to the U.S. Food and Drug Administration in Q1 2013. In addition, in
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`November 2015, the German Federal Institute for Drugs and Medical Devices
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`(BfArM) has granted national marketing approval for RizaportTM for the
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`treatment of acute migraines under the European Decentralized Procedure
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`(DCP). According to Merck’s annual report, sales of Maxalt® were $638 million in
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`2012. IntelGenx and RedHill are currently looking for a partnership or alliance
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`opportunity to commercialize RizaportTM.
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`INDICATED FOR OPIOID DEPENDENCE
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`An ANDA for an oral film product indicated for the treatment of opioid
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`dependence was submitted in July 2013. The ANDA was filed by IntelGenx's U.S.
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`based co-development and commercialization partner for this product, Par
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`Pharmaceutical. According to IMS data, the oral film market for opioid
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`dependence was worth more than $1.4B US in 2014.
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`TADALAFIL FILM – INDICATED FOR ERECTILE DYSFUNCTION
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`INT0007 is a tadalafil film is a new product opportunity formulated using
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`VersaFilm™, IntelGenx’s proprietary thin film technology. Tadalafil is one of the
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`three major PDE5 inhibitors in the erectile dysfunction market. Compared with
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`the competitors, tadalafil shows longer duration of action and less food effect.
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`IntelGenx’s tadalafil film offers an improved discrete dosage form that does not
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`require water intake. IntelGenx tadalafil film formulations have been tested in
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`various clinical trials to
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`improve the pharmacokinetics and optimize the
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`formulation. The latest formulation successfully demonstrated bioequivalence to
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`Cialis® tablet in a pilot study. Tadalafil film’s development program targets launch
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`readiness ahead of Cialis® patent expiry, which could lead to tadalafil VersaFilm™
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`being the first competitor to Cialis® tablets. IntelGenx is currently looking for a
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`partnership or alliance opportunity to complete development and commercialize
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`tadalafil VersaFilmTM.
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`LOXAPINE FILM – INDICATED FOR SCHIZOPHRENIA
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`Loxapine is for the treatment of anxiety and aggression in patients suffering
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`from schizophrenia or bipolar 1 disorder.
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`Loxapine oral film will utilize the company's proprietary VersaFilm™ technology,
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`allowing for an improved product to offer patients significant therapeutic
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`benefits compared to existing medications. A fast acting loxapine oral film
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`dosage form that can be used to effectively treat acute agitation associated with
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`schizophrenia or bipolar 1 disorder in non-institutionalized patients while
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`reducing the risk of pulmonary problems is needed as it could substantially
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`reduce the potential risks of violence and injury to patients and others by
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`preventing or reducing the duration and severity of an episode of acute agitation.
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`IntelGenx has demonstrated in a successful pilot study that buccal absorption of
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`the drug from the loxapine oral film results in a significantly higher bioavailability
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`of the drug compared to oral tablets. IntelGenx is currently optimizing the film to
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`further improve time to reach peak plasma concentrations. According to
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`Datamonitor, sales of schizophrenia drugs across the seven major markets (the
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`US, Japan, France, Germany, Italy, Spain, and the UK) were estimated at $5.2
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`billion in 2012 and by 2021, the market is forecast to grow to $6.9 billion at a
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`compound annual growth rate (CAGR) of 3.3%.
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`Agitation associated with schizophrenia or bipolar mania is not uncommon, and
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`if left untreated can rapidly escalate into physically aggressive behavior that can
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`be potentially dangerous to the agitated individual and others. In a clinical setting
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`agitation associated with schizophrenia and bipolar mania are often effectively
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`managed with behavioral and psychological techniques, with unexpected acute
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`agitation typically being treated with parenterally administered sedatives such as
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`benzodiazepines and/or antipsychotic drugs such as olanzapine and ziprasidone.
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`On December 21, 2012, the U.S. Food and Drug Administration approved a
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`loxapine product formulated into an inhaled powder for direct administration to
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`the lungs and is indicated for the treatment of acute agitation associated with
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`schizophrenia or bipolar 1 disorder in adults. A statistically significant reduction
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`in agitation occurs at 2 hours, and an improvement is achieved at 10 minutes
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`after administration. The onset of a statistically significant reduction in agitation
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`occurs at 5 minutes. However, to mitigate the risk of bronchospasm, inhaled
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`loxapine powder must be administered only in an enrolled healthcare facility,
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`and only to patients that have been pre-screened to ensure they are not
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`susceptible to pulmonary issues.
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`Loxapine oral capsules have been available for the treatment of schizophrenia
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`since about 1988, with the typical dosage being 30-50 mg twice daily. The
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`loxapine capsules are unsuitable for treating acute agitation associated with
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`schizophrenia or bipolar 1 disorder because onset of therapeutic relief occurs
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`approximately 20-30 minutes after administration. Such delayed onset of relief
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`would significantly increase the risk of injury to a person being treated and those
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`administering treatment.
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`INT0036 is indicated for the treatment of schizophrenia and utilizes the
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`company's proprietary VersaFilm™ technology, allowing for an improved product
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`to offer patients significant therapeutic benefits compared
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`to existing
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`medications. IntelGenx has demonstrated in a successful pilot study that buccal
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`absorption of the drug from the INT0036 film product results in a significantly
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`higher bioavailability of the drug compared to oral tablets. According to
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`Datamonitor, sales of schizophrenia drugs across the seven major markets (the
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`US, Japan, France, Germany, Italy, Spain, and the UK) were estimated at $5.2
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`billion in 2012 and by 2021, the market is forecast to grow to $6.9 billion at a
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`compound annual growth rate (CAGR) of 3.3%. IntelGenx is currently looking for
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`a partnership or alliance opportunity
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`to complete development and
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`commercialize INT0036.
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`GENERIC FORMULATION INDICATED FOR PAIN MANAGEMENT
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`INT0039 is a film product to the management of pain based on IntelGenx’s
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`proprietary thin film technology. IntelGenx is currently looking for a partnership
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`or alliance opportunity to complete development and commercialize INT0039.
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`CNS APPLICATION
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`INT0040 is a CNS application indicated for the management of degenerative
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`diseases. IntelGenx proposes the development of a fast onset of action film
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`product for use
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`in degenerative diseases using VersaFilm™,
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`IntelGenx’s
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`proprietary thin film technology. IntelGenx is currently looking for a partnership
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`or alliance opportunity to complete development and commercialize INT0040.
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`ALZHEIMER’S DISEASE
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`INT0043 is a unique repurposing opportunity for the treatment of Alzheimer ’s
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`disease. IntelGenx is developing a film product based on the VersaFilm™
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`proprietary thin film technology and using an already FDA approved drug that
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`has demonstrated potential for the treatment of Alzheimer ’s disease. IntelGenx
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`is currently looking for a partnership or alliance opportunity to complete
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`development and commercialize INT0043.
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`MA NUFA CTURING
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`Overview
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