IntelGenx Technologies Corp (IGXT)

[TheRagman]

IntelGenx: innovative technologies to reshape drug delivery

10:59 am by Fiona MacDonald

The company’s plans include the reintroduction of existing drug compounds as branded products, tailored specifically to drug release profiles and targeting specific absorption sites.
The company’s plans include the reintroduction of existing drug compounds as branded products, tailored specifically to drug release profiles and targeting specific absorption sites.

Unlike most pharmaceutical companies, Montreal-based IntelGenx (CVE:IGX) (OTCQX:IGXT) has no plans to develop new drugs, concentrating its efforts instead on using its three proprietary enhanced drug delivery technologies to develop new therapeutic entities (NTEs).

The company’s business strategy, says president and CEO Rajiv Khosla, is to use these three innovative controlled-release drug delivery platforms in conjunction with existing drug compounds for NTEs that have a meaningful benefit for patients and their caregivers.

In office since the start of this year, Khosla, himself a Ph.D. in pharmaceutical science, points towards the ability of the three drug delivery technologies to “unlock the full therapeutic potential of a drug”. With this in mind, the company’s plans include the reintroduction of existing drug compounds as branded products, tailored specifically to drug release profiles and targeting specific absorption sites.

The three technology platforms themselves, which can be developed with various drug release profiles, including fast, constant, slow and continuous release, are designed with the challenges sometimes presented by oral drug delivery in mind.

Of these platforms, the company’s multilayer tablet technology, VersaTab™, is a species of controlled-release tablet, with the ability to carry a high drug loading and from which the active components are released over an extended period of time, thus allowing for a decrease in dosing frequency-- a boon in cases where patient compliance might be at issue.

The second of IntelGenx's platforms, the Mucoadhesive tablet AdVersa™, is similarly geared towards slow and/or extended release, with its delivery system dependent on the AdVersa™ tablet adhering to the patient's gum or cheek. This means of administration makes it a good fit for cases in which drug permeability is high and fast absorption is required, for example, in cases where the dosage is formulated for rapid dissolution, thereby increasing the rate of drug adsorption.

“Some drugs are unstable in the gastro-intestinal environment,” says Khosla, “so the Mucoadhesive tablet allows us to deliver drugs into the body without them having to go through the stomach or GI tract.”

Thus, this means of drug delivery is especially useful in cases where the drug is directly irritating to the GI tract mucosa, where the drug can undergo a high metabolic first pass effect, or in instances in which the active ingredient is either expensive or poorly soluble.

An increase in the time the medicine is in place can also adjust the system to achieve a predetermined drug release pattern allowing for customization of the process. The other features of the technology are its suitability in cases where immediate or rapid release is required, or where high patient compliance --“always a problem the more pills are involved”, says the CEO -- is an issue of particular concern.

Perhaps most intriguing is the Oral Film technology, VersaFilm™, a film designed for placement on or under the tongue, to be dissolved subsequently.

It is this technology that Khosla points to as being of primary interest, saying the “focus of the company is to become the leader in pharmaceutical film strips.”

Despite a thickness of 10-50 microns, the product is capable of up to 50mg drug loading, with disintegration time from 30 seconds to 10 minutes and an onset time ranging from 15 minutes to a matter of hours. The benefits of this method include adjustable onset of action and discrete administration of doses.

Especially suitable for the delivery of a variety of drugs, the platform also turns up trumps on the convenience front, measuring 2-8 cm sq, (making for handy unit-dose packaging) and requiring no water, meaning its ease of administration is a perfect fit for pediatrics or geriatrics.

The ideal drug candidate for the film strip platform would be something that “requires rapid onset”, says Khosla, possibly a drug that would otherwise have to be injected or perhaps administered nasally, neither of which are popular with patients.

From here, the company is looking to partner with the right partner for strategic development and distribution, with current tie-ups including DAVA Pharmaceuticals, Inc, Edgemont Pharmaceuticals, LLC, Par Pharmaceutical, Inc, and RedHill Biopharma Ltd.

The American market provides fertile ground for IntelGenx as the nature of the regulatory protocols in place “encourages what we're trying to do,” says Khosla.

As the use of existing drugs leads to “a more contained” set of tests than those usually anticipated by pharma developers, “the pathway develops quite rapidly,” says Khosla. “It gives us a much reduced development risk profile.”

With the American market its main target also by virtue of its size, IntelGenx is mindful of the fact that the platform has to add a therapeutic benefit to the product beyond patient convenience, a factor insurance companies are unwilling to pay for.

This imperative is addressed in the Forfivo XL® product approved by the U.S. Food and Drug Administration in 2011, which is currently licensed and marketed in the U.S. through a partnership with Edgemont Pharmaceuticals LLC.

Forfivo XL®, indicated for Major Depressive Disorder, is Bupropion formulated using VersaTab™, meaning that the dose – heretofore available only in 150mg and 300mg tablets – can now be delivered in the 450mg doses approved by the FDA in a single tablet.

Khosla points out that the product was developed to decrease the risk of dosing errors and improve patient compliance and thus efficacy. It also potentially decreases the risk of seizures.

Beyond that, the company's pipeline is replete with products – among them the Rizatriptan film, which is indicated for migraines and formulated using VersaFilm™, co-developed in partnership with RedHill Biopharma.

Rizatriptan, which provides a quick onset of action for migraine sufferers, is prescribed for the treatment of children and the elderly, two audiences likely to benefit from the ease of administration of the film formulation. The VersaFilm™ rizatriptan product was submitted for regulatory approval to the U.S. Food and Drug Administration in 2013.

Also formulated using VersaFilm™ is tadalafil film, indicated for erectile dysfunction, in a discrete dosage form that does not require water intake. The most recent formulation is being finalized for testing in a forthcoming pilot study.

IntelGenx’s shares have risen nearly 67% since the beginning of the year. Its stock has a 52-week trading range of 45 cents to C$1.32.
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