IntelGenx (OTCQX:IGXT; TSX-V:IGX) has multiple milestones on tap this year with its oral film drug delivery platform, VersaFilm, as it continues building strategic partnerships in the pharmaceutical industry.
“Achieving these milestones will mean that later this year or in early 2018, we will for the first time do commercial manufacturing, validating a strategic decision several years ago to move beyond R&D and become a full service company,” Horst Zerbe, chairman, president and CEO, says in an interview with BioTuesdays.
Dr. Zerbe says another extremely important event this year will be proof-of-concept results for its Montelukast VersaFilm to treat and possibly reverse moderate Alzheimer’s disease. IntelGenx is repurposing montelukast, which is currently approved for asthma.
“This could be a transformational event, making 2017 a critically important year for us,” he adds.
Dr. Zerbe explains that oral thin film delivery has the potential to reduce side effects, improve bioavailability and achieve faster onset of action. Oral films also can be used for lifecycle management of existing drugs and to repurpose existing drugs for new indications.
“We have partnered most of our product pipeline, which is an indication that we have earned the trust of our partners and increased our credibility in the pharmaceutical industry,” he adds.
IntelGenx’s partners include U.S.-based Par Pharmaceutical, Endo Pharmaceuticals of Ireland and the U.S., Chemo Group of Spain and RedHill Biopharma of Israel.
The company has granted Chemo Group an exclusive worldwide license to commercialize two generic tablets and a U.S. license for two other generic oral films. The companies are in discussions for a deal for a fifth product.
IntelGenx’s most advanced VersaFilm product is Rizaport for migraines, which received European marketing approval in November 2015.
Dr. Zerbe says the strategic partnership with Chemo gives IntelGenx upfront milestones, R&D revenues and a share of profits from future sales. To-date, payments from Chemo exceed $1-million. The combined market of the four products tops $7-billion.
“Chemo Group has chosen IntelGenx as its primary source of new and innovative products,” he adds. “This relationship has the potential for numerous future product agreements.”
IntelGenx completed construction in the first quarter last year of a state-of-the-art oral film development, manufacturing and packaging plant in Montreal. The 17,000-square-foot facility will be fully operational in the current quarter and Dr. Zerbe says work on an expansion is already underway.
“Besides lowering costs and quality controls, the plant will de-risk any investment in new products and offers our partners one-stop shopping,” he adds.
IntelGenx’s most advanced VersaFilm product is Rizaport for migraines, which is partnered with RedHill Biopharma and received European marketing approval in November 2015. RedHill is funding the development program and the companies share net revenues.
“Rizaport validates our film technology but we have several other products in the pipeline with a much greater market potential,” Dr. Zerbe suggests, pointing to tadalafil for erectile dysfunction and montelukast for CNS disorders.
In 2016, IntelGenx and RedHill signed distribution agreements for Rizaport with Grupo Juste for Spain, including a first right of refusal for ten Latin American countries, and with Pharmatronic for distribution in South Korea. Discussions are continuing with additional commercial partners.
Dr. Zerbe says IntelGenx and RedHill plan to resubmit Rizaport for U.S. marketing approval in the first half this year, with an expected U.S. launch most likely in the first quarter of 2018.
Last November, IntelGenx obtained a license to Eli Lilly’s tadalafil dosing patent, the active molecule in Lilly’s erectile dysfunction drug, Cialis. “This offers us a free and clear path to partnering and launching Tadalafil VersaFilm, without patent litigation,” he adds. Cialis’ substance patent expires in November this year.
IntelGenx previously demonstrated the bioequivalence of its tadalafil oral film, compared with the Cialis tablet. Dr. Zerbe explains that orally disintegrating films, without the need for water, provide unprecedented patient convenience and a discrete dosing alternative.
The company has successfully completed a Phase 1 study with Montelukast VersaFilm and seen remarkable anecdotal evidence that a patient with a diagnosis of moderate-to-severe dementia Could return to mild dementia after two months of treatment.
The company plans to file a 505(b)(2) NDA submission for Tadalafil VersaFilm with the FDA in the second quarter this year, with an expected U.S. approval in the second quarter of 2018.
In its program for schizophrenia and bipolar 1 disorder, IntelGenx is developing a fast-acting loxapine oral film dosage to treat acute agitation in non-institutionalized patients.
Dr. Zerbe explains that Loxapine VersaFilm is designed to replace an existing inhalation device, which must be taken under supervision of a physician. “Our film product does not need physician supervision and has the potential to reduce the risk of pulmonary problems,” he adds. “This is a good example of how a film can provide a significant therapeutic benefit and ease of use for patients.”
A Phase 1 study with Loxapine VersaFilm has confirmed its fast onset of action. The company is optimizing the existing formulation, with results expected in the third quarter this year.
In moderate Alzheimer’s disease, Dr. Zerbe says the company has successfully completed a Phase 1 study with Montelukast VersaFilm and seen remarkable anecdotal evidence that a patient with a diagnosis of moderate-to-severe dementia achieved a return to mild dementia after two months of treatment.
“When treatment was discontinued, the patient returned to a state of moderate-to-severe dementia and when treatment was restored, the patient improved again,” he adds.
Dr. Zerbe points out that there is no approved treatment that has the potential to reverse the effects of dementia-related diseases and at best, existing treatments only slow down disease progression.
The Phase 1 study also demonstrated significantly increased bioavailability after administration of Montelukast VersaFilm, compared with the commercial tablet, and that the drug also crosses the blood/brain barrier when given as a film. “These findings were very important,” he adds.
IntelGenx plans to begin a Phase 2a proof-of-concept study in the current quarter, with first efficacy data available in the first quarter of 2018.