IntelGenx Corp (OTC:IGXT) announced entering into a binding term sheet agreement for the packaging of pharmaceutical oral film products, which its CDMO customer is aiming to commercialize in the United States. The company will package the product at the cGMP manufacturing facility in Montreal.
Dwight Gorham, IntelGenx’s CEO said that besides a fresh revenue stream, this agreement facilitates the ability to expand CDMO business by giving extra services to end-to-end CDMO services clients. Further, it would give services to the U.S. and Canadian markets. Gorham is looking forward to building robust partnerships.
Leading drug delivery company focusing on manufacturing of pharmaceutical firms, IntelGenxhas superior film technologies including DisinteQ™, VersaFilm®, VetaFilm® and transdermal VevaDerm enabling next-generation pharmaceutical products.
IntelGenx Corp announced the completion of patient enrollment in the ongoing Montelukast VersaFilm® Phase 2a clinical trial in patients. This is for patients with mild to moderate Alzheimer’s Disease.
The firm enrolled 52 patients in the study, 18 fewer than earlier planned, in a study design modification that received a No Objection Letter from Health Canada. The letter gave authorization for proceeding with study changes. The company in consultation with statistical consultant, Cogstate Ltd., assessed on adjusting p-value.
Dwight Gorham, IntelGenx’s CEO said that recent advancements in treatments of AD have been impressive but there is little doubt on significant unmet medical needs. Gorham further stated that the COVID-19 pandemic halted the BUENA trial’s recruitment for about 18 months. The company is confident on Health Canada-authorized study design modification enabling to harness of data from some patients to detect the effects of Montelukast VersaFilm. He further stated that the firm is looking on completing the BUENA trial in quarter one of 2024 and report trial results.
GlobalDatahad confirmed that the AD market will reach $13.7 billion in 2030 across eight major markets, which is a compound annual growth rate of 20.0% from $2.2 billion in 2020.
Montelukast is a leukotriene receptor antagonist approved by U.S. Food and Drug Administration in 1997 for treating asthma and seasonal allergic rhinitis.
IntelGenx is working on repurposing Montelukast for treating neurodegenerative diseases through the re-formulation of the drug into anoral film-based product. The firm’s proprietary VersaFilm® technology is suited for special needs.
Montelukast VersaFilm® product provides several distinct advantages over tablets for Parkinson’s Disease and AD patients. This includes minimization and avoidance of
first-pass-effects, improved API bioavailability, ease of administration, lower dosing and toxicity, improved compliance, and better acceptability.IntelGenx’s oral film crossed the blood-brain barrier, an important feature for treating degenerative brain diseases.
IntelGenx’s highly skilled team gives comprehensive pharmaceutical services to pharmaceutical partners, including analytical method development, R&D, clinical monitoring, IP as well as regulatory services. The firm’s state-of-the-art manufacturing facility provides full service by giving lab-scale to pilot- and commercial-scale production.
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