IntelGenX reports on thin film market rollout, patent
IntelGenX Corp. (TSXV: IGX | OTCQX: IGXT) reported progress on the rollout of its oral film drug delivery system, which is emerging as a significant core business line supported by a $6 million state-of-the-art manufacturing line.
IntelGenx Corp. and RedHill Biopharma Ltd. announced a binding term sheet agreement with Grupo Juste S.A.Q.F for the commercialization of RIZAPORT™, a unique oral thin film for the treatment of acute migraines. The agreement pertains to sales and marketing in Spain. A definitive agreement is expected to be in place within 45 days from now.
The financial terms of the agreement were not disclosed but Grupo Juste is a prominent private Spanish enterprise with over 90 years of experience in the research, development and commercialization of proprietary pharmaceutical products, including migraine and other central nervous system (CNS) drugs, in Europe, Latin America and other jurisdictions.
IntelGenX new business line is based on its proprietary VersaFilm™ technology, which permits to register specific delivery systems for already approved drugs.
For example, IntelGenX U.S. formulation patent covering RIZAPORT™ has been issued by the U.S. Patent and Trademark Office (USPTO) on April 5, 2016 under patent number 9,301,948 and will be valid until 2034.
The patent is summarized as follows:
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An instantly wettable and rapidly disintegrating oral film dosage form without a surfactant and without a polyalcohol was achieved by combining at least one water soluble polymer that is not a copolymer of vinylpyrrolidone, at least one active agent, a copolymer of vinylpyrrolidone and titanium dioxide. In certain embodiments, the film comprises hydroxypropyl cellulose or a combination of hydroxypropyl cellulose and a polymer or copolymer of vinylpyrrolidone or a substituted vinylpyrrolidone as the water soluble polymer(s). A plasticizer, and optional additives selected from synthetic sweeteners, natural sweeteners, flavorants, antioxidants, colorants, and opacifiers, can be added to the disclosed film oral dosage forms.
In other words, it is a thin film that is pleasant tasting that dissolves in the mouth to deliver drugs.
RIZAPORT™ is the first rizatriptan oral disintegrating film for the treatment of migraine to achieve EU marketing approval. RIZAPORT™ is a new product opportunity co-developed in partnership with RedHill Biopharma and formulated using VersaFilm™, IntelGenx’s proprietary thin film technology.
A 5-HT1 receptor agonist and the active drug in Merck & Co.’s Maxalt®, RIZAPORT™ 5mg and 10mg was approved for marketing in Germany in October 2015, under the European Decentralized Procedure. A New Drug Application for RIZAPORT™ was also filed with the U.S. FDA in 2013 and a CRL was received in 2014.
Rizatriptan is considered one of the most effective oral triptans, a class of molecules that constricts blood vessels in the brain to relieve swelling and other migraine symptoms.
The worldwide annual sales of triptans were estimated to have exceeded $870 million in 2014.
RIZAPORT™ is based on IntelGenx’s proprietary “VersaFilm™” technology. It dissolves rapidly and releases its active ingredient in the mouth, leading to efficient absorption of the drug through the gastrointestinal tract.
The administration method of the RIZAPORT™ oral thin film, which does not require the patient to swallow a pill or consume water, along with its pleasant flavor, presents a potentially attractive therapeutic alternative for many migraine patients, including those who suffer from migraine-related nausea, estimated to be approximately 80% of the total migraine patient population.
Dr. Luc C. Duchesne is a Speaker and Author with a PhD in Biochemistry. With three decades of scientific and business experience, he has published ... <Read more about Dr. Luc Duchesne>