• Multilayer tablet technology, VersaTab™, which allows for the development of oral controlled release products;
• Oral film technology, VersaFilm™, for the immediate delivery of pharmaceutically active substances to the oral cavity for oral or gastro-intestinal absorption; and
• Mucoadhesive technology, AdVersa™, for quick or controlled release to control drug delivery absorption kinetics/rates.
The company has established partnerships with DAVA Pharmaceuticals, Edgemont Pharmaceuticals, Par Pharmaceutical, and RedHill Biopharma, and is also in discussions with several other potential partners for various products.
Because IGTX is developing enhanced formulations of currently marketed therapies, the company has a vantage point over many traditional pharmaceutical and biotechnology companies. IGTX’ products generally require fewer clinical trials to achieve efficacy and safety data for regulatory approval, which means the company can accelerate development and sees lower risk for failure than other industry players.
The company’s VersaFilm™ rizatriptan contains a strip of thin polymeric film comprised of components that are already approved by the U.S. FDA for use in food, pharmaceutical, and cosmetic products. Rizatriptan was developed by Merck & Co. available in 5 and 10 mg tablets (Maxalt) and orally disintegrating tablets. IGXT has formulated rizatriptan as an immediate release oral film based on its VersaFilm technology.
The FDA last week accepted for review IGXT’s New Drug Application (NDA) for IGXT’s VersaFilm™ rizatriptan, which the company believes is the first oral film product for the treatment of migraine for which a 505(b)(2) NDA has been submitted to the FDA. The review is expected to be completed in the first half of 2014.
From a financial standpoint, the company in the first quarter of 2013 marked improvements across the board. Revenue of $0.2 million consisted of $0.1 million of royalty income and $0.1 million of deferred license revenue, both related to Forfivo XL™. Revenue in the first quarter of 2012 was $0.1 million.
The company decreased its total expenses to $0.6 million from $0.7 million in the first quarter of the year prior as clinical study costs incurred in the first quarter of 2012 were not repeated in the first quarter of 2013.
IGXT trimmed its net loss in the first quarter 2013 to $0.05 million from $0.6 million in the first quarter the year prior, maintaining a loss per share of $0.01.
The company expects to be cash flow positive and profitable at the operational level throughout 2013, and as of March 31, 2013, had cash of $2.2 million vs. cash of $2.1 million as of December 31, 2012.
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