There’s been a lot of news lately about major pharmaceutical company’s pipelines getting very thin. Patents are expiring for some major drugs, most notably, Lipitor, Pfizer’s multi-billion dollar a year drug and one of the greatest selling drugs of all time. Big pharma has never been known for strength in developing new compounds, but rather in scouring the smaller biotechs for promising drug candidates and acquiring them in an attempt to secure prosperous years to come. In the next several years, as pipelines continue to wear thin, mergers and acquisitions within the biotechnology industry very well could be the talk of the market and there are several junior biotechs that are vying for prime positions.
Ville St-Laurent (Quebec), Canada-based IntelGenx Corporation is a unique drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract and has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. With an ever-growing pipeline, the Company is also developing products for multiple indications including for the treatment of severe depression, osteoarthritis, hypertension, erectile dysfunction and pain management. IntelGenx has already successfully demonstrated bioequivalence in humans with two different thin film products, which is positioning the company as an industry leader with its products.
Today, a significant milestone was announced for IntelGenx as the completion of a pilot study indicated that the Company has successfully developed a novel oral film, INT0022, which is bioequivalent to a leading branded anti-psychotic; bumping the Company’s total of successful studies demonstrating bioequivalence to three. INT0022 has been developed using IntelGenx’ proprietary immediate release “VersaFilm” drug delivery technology. If successfully developed, IntelGenx will enter into the global anti-psychotic market which was estimated to be worth $22.5 billion in 2008.
A randomized, two-period, two-way crossover study in healthy male subjects, the study was designed to determine whether INT0022 is bioequivalent to a leading anti-psychotic product as measured by industry standard pharmacokinetic measures, peak plasma concentration (Cmax) and area under the curve (AUC). The study results indicate that INT0022 falls within the range of bioequivalency for both Cmax and AUC and allow IntelGenx to advance the product to the pivotal bioequivalency study.
While this company is flying under the radar of the investment community at this point, as shown in the under $18 million market cap, IntelGenx may start to see some recognition from larger pharmas in the future. As with any novel compound or drug delivery system, it’s a long road to fruition, but substantial rewards can be achieved. Proper due diligence on this junior biotech is encouraged.
More information on IntelGenx and its pipeline can be found on the Company’s website at www.intelgenx.com