The US company has already identified one prescription drug candidate for the platform technology licensed from MonoSol Rx, a privately held drug-delivery company based in Warren, New Jersey. Adams believes a number of its respiratory products could carve out a niche with the "unique" oral delivery vehicle. The financial terms of the licensing and collaboration agreement with MonoSol Rx were not disclosed, nor were the products involved. MonoSol has granted Adams an exclusive, royalty-bearing, non-transferable licence to use its proprietary thin-film technology to develop and market two or more respiratory products in North America. Adams also has rights of first refusal to develop a limited number of other prescription respiratory products under the agreement. As things stand, it noted, there are no prescription drugs for respiratory disorders employing the thin-film delivery system. MonoSol is responsible for completing the product development work and will be eligible for milestone payments. Adams will handle all aspects of clinical development, regulatory submission and commercial operations. Under a separate product supply agreement, MonoSol will manufacture and supply any finished products resulting from the collaboration. Branded as PharmFilm, MonoSol's Orally Dissolving Films (ODFs) are already used in breath-freshening strips (TheraBreath) and in OTC medicines containing the cough suppressant dextromethorphan HBr and the cough/cold remedy diphenhydramine citrate. The company also has a number of pharmaceutical products in development for the US, European and Asia Pacific markets in various categories including antihistamines, antidiarrhoeals, antiflatulents, anti-emetics, cough/cold products, hypnotics and pain relievers. The PharmaFilm technology offers a convenient, portable, easily administered and pleasant-tasting dosage form that improves patient compliance, MonoSol says. ODFs have been shown to disintegrate faster than existing quick-dissolve technologies, and with less fragility, it claims. High drug loads can be achieved with proprietary taste-masking techniques while "easily" maintaining drug content uniformity. Moreover, ODFs have a number of cost advantages in high-volume production and are particularly amenable to Process Analytical Technologies, MonoSol adds. Other cited benefits include unit-dose packaging and distribution, avoidance of spills (e.g., as a replacement for paediatric suspensions), rapid development and scale-up timelines, and an all-aqueous manufacturing process. Adams Respiratory Therapeutics sees the oral thin-film technology as a "compelling opportunity" for both prescription and OTC medicines. Its ease of use makes it particularly suitable for products aimed at groups with special needs, such as children or the elderly, pointed out spokesperson Janet Barth. She noted that platform technology was a hallmark of the Adams business, exemplified by the 12-hour extended-release formulation of its banner expectorant Mucinex (guaifenesin) and the 12-hour liquid technology licensed last June from Belgium's UCB, in parallel with the acquisition of the cough suppressant Delsym (dextromethorphan polistirex). Moving the first compound incorporating MonoSol's thin-film system into clinical development would "not be a fiscal 2007 event", Barth commented. Nonetheless, she added, the compound involved was a tried and tested respiratory drug, which could help to shorten regulatory timelines.
