Industry Update: the Latest Developments in Therapeutic Delivery

Abstract

The present industry update covers the period 6–15 January 2012, with information sourced from company press releases, regulatory and patent agencies, as well as the scientific literature. Despite the preceding holiday break, a number of new announcements were made and there is an ever-increasing desire to formulate molecules with difficult properties, such as complex small molecules, macromolecules and biologics in particular, for product life cycle management where reformulations are a proven strategy and novel drug–device combinations are applied; Kedem with Gleevec® and ForesightVision4 with Lucentis® are recent examples. For many conventional pharmaceutical therapies, the efficacy may be improved and the side effects reduced if the therapy is administered continuously (although potentially variable rate), rather than through conventional burst-release techniques. BioDelivery Sciences with polymer film technology and Abbott’s drug-eluting bioresorbable therapy Esprit™ are proof points for this trend. Additional drivers include the desire to eliminate or minimize the danger of needlestick injuries, increase patient compliance by simplified or reduced stigma delivery methods and reduced health care costs. The mirconeedle or needle-free approaches of Clearside Biomedical, Bioject and the development of nanoparticle-based formulations – ‘smart’ nanoparticles – structures used in drug- or gene-delivery systems show progress from various research laboratories. Finally, multiple clinical trials as conducted by Alnylam and partners were reported and increase confidence in the formulation of novel siRNA drugs.