A-fects™ lipid Technology The proprietary, product-driven A-fects™ lipid technology is based on artificial envelopes created by lipids providing a significant advancement for transmucosal delivery. A-fects™ are a new type of liposomes containing membrane spanning lipids derived from archaebacteria. These new liposomes are superior to conventional liposomes in many respects. As archaebacteria thrive in extreme environments e.g. extremely high or low temperatures, highly acidic or basic milieu, archae-lipids are chemically stable over a much greater range of temperatures and pH conditions compared to conventional lipids. This presents a significant advancement for the delivery of therapeutics, allowing for more varied routes of administration, especially the oral route. Bernina has developed a variety of archae-lipids, uncharged as well as positively or negatively charged, that accomplish the passage through the GI-tract and facilitate the uptake of orally administered peptides. A set of modified lipids mediating target specificity complements the highly variable A-fects™ toolbox. Artificial Envelopes The Artificial Envelope™ delivery technology combines conventional, pharmaceutically accepted - off the shelf - lipid components with the A-fects™ technology to create a new generation of drug delivery systems. Toxicity Extensive toxicity studies have been carried out in vitro and in vivo (rodents). Even with intravenous administration of high doses, no acute toxicity (NOE level 1000 mg/kg), no genotoxicity, no immunotoxicity and no CNS-toxicity was observed. A moderate repeated dose toxicity has been observed at very high i.v. doses (NOE level 100 mg/kg*days). Production process The production process is standardized and reproducible. At this point the preformulation of a new compound/peptide can be accomplished in a matter of weeks allowing for the application of the A-fects™ technology for a variety of new projects. Intellectual Property Status Bernina Plus owns a set of issued patents as well as pending applications that cover the A-fectsTM technology. The IP applies to the use of synthetic lipids as well as lipids derived from nature. The IP-Portfolio comprises 3 granted patents (2 US + 1 DE) and 14 patent applications, covering several variants of lipids, formulations and methods for synthesis and purification of lipids. The portfolio consists of both own and in-licensed property rights. Currently, no licenses for the A-fects™ technology have been granted. home impressum