Sancilio & Company, Inc., founded in 2005, has the goal to become a leading integrated specialty pharmaceutical company through continued execution and implementation of the following strategies:
- Develop differentiated products by applying our Advanced Lipid Technologies™ (ALT™) platform to FDA-approved active ingredients for approved and new indications. We have several product candidates formulated using ALT™ under development that target a broad range of unmet medical needs in the therapeutic areas of lipid disorders, cardiovascular disease, hematology disorders and orphan diseases, including product candidates that relate to formulations of omega-3 essential fatty acids, omega-6 essential fatty acids and fat-soluble micronutrients, which are lipid and lipophilic compounds. We also utilize our proprietary ALT™ in connection with formulation development for some of our contract development customers in the hormone area. We believe the mechanism of ALT™ makes it potentially applicable to expansion into other therapeutic categories.
- Utilize the FDA’s 505(b)(2) regulatory pathway and the Orphan Drug Act, as applicable, to continue to advance, benefit from, and commercialize our product candidates.
- Leverage our vertically integrated infrastructure to drive profitability. Our management and scientific personnel have significant expertise in formulation development, packaging and clinical study services as well as manufacturing, particularly related to soft gelatin encapsulation manufacturing methods.
- Evaluate internal and external business development opportunities to accelerate and maximize the potential of our product candidates worldwide. We will continue to identify new product candidates that lie within or complement our therapeutic areas of focus through acquisition, in-licensing or co-promotion. We do not intend to build a large sales force focused on marketing to primary care physicians and instead plan to rely on outlicensing or co-promotions for the marketing of those products that have broad commercial application, while retaining commercial rights to product candidates that can be distributed using a small, focused sales force.
Our main focus is on the development of novel therapies for application in the emerging field of lipidomics. Lipidomics is the science related to the structure, function, interaction and movements of cellular lipids and their relationship to diseases. Lipid dysfunction and lipid disorders are linked to a number of diseases and we believe that, based upon available studies, currently available treatments of lipid disorders and their related diseases result in inconsistent absorption of the drug’s Active Pharmaceutical Ingredient (API) and thereby exhibit poor efficacy. We believe that the APIs of our product candidates, formulated using ALT™, will be more bioavailable than current therapies and will have the potential to improve efficacy and lower effective doses. We believe our formulations will potentially improve patient compliance associated with existing therapies because they may result in less frequent dosing than required by those drugs to be effective, eliminate any food effects that may inhibit the absorption of the drug compound, and reduce certain side effects.