We are a fully integrated specialty pharmaceutical company, engaged in the research, development, manufacturing & commercialization of pharmaceutical product candidates that utilize our proprietary Ad...
We are a fully integrated specialty pharmaceutical company, engaged in the research, development, manufacturing & commercialization of pharmaceutical product candidates that utilize our proprietary Advanced Lipid Technologiesâ„¢, (ALT). ALT is designed to enhance the bioavailabiliy of lipid & lipophilic active pharmaceutical ingredients, or APIs. We have 6 pharmaceutical product candidates in our pipeline that are under development. We also purchased 4 approved Abbreviated New Drug Applications, or ANDAs, that are awaiting approval by the FDA, for a manufacturing site change to our facility. In addition, we provide third party pharmaceutical companies with licenses to our technologies. We are assisting third parties in the development of ANDAs & 505(b)(2) New Drug Applications, or NDAs. Whether for our own portfolio or for third parties, the product candidates contain APIs that consist of substances already approved by the FDA for similar indications or for substances generally regarded as safe. Our main focus is on the development of novel therapies for application in the emerging field of lipidomics. 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 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.