The Building Blocks of Our Success
We are focused on pursuing a cost-effective, capital-efficient approach to drug development. Historically, developing pharmaceutical products has been considered an expensive and time-consuming process. We believe that our proprietary technology platform shall permit us to advance multiple candidates into clinical bioequivalence studies and through regulatory approval via the 505(b)(2) pathway, without the need for extensive efficacy studies. We focus our product development efforts on existing, well-known products that are sub-optimally formulated and that have a history of manufacturing difficulties, which our approach is specifically designed to solve. Our next-generation formulations are true solutions, without the need for high-energy manufacturing processes or complex machinery, and are intended to influence usage and appeal to cost-conscious hospital purchasing managers as well as end-user medical professionals who want easier-to-use, safer and more practical versions of widely-used sterile injectable drugs.
Intellectual Property: A Dual-Layer Approach
Our patent estate consists primarily of technology platform patents. Included are four issued U.S. patents covering the principles underlying our reformulation technology, and multiple pending applications that focus on additional aspects of our approach as well as the particular formulations we use for specific products. As such, therefore, there is a dual layer of defense: the technology platform patents, which protect our approach to reformulating sterile injectable drugs, and product-specific formulation patents, which are designed to, as applicable, enhance the market value of our pipeline candidates.
We aim to continue to expand our patent portfolio by filing for patent protection on new developments with respect to our product candidates without infringing upon any existing patents covering the branded reference products that we seek to optimize with our proprietary technology. None of the products that we are developing remain under composition-of-matter protection, providing us with freedom to operate. Patents expire 20 years from the date of filing.
Robust, Broad-Ranging Product Portfolio
We currently possess a pipeline of dozens distinct drug candidates based on existing active pharmaceutical ingredients (APIs) that are sub-optimally formulated in their currently-marketed forms. In addition, we estimate that our proprietary technology platform is applicable to the reformulation of as many as 50 products currently on the market in the U.S. and elsewhere.
A full GLP animal toxicity study (rodent and non-rodent) and pharmacology safety study of the selected sugar-lipid for intravenous applications have been successfully completed which enable the company expending its product pipeline and a filed DMF (drug master file) is under the US FDA review. We aim to forward integrate on the basis of the first product approvals we receive in the United States and market our own products with a focused, highly specialized hospital-facing sales force. Outside the U.S., we aim to establish selective partnerships with entities possessing extensive territory-specific expertise in order to develop and commercialize our products. These partnerships may be on a contract, technology licensing or product-specific basis.