KemPharm believes that its LAT platform technology offers the following potential benefits:
- Improved drug properties. KemPharm seeks to develop NME prodrugs with improved attributes over FDA-approved drugs, such as reduced susceptibility to abuse, enhanced bioavailability and increased safety. For example, the molecular structure of KP201/IR is resistant to tampering and deters abuse.
- Composition-of-matter patent protection. KemPharm’s prodrugs combine an FDA-approved parent drug with one or more ligands to create NMEs and may be eligible for patent protection as novel compositions of matter, provided that all other applicable requirements are met. Our strategy is to seek patent protection not only for our NME prodrug product candidates, but also for related compounds with the intention of creating heightened barriers to market entry.
- 505(b)(2) NDA pathway. KemPharm’s LAT platform technology allows the company to develop NME prodrugs that may be eligible to use the 505(b)(2) NDA pathway. Under that regulatory pathway, if we are able to demonstrate the bioequivalence of one of its product candidates to an appropriate approved drug, we will then be able to reference the FDA's previous findings of safety and effectiveness for the approved drug in our 505(b)(2) NDA submissions. This may allow us to avoid the significant time and expense of conducting large clinical trials and eliminate the need for some preclinical activities.