KemPharm’s strategy is to employ its LAT® (Ligand Activated Therapy) technology to discover and develop prodrugs that are new molecules that can improve one or more of the attributes of approved drugs, such as susceptibility to abuse, bioavailability and safety. Elegant in design and utilization, the LAT® technology has been proven effective for over a decade in numerous clinical and preclinical trials.
We employ our LAT® (Ligand Activated Therapy) technology to improve the attributes of approved drugs. The ligands we typically use have been demonstrated to be safe in toxicological studies or have been granted Generally Recognized as Safe (GRAS) status by the FDA.
When prodrugs are administered, targeted human metabolic processes, such as those in the GI tract, separate the ligand from the prodrug and release the parent drug, which can then exert its therapeutic effect. KemPharm’s ability to discover the unique parent drug-ligand chemical combination differentiates our prodrugs from other drug products on the market. Fundamentally we create new molecules that can impart key advantages, enabling the creation of potentially safer, more effective and therefore differentiated products.
Since our founding, KemPharm® has employed its LAT® technology to create a portfolio of product candidates that we believe will offer significant improvements over FDA-approved and widely prescribed drugs.
LAT® Value Proposition
From our founding in 2006, KemPharm® has been and continues to be a prodrug discovery company focused on building a portfolio of prodrugs that represent an improvement over currently approved drugs and address unmet medical needs in large, established markets.
Our LAT® prodrug discovery technology seeks to improve the properties of existing drugs by identifying pharmaceuticals that address a large patient population where conversion to a prodrug could enable better treatment outcomes, alleviate unwanted or unintended side-effects or enhance the marketability of the drug.
Prodrugs offer an attractive risk-reward profile in that prodrugs can both improve the performance of the parent drug and offer a developmental time horizon that is vastly shorter than a traditional new chemical entity. Moreover, because prodrugs are considered new molecular entities they may be eligible for patent protection as novel compositions of matter, provided that all other applicable requirements are met.
KemPharm’s internal focus is on developing prodrugs in the ADHD/attention deficit disorder, central nervous system disorders, and pain management spaces. However, any area where gaps in treatment combined with patent expirations offers an opportunity for prodrug technologies to improve drug performance and capture market share.
Improved drug properties. KemPharm® seeks to develop prodrugs that are new molecules with potentially improved attributes over FDA-approved drugs, such as enhanced bioavailability, extended duration of action, increased safety, and reduced susceptibility to abuse.
Composition-of-matter patent protection. Composition-of-matter patent protection. KemPharm’s prodrugs are new molecules and thus 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 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® technology allows the company to develop prodrugs that may be eligible to use the 505(b)(2) NDA pathway. Under that regulatory pathway, if KemPharm is 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.