The BMO Kit (BioMimetic Oxidation Kit) enables scientists to synthesize milligram quantities of metabolites within their own lab in days.
The Importance of Metabolites in Drug Development:
In 2008, the FDA, emphasizing the importance of metabolite toxicity testing in the drug development process, released guidance for drug metabolite safety testing (MIST). Indeed, drug toxicity, which accounts for roughly 40% of clinical drug failures, is a leading cause of the high drug attrition rates that have contributed to the skyrocketing drug development costs witnessed over the past few decades.
Traditionally, drug metabolites have been both difficult and hugely expensive to synthesize. Conventional methods of metabolite synthesis, such as those that employ the use of microsomes or synthetic chemistry, are extremely costly and time consuming. Consequently, drugmakers often choose to forgo metabolite synthesis, and subsequent metabolite toxicity testing, early on in the drug development process, opting instead to wait until lead compounds are further along in development before carrying out these essential functions. This decision, perceived to be a calculated risk, ultimately comes at huge price, as drug makers lose millions each year on investments in lead drug candidates that eventually turn out to be failures due to toxicity.
Through our revolutionary technology which enables inexpensive and rapid metabolite synthesis, HepatoChem is seeking to transform the way drug companies develop their pipeline. Instead of forgoing what was previously un-economical early metabolite production, drugmakers can now, through our exclusive BMO Kit, quickly and easily produce cost effective testable quantities of metabolites in-house even at the earliest stages of drug discovery. This new capability, which enables affordable early metabolite toxicity testing, offers drug companies the opportunity to save millions each year through dramatically improved drug pipelines.
Early metabolite identification and knowledge can potentially be hugely beneficial when it comes to IP protection. Through early understanding of lead drug metabolites, drugmakers possess the knowledge to determine whether metabolites, merit IP protection. In such cases, metabolite IP provides additional protection of related marketed drugs. Several well known cases in which a drug company failed to file IP on a drug metabolite that ultimately proved more active than its parent compound serve to illustrate this point. In such cases, the metabolite of the lead compound ended up becoming a blockbuster pharmaceutical, but was marketed by a competitor of the parent compound owner. The use of HepatoChem’s exclusive BMO Kit will help drugmakers avoid this fate and further increase the quality of their drug pipelines.
Implicit in the early metabolite synthesis enabled through our BMO kit are the rapidly expedited processes of metabolite identification, quantification, stability and profiling. By employing our technology, the scientist will make redundant the highly expensive and time-consuming conventional synthetic methods used to access metabolites. Quick access to substantial quantities of the metabolite affords cost savings over extensive MS/MS and LC/NMR studies necessary for metabolite structural identification from biological matrices. Given that the conventional methods currently used for metabolite identification can cost thousands in labor and require huge capital investments, the implied savings enabled through our exclusive technology are enormous. With substantial quantities of the metabolite accessible, extensive metabolite stability, activity and biological profiling studies are attainable. More metabolism data in hand earlier in the drug development process leads to more informed decisions. In addition to these immediate cost savings, the use of our BMO Kit provides an improved drug pipeline quality, further reducing costs throughout the drug development process.
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Examples of Metabolite Synthesis
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While microsomes have proven valuable as a predictive tool, their productive capabilities are limited. Biomimetic Chemistry, on the other hand, possesses the advantages of both chemistry and biology and is thus a much more efficient tool for metabolite synthesis.
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