tag:blogger.com,1999:blog-36634196.post3348494443235296330..comments2023-10-09T11:33:37.853-05:00Comments on The IN VIVO Blog: DotW: Open Your MindChris Morrisonhttp://www.blogger.com/profile/04075266444951558159noreply@blogger.comBlogger1125tag:blogger.com,1999:blog-36634196.post-60023337875875583192009-06-05T17:17:26.557-05:002009-06-05T17:17:26.557-05:00Relative to GSK/Concert Deal there will have to be...Relative to GSK/Concert Deal there will have to be a new definition of "Me-too" drugs that are so oft criticized as any D-analog would be the ultimate illustration with current classification moved down several levels. These compounds are a bit like someone wearing the same clothes everyday except changing underwear and socks: Might not be able to see any differences unless the socks clash. <br /><br />I do not understand the business model on these. As NCEs they will require full Clinical Trials and NDA submission (although most the chemistry/supply chain probably only tweaked). By the time they get approved will probably be competing with Generics so unless big advantages in safety/efficacy what is the market potential? <br /><br />Frankly as a Chemist the fact they can get solid Patent coverage is astonishing to me. Replacement of H-atom with D-atom would seem obvious to sophomores in Org Chem, as would expectation of some differences in metabolism and perhaps other safety profile (good and bad possibilities). If significant enough to be useful there might be room to Patent as an "improvement" but a core Composition of Matter claim is a stretch. (Tung is technically incorrect as some physical characteristics will be different, such as NMR, IR and MW, although these typically do not have clinical meaning since are applicable for analysis purposes).<br /><br />CMCguyAnonymousnoreply@blogger.com