And I was tasked to create a process that would cleave some unwanted isomers from the small molecule...they were a bi-product of the fermentation process....so I was aware more than ten years ago of the drug potential since we were conducting preliminary CMC studies to see how profitable the marker would be. Then, we got sidetracked with Prozac and Lunesta and the rest is history... I always wondered who would pick up the slack on the SM and paten away from the art SP had in place, and Bazinga fiv came forth,,,one is right hereunder your nose! RNN. You see 3117 acts as an an enzyme antagonist and it binds to cells with abnormal telomeres,,,just lock and key stuff,,,the cells membrane permeation causes little disuation since it is small molecule. It is very effective and will be effective until a cell mutation moots its efficiency which may or may never happen. INO seems to be on target to fix that problem though with a slam duck force the cell membrane open via electron channeling. I digress, but wait, can you just imagine electroporation in combination with small molecules? WOW! it would be like issuing mini neutron bombs. Anyway, the product is a winner. Many corps were in the race to make the same molecule and most lost out. I believe Millenium sold the right to a few patents, but Rexahn already beat them to it so they looked to other markets. As for Teva. They made a business decision which is to focus on one particular therapy area. Most corps are going that route now, so even a slam dunk winner long term may not be a valid portfolio product based on corporate recognition. I mean could you just imagine Fresenius purchasing an oncology product? Doesn't make sense...so Teva did the right thing and if Sanofi or Roche or Merck pick this one up,,,see yah! Light out !!!! fast track all the way.
Also, please realize that the patent filing in Europe for Archexin is a clever move that many many biotech holding companies have on their radar. You see, in the EEU the clinical evaluation process is much quicker, so long s it can be proven out with explanation in anomolies, adverse events, insufficient populations, or mix-ups in controls and standards...i have also seen botched IQ, PQ and OQ of equipment used in studies in the US set back corps months if not years due to idiot validation processes. Not in the EEU. They allow recreations and proven processes in lieu of re-creating the wheel. They also have a serious waiver process at clinical sites which allows more participants. Difficult to sue on malpractice tort there... I mean, I can go on and on...but you see the EEU is a back door for quicker entry of any medical device r pharma product in the US. So, they just need all that compilation of proven data, perhaps a follow up fast tier clinical (months) study for a peer review validation and you have a back door entry process which cuts down the US FDA process by 60% on average. How do I know this? I do it all the time for my company. US Agency's, I hate to say are more effed up than you think. One more thing, at the FDA regional office which I have been too, No microwave ovens are allowed to reheat lunch food! Want to know the reason ? Conclusive evidence by corporate data and agency data that many foods are carcinogenic because of the free radicals that microwaves create. Did you know that a 1 pound microwaved slab of salmon creates enough hexane to combust a 4 cylinder engine for two cycles? Now is hexane good for your body? NO!!! Yet the FDA doesn't go Jihad on GE and the rst of these pimping corps...Me? I will not heat anything in a microwave now, perhaps on occasion, but not everyday. Interesting stuff going on under our noses folks!