Rick,
I will tried. In several steps. With best of my capacity (which is limited, but so far did give good results).
MZ-winner doesn't come overnight. If at all. Example are TTP, NBIX, CELG,..it took more than two years for each. Maybe will never come here. So far REGN is at three years dormant stage. However, I believe that message will go through and I hope wake-up call will materialize.
For the beginning few thought on “Yancopoulos Institute for Basic Research” and FDA licensed bio-manufacturing facility.
I believe that real break through new drug will not come without deep and complete understanding of the basic science and *life secret*. Several new bio-drug (Enbrel, Herceptin, Rituxan,..) actually were ahead of underlain science at some point, but science did quickly ketch-up and explained why are this drug so effective. Going forward (and as discussed at MLNM and elsewhere at SI and now recognized among pharmas and bts) not only target validation but also identifying and selecting the best point/target in complex cascade of the disease pathology is the only way and *blind* without help from basic research. Otherwise we will return to *trial and error* approach.
So, Yancopoulos/REGN work on basic science is a right choice, imo. Yes, long one and without (for now) real results (Axokine still have a chance to be first one). However, Yan was the only one who openly criticize Folkman & Com (read ENMD) work on anti-angiogenesis as (in the most part) a crap-shot. I believe that he will be able to prove this. Otherwise he would not put his scientific reputation on stake.
Counting manuscripts in top scientific journals REGN is on top of list. Knowledge is *priceless*, and there is no substitution. Luck can help intermediary, but long term....????
Short comment on recent news about bio-manufacturing FDA compliance. So far among bt only big shot (CHIR, AMGN, BGEN, CNTO, IMNX, GNE..) were able to build independently manufacturing facility for bio-products. For all other bt this is the last step, and usually results in delay, incompetence, unresolved FDA issue and ultimately delay/failure, or.... Results are known.
REGN is now ahead of his own drug-development cycle. Having this facility on place and operational they did: 1. separate themselves from any future contract manufacturing dependence and uncertainty, 2. build franchise business unit which can generate (with minimal investment in expansion) ~$50-100 MM annually and with very good margin, 3. leverage business plan and reduced forward risk, 4. will keep significant portion of the drug revenue (if and when they reach market) in house, 5. significantly reduce BLA preparation and review time by FDA (when it come to that point), ....
People who directly deal with this FDA issue can describe much better than I did importance of having their own facility ready for bio-drug production and marketing. Not to mentioned that BGEN, NDA, AMGN are investing >$100 MM each in their own new manufacturing facility. One have to ask why?
Also, I have to mention that REGN did build and upgrade this business unit with significant finical help from MRK. One point for successful business approach where own knowledge and experience are combine with others money.
More on REGN drugs pipeline and pharma business plan in following posts.
Miljenko
PS: It isn't succinctly description. :(
I may sound like preach, but few lurks may got interested and trigger their own DD.
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