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Tekterra

06/08/17 5:15 PM

#27690 RE: fred198484 #27688

Thanks Fred, interesting development on the FDA side of things. We have had discussions in the past that FDA will remove those drugs that post a risk to abuse and public health. And, now it begins with ENDO's version. This just means more market shares for the new and improved version like Rexista, or PTIE Remoxy.

Sucks to be Endo but I wonder if what they would do? ENDO now merged with PAR have good relations with IPCI in the past. Between PTIE and IPCI, PTIE have bad track records on FDA approval, but supposedly they have a clear path now after the FDA requiring additional trials. There aren't that many choices out there for Oxycodone with ADF technology. It be interesting to see either PTIE or IPCI gets a deal signed. Still, IPCI is ahead in the race compare to PTIE who is waiting on year end results on the additional trials before filing for the fourth time with the FDA.

I'd say IPCI have better chance here. Recently EGLT ARYMO ER was covered by large payer in the US. All this indicates a favorable trend in embracing ADF technology on opioid pain killers.

It's all on the Purdue trial now, the sooner this ends the sooner we see a partnership. IPCI wanted Rexista as plug and play product, and that isn't happening with the law suite going on.

Samsa

06/08/17 7:34 PM

#27694 RE: fred198484 #27688

Fred.....actually it should be a non event for IPCI. Endo's Opana is an oxymorphone hydrochloride. Rexista is a Oxcodone hydrochloride. I am not a physician but I do not believe Oxymorphine and Oxycodone products are issued for the same types of pain. I may be wrong on this one. if they are not synonymous, then Rexista would not fill the gap left by taking Opana off the market.

as a side note, I think we see Endo challenging that FDA decision. I do not think they ever took original Opana off the market, they just came out with this new version which was to be ADF. I didnt read where they took off the original formula or this order will effect the original formula. In essence the way I read this while they may be forced to take the new version off the market what stops them from re-marketing the old version? It wasn't addressed. I can see this one being a lawyers gold mine LOL

WeeZuhl

06/08/17 8:46 PM

#27695 RE: fred198484 #27688

Sorry Fred, Rexista likely has similar problems




The FDA is removing Endo's opioid Opano ER from the market. It will be interesting to see the reasons and fallout from that for IPCI. It should be positive given Rexista is a solution for Opano's problems, but the market is weird, so you can't be sure.






Since both drugs use PEO as ADF formula, Rexista is much more likely to have the same problems as Opana than to provide a solution. Pesky facts.



AngeloFoca

06/08/17 9:54 PM

#27701 RE: fred198484 #27688

The FDA is removing Endo's opioid Opano ER from the market

Somebody please slide another chair to the negotiating table... for ENDO... please.

All I ask is that there be more than one suitor who "comes a calling" for Rexista... that will guarantee us fair value.