Replies to post #238839 on Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

It could be Pfizer's legal strategy vs Elite

I do find it very bizarre that Troxyca has not launched yet.

There are a zillion possible reasons for a TRoxyca launch delay, but it could be legal strategy. Elite and Pfizer are going to battle it out in court. Pfizer will sue as soon as Elite files an application for either morphine or oxycodone with antagonist naltrexone. Both of Pfizer's NDA's are covered by the same patent (8,685,443). Their patent is for a "subunit" to sequester naltrexone while Elite's patents cover a separate naltrexone bead. In my opinion, Pfizer would rather fight Elite on the Embeda battleground than on Troxyca battleground, for several reasons.

First, Embeda has no remaining FDA exclusivity, while Troxyca has FDA exclusivity until Aug 19, 2019. Elite cannot market anything using Troxyca as RLD until at least then, but with application approval Elite could market generic Embeda immediately. Generic Troxyca is already tied up for 2&1/2 years by FDA, and Pfizer would be happy to tie up Embeda for a few years in court.

Not sure if any of that matters, but the other thing is that Troxyca has 1 listed patent with FDA while Embeda has 9 listed patents. Pfizer may feel more comfortable with that position. For whatever reason, it may be that Pfizer wants to force Elite's hand and will hold Troxyca until they see Elite's morphine ER application. Further, Nasrat may be doing a little head-fake. I'm not fully convinced there isn't going to be a surprise 505b2 NDA in our future instead of a string of ANDA's.

My 2 cents...






Embeda:
http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=022321&Appl_type=N

Troxyca:
http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=207621&Appl_type=N

[mrwrn2010]

As do I.

[lasers]

As I have posted many times, Purdue/Pfizer technology for both Embeda and Troxyca is hot melt extrusion to fuse together (1) the polymer encased Naltrexone antagonist and (2) the ER polymer encased Agonist, (Morphine, Oxycodone, etc.)

Just as Commercial Embeda could not be made stable it is now looming big nor can Commercial Troxyca be made stable.

The high tmperature and high pressure in the barrel of the extruder, needed for fusion does serious wall damage to the polymers encased opioids so that the resulting drug is unstable and will have serious life threatening dose-dumping problems in the patient's body fluids.

The exact reason why Embeda was withdrawn for 4 years. The more Naltrexone quantity ratio to be extruded and the higher temperature and pressure results which thereby cause even more polymers wall damages.

This is the exact reason that Purdue never went Commercial with their technology. Purdue owns the Embeda technology and not Pfizer/Alpharma/King which were sued successfully for Patent Infringement.

"Just as Commercial Embeda could not be made stable it is now looming big nor can Commercial Troxyca be made stable." Hence the "Russian Roulette" risk every time one took the drug.

$ELTP SequestOx technology is very simple, low temperature, low pressure tech so that every capsule of the two-bead drug is stable every time.