Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Maz, this has nothing to do with SequestOx

I guess, what I'm saying is it appears these results could be potentially used to address the CRL for SOx and given the positive results (which the Tmax was certainly measured), and thereby pave the way for a quicker approval than previously thought. The dots seem to connect; two birds, one stone. I don't like feeling this optimistic on speculative plays, but it certainly seems to fit what would be needed. Jeez, that would be a real coup, or am I missing something?

The pivotal study revealed this week is for OxyContin, which is different from SequestOx in every way, other than oxycodone. OxyContin is 12HR ER hard-shell tablet, and SequestOx is IR antagonist ADF capsule. The pharmacokinetics are vastly different, and nothing at all can be inferred about SequestOx from this study.

It just seemed to be out of left field. Elite Pharma from the moment of inception was meant to commercialize the antagonist ADF. We have a pipeline of antagonist ADF drug candidates that are in every stage of development- with their progress only restrained by a limited R&D budget. So what in the world would make an antagonist ADF company start making batches of hardshell tablets? It takes substantial resources to develop a product to the point of finishing a pivotal study, including making commercial batches. Why? Why now? Where did he get the recipe? I said earlier I suspected it came from Epic, and maybe even Elite helped with the engineering. Could also be the Actavis' recipe, but I STRONGLY DOUBT it was developed in house from scratch. Somebody provided Nasrat with the recipe for a highly-lucrative compound. Why?

When has anyone ever read a PR about a bioequivalence study that reported when the study was initiated? I've never seen it, and it stuck out at me. Why would he include the fact that it was started in November?

So just as you said, Maz, connect the dots; two birds, one stone. November 14 is when Epic (PuraCap) put the final nail in the Purdue patent litigation when the Supreme Court refused to hear the case. If there was a pre-existing agreement between Elite & PuraCap, it was November 14th when both parties would have known that things need to start moving forward. According to the PR, Elite had already done a pilot study (presumably with the Epic formula).
When they got word from PuraCap in November, they knocked out the pivotal study and here is where they killed 2 birds with one stone. They collected the data they need for their own ANDA application later this year, and they also proved to PuraCap that they are ready to start pumping out commercial batches of generic OxyContin as soon as the Epic ANDA gets Full Approval.

What is confusing to many people is the difference between patent protection and FDA marketing exclusivity. Even though Purdue has lost all of the patent litigation so far, they still have marketing exclusivity from FDA until August 2018. The current 3 year exclusivity period is due to Pediatric indication that was added on in August 2015. Nothing will be approved by the FDA that uses OxyContin as RLD until the marketing exclusivity has expired. But there is an important exception to Pediatric Exclusivity, as demonstarted by Collegium Xtampza. The Hatch-Waxman Act specifically disallows Pediatric Exclusivity to be applied against an applicant who challenged a patent in court and won. That is the only reason Xtampza was approved prior to August 2018. But the same rule also applies to the handful of companies that beat Purdue in court over ANDA apps. Those few companies are now expecting their generic OxyContin ANDAs will be approved soon, and only those few companies will have the opportunity to participate in the generic OxyContin market until August 2018.

The exciting part, if any of this is remotely true, is that substantial ELTP revenue from generic OxyContin is not 3 years away but more like 3 months away. This week's PR shows that Elite is ready, and all it will take is the word GO and a flip of a switch.


OXYCONTIN = $3 BILLION/YR
Generics could cut it down by half... $1.5 BILLION
Give half to brand-names... $750,000,000

That leaves 3-5 generic competitors to split $1+ billion dollars over 18 months and possibly starting very soon. FDA repeatedly has said they want more generic ADFs. We're about to find out if they really mean it.