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Couch, I feel better now.
Added 16,000 at .332. Both of my accounts are now back in good order with share counts divisible by 10,000, as is right and proper. My OCD exacerbation is now resolved. Thanks to the MM's for this opportunity to top-off my accounts and resolve my neuropsychiatric dissonance. Ahhhhhhhhhhhhhhhhhh, that's the stuff!
First report of this. Sweet deal, Nasrat.
Nice e-mail N2K.
By so specifically detailing your concerns, you've boxed them in to disclose public info if anything is awry with the Epic SequestOx deal. I'd say you got about as much of an answer as you could rightfully expect. Steady as she goes, keep on keepin' on, "business as usual."
I've always subscribed to the theory that the SequestOx deal was the real value asset in Humanwell Epic acquisition. Just like that they've gotten themselves a foothold in the U.S. opioid market. I'm a strong proponent of the deal, and I believe it is a benefit to Elite to have a more muscular partner in the rollout. I also expect the future milestone payments will not only be prompt and in-full but also will no longer be preceded by the obligatory ELTP share sell-off by Epic Investments. And I'm positively thrilled by the movement to independent directors and away from Epic insiders. Those guys saved our ass, and they will be handsomely rewarded. But I'm glad to have them at arm's length.
Another Nasrat Question: Did You Kill KemPharm?
The FDA is now well-familiar with SequestOx HAL data. Did the excellent performance and impending approval of IR opioid SequestOx contribute to the rejection of IR opioid Apadaz and the demise of KemPharm?
Thanks MJ.
Question: Pfizer's antagonist ADF ALO-02 had less than impressive HAL results with crushed tablets orally ingested. How does Elite's antagonist ADF ELI-201 perform on HAL studies when crushed and orally ingested?
Perfect timing for SequestOx approval.
I would like to personally thank KemPharm and the FDA for the high drama leading into the first ever approval of an immediate-release opioid with Category III ADF label. SequestOx is the flagship proof of concept of the ELTP modular 2 bead pharma ADF technology. Unlike KemPharm's prodrug ADF, SequestOx ADF properties are confirmed in HAL trials: effective, durable, and aversive. Approval of SequestOx is just the beginning...
http://www.fiercebiotech.com/fda-overrides-adcomm-shoots-down-kempharm-s-opioid
I would like a peek at that letter.
Didn't see that one coming. Any thoughts on the outright rejection?
Well that's interesting, Heidi.
Interesting deal for ADF development.
Looks like mostly European (UK) interests developing an ADF for U.S. Market. As of yesterday, SkyePharma is now merged with Vectura, whoever the hell that is. The details are interesting, especially since the claims of their physiochemical barrier technology sound very similar to IPCI’s claims about Rexista. There are no other drugs in development using this technology, and the deal basically sets up a four year development to market timeframe. Based on the data available on the Lucideon website, the technology is already well-developed at this point, but it does not sound like they have even started a specific agonist formulation as of yet, whereas IPCI has announced bioequivalence to OxyContin and claims NDA to be filed in next few months. The basic gist of the deal is US $6 million over 4 years with “single digit share of Skyepharma's royalty revenues from in-market sales of the product,” whatever the hell that means. Lucideon will provide “specialist expertise with its technology” but sounds like the agonist formulation work will be done in-house by SkyePharma/Vectura.
http://www.pharmatimes.com/news/skyepharma_buys_access_to_abuse_deterrent_drug_delivery_tech_1036803
We know it.
Pfizer's Oral Problem.
First is the large volume extraction issue, where oxycodone is selectively extracted with multiple common solvents. This problem is for whole beads and not applicable to ELTP 2 bead tech, which has different polymers and sequesters naltrexone differently (i.e. not buried in the core of oxy). It has been reported in multiple ways that ELI-200 passed this kind of common solvent extraction. Since ALO-02 solvent extraction requires a relatively large amount of fluid, it rules out IV injection but makes for a lovely oxy cocktail.
But there's also this: ALO-02 does surprisingly bad on crushed oral ingestion HAL studies. The following graph shows the data differently than we are used to seeing on the drug-liking curve. (Remember what I said about being suspicious of any ADF without a published drug-liking curve). Here, they take the peak number from the drug liking curve and show it as a bar graph. Below that is a bar graph for "Take Drug Again." It speaks for itself, especially the higher dose.
This is a trick question.
Exactly right.
This must be what Pfizer is talking about?
http://blogs.fda.gov/fdavoice/index.php/2016/02/changing-course-a-new-approach-to-opioid-pain-medication-at-fda/
Teva's Vantrela gets ADF nod from AdComm.
Teva's Vantrela hydrocodone ADF is recommended to get Category III ADF label by AdComm, and rightly so. It looks good on the drug liking curve:
For comparison, see the SequestOx drug-liking curve, which will be the first immediate-release opioid to receive Category III ADF label from the FDA:
Shows Mean Drug Liking on Visual Analog Scale (VAS). Time is on horizontal axis. On the verticle axis, anything above 50 means they liked it, below 50 they disliked it. Notice the expected liking of snorted oxyIR (green). ELI-200 (blue) has ZERO drug liking, indicating an EFFECTIVE ADF. ELI-200 is *disliked* at the outset (blue line falls below the placebos (red & yellow)). This means it is an AVERSIVE ADF. Also, ELI-200 never bumps above the placebo line, indicating it is a DURABLE ADF.
ELTP 2 bead pharma ADF is EFFECTIVE, AVERSIVE, DURABLE, and MODULAR across the entire spectrum of opioid agonists and time-release profiles. Fully-licensable. The Golden Ticket.
N2K, he seems to have a different target...
Zogenix ER Bunionectomy
https://clinicaltrials.gov/ct2/show/NCT02197156?term=Bunionectomy+and+ER&rank=1
This is a Phase 2 trial where each participant received one single dose of drug after surgery. Really, you should just take my word for it at this point. There will be no true ER/LA opioid Phase 3 efficacy study for moderate-severe chronic pain that uses an acute pain bunionectomy trial.
Xartemis XR = 7.5mg hydrocodone
It may be "XR" (12 hour release), but Xartemis XR contains half the hydrocodone (7.5mg) compared to the equivalent dose of oxycodone used in the ELI-200 bunionectomy trial (15mg). ELI-201 Phase 3 would not evaluate acute, post-op pain but rather chronic pain, and the dose will be higher than 7.5mg- 15mg, more like 30-40mg- much too high for opioid-naive post-op patients.
505b2 with bioequivalency bridge to freshly-approved ALO-02 will save 6-12 months and millions of dollars.
Bring on ELI-301
Yep, ELI-301 (morphine ER) should be Elite's third ADF opioid NDA application of the year, after ELI-200 and ELI-201.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM505122.pdf
Yes and no.
Troxyca Extraction Issues
There are several issues identified. I do not believe any whole pellet studies can be extrapolated to Elite's 2 bead technology, and their most significant issue was in large volume extraction from whole pellets. Large volume essentially rules out IV abuse, but the preparation could be orally ingested.
There was one issue identified with crushed pellets, which would be essentially the exact same as crushed ELI drugs. There was selective extraction of oxycodone without naltrexone in solvent M27. I suspect crushed ELI drugs should have this same issue. This is not going to be a problem because extraction requires a large volume and the solvent is organic (not household, not readily available, not consumable or injectable). In order to utilize the extracted product, it would require extraction from the organic solvent, which is another multi-step, multi-reagent process.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM505128.pdf
Nice article, but take caution...
I especially liked Figure 2. But this is from January 2015, and the info is out-of-date in regards to Elite and competitors.
Great catch, Couch
No 10-Q filed since January.
What else is there to say?