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Jimmy Joe, this caught my eye in January.
http://www.wsj.com/articles/depomed-to-buy-u-s-rights-to-nucynta-from-j-j-unit-1421357503
I wasn't thinking about it like that.
ELI-200 Revealed!
Based on my analysis of the Phase 3 efficacy trial published today on clinicaltrials.gov, my opinion is that ELI-200 has been revealed as:
1. Oxycodone
2. Intermediate dose = 15mg
3. Intermediate time-release = 6-8 hours
I believe ELI-200 is a novel, intermediate-release abuse-deterrent oxycodone formulation. As such, ELI-200 can be used “as needed” for acute pain and breakthrough pain, like OxyIR; and ELI-200 can be used “scheduled” for chronic pain, like OxyContin. Look at the chart below. Immediate-release opioids dwarf extended-release opioids in total prescriptions, and ELI-200 captures both.
Example Rx’s:
1. OxyNal 15mg 1 tab PO Q6H prn moderate-severe pain
Dispense: #20 for 10 days
2. OxyNal 15mg 1 tab PO Q8H sched
Disp: #90 for 30 days
3. OxyNal 15mg 1 tab PO Q8H sched and 1 tab PO Q8H prn breakthrough pain
Disp: #150 for 30 days
Lasers, I'm confused by what you're saying.
Lasers, why would IR-ADT defeat the purpose of ADT? Drug abusers crush and snort oxy-IR and Percocet exactly as they do OxyContin, probably more so because the oxyIR and Percocet are so much more ubiquitously prescribed than ER formulation and they do not come with a turtle shell abuse blocker. The naltrexone bead will prevent this kind of crushing abuse in IR opioids just the same as it prevents crush-type abuse with ER opioids. Naltrexone bead will not prevent oral abuse with either ER or IR opioids, unless it is crushed first (i.e. "parachuting"). However, one could make an argument that adding a time-release component to oxy-IR such that it releases over 6-8 hours instead of 3-4 hours is, in itself, a minor deterrent to oral abuse.
The abuser might prefer the ER opioid because bigger dose gives bigger high with less filler material to snort/inject, but as the chart below shows, ER opioids are but a drop in the giant bucket of IR opioids.
http://www.chronicpainperspectives.com/articles/feature-article/article/risk-evaluation-and-mitigation-strategies-rems-red-tape-or-a-remedy-for-opioid-abuse/8dd36b8e70b1db8988b98310efa863c9.html
According to my references, OxyIR comes as 5mg, 10mg, 15mg, and even 30mg, so this could very well be plain old OxyIR. The reason I believe this is an intermediate time-release opioid and not an immediate-release (oxyIR) is because 15mg would be far too sedating in an opioid-naive patient (especially 3 doses in 12 hours), and the study's exclusion criteria clearly excludes anyone with any concurrent opioid use (#21) or oxycodone exposure within 30 days (#26).
In summary, in my opinion, Elite is testing an intermediate-release ADT-oxycodone product which would be dosed at 6-8 hour interval instead of 4-6 hours for oxyIR or 12 hours for OxyContin. As far as I can tell, there is no direct comparator to this product, which may be why the efficacy trial is needed in the first place.
Why do I think this is a big deal? See the chart above for the number of IR prescriptions vs. ER prescriptions. What the intermediate-release oxy will do is the straddle the line between both. Okay to use on an as needed (PRN) basis for acute/temporary problem, but also okay to use on a scheduled basis for longer term pain issues. Also, okay to use scheduled every 8 hours with an extra as needed dose for breakthrough pain. As I said earlier, a GAME CHANGER. A new, novel drug that can be used as both an IR and ER.
Oh, Nasrat... my, my, my...
BTW and FYI, "parachuting" as mentioned above is a method of oral drug abuse in which the tablet(s) are crushed, wrapped in tissue, and swallowed. This allows for rapid G.I. absorption and therefore approximates the rush of snorting.
Game-changer. Brand-new drug. OxyNal 15mg PO q6-8h prn moderate-severe pain.
It's definitely oxy, but 15mg is too high dose to be oxyIR. The timing interval is too short to be OxyContin. This may be a novel intermediate time-release formulation.
Couch, don't forget about the bond issue.
Management used proceeds from generic drug sales to retire some of the NJ bonds and get current on all the rest. This led to removal of the "Going Concern" language from the auditors. This move did not buy an ounce of API, pay for any equipment, or fund any study. But it was a critical step in proving the health of the company and will allow for a stronger negotiating position with any potential suppliers and partners. It will attract more investors, and eventually allow for uplisting to NASDAQ.
http://www.elitepharma.com/press-releases/elite-pharmaceuticals-inc-reports-financial-results-for-the-second-quarter-of-fiscal-year-2015/
Will ELTP Generic Naltrexone Generate Bariatric Revenue?
Short answer: maybe, but not any time soon. However, the branded drug Contrave and its path to FDA approval has multiple points of relevancy to Elite and to this message board in particular.
Contrave is an obesity drug that was approved by the FDA in late 2014. Similar to Elite’s abuse-deterrent opioids, it combines two drugs (bupropion and naltrexone) that are well-known to the FDA and have long-established safety profiles as individual drugs. One of those components, naltrexone, is also manufactured by Elite as a generic version of Revia for use in treatment of opioid and alcohol addiction. Elite already has a nice pipeline of generic obesity drugs, including phentermine and phendimetrazine. But given the FDA approval of Contrave, should ELTP generic naltrexone also be considered a bariatric drug? And what is the likelihood it will generate revenue as part of a generic substitution version of Contrave?
First, Contrave has yet to generate revenue as an obesity drug. If it proves safe and effective, doctors will prescribe it, and it might make money. But maybe not, and here’s why: Orexygn is heavily subsidizing its use in order to tally up the number of sripts written and to acquire market share. The U.S. marketing partner is Takeda, and the sales rep was in my office this week to hawk their “Scale Down” program. When the patient signs up, they get a free wireless scale which tracks their weight and sends personalized text messages to the patient. There is a pharmacy savings card so that cost for the medication is $45/month for insured patients and $60/month for patients without prescription coverage. Currently, there is no time limit on these prices. A pharmacist friend of mine confirmed that his cost for #120 tablets is $191.70, which would correspond to a retail cash price of approximately $300/month.
So Orexigen/Takeda appear to be subsidizing the cost of Contrave by providing a 75% discount. One might also consider the cost of the free scale as an additional subsidy, but I suspect Orexigen/Takeda will be collecting those weights in order to compile data and publish a post-marketing study of weight-loss results. So let’s hypothetically say that their data is beautiful and the drug is well-tolerated and becomes a blockbuster. The subsidies end, and the price goes up to $300/month. Now doctors and patients will be seeking a cheaper generic alternative, and Elite’s generic naltrexone will start to generate obesity revenue, right? Well, no, maybe not. Each Contrave tablet contains 9mg naltrexone and 90mg bupropion in a time-release formulation. Over the first 4 weeks, the regimen is tapered up to the maintenance dose of two tabs twice daily for a total daily dose of 36mg naltrexone and 360mg bupropion. The closest generic regimen would be a half-tab naltrexone 50mg twice daily and 1.5 tabs bupropion 100mg twice daily. According to goodrx.com, the retail cost of the 30 tabs naltrexone is $120, and the cost of the 90 tabs of bupropion is $100/month. So the off-label generic regimen, which is not time-released and does not have an exactly matching dose of either drug, is only about 25% cheaper at $220/month vs. $300/month for the branded, on-label, time-released drug. It’s not at all clear that doctors and patients would choose the cheaper generic in those circumstances, although insurance companies may be more likely to cover it because it is generic.
In my opinion, the most compelling part of the Contrave story is the recent conduct of Orexigen management. Contrave was first submitted to FDA for approval in March 2010, and the application was based on multiple clinical trials that evaluated more than 4500 patients. A complete response letter was received in January 2011, in which the FDA expressed concern about the cardiovascular safety of long-term use in overweight subjects. In September 2011, the company announced they had come to terms with the FDA on a cardiovascular outcomes trial (CVOT) for Contrave which contained an intriguing promise: the FDA stated that "if the interim analysis meets the specified criteria to exclude an unacceptable increased cardiovascular (CV) risk, the drug could be approved." Essentially, the FDA was saying that if the early data looks okay, then they would approve the drug before the study was completed.
The application was resubmitted in December 2013, and true to their word, was approved by the FDA in September 2014. But a funny thing happened earlier this month. As it turns out, the CVOT interim data was not just okay, it was awesome. It showed a 41% reduction in CV events, independent of the weight loss. Catch that? No matter the amount of weight loss, Contrave decreased CV events by almost half compared with placebo, making it the most effective heart drug in the history of the world. Even though anyone with a rudimentary knowledge of science or statistics would know that those results would not likely hold up once the rest of the data was collected, Orexigen just couldn’t wait. Even though only a half a handful of people should have been privy to the data, management proceeded to tell lots of people, including a patent application. Larry Huston at Forbes.com has been all over this story, and his series of posts are worth the read. In brief:
Forbes.com
I can remember sitting in a Pharmacology lecture during my second year of medical school, and the lecturer discussing abuse deterrence by combining agaonist and antagonist in one capsule. This was 10 years before FDA approved Embeda. Brilliant!, I thought.
A few years ago, I was looking for a development stage generic pharmaceutical company, and that's how I found ELTP. At that time, it seemed like their ADT pipeline was a long way off. Now we're literally weeks away from FDA submission. Brilliant!
Lasers, physicians tend to be fiscally conservative, but despite the fact that ELTP trades OTC, many of my hospital colleagues across multiples specialties have joined me as Elite shareholders. Not surprisingly, there has been an especially enthusiastic response from the Emergency Department. Those docs are on the front lines in the war against diversion of prescription narcotics, and they are daily witnesses to the adverse effects of prescription drug abuse. They understand that at some point in the near future, every prescription written for an opioid painkiller will be an ADT-opioid, and they know that Elite's modular tech will allow doctors to choose whichever opioid agonist is the most appropriate for their patient.
During One Week in June, 2013
Half-million shares ELTP, less than $0.07/share, total fees $26.85. (Suck on that, Vanguard!) Wish I had more dry powder then, wish I had more dry powder now. I understand that its harder to think like this if you’re underwater or if you feel pressured by a certain self-imposed timeline. But the ultimate value investor said it best…
“If you aren't willing to own a stock for ten years, don't even think about owning it for ten minutes.”
Warren Buffett
Chairman's Letter, 1996
Thanks hyder. Reposted with editing advice from Lasers...
This is my first post, but I've been lurking on your board for years.
I have accumulated shares in the 7 digit range, and I have only sold shares one time to pay some taxes. I have since repurchased those shares in triplicate, and I have no plans to sell any more shares until the buyout occurs.
Lasers, I want to wholeheartedly thank you for everything you contribute here. There have been weeks at a time when I only had time enough to log on and scan the board for what you posted. When it comes to ELTP, I am a strong subscriber to your philosophy of Buy, Hold, Accumulate.
On this subject, I think it has become apparent that ELI-200 is Oxy-IR (immediate-release oxycodone). ELI-201 is Oxy-ER (Oxycontin). ELI-202 is Percocet (acetominophen/oxycodone). And ELI-216 is once-daily Oxy-ER. I think the morphine formulation is probably ELI-300 and ELI-301, which are the only opioids listed on the website under Generic Pipeline (as in, generic Embeda). All other opioids are listed under Branded Pipeline.
I've gone back and re-read all the PR and CC's. NH never refers to ELI-200 as extended release. Nowhere on the website does it refer to ELI-200 as extended release. When asked about ELI-200 specifically on the CC, he cunningly referred to ELI-201 instead of answering the question as asked. I don't think this was by accident.
Obviously, ELI-201 is twice daily oxy. But that does not exclude ELI-200 also being an oxy formulation. The Withdrawal study specifically sets the dosing at every 6 hours-- this is OxyIR!
As far as I'm concerned, this is a major development. I am an internist with 10 years experience. I can count on one hand the number of times in my career that I've prescribed MS-Contin (twice daily morphine without ADT), and I've never once written for Embeda. Even OxyContin I've only written a half dozen times in 10 years. But I prescribe OxyIR a half dozen times per week. OxyIR is a standard order on my hospital admission order set. When a patient needs opioids, I write for OxyIR.
This is, in my opinion, a thrilling development. Many, many more scripts get written for immediate-release opioids than extended release. And how is Purdue going to challenge ADT Oxy-IR when they do not even manufacture it? Let them challenge ELI-201, and ELTP will be well-funded to fight them with ADT Oxy-IR (ELI-200).
Once again, Nasrat Hakim looks like the smartest guy at the party, and I cannot wait to see what he has in store for us in the future.