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As an investor in Elite since '04 I can tell you my personal opinion is that Elite will never go that low ever again. What is happening right now is very special and what many of us long-term investors have been waiting years for.
It's the execution of well thought out plan that now hinges on positive data coming from study results over the next two months. If you think that data will not be positive then so be it. But as a physician who has followed this company for 10 years I believe this delivery system will be best practice whether it is Elite or any other pharma company that produces it. It just so happens that Elite currently has the patents and the financial ability to move forward.
Elite's management knows if they validate the data and get one ART product submitted they are a target for numerous pharma companies who will be vying to buy them out. By doing the work on ELI200 you validate to an acquiring company that your tech is proven and they are buying the legal protection/patents and an infallible approval process via the FDA that will allow the acquiring company to produce/license 10-15 ART products.
I think Elite gets bought out between submission and approval by a company that doesn't want to get into a multi billion dollar bidding war.
Are you saying .25 or 1.25? It is going to 1.25, and soon, and never again will it go to .25.
The FDA is backing itself into an corner right now with these approvals. It's bewildering... These so-called abuse deterrent drugs will look the same as the original formulations that created this epidemic once true ADTs are released.
This should be good for Elite and anyone else entering the marketplace. Priority review will fast-track Elite's ART products. Only a handful of companies will be in this billion dollar marketplace over the next decade. In my opinion Elite will be bought out during this period - likely early on - but Elite's technology/delivery system will garner the lion share of the ART market for whoever purchases Elite and furthermore this tech will be considered best practice in patient care and widely adopted throughout the healthcare system (assuming the prices are competitive due cost containment, which they should be).
Lynn Webster is a scientific advisor which is interesting to say the least. Wether that is good or bad is to be determined. That said, they are years behind where Elite is right now so for now, no.
Nasrat said "nobody can stop us"! LOL
Yes and CC should be following day, Tuesday.
Should be next Mon or Tues for financials.
Senderos the manufacturing of ALO-02 is similar to Embeda's one-bead delivery platform tech which means right now you cannot assume the stability issues have been fixed. In addition, and of greater concern, would be the fact that in a clinical study of 400 pts, 60% of the pts discontinued taking the drug during a 12-month period, 20-30% due to the drugs side effects. Elite's delivery system is two-bead which is far less likely to have these types of stability issues.
Embeda, a morphine/naltrexone combination delivered by capsule, was approved by FDA for use as a Schedule II drug, with the label: Embeda can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Embeda in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. The key point is that there was no data filed with the registration suggesting that there was evidence that Embeda is less likely to be abused than other extended-release morphine drugs. In addition, in a clinical trial, 11% of patients have naltrexone showing up in their blood stream. Net, Embeda is viewed as a marginal improvement over morphine alone.
So we have Embeda we have a lot of emphasis by the vendors, manufacturers, drug companies, pharmaceutical agencies to try to develop substances which have deterrents against abuse. That doesn’t really solve the problem because for every system there is somebody who has the wherewithal, the knowledge, the background, the training, the experience to kind of thwart the efforts at limiting the abuse potential of every agent that has ever been developed. However, you need to be able to produce the drug without stability issues!
It has been since March 2011 and Pfizer obviously has not been able to correct the stability issues. Pfizer said it would have this fixed in a matter of months.
How this relates to Elite: Well, if they can prove that they do not have stability issues with their version of Embeda, things get very interesting. Furthermore, Elite's ART is the first I have seen that actually can mitigate those aforementioned folks with the wherewithal, knowledge and background to thwart the abuse resistant properties of the drug. This will be proved in the upcoming human abuse liability studies.
Nothing that I have heard. We actually had Pfizer reps here in early April but I hide as soon as I see any pharma or med device rep. Will ask next time. That being said, I am not sure what they are going to do differently to mitigate the issues?
IMO it would be largely for licensing.
Lasers: Fantastik high-level overview of the patents. Thanks
On deck: microtablet delivery systems
In due time. Think we need to get over a dollar to start seeing that type of buying.
That's right. Gabelli did own it the past but it was 150K shares or so if I recall. This is new.
Very nicely done. Thanks for putting this together.
Elite has now secured $50 million total in funding from Lincoln Park Capital. I would say that the team at LPC, including Dr. Beaubaire http://lincolnparkcapital.com/team.html, liked the data they were shown while LPC was doing extensive due diligence before committing to this level of funding.
Based on what? Many of those drugs had been marketed for a very long period (10, 20+ years), been widely available to the public with none to minimal side effects. I would say that FDA decision came out of nowhere.
To the moon. $$$$$$$$$$$$PENNIES TO... DOLLARS$$$$$$$$$$$$$$ right?
Lasers - patent date set today. 413/863,76 on 4/22/14
Patent Update
13/863,764 Abuse-Resistant Oral Dosage Forms And Method Of Use Thereof
Patent Issue Date: 4/22/14
I agree billions of dollars for all...
Ok, that's twisting words a bit. Yes, every drug is chemistry but your comment is also highly inaccurate. Numerous ART/ADT drugs approach the problem by making it difficult to abuse whether it is the the makeup of the outer shell, having it cause significant pain when snorted etc., or solidifying when heating to liquid. Elite's approach is the opposite. The barrier to the big abuse issues is hindering the inability to crush snort and/or inject. Elite's approach masterfully deals with that very complexity. A small fraction of people will always take a handful of pills but frankly that is such a small population in the general abuse pathway to heroin population.
As you know medicine is both an art and a science. It looks like many companies have very promising therapies. Elite is one them.
Is it being held up or held down?
I believe actual investors will continue to find out about Elite and take long-term positions away from some of the "investors" on the OTC.
Time will tell. I have been in for a decade, can wait a couple more years. But I can tell you from my clinical experience that a chemistry approach is the way to go and that Elite is onto something huge. This market will be made up of only a few companies and Elite is one of them. I know it's unfathomable.
We will have to disagree on that one. But surely as Drs. we can ought to agree this is a pretty remarkable tech, no? http://www.elitepharma.com/How_AR_Tech_Works.pdf
Explain to me how they are not?
I am confused. Billion dollar patents are not reflected in revenues?
Couch - That's is absolutely correct. Everyone in the industry looks at what happened to Pfizer with their ART/ADT attempts and is not willing to make the same mistake.
In 2010 Pfizer purchased King Pharmaceuticals for $3.6 billion or $14.25 a share in cash (a 40 percent premium over King’s closing price the previous day). All three of the drugs (Embeda, Remoxy and Acurox) that made King such a buyout target have proven to be a disaster for Pfizer. How does this correlate to Elite? Well, Elite is going to be producing a better Embeda, in addition to a whole line of ART/ADT opioids. What do you think that does to the value of Elite? The great irony in all of this is ten years ago a friend of mine told me about ELI. Guess where he worked at the time? Pfizer.
Mr. Treppel: "If you're familiar with the valuation accretion curve in pharmaceuticals, a little effort goes a long way in terms of creating value in pharmaceutical products. What I mean by that is that if you have a formula that's worth X, if you can make a pilot batch, it's X times two. If you can make a commercial batch, well, it's X times some number, and finally, if you can do a bio study that's successful, well, it's X times many, many times. And that's our goal here. Okay? So for not an extraordinary amount invested, you get a lot in return."
Mr. Treppel: "It's all a matter of risk profile. The least risky business is a straight contract research service. The company just gets paid to do formulation work. It doesn't take any of the risk, but also doesn't get much of the economic rewards either. The next stage is that, instead of doing just formulation work, the company does some of the early-stage clinicals, and following that does some of the late-stage clinical trials. The value accretion curve in pharmaceuticals is very high, and what that means is that the difference in value between licensing a product that has completed Phase I versus licensing a product that has completed Phase III or has an NDA already filed, is logarithmic. The value of a product accretes very rapidly once it gets into human clinical trials.
Yeah I agree. That was not from a medical journal. lol.
FDA STATEMENT: FDA Commissioner Margaret A. Hamburg Statement on Prescription Opioid Abuse
For Immediate Release: April 3, 2014
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391590.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
For more than a decade, the U.S. Food and Drug Administration has been working to address the important public health problems associated with the misuse, abuse, addiction and overdose of opioid analgesics, while at the same time working to ensure continued access to effective and appropriate medications for millions of Americans currently suffering from pain. I firmly believe that these goals are compatible, and that actions to address one should not be at the expense of the other.
Tragically, the most recent data shows that more than 16,000 lives are lost each year due to opioid-related overdoses. In fact, drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. We know that the illegal diversion, misuse, and abuse of prescription opioids are often fueled by inappropriate prescribing, improper disposal of unused medications, and the illegal activity of a small number of health care providers. This highlights the important role that education of prescribers and patients can play in addressing this epidemic. The FDA has taken steps to address this but more work remains to be done.
Combatting the serious public health problem of misuse, abuse, addiction and overdose from opioid analgesics is a high priority. Since 2001 the FDA has taken a number of actions designed to help address prescription opioid abuse and to encourage the development of new drug treatments for pain. These actions include:
• Revising the labeling for opioid medications to foster their safe and appropriate use, including recent changes to the indications and safety warnings of extended-release and long-acting opioids.
• Requiring that manufacturers conduct studies of the safety of long-term use of prescription opioids.
• Improving appropriate prescribing by physicians and use by patients through educational materials required as a part of a risk mitigation strategy for extended-release and long-acting opioids.
• Using the agency’s expedited review programs to advance development of new non-opioid medications to treat pain with the goal of bringing new non- or less-abusable products to market.
• Working with other federal agencies and scientists to advance our understanding of the mechanisms for pain and how to treat it, including the search for new non-opioid medications for pain.
• Recommending that hydrocodone-containing combination products have additional restrictions on their use by rescheduling them from Schedule III to Schedule II.
• Strengthening surveillance efforts to actively monitor the changing nature of prescription opioid abuse and to identify emerging issues.
• And, importantly, encouraging the development of medications to treat opioid abuse, such as buprenorphine for use in medication-assisted treatment, and to reverse opioid overdoses, such as naloxone.
Today’s FDA approval of Evzio (naloxone autoinjector) provides an important new tool in our arsenal to more effectively combat the devastating effects of opioid overdose, which is one part of our comprehensive work to support opioid safety. Reflecting the FDA’s commitment to encouraging important new therapies, the FDA’s review of Evzio was granted priority status, and the application was reviewed by the FDA in just 15 weeks.
This product is the first auto-injector designed to rapidly reverse the overdose of either prescription or illicit opioids. While the larger goal is to reduce the need for products like these by preventing opioid addiction and abuse, they are extremely important innovations that will help to save lives.
The FDA will continue to work to reduce the risks of abuse and misuse of prescription opioids, but we cannot solve this complex problem alone. A comprehensive and coordinated approach is needed; one that includes the White House Office of National Drug Control Policy, the Drug Enforcement Administration and many of our sister agencies within the Department of Health and Human Services, as well as state and local governments, public health experts, health care professionals, addiction experts, researchers, industry, and patient organizations.
I am confident that this can be accomplished, but we will all need to work together to invest in strategies and responsible approaches that deter or mitigate the effects of abuse while preserving access to pain medicines for the patients that need them the most.
For More Information:
Information on Opioid Medications
News Release: FDA approves new hand-held auto-injector to reverse opioid overdose
FDA STATEMENT: FDA Commissioner Margaret A. Hamburg Statement on Prescription Opioid Abuse
For Immediate Release: April 3, 2014
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391590.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
For more than a decade, the U.S. Food and Drug Administration has been working to address the important public health problems associated with the misuse, abuse, addiction and overdose of opioid analgesics, while at the same time working to ensure continued access to effective and appropriate medications for millions of Americans currently suffering from pain. I firmly believe that these goals are compatible, and that actions to address one should not be at the expense of the other.
Tragically, the most recent data shows that more than 16,000 lives are lost each year due to opioid-related overdoses. In fact, drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. We know that the illegal diversion, misuse, and abuse of prescription opioids are often fueled by inappropriate prescribing, improper disposal of unused medications, and the illegal activity of a small number of health care providers. This highlights the important role that education of prescribers and patients can play in addressing this epidemic. The FDA has taken steps to address this but more work remains to be done.
Combatting the serious public health problem of misuse, abuse, addiction and overdose from opioid analgesics is a high priority. Since 2001 the FDA has taken a number of actions designed to help address prescription opioid abuse and to encourage the development of new drug treatments for pain. These actions include:
• Revising the labeling for opioid medications to foster their safe and appropriate use, including recent changes to the indications and safety warnings of extended-release and long-acting opioids.
• Requiring that manufacturers conduct studies of the safety of long-term use of prescription opioids.
• Improving appropriate prescribing by physicians and use by patients through educational materials required as a part of a risk mitigation strategy for extended-release and long-acting opioids.
• Using the agency’s expedited review programs to advance development of new non-opioid medications to treat pain with the goal of bringing new non- or less-abusable products to market.
• Working with other federal agencies and scientists to advance our understanding of the mechanisms for pain and how to treat it, including the search for new non-opioid medications for pain.
• Recommending that hydrocodone-containing combination products have additional restrictions on their use by rescheduling them from Schedule III to Schedule II.
• Strengthening surveillance efforts to actively monitor the changing nature of prescription opioid abuse and to identify emerging issues.
• And, importantly, encouraging the development of medications to treat opioid abuse, such as buprenorphine for use in medication-assisted treatment, and to reverse opioid overdoses, such as naloxone.
Today’s FDA approval of Evzio (naloxone autoinjector) provides an important new tool in our arsenal to more effectively combat the devastating effects of opioid overdose, which is one part of our comprehensive work to support opioid safety. Reflecting the FDA’s commitment to encouraging important new therapies, the FDA’s review of Evzio was granted priority status, and the application was reviewed by the FDA in just 15 weeks.
This product is the first auto-injector designed to rapidly reverse the overdose of either prescription or illicit opioids. While the larger goal is to reduce the need for products like these by preventing opioid addiction and abuse, they are extremely important innovations that will help to save lives.
The FDA will continue to work to reduce the risks of abuse and misuse of prescription opioids, but we cannot solve this complex problem alone. A comprehensive and coordinated approach is needed; one that includes the White House Office of National Drug Control Policy, the Drug Enforcement Administration and many of our sister agencies within the Department of Health and Human Services, as well as state and local governments, public health experts, health care professionals, addiction experts, researchers, industry, and patient organizations.
I am confident that this can be accomplished, but we will all need to work together to invest in strategies and responsible approaches that deter or mitigate the effects of abuse while preserving access to pain medicines for the patients that need them the most.
For More Information:
Information on Opioid Medications
News Release: FDA approves new hand-held auto-injector to reverse opioid overdose
This is great news Lasers.
What are you asking/saying?
No antagonists or aversive agents... Someday companies will not be able to use the ART or ADT naming conventions with these types of products.
I can only imagine the amount of ED cases we will see from users hurting themselves due to the high melting point and trying to inject a partially solidified liquid into themselves.
Only a small portion of drug abusers are affected by these built-in deterrents, Dr. Edward Michna, Director of the Pain Trials Center at Brigham and Women's Hospital in Boston, who was not involved in this research, told Reuters Health.
The hospital I practice at banned any RX of Zohydro within our entire system (two academic medical centers and 15 community health centers). I have only seen this happen with two other drugs in the last 20 years. Now, the state has taken it on and has banned it state wide in MA. More states surely to follow. Very good sign for companies such as Elite as pressure from the gov't will push ART to the forefront.
http://www.bostonglobe.com/metro/2014/03/27/with-heroin-overdoses-rise-gov-patrick-declares-public-health-emergency-mass/hOajTIJNKnSHKAnWjZ6wYL/story.html