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In my previous article, titled Elite Pharmaceuticals: Call It A Comeback Story, I explained how Elite Pharmaceuticals (OTCQB:ELTP) had turned the corner and was on the verge of achieving the goals that had investors excited prior to the market crash. This is a follow up to that article and will review recent and highly significant events. As the company continues to execute on their business plan, it is becoming more and more likely that Elite is going to once again be a major player in a huge market.
Before the market crash, they were on the AMEX and were at the forefront of this segment. Now this company is fundamentally stronger and able to finally bring these products to trial and ultimately to market. The technology has always been sound and new leadership has been meeting and exceeding their aggressive goals. This is a unique long term opportunity to take on minimal risk and potentially hit a home run.
Here are the latest events to be covered in this article:
Elite has finally begun the trials that have been anticipated for several years. A twice daily Oxycodone (Oxycontin) product identified as ELI-201 has entered a short pilot bio-equivalence study on December 5th. Oxycontin represents a $2.7 billion dollar market within an eight billion dollar opioid market. This is likely the biggest news in company history.
However, armed with a truly modular technology, Elite is attacking this market on many fronts. Elite announced a second unnamed product which enters larger pivotal BE studies January 10th. Then there will be a pivotal BE study in the beginning of March for ELI-201. In the most recent conference call, the company also noted that a third once daily Oxycodone product will be trialed in that same time-frame. There is no once daily product on the market.
Overall, we now know that Elite is working on at least four abuse deterrent opioid products. Oxycontin, once daily Oxycodone, a morphine product and a third currently unnamed Oxycodone product. This first trial should conclude on approximately 12/22. Elite has been through similar studies and saw excellent results.
Elite has hired Camargo, a leading expert in the field at pursuing drug approvals via the 505(B)(2) route. This will expedite the process and ensure that the company is able to deliver the type of data the FDA will require in order to garner an approval. This is an abbreviated NDA process which will limit the number of years (3-5) Elite will be able to garner exclusivity but they will use their ever growing patent and IP rights to limit competition.
Another consideration is will the FDA give this product abuse-deterrent labeling? As we know, they will not approve any Oxycontin product unless it shows a significant level of abuse deterrence. A study published September in the Journal of Psycho-pharmacology 2013 27: 808 J Psychopharmacol notes that a hypothetical ER Naltrexone and Oxycodone product exhibits the least amount of attractiveness, value, likelihood to abuse, overall desirability, and street value.
The reason this is so important is that there are basically three key areas for Elite to overcome in order to reward their shareholders with massive returns on their investment.
THERE'S MORE!!!!
In my previous article, titled Elite Pharmaceuticals: Call It A Comeback Story, I explained how Elite Pharmaceuticals (OTCQB:ELTP) had turned the corner and was on the verge of achieving the goals that had investors excited prior to the market crash. This is a follow up to that article and will review recent and highly significant events. As the company continues to execute on their business plan, it is becoming more and more likely that Elite is going to once again be a major player in a huge market.
Before the market crash, they were on the AMEX and were at the forefront of this segment. Now this company is fundamentally stronger and able to finally bring these products to trial and ultimately to market. The technology has always been sound and new leadership has been meeting and exceeding their aggressive goals. This is a unique long term opportunity to take on minimal risk and potentially hit a home run.
Here are the latest events to be covered in this article:
- Announcement of Pilot BE trials starting, Pivotal BE trials scheduled for Jan 10th and additional trials scheduled for March.
- Key patent 13/863764 is about to be awarded to Elite
- Financial results for Q2 2014
- Epic Pharmaceuticals to manufacture and market the recently acquired 12 approved Generic drugs
- Elite's Chairman agrees to convertible note. Additional unsecured loan made by current CEO.
- Quarterly company conference call
- Filing of SEC Form 8-A12G - (Share holders rights plan) Also known as a "poison pill" or anti hostile take over measure
Elite has finally begun the trials that have been anticipated for several years. A twice daily Oxycodone (Oxycontin) product identified as ELI-201 has entered a short pilot bio-equivalence study on December 5th. Oxycontin represents a $2.7 billion dollar market within an eight billion dollar opioid market. This is likely the biggest news in company history.
However, armed with a truly modular technology, Elite is attacking this market on many fronts. Elite announced a second unnamed product which enters larger pivotal BE studies January 10th. Then there will be a pivotal BE study in the beginning of March for ELI-201. In the most recent conference call, the company also noted that a third once daily Oxycodone product will be trialed in that same time-frame. There is no once daily product on the market.
Overall, we now know that Elite is working on at least four abuse deterrent opioid products. Oxycontin, once daily Oxycodone, a morphine product and a third currently unnamed Oxycodone product. This first trial should conclude on approximately 12/22. Elite has been through similar studies and saw excellent results.
Elite has hired Camargo, a leading expert in the field at pursuing drug approvals via the 505(B)(2) route. This will expedite the process and ensure that the company is able to deliver the type of data the FDA will require in order to garner an approval. This is an abbreviated NDA process which will limit the number of years (3-5) Elite will be able to garner exclusivity but they will use their ever growing patent and IP rights to limit competition.
Another consideration is will the FDA give this product abuse-deterrent labeling? As we know, they will not approve any Oxycontin product unless it shows a significant level of abuse deterrence. A study published September in the Journal of Psycho-pharmacology 2013 27: 808 J Psychopharmacol notes that a hypothetical ER Naltrexone and Oxycodone product exhibits the least amount of attractiveness, value, likelihood to abuse, overall desirability, and street value.
"By contrast, ORF and the hypothetical oxycodone/naltrexone product were ranked the least attractive, least valuable and least desirable opioid products, as well as the opioid products least likely to be tampered with."If you take a look at slide 7 on this presentation from the Abuse Deterrent Formulation Meeting held in Bethesda Maryland, it shows the results of this study and how this type of product ranks in these critical areas. Presenters were some of the most educated in the field ranging from the FDA to Scientists and university researchers to senior leadership at numerous related companies.
The reason this is so important is that there are basically three key areas for Elite to overcome in order to reward their shareholders with massive returns on their investment.
- Will the product relieve pain and perform similarly, i.e. is it "bio-equivalent" to the branded product?
- Will Naltrexone be sequestered?
- Will it be considered to be abuse-deterrent to drug users compared to regular Oxycontin or even new Oxycontin which may have set the bar for approval?
THERE'S MORE!!!!
