The below article will attempt to show how the development-process will effect stock price as studies are completed, results announced, and product launch nears...
Those of us following Elite Pharmaceuticals for some time, remember way back, C.O.B. Jerry Treppel outlined in a conference call July 3rd, 2012, those now famous comparisons of product launches to a baseball game... Talking about doubles, triples, and homeruns! The product launches of the 8 generic drugs were nice doubles.... They moved us along and kept us in the game... Really didn't score much with the stock price, but ELTP kept swinging...
Jerry Treppel knows, that as products progress through the development process, they increase in value at an EXPONENTIAL RATE, as they move through the Phases of FDA development requirements... Example...suppose you have a new drug for a 500 million dollar potential treatment market:
Phase one initiated: drug is worth 1 million dollars
Phase one completed: Drug is worth 4 million dollars
Phase two initiated: Drug is worth 16 million dollars
Phase two completed: Drug is worth 64 million dollars
Phase three initiated Drug is worth 128 million dollars
Phase three completed Drug is worth 256 million dollars
FDA approval- Drug is worth 500 million dollars!
That's the way a normal 3 phase FDA New Drug Application process will work, and what Jerry Treppel was up against, as the Phase 2 and Phase 3 studies take years and cost tens of millions of dollars to complete....
But wait, There is another way.... and that's the beauty of the current plan... It's called the 505b2 NDA submission alternative.
Anyone wanting more info on Camargopharma and what they can do for a drug company seeking 505b2 development should click on this link:
Jerry Treppel realized he needed assistance with the product development, so he contacted Nasrat Hakim, an industry veteran Big Pharma leader, and they worked out a deal where Nasrat would become CEO and lead the development of the Abuse Resistant Technology drugs, and contracted with the leading development firm of Camargopharma, the #1 505b2 development firm, to lay out the roadmap for 505b2 product development, including designing studies needed for collecting data needed to proceed to the final stage of a NDA filing for a 505b2 product approval!
The press release on December 5th, outlining the beginning of PK studies, and the timetable for the initiation of studies for development of 2 drugs, was a double folks!
From the Press Release-
Elite Pharmaceuticals, Inc. ("Elite" or the "Company") ("Elite") (OTCBB:ELTP) announced today the first dosing of a pilot bioequivalence study in healthy volunteers for ELI-201, the Company's twice daily abuse deterrent oxycodone/naltrexone product.
Elite has met the goal of starting the bio study for ELI-201 in December. A pivotal bioequivalence study for a second abuse deterrent product is scheduled to begin dosing in January 2014, and the pivotal bioequivalence study for ELI-201 is scheduled to begin dosing in March 2014. The bioequivalence studies for these opioid abuse deterrent products are being conducted under the direction of Camargo Pharmaceutical Services.
"The start of the ELI-201 pilot study marks a major milestone for the development of products utilizing our proprietary abuse deterrent technology," said Nasrat Hakim, Elite's President and CEO. "I am extremely pleased with the progress Elite has made with the development of this technology. We have set several initiatives in motion and all of our research and development projects are on or ahead of schedule. We appreciate the guidance and expertise that has been provided by Camargo and look forward to this next phase for the Company."
Finally, the FDA submission process is not cut and dried, a,b,c,d process, but, like the patent process, will require interaction with the FDA, clarification, and possible re-submission of certain results... However with Camargopharma leading the design and development, and Nasrat Hakim leading the implementation of studies, investors can now be confident that the ELI-216 Abuse Resistant Technology containing generic for Oxycontin is well on the way to FDA approval and Launch on the USA market.
The stock price responded to the NEWS of Nasrat Hakim's appointment as CEO and the renewed focus on ART drug development with a DOUBLE in price... It has not responded yet to the NEWS of the launch of PK studies, and the timetable of more studies.
But, in my opinion, the price will rise, and may rapidly rise as we progress through the remainder of the winter and spring of 2014.
As I indicated above - milestones reached will exponentially increase the value of the drugs in development. So the successful completion of PK studies on December 22 is the milestone to watch. It will take some time for study results to be compiled though, so the stock may or may not respond as that date arises. However, as further studies are started and completed, and as other developments appear, the stock will begin to rise and will continue to rise.
The other developments could be - Announcement by partner Epic Pharma of Launch of the first of the 12 new drugs it is developing for Elite Pharma.
A BIG PHARMA partner that will help develop and fund studies on other drugs requiring Phase 1, 2, and 3 trials for traditional NEW DRUG APPLICTATIONS. This deal could also include manufacturing and marketing arrangements for the current ART drugs that Elite is developing alone.
Of course, the SEC 10Q earnings report showing large Revenue Gains for the current portfolio of drugs and MILESTONE PAYMENTS for the drugs being developed will also be a positive for the stock.
The future has never looked brighter for Elite Pharmaceuticals and its investors.
Disclosure: I am long OTCQB:ELTP.