Replies to post #33646 on Elite Pharmaceuticals Inc (ELTP)

[tangerine]

Total assets 10,311,717

Funny how you missed the 3.3m investment in Novel Labs which as discussed over and over is worth a lot more then the 3.3m evaluation done in 2006.

Its right there where you pulled the numbers yet you omitted despite all the conversations we have had about it.


http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79145196

[Couch]

Elite's initial studies in humans showed results that strongly supported the premise of the ART(TM) including demonstrating little or no release of the antagonist in the intact dosage form. Based upon our investigations to date, similar results are not found in any literature reports.

Do you have any links that show the counter? LOL LOL

This is why Elite will have no problem with BE studies or FDA Phase III.

[Couch]

The studies were conducted on sixteen healthy human volunteers. Test subjects were given a single dose of intact and crushed forms of OxyNal™ under fasted conditions. Oxycodone and naltrexone levels were measured in the subjects' blood. The following results were achieved:

Performance of Intact Capsules: This study was designed to evaluate the pharmacokinetics of OxyNal’s™ formulation when it was administered to the subjects in its unaltered form. The results showed that no quantifiable blood levels of naltrexone were released at a limit of quantification ("LOQ") of 7.5 pg/mL while the oxycodone showed a typical release profile for a 12-hour product, thus provides the desired effect of pain relief. This data is consistent with the premise of Elite's ART™, that essentially no naltrexone is released and absorbed when administered as intended.

[Couch]

The initial study successfully demonstrated the euphoria-blocking effect of ELI-216. This study was designed to determine the optimal ratio of oxycodone hydrochloride and opioid antagonist, naltrexone hydrochloride, to significantly block the euphoric effect of the opioid if the product is abused.

The study successfully demonstrated the euphoria-blocking effects of ELI-216. Without abuse deterrent technology, the subjects (n=17) dosed with crushed oxycodone hydrochloride 40 mg extended release capsules reported a high level of euphoria during the first three hours (average peak of 71 on the euphoria scale) and ELI-216 crushed (n=11) showed very low levels of euphoria (less than 10 on the scale). The study showed similar results with other levels of oxycodone hydrochloride. The study also helped determine the appropriate levels of naltrexone hydrochloride required to reduce or eliminate the euphoria experienced by subjects who might take crushed product to achieve a “high”.

[Couch]

“We are pleased to have reached agreement with the FDA on the Special Protocol Assessment for our Phase 3 clinical trial for ELI-216, our abuse deterrent oxycodone formulation. The SPA agreement is a significant milestone for Elite and provides a clearly defined pathway towards regulatory approval of the company’s New Drug Application.”

[Couch]

Dr. Stuart Apfel, Elite's Chief Medical Officer, commented, "We are honored to have been selected to present our findings at this year’s AAPM. This study illustrates the fact that varying ratios of the opioid and naltrexone, in a combination formulation, may impact differently on a subject’s euphoria and related sensations. We are not aware of any previous published studies that demonstrate this observation. The study suggests that the ratio of agonist to antagonist is an important consideration in combination drugs designed to deter tampering or abuse of opioid analgesics.”

Lynn Webster, M.D., head of Lifetree Clinical Research in Salt Lake City, and the lead investigator for the abuse-deterrent study, said, "Prescription drug abuse is a national crisis. If we are going to use powerful pain killers like opioids we need them to be less attractive to abuse. Elite is advancing a formulation which may help deter abuse while providing a medication that will be effective in treating intractable pain."

[Couch]

Northvale, New Jersey, Tuesday, May 22, 2012: Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB: ELTP) announced the issuance of U.S Patent No. 8,182,836 entitled “Abuse-Resistant Oral Dosage Forms and Method of Use Thereof” by the United States Patent and Trademark Office (USPTO). The issuance of this patent will further protect Elite’s proprietary formulation for abuse resistant products utilizing the pharmacological approach. The Company has additional patents pending for its technology.

"The issuance of this patent is an important milestone for the company. It validates our pharmacological approach to the development of abuse-resistant drug products and provides additional value for these products,” said Jerry Treppel, Elite’s Chairman and CEO.

[Couch]

Chris Dick - Elite Pharmaceuticals, Inc. - COO and President
Well, I think our strategy, Anthony, is around doing an ANDA or 505(b)(2) that we can control ourselves. And we think -- which is what I was talking about earlier about doing bioequivalent studies and those types of studies -- to get a product on the market with the abuse resistant technology.
We think if we think if we can do that type of thing, then the value for the -- a product that would require a full efficacy study will go up, and we'll do it in that kind of timeframe. So strategically we're kind of looking at it as a two-step process. Do these first and then do a bigger strategic alliance on a more costly study.

Jerry Treppel - Elite Pharmaceuticals, Inc. - Chairman and CEO
Full disclosure here. There's no question that the issuance of that patent has piqued the industry's interest. Okay? And we know that from the calls
that we get.
But, as I said before, piquing interest is not the same thing as I want to sit down and discuss terms with you. And we think in order for that to happen, as Chris just said, you have got to demonstrate to people that I can commercially make -- scale it up; I've done the biostudies; I have a product. Okay? And that's our goal, and we will get there in this fiscal year.