Real Wall Street, Please Meet Elite

While Jerry Treppel does not usually appear concerned with the day-to-day PPS of ELTP, its investors are suggesting that most promotional pieces like the news release that was put out by Wall Street PR (not Wall Street Journal, but it helps...) is the best way to attract new investors.  A higher PPS might even legitimize ELTP in the eyes of institutional investors in the wake of the latest company headlines: 

Last month, Elite Pharmaceuticals was awarded U.S Patent No. 8,182,836 clearing the way for them to begin producing a time-release opiate that prevents users from abusing their product. However, it was today’s announcement of a $500,000 bridge loan that saw the stock gain nearly 15% on a day that saw the biggest across the board stock price drop in three weeks.

Investors like articles like this because the company's own PR about receiving the 216 patent was far from a sales pitch.  However, the information reeks of legitimacy as IHUB board wars continue to be waged.
The fluff piece further addressed the latest official loan PR by stating:

Jerry Treppel, Elite’s CEO, has agreed to provide a line of credit not to exceed $500,000 to the company he runs. The loan is being made in order for Elite to accelerate its commercialization of its existing products and the development of new products that await patent approval. The loan has been granted at a 10% annual interest rate with interest payments to be paid quarterly beginning in three months time.
The company has already begun purchasing equipment and hiring staff in anticipation of the finalization of the loan terms.

Meanwhile, the IHUBBERS are scratching at each other's eyes with both sides (basher and non-basher) making their claims.  On IHUB, where boundless "pumping" is the signature name to the game, a few bashers refuse to back down. 

Lasers, (on fire of late) says:

NDA505(b)(2)is approval request of a new drug dependent on a Commercial drug approved by the FDA.

You have been given links to NDA505(b)(2)in prior posts.

Embeda ALO-01 went this route by claiming Purdue approval OxyContin is similar. Pfizer/King ALO-01 was granted a NDA505(b)(2)approval in 2009.

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022321s000ltr.pdf

Pfizer is applying the NDA505(b)(2)route to ALO-02. Notice the comparison by including Purdue OxyContin in the public wording.

http://clinicaltrials.gov/ct2/show/NCT01557257

Drug: OxyContin

The problem is that in 2010 Purdue's OxyContin OC (agonist/antagonist)was replaced as OxyContin OP (hard shell agonist only). Purdue had continuing manufacturing problems with their 1-bead OxyContin OC and after several recalls gave up on it.

http://www.purduepharma.com/news-media/2010/04/statement-of-purdue-pharma-l-p-regarding-fdas-approval-of-reformulated-oxycontin-oxycodone-hcl-controlled-release-tablets/

Both 1-bead manufacturing techs Pfizer's Embeda ALO-01 and Purdue's OxyContin OC have manufacturing problems. OxyContin OC has been taken off the market in 2010 and Embeda ALO-01 has been recalled/stopped since 2010.

Until Pfizer solves the manufacturing problems for ALO-01, it cannot be expected that the FDA would approve 1-bead ALO-02! 

This was rebutted by Dr Low: 

No, a 505b2 is available only if the active ingredient is the same. The Embeda approval did not rely on Purdue's oxycontin in any way. It is totally illogical to try to link the AL)-02 approval to any manufacturing issues that Purdue may or may not be having

As the pro-ELTPs hissed, Lasers was busy brainstorming, and fired off another interesting speculative notion:

How about this as a speculation?

If the partner for ELI-216 Phase III trial is Watson/Actavis. Watson foots the cost for the ELI-216 Phase III and in return Watson and Elite structure a contract for Elite to apply it to Watson Morphine Sulphate opioid product that is in competition with Pfizer/King Embeda.

Elite's new 15,000 sq ft manufacturing space is idle.

Elite keeps 100% of the profits for ELI-216 oxycodone/naltrexone and in turn JVs with Watson to manufacture Watson's Morphine opioid at Elite's NJ 30,000 sq ft facilities.

Expected cost for Elite's FDA 300 person ELI-216 Phase III trial is $7 mil. Watson funds it and Watson gets $7 mil back many times over with the profits from the successful marketing of its new Morphine agonist/antagonist ELI-216 2-bead product manufactured by Elite for Watson.

Ongoing concern/speculation over who will finance ELTP and their products is surging.  There has been significant interest during the last two years from various companies like Actavis, Socius, HlTK, EPIC, TPN and TAGI (as noted by poster Tangerine).  July 1st is around the corner, stay tuned for more!

OTC Equity Profiles ELTP

Here is that OTC article that is currently making it's way through investment boards...

Elite Pharmaceuticals, Inc. (OTCBB: ELTP) Continuing Development of Oral Controlled Release Product Formulations It was a wild few days for Elite Pharmaceuticals, Inc. (OTCBB: ELTP) last week as shares of the specialty pharmaceutical company dedicated to developing and commercializing oral controlled release product formulations hit a six-month high of 0.1740 on Tuesday, fell to a low of 0.111 on Wednesday, climbed to 0.1498 on Thursday before closing out the week at 0.1200. With the volatility came high trading volume as ELTP consistently topped their average while investors looked to find the right time to jump in. ELTP has started the trading week off in the same spirit as last with their share price bouncing from a low of 0.1171 up to 0.1400. Those shares are currently trading around the 0.1310 level, just above their 50-day moving average of 0.1266 and their 200-day moving average of 0.1008. The only news coming from ELTP as of late was their announcement back on May 22, 2012 that they had been issued a U.S. Patent entitled “Abuse-Resistant Oral Dosage Forms and Method of Use Thereof” by the United States Patent and Trademark Office (USPTO), a patent that ELTP says will further protect their proprietary formulation for abuse resistant products utilizing the pharmacological approach. Company CEO, Jerry Treppel, called the patent issuance, “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.” Given the steady rise in prescription drug abuse the controlled release products developed by ELTP could have a significant role in how drugs are administered in the future. At the moment ELTP has four ANDA products partnered with a sales and marketing partner; two of these ANDA’s have launched, one ANDA is in the process of a manufacturing site transfer and a fourth ANDA is currently under review by the FDA. Their lead pipeline products include a once-daily abuse resistant opioid, and a once-daily opioid. They are sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. These products are in a Phase III pending stage. Back in March ELTP announced that they had entered into an agreement to develop, for a private Hong-Kong-based company, a branded prescription pharmaceutical product. Under the terms of that deal the private company would provide the formulation for the product and ELTP would undertake a development program for the product. This deal certainly has some advantageous for ELTP as the private company will be responsible for the filing of the New Drug
Application for the finished product and the NDA will be filed under that company’s name. Once the NDA has been approved ELTP will retain certain rights to manufacture the product while the private company maintains the responsibility for the marketing and sales of the final product and ELTP will be paid milestone payments for the development work. The big question investors have for ELTP is where are they headed, the company seems to have their hands in a lot of different areas right now but according to their most recent quarterly report, for the period ended December 31, 2011, they identified their strategy as “focusing its efforts on the following areas: (i) development of Elite’s pain management products, including abuse resistant products, (ii) set up and launch of approved generic products; (iii) the development of the other products in our pipeline including the eight products pursuant to the Epic Strategic Alliance Agreement; (iv) commercial exploitation of our products either by license and the collection of royalties, or through the manufacture of our formulations, and (v) development of new products and the expansion of our licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations.” It’s hard not to have some respect for ELTP given what went down with the FDA back in March 2011 when they decided to pull 500 cough/cold and allergy related products from the U.S. market, among them the daily allergy products manufactured by Elite, Lodrane 24 and Lodrane 24D. ELTP didn’t duck this obstacle or use it as an excuse to their shareholders, instead they have worked hard to move forward and if things work in their favor there could be a nice reward for shareholders who built a strong position at a low price.

Here is that product list

Methadone Contract mfg - Launched jan 2012 Phentermine
ELTP Generic - Launched April 2011 Hydromorphone
ELTP Generic - Launched March 2012 Naltrexone
FDA supplement - Change of facility Undisclosed ANDA TAGI.
Pending FDA Approval-Scheduled Drug New ANDA recent App
Pending FDA Approval Epic 1
Pending FDA Approval Epic 2
N/A Epic 3 N/A Epic 4 N/A Epic 5 N/A Epic 6 N/A Epic 7 N/A Epic 8 N/A Lodrane D
Launched August 2011 Lodrane 24
ECR working with FDA - 3rd-4th qtr 2012 Lodrane 24D
ECR working with FDA - 3rd-4th qtr 2012
HITK 100m generic
Development/ Pending FDA Appr. -1/2011 Hong Kong NDA Develop.
In development  Signed March 2012 Mikah Development NDA
In development? Isradipine
Pending FDA App. - Transfer work begun Phendimetrazine
Pending FDA App. - Transfer work begun Eli 216
Scaleup of commercial batches-Patent for formulation approved Eli 154 - Need partner for half (Editor - I think this was ditched.)