Wednesday, December 18, 2013

Elite Pharmaceuticals: Swinging For The Fences

OTCQB:ELTP
Editors' Note: This article covers a stock trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.

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 Announces trials started for ELI-201 and next products scheduled
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.
  1. Will the product relieve pain and perform similarly, i.e. is it "bio-equivalent" to the branded product?
  2. Will Naltrexone be sequestered?
  3. 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?
Just based on the science of the product, answer three seems to be clear and this study re-enforces what management obviously believes as does Pfizer for that matter as they pursue their one bead product. The first two questions will be settled soon but since Elite is already a very capable drug manufacturer being led by incredibly experienced industry veterans who are personally invested, and trials are being managed by Camargo a leading expert in the field, the odds are very good.

THERE'S MORE!!!!

Wednesday, December 11, 2013

Does America's Pill Epidemic Strengthen ELTP's Position For Investors?

Wouldn't long term investors like to know what the future holds for Elite Pharma?  Does the Affordable Care Act benefit from an abuse resistant drug? 

Is management really giving a fuck about investors?

Why didn't their latest PR, which stated ELTP was entering into human bio studies, shoot this baby to the North Pole?  In fact it's been all red since the drop...

Is December just a throwaway month for the market?

Who has the upper hand in the ongoing epic saga that is Tangerine vs. Dr. Lowenstein, lolol.

All these questions and the funniest ELTP fanatic name.   The votes are in and the funniest commentator name in all website threads is, by far, Gay Louis.

Good luck, investors!

Wednesday, October 9, 2013

Your ELTP DD Root Source

10 GREAT DD Links for You to Absorb.  For investors new, long and undecided - allow these to help pave the way. 

1) http://www.wsw.com/webcast/rrshq23/register.aspx?conf=rrshq23&page=eltp&url=http%3A//www.wsw.com/webcast/rrshq23/eltp/

2) http://seekingalpha.com/article/1518902-elite-pharmaceuticals-ceo-discusses-f4q-2013-results-earnings-call-transcript

3) http://seekingalpha.com/article/1688112-elite-pharmaceuticals-call-it-a-comeback-story

4) http://seekingalpha.com/user/4199131/instablog

5) http://investorshub.advfn.com/boards/read_msg.aspx?message_id=92544794

6) http://investorshub.advfn.com/boards/read_msg.aspx?message_id=92373368

7) http://investorshub.advfn.com/boards/read_msg.aspx?message_id=92212898

8) http://investorshub.advfn.com/boards/read_msg.aspx?message_id=92170858

9) http://investorshub.advfn.com/boards/read_msg.aspx?message_id=92034478

10) http://investorshub.advfn.com/boards/read_msg.aspx?message_id=87338918

Article - Elite Pharmaceuticals: Call It A Comeback Story

From a ELTP "long" investor.... In my previous article published on May 28th titled Actavis: Abuse-Deterrent Opioid Connections, I noted connections and relationships to watch for between Actavis (ACT) and several companies. As it turns out, several of these companies have played a role in the re-emergence of the relatively unknown Elite Pharmaceuticals (ELTP.OB). This article will examine these recent events and evaluate the opportunity this presents to investors. In my opinion, this is an incredible comeback story that will not go unnoticed much longer. About seven years ago, Elite Pharmaceuticals traded on the AMEX, was popular among investment firms, and had a bright future with controlled release and abuse resistant opioid technologies. However, mistakes by management, coupled with the down turn in the economy left the company short of being able to attain their goals and on the verge of bankruptcy. An interesting read is this 2006 interview in the Wall street Journal with the former CEO Bernard Berk. Elite was an innovator but ran out of time and money when the market crashed shortly thereafter. The technology was there but the financial sustainability was not. A stock that used to trade for dollars now trades for eight cents. But that is starting to change. What has happened since May 28th? In June they announced sales of their existing drugs resulted in a record quarter. In August they announced senior management from Actavis has taken over key roles at Elite. In addition in August they announced numerous FDA approved drugs have been added to Elite's growing pipeline. In their most recent earnings conference call Elite announced they were on the verge of getting their abuse deterrent products into the final stages needed to garner FDA approval. During the Rodman and Renshaw Conference, CEO Nasrat Hakim noted that they have been approached by several companies regarding Elite's technology including meetings with a CEO the day before and the Chairman of a major pharmaceutical company two weeks prior. Elite previously cited in their filings "doubt as to our ability to meet our business objectives and to continue as a going concern." Their most recent 10q removes that language. Read the rest of the article here: Seeking Alpha ELTP Article

PR: Elite Pharmaceuticals Announces Manufacturing and License Agreement for Twelve Generic Products

Read This PR! Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) announced today the signing of a Manufacturing and License Agreement ("Agreement") with Epic Pharma, LLC ("Epic"). Pursuant to the Agreement, Epic will have the right to manufacture, market and sell in the United States and Puerto Rico twelve generic products owned by Elite. Of the twelve products, Epic will have the exclusive right to market six products and the non-exclusive right to market six additional products. Epic is also responsible for all regulatory and pharmacovigilance matters related to the products and for all costs related to the site transfer for all products. Pursuant to the Agreement, Elite will receive a license fee and milestone payments. The license fee will be computed as a percentage of the gross profit, as defined in the Agreement, and earned by Epic as a result of sales of the products. The license fee is payable monthly for the term of the Agreement. The first milestone payment is due on or before November 15, 2013. Subsequent milestone payments are due upon the filing of each product's supplement with the U.S. Food and Drug Administration ("FDA") and the FDA approval of site transfer for each product as specifically itemized in the agreement. The term of the License Agreement is 5 years and may be extended for an additional 5 years upon mutual agreement. "We are delighted that Elite elected to further develop our partnership by awarding this licensing agreement to Epic for these recently acquired products. This is a natural extension of our ongoing collaboration with Elite and allows Elite to leverage Epic's ability to manufacture on a large scale," said Jeenarine Narine, President and COO of Epic. Nasrat Hakim, President and CEO of Elite, stated, "Epic continues to be a valuable partner to us. Epic is able to provide significant manufacturing resources for making these large volume products and this will allow Elite to maximize our profit potential for our generic business while we devote our resources to the development of our abuse resistant products utilizing our proprietary technology."

Tuesday, October 1, 2013

Investor Asks a Great Question

Elite's major inside owner, Epic converted out of their Preferred. 8k released They were the major holder by far and insiders of the company. This represents almost all of Elite's preferred shares. Almost all gone except scraps... The CEO just noted they have been having discussions with major pharmaceutical companies on partnerships very recently including the CEO of one and the Chairman of another..... Listen to the R&R investors conference Why did Epic do this? A) To sell their shares? b) They didn't like having preferred shares because it made them feel superior which left a bad taste in their mouth? c) Because of substantial events upcoming which they and the company would be better served for them to be in common shares? Now before everyone starts picking A because they already sold their shares.... Epic already had plenty of shares to sell which would last them many, many quarters, can't sell these for 6 months, and is restricted in what they can sell and how often, so we KNOW selection "A" is not the correct answer. So it is B or C.. ?

Tuesday, August 13, 2013

Nasrat Hakim is New President and Chief Executive Officer of ELTP; Doug Plassche Named Executive Vice President of Operations

Nasrat Hakim and Doug Plassche are now heading up Elite Pharmaceuticals in an effort to bring a grip of drugs to the marketplace. A series of events beginning with last week's acquisition of 12 (+1 anda) patented drugs from Mikah. Volume up, selling down. The rumor mill is sweltering and has a good vibe, and importantly, ELTP's move to bring these guys in to fill big shoes appears a subtle stroke of genius at the moment. Lets not forget that earnings are due out this week, so all hopes are for this reporting to really take things up a notch. Historically, during the last 3 years, earnings have been one let down after the next, until last quarter when signs of life finally arrived. Cautious investors are careful not to fall victim, wisely, to some makeshift crew. But ELTP is trying to side-rail these notions and become a legit threat to market share. Things are getting interesting, but the outcome is far from predictable. Stay tuned...

Wednesday, July 3, 2013

$ELTP Conversations (Ihub high and Dr. Low points)

Just squirting around the Ihub boards and here's a recent summary of the soap opera-ish developments of Elite Pharma.  Lots of waiting and a decreased PPS allows for a lot of drama on both sides of the prospective outlook on the company.  And while on paper, and on the C.C. with top management, the company appears poised for prosperity, there are plenty of naysayers offering bashlines that haven't faded.  A lot of investors felt that at the .07 range, the company would be well priced for a public takeover, but there's not much to go on to substantiate this to be in the interest of the co. or its investors.  Indeed with such a mighty strong looking pipeline, and recent news, the PPS would have shot up to challenge the .25 range we remember from a couple years back.   The gamble is that any of the available speculation should be considered, and there's a lot to sift through if you can handle a hefty load of garbage filler posts.  Be ready for anything, ELTP is loading the boat on hope and pipeline, see if it runs.  

Aqua Says: I'm certain with the 8 commercial and partnered drugs, 2 ADT/ART patents, record breaking earnings in company history, LPC financing, and clinical trials starting by the end of this year that Jerry and his team are building a super hot rod company. Cheers!

Big Green 101 says:  If I was to get investors involved in ELTP, I would focus on 1) the multi-products the they have and 2) Revenues - (they) appear to be growing. (Still cautious on the point of growth which will be known in the next reporting period soon.)

Tangerine says:  How many OTC companies have numerous FDA approved drugs? Have record revenues, far exceeding what most thought they would be? Drive positive cash ? The numbers are speaking for themselves at this point...

Or what is really amazing is how many drug companies have what 8 drug companies as partners in the business on various products including the development of both generic and branded products for them...

All these drugs bring revenue and its obvious some are really settling into a groove. Some are still pretty new and we have three more approved not even incuded in those revenues. And generic of half of Qysmia should do very very well as should Naltrexone.

And another dozen in the pipeline - that is a fact.

Dr. Lowenstein says: 
Lol lol all that and a 7 penny.

B_MT says:  8 FDA approved products, $10 million line of credit, awarded two patents for ART/ ADT tech,human trials by year's end, highest quarterly revenue in company history......THAT IS PROGRESS!

Tangerine also added:  I have given you the numbers many times. In the Q for sept 2011, the fully diluted count was at 454m. This includes all the warrants, milestone shares, preferred. It is now at about 527 with LPC deal. For all these shares to come to light, that would mean the following

1)All the warrants converted - lots of cash to Elite

2) All the EPIC drugs were filed and approved - Pretty much straight profit to Elite forever, and warrant conversions....again lots of cash

3)Preferred converted which means the little remaining finance dilution from old bad deals is completely over. Almost over now

4)We cashed in all the LPC funds to fund many trials and studies - However if all the warrants cashed out, we wouldn't need this money would we? So you can't really claim both.

And this doesn't include Novel which changes everything

And if all these things happened and all these shares came to light and lets say the number was at 500m....(old warrants will be coming off) the market cap at the current PPS would be about 40m dollars.

I have a current value on Elite of about 125m dollars now. You think with 20-25 drugs bringing in revenue, all the studies and ADT products, all the other products and partnerships that would come in this timeline, the company would only be worth 40m dollars? It would be worth a lot more then that without the abuse deterrent products!!!!

Lets be real here. The is ridiculously undervalued as it is. Add all those other items and what is the company worth? And for all these shares to come to light I think we are in the 15-20m in cash range. You have any idea how many products they could develop with that cash?

And this still doesn't include Novel

Sunday, June 30, 2013

$ELTP Poised and READY FOR BLASTOFF

All the pieces are coming together for Elite Pharmaceuticals. 



The question is when and how the following points, as posted by NASDAQ2020, on the iHub boards, will be executed and ... well you can take a guess.  Anything could happen.  Shit, maybe the Dr. will prove right.  Fuck that, we're here for positives and that lunatic is all about inciting mini-doubts and planting the seeds of hate.  Guilty on all charges... We move forward, don't worry about the PPS and the douche-bags scaring everyone.  With all the surprises in store, we obviously don't want to get carried away and say things we can't possibly support by fact.  Wish away, but remember that this is STILL, somehow, just a 7 cent stock until some of the other components defog/defrost and crystallize an upward motion of ELTP.  We're rooting for management not to fuck this one up.

--Billion dollar pipeline made up of a complete line of NDA and ANDA abuse resistant (ART) opiods and multiple generics
--8 FDA approved drugs: hydromorphone, phentermine 37.5 mg, lodrane D, methadone, phendimetazine, phentermine 15mg, phentermine 30mg, naltrexone 50mg
--Manufacturing revenue for the 4th quarter(2013 fisical) totals $969 for an increase of $569K, or 142% from the previous quarter.
Royalty & Lic. revenue for the 4th quarter(2013) totals $368 for an increase of $212K, or 135% from the previous quarter.
Lab fee revenue for the 4th quarter totals $187 for an increase of $76K, or 68% from the previous quarter.
--4th quarter 2013 1.5 million in revenues best in co. history
--launched drugs continue to gain market share
--cash flow positive (CFP) possibly next quarter, not including R&D cost, the Board of Directors making break even operations essential
--$10 Million equity line of funding secured from Lincoln Capital Fund (LPC) 04/22/2013 for product development, temporary working capital, pilot studies and trials used $320k so far
--600 % increase in market cap in 2 years
--out standing shares 374K
--ELI-154 24 hr ER oxy (w/o ART) still in scale up will be sold on the European market looking for a partner
--12 hr oxycodone with ART starting pilot studies calendar 2013 for a 3 Billion dollar market will pave the way for the once a day which will only have to demonstrate (prove) bioequivalence to the twice a day formula
--ELI-216 is a controlled release 24 hr NDA abuse resistant(ART) oxycodone requiring Phase III clinical trials
--a partner for commercialization of ELI-216 will be done once human data gathered(multiple short studies required) then discuss with FDA JT wants to license after studies and trials complete making it worth much more due to the steep accretion curve in the pharma field
--ELI-216 is a priority with Elite and further along than most people think, per the CEO
--FDA likes the pharmalogical approach to abuse resistance per the CEO
--1st patent for ELI-216 8/182,836 abuse resistant oral formulations and method of use thereof (approved May 22, 2012) method for making an abuse resistant drug
--2nd patent for ELI-216 8/425.933 formerly 12/640,344 (04/23/2013) combined with first patent, gives Elite 20 years of propietary protection on their 2 bead ART: formulation to make an existing drug abuse resistant
--patent 13/863,764 Child Continuity Data strengthens Elite's patent protection of 2-bead ART giving it triple patent propietary protection
--2-bead abuse resistant opiods could replace the inferior abuse deterrent(easily defeated) opiods now on the market
--Elites ART is modular (plug and play system), not for just oxycodone it can be used on ALL opiods just add a different opiod bead to the standard sequestered naltrexone bead
--NE 30 polymer for sequestering naltrexone was found to be far superior to other polymers
--Elite has advanced the development of this technology(twice/day) through commercial scale up 05-2013
--The Company expects their first commercially scaled-up, abuse-resistant opioid(twice daily) product to enter human pilot studies late calendar 2013, Work has also been conducted on another abuse-resistant opioid product(once/day)
--Elite may license these ART products at a later date to a third party who could provide funding for the remaining clinical studies and who could provide sales and distribution for the product.
--BE and PK studies for ART progressing, some were due finished by March 31, 2013
--Patent pending 13/379,481 microtablets for use with Elite's abuse resistant products
--Patent pending 13/379,486 microtablets 0.25-1.0mm, smallest in the industry for use with ALL medicines
--patent 12/075,816 for Sequestering polymer acrylic co-polymer composition: ON HOLD while Elite and lawyers Washburn & Woodcock strategize to add more claims

***The recent guidances and actions by the FDA related to extended release opioids and specifically oxycodone demonstrates the FDA support for abuse resistant technologies
Opioid products incorporating abuse resistant technologies have become a public health priority and these recent actions appear to be a major step towards the FDA eventually requiring that all extended release opioids utilize these technologies.
January 9, 2013, the FDA released its new draft guidance document, titled "Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling". The document discusses what it will take for an opioid formulation to secure an abuse resistant label. The implications for companies that meet these expectations are significant and even more so for those that meet these requirements and have patented abuse resistant technologies.
March 2013, 48 state attorney generals called on the agency to require generic makers to produce tamper-resistant versions of opioid medicines
--the STOPP ACT - a bill before Congress NOW, introduced by US Rep's Rahall, Rogers and Keating. The law will prohibit any old-formula opiod from entering the market if the FDA has an equivalent abuse deterrent/resistant opiod approved
--CLADD petitions FDA to reject all opiods without ART
--FDA's Purdue ruling April 16, 2013 : prohibits new original non-abuse resistant oxycodone from being made in generic form, unless it has an abuse deterrent/resistant properties. FDA will not accept or approve any ANDA applications based on the original OxyContin formulation
--the FDA decision basically requires generic companies to buy or develop their own abuse deterrent/resistant technology: it effectively eliminates much of Elite's competition which has no ART thus making Elite's 2-bead ART MORE VALUABLE
--going foward all new generic and probably NDA branded opiods will be required to have Abuse deterrent/resistant properties
--May 10, 2013 Endo Health (ENDP) ruling
--Elite's Competition being taken out one by one by the FDA
1) Pfizer PFE
2) Endo Health ENDO
3) Pain Therapeutics PTIE
4) Acura Pharma ACUR
5) Durect Corp DRRX

--Elite owns approx 10% of Novel Labs, Gavis and recently Wintac: Novel and Elite have an ongoing dialog for monetization a lot goes into determining the value of a private co.
--Novel Labs adds to Elites value estimates for Novel's value range from 10 to 50 million dollars CEO admits value is worth more than their initial investment
--There are accordingly a total of 30+ products including a generic morning after (PLAN B) pill currently identified as being approved/marketed by Novel and Gavis, with such total representing an increase of 4 products as compared to a comparable point in the prior year
--Novel has provided to the Company, copies of its prior year tax returns and management prepared forecasts showing growing revenues
--CEO and officers being paid with stock
--CEO Jerry Trepple loaned the co. 1 million dollars unsecured (non-dilutive) 600k used considering taking stock as repayment of loan
--CSO of Elite is Epics president and works for shares of ELTP
--VP @ Actavis/Mikah is a special consultant to EPIC
--COO President Chris Dick replacement will be an expert in 505 b2 development per the CEO
--multiple partners have no concerns: Watson/Actavis, Mikah, Epic, TAGI, The Pharm Network, ECR, Precision Dose, Celgene Corp, TPN/Ascend, Novartis, SmithGlaxoKlein and the undisclosed Hong Kong Pharma
--interest paid in full on loans
--New Jersey(NJEDA) tax credits
--contracting deals with other pharmas
--TWO 15,000 sq/ft FDA-DEA-cGMP registered manufacturing labs for research, development and manufacturing from concept to commercialization
--NEW packaging line operational and adding revenue to the bottom line by making and saving the co. money
--29 employees double of two years ago
--4 drugs in * SCALE UP *
--phentermine 15 & 30mg launched (April 11, 2013) is competing with Qsymia(phentermine and topiramate)
--current API supplier for phentermine has reduced its cost thus increasing profitability and making product more competitive
--approving additional sources of API may increase profits further
--Acend Labs has new contracts for methadone
--hydromorphone best quarter ever(ending Mar 31, 2013)
--Hong Kong Pharma NDA development over a year to go
--MIK-001 505b2 NDA maybe an improved Embeda on schedule in development
--HITK's intermediate for a generic of a branded 100 million dollar drug
--first of 8 Epic drugs due out anytime(from the Stategic Epic Alliance)
--505(b)(2)opportunities's for 12 hr ART generics and NDA's where Bio-equivalency studies alone are enough (no phase III)
--Naltrexone FDA approved, launch pending (July-Aug 2013) production began late June 2013
--citizens petition with FDA for 100% owned ANDA 12hr ext release brompheniramine pseudophedrine (Drixoral equivalent) antihistamine/decongestant to compete with Avanthi Inc generic
--Lodrane 24D equivalent waiting on feed back from FDA they will tell them which pseudoephedrine salt to use and which product to use to run trials against
--undisclosed 100% Elite owned ANDA approx 1 year
--CEO's goal is to commercialize a COMPLETE LINE of abuse resistant opiods
--Uplisting to the NASDAQ exchange per the CEO, IR indicating ASAP, may include RS with blockbuster launch partner so to maintain PPS
--CEO obligated to look at ALL buy out offers obligated to maximize shareholder value

Wednesday, February 6, 2013

Elite Pharmaceuticals Adds NALTREXONE Officially


ELITE PHARMACEUTICALS ANNOUNCES FDA APPROVAL OF SUPPLEMENTAL APPLICATION FOR NALTREXONE
NORTHVALE, N.J. – February 6, 2013 – Elite Pharmaceuticals, Inc. ("Elite”) (OTCBB: ELTP) announced today that on January 31, 2012, the U.S. Food and Drug Administration approved the Company’s supplemental application for the manufacturing and packaging of naltrexone hydrochloride 50 mg tablets.  This approval will allow the Company to commence the commercial manufacturing and packaging of this product for its sales and marketing partner, which will distribute the product as part of a multi-product distribution agreement.
Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid addiction.  For the twelve months ending December 31, 2012,  Revia® and its generic equivalents had total U.S. sales of approximately $16 million according to IMS Health Data.

 Why is this important?  This is a golden opportunity for the growing Elite.  They have a chance of reaching into the market for this drug giving them more leverage as they create a money stream heading north.