ELTP Stagnates - What is Brewing?

There is so much speculation about what is happening with Elite Pharmaceuticals.  Will they be bought?  Will they release drugs as planned?  Will there be a reverse-merger?  Will they not do a damn thing?  Hey, all sides MUST be looked at, right?

Well, here are a few links you DD addicts want to know about.

Canadian Patent Info:
http://brevets-patents.ic.gc.ca/opic-cipo/cpd/eng/patent/2541371/summary.html

Extract:

Extended release formulations for the delivery of opioid agonists, including
oxycodone, are provided which exhibit low peak to trough plasma concentration
fluctuations and sufficiently high plasma concentrations over an extended
period of time to provide a once a day dosage administration, wherein the
formulations provide pain relief for up to 24 hours. The extended release
formulations may be customized to achieve the desired plasma concentration
profile, e.g. two or more different extended release drug-loaded pellets or
granules may be combined in a formulation. Additional formulations include
combinations of drug loaded and extended release opioid agonists-loaded
pellets or granules. Other formulations include a combination of an opioid
agonist and an opioid antagonist, as well as a combination of an opioid
agonist and a NSAID.


European Patent Info:
https://register.epo.org/espacenet/application?number=EP04789144&tab=main

Publication	Type :	A2   Application without search report
	No. :	EP1677768
	Date :	21.04.2005
	[2006/28]
	Type :	A2   Application without search report
	No. :	WO2005034859
	Date :	21.04.2005
	[2006/28]
International search report:	Date:	14.07.2005
	Authority:	US
Classification	International :	A61K9/22, A61K9/20, A61K9/14, A61K9/16	[2006/28]
Designated contracting states	AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IT, LI, LU, MC, NL, PL, PT, RO, SE, SI, SK, TR    [2006/28]
Title	German :	FORMULIERUNGEN VON OPIOIDEN MIT VERZÖGERTER FREISETZUNG UND ANWENDUNGSVERFAHREN DAFÜR	[2006/28]
	English :	EXTENDED RELEASE FORMULATIONS OF OPIOIDS AND METHOD OF USE THEREOF	[2006/28]
	French :	FORMULATIONS D'OPIOIDES A LIBERATION PROLONGEE ET METHODE D'UTILISATION DES FORMULATIONS	[2006/28]
Entry into regional phase	03.05.2006	National basic fee paid
	03.05.2006	Search fee paid
	03.05.2006	Designation fee(s) paid
	03.05.2006	Examination fee paid
Examination procedure	03.05.2006	Examination requested   [2006/28]
Fees paid	Renewal fee
	11.09.2006	Renewal fee   patent year  03
	12.09.2007	Renewal fee   patent year  04
	15.09.2008	Renewal fee   patent year  05
	11.09.2009	Renewal fee   patent year  06
	14.09.2010	Renewal fee   patent year  07

From a Post RE: Elite (eltp)

The following is a post from one of the message boards with some good Elite DD.  Here ya go...

Elite Pharmaceuticals is a manufacturing company. Previous management ran it as a mostly R&D shop pouring 10s of millions of dollars into their technology. This includes R&D, settlement with the original inventor, and ultimately some dilution to keep the company out of bankruptcy. The company on the brink of bankruptcy in 2009 changed management and began on a more stable path.

The plan?

Focus on manufacturing generics while continuing to move forward with their unique and powerful patent pending pipeline. This would allow for profitability, partnerships with top notch partners and a long term future. There were offers from companies to buy out Elite but ultimately the company found solid enough ground to maintain their ownership and move forward.

Management and ownership

Elite has a unique relationship with Epic Pharmaceuticals. Go to their website and see who they are. Epic has over 200 employees. Epic and Elite share board members and the Chief Scientist. These folks own very large quantities of Elite stock. Jerry Treppel, Elite CEO takes a minimal salary and receives the rest in stock. I also am pretty sure he was a large investor in Elite prior to the stock price demise in 2009 and has taken this role to help ensure that investment pays off. Recently, there have been numerous stock purchases by Elite Insiders. Go read the form 4s!!

Also in the most recent conference call, it was established that Elite is not looking for a reverse split and fully intends to get back on the big boards without this being needed. Calls to IR reveal, they are actually targeting the Nasdaq which means dollars per share.

Epic has purchased ANDAs for Elite. Epic has warrants for huge blocks of Elite stock that can be exercised to ultimately own a majority of Elite. Over 100 million shares I believe at .065. In the recent agreement with Epic, all in the SEC filings, Epic continues to use Elites facility which is either in the process or has already completed a large expansion. Elite will gain 15% of the profits of 8 drugs made by Epic at the Elite facility. This is just Elite collecting a large check and riding Epic who stands to benefit the most from the increase in PPS. Elite’s facility is on the front page of Epics website. Epic has a bunch of FDA approved ANDAs on the FDAs March approval list. Elite has the drugs below noted as well.

ANDAs for Phentermine, Hydromorphone as well as a yet to be disclosed two drugs have been assigned over to Elite from Epic. A gastro intestinal drug is in the works. These drugs along with Naltrexone have domestic sales in excess of 120 million dollars. That is just domestic. Elite’s distribution here is TAGI which can distribute worldwide.

Phentermine was shipped a few weeks ago. Note the stock price rise from this and the Epic deal as well as well as the incredible volume that followed. Also Phentermine received tons of press recently as an effective and possibly preferred diet drug that limits appetite. CNN, MSNBC ran info on this drug on the front pages of their websites.

Hydromorphone and Naltrexone are knocking on the door with a launch pending status. Elite’s facility is an FDA, DEA “state of the art” approved shop that has been making drugs for years. That is no easy feat. Shareholders are reaping the benefits of the millions poured into the facility during the companies R&D stage.

Other drugs coming out:

Go to the Elite site and review their pipeline. Epic is going to develop and provide additional ANDAs to Elite. Elite has done some classified R&D work with Mikah Pharma in exchange for an ANDA Naltrexone. Will work for ANDAs!!! What I still wonder about is, what were they working on? Remember this is a wonderful R&D company that is now fully using their manufacturing facility to be profitable which based on their last statements, have already achieved.

Elite’s technology:

Elite’s specialty is extended release and abuse resistant drugs. They have received and have multiple patents pending regarding this technology. Remember the 10s of millions of dollars they spent that almost put them out of business? That is what it was spent on. Also PH1 and Ph2 trials completed. PH3 is pending to begin with the approval of the patent. Also a European partnership is in the works per the last conference call. WIPO has assigned patents internationally. Go to the WIPO site and read what that means.

Oxycontin – If you watch the news you know how popular this drug is. It is billions of dollars and highly abused. Elite is using their technology to market this drug first although the technology works for other abused drugs and regular drugs as well. Both a 24 hour version and abuse resistant versions.

Elite’s Pharmacological approach – Elite uses Naltrexone to offset the ability to crush the Oxycontin and get high. Remember the ANDA they got from Mikah that is pending launch? That’s right; it’s the same Naltrexone drug. It is used to treat alcoholics and addicts with a high degree of success as it prevents the brain from receiving the ability to absorb the higher concentration of the Oxy.

The pending patent is based on Elites ability to do this effectively and in their own proprietary manner. It can be used with other Opiates. Hydromorphone (Dilaudid) an opiate has similar abuse problems. Yep, again, the same drug noted above pending launch by Elite. Could an abuse resistant Hydromorphone drug be in the works? It would make sense wouldn’t it? Not hard to connect these dots.

Elite’s 24 hour Oxy – Elite has been able to successfully maintain blood plasma levels sufficient for a 24 hour version of this drug. Google 24 hour Oxycontin and see if anything comes up. Elites got this one and the patent is pending. Imagine being able to take one pill per day to maintain relief from pain. Take it before you go to bed every night.

This tech also works on other drugs. These are billion dollar drugs. Imagine one that is also abuse resistant. It could easily become the pain drug of choice. Doctors can feel safer prescribing it as well and patients can maintain their relief from pain without risk of abuse!

The patents for both of these can be found on the Patent website. They are in their 3rd or 4th round of review which is common for pharmaceuticals. Go read them, but I warn you, they are dry and in legal language that takes several readings to begin to understand the arguments. Elite IR has noted to me that the attorneys representing Elite are some of the best in the business.

Recently Elite has been put in articles alongside Pfizer and other major players as the key companies in this field. It is a multibillion dollar field. Little Elite has 100 million float shares and a max count if everything was exercised and then sold by Epic of about 300 million.

Epic has no reason to do this. They are the ones that are going to benefit the most, including some of their executives. They would lose money for no reason. Also consider this; every dollar that Epic puts into Elite, is likely an expense and taken off their tax liability. As Elites PPS goes up, so does Epics wealth. So, effectively they increase their value with tax free dollars. I am pretty sure about this but I am not a tax accountant to be fully transparent here.

Recently generic and abuse resistant drugs have been in the news for a few reasons. There is a major problem with the abuse of prescription drugs especially opiates like Oxycontin. Also the cost of health care is driving the importance of generic drugs. Elites timing couldn’t be better.

So, it can’t all be good right? Elite stands to lose their main revenue source (Lodrane) with this drug, time released and 24 hour versions. Marketed by ECR through HITK, this was a 3-4 million dollar revenue stream. The FDA in March set out a timeline to pull these drugs off the shelves in 6 months. ECR has been working with the FDA since 2010 to keep this drug on the shelves. The main ingredients have been in service for over 45 years and they were not pulled for safety reasons per the ECR CEO e-mail posted on the Yahoo website.

ECR is also working through Congress to keep it on the shelves while they get the FDA all the information required for an NDA. This is going to cost ECR ~5 million dollars and they are spending it. Why? Because it is worth ~15 million to HITK. There has been discussion about keeping the instant version on the shelves as well as a relabeling of the product. This could end up being a “lemons into lemonade” situation. If ECR gets the NDA, they could take advantage of their new increased market share and reduction in the number of competitors.

Note what happened to the stock price when Lodrane was pulled. The stock price dropped back to .04 for a few days or so. I doubled down. The stock then proceeded to blow up with increasing volume as the Epic news rolled in alongside Phentermine shipment news. Lodrane revenue is replaced and Epic ensures Elite will march forward regardless.

Other negatives I have read

1) Dilution – As explained above, Epic would never dilute at the current PPS. First of all they could never dump that many shares. The form 4 would cause a complete sell off as well. That would be committing suicide. Talk about killing the golden goose!!! Any sell off would be reported in the SEC docs.

2) Trellus (Insider selling) Trellus helped finance Elite as explained above. They own ~ 20 million shares. They sell a very small portion of their shares about once a month. My understanding is it is to pay bills. They are way underwater on Elite. Note they haven’t sold during the recent run up. They are holding for the long term. Trellus not really selling despite the run from .04 to .26 tells you they think that better times lay ahead.

3) Lodrane – Addressed above.

4) There is no money in pain medication. One of my favorites

5) There is no money in generics. Just silly and not worth addressing.

6) Elites facility is not FDA approved. They have been used to manufacture drugs for years and are also DEA approved.

7) Bankruptcy – This fear was in 2009 and the deal with Epic ensured this will not be the case.

8) It’s a scam/pump and dump – This Company only puts out real press releases and delivers info via their SEC documents. Their IR person is easily available for discussion. They laid out an outstanding business plan and have been executing it on queue.


9) They are in default – My understanding is you can call of the creditor/manager of the debt and find out that this is not the case. Bridget Schessler is the name I believe. Again, see Epic agreement as well.

10) It takes years to get a drug through the FDA – That’s true, except Elite has been working on this for years and again, 10s of millions of dollars spent. They are closer than ever!

11) Not a profitable company. Elite says they just had their first profitable quarter. Also keep in mind Lodrane is still on the shelves. A good quarter should be forthcoming. I didn’t even get into all the milestone payments they are due for meeting their obligations to HITK and Epic.

Conclusion
The story of Elite is one to root for. A company with outstanding products, R&D, technology almost goes out of business. Then through new management, hanging on by the skin of their teeth they put together a sensible business plan to profitability all the while focusing on their patents. They reach profitability, have Epic backing them and are closer than ever to delivering what they set out to do ~10 years ago.

Their products are in the news, mentioned alongside companies like Pfizer. They are also undergoing a substantial expansion of their facilities. What I have written above is qualitative and actually not everything to be excited about but it helps to understand what is going on with this company and why the stock is moving and likely to move again soon.

However, go do your own research. Go read the documents. Focus on what the company has delivered to the SEC and to their investors. Listen to their last conference call and presentation. Call Dianne with IR. It is not a case of “if” with this stock, it is a matter of when and how fast and how high. I own ~400k shares with a handful to trade so I can increase my total share count. This is my analysis. This is what I believe to be real.

Post of the Longs: Dem Makes DD Easy

FOR BASHERS (in big font)

A lot of the links have sadly been killed... so I've removed bad ones and will continue to provide links to new improved research links in the future...
** ELTP already has FDA Approval on 3 products:
http://www.elitepharma.com/ (See Company Pipeline)

** ELTP signed an agreement with HITK which trades on the NASDAQ at over $23.00+ per share to develop a generic version of a prescription product for which the branded product had sales in 2010 of over $100 million.

** The signature of the HITK:NASDAQ CEO (David Seltzer) is on the ELTP 8-K below confirming their agreement:
http://www.otcmarkets.com/edgar/GetFilin...

** From the post below, ELTP had 1% Institutional ownership two years ago, but now ELTP has 36% Institutional Ownership:
http://investorshub.advfn.com/boards/rea...

** And now, ELTP reports basic net income of $0.06 per share and fully diluted net income of $0.02 per share for its “fiscal” third quarter ending Dec 31, 2010:
http://ih.advfn.com/p.php?pid=nmona&arti...

>> Basic Net Income = $0.06 per share
>> Fully Diluted Net Income = $0.02 per share

The link below confirms that ELTP trades on the OTCBB within the Sector titled Healthcare within the Industry titled Drug Manufacturers – Other:
http://biz.yahoo.com/p/511conameu.html

The link also confirms that the Industry titled Drug Manufacturers – Other has 37.70 as its Price to Earnings (P/E) Ratio. This is important because the P/E Ratio is the multiple that is used with the Earnings Per Share (EPS) to derive where a stock should fundamentally trade. As you can see from above, I could logically use 37.70 as the multiple or P/E Ratio, but I will instead use 12 which is very conservative indeed considering the growth rate for those stocks trading within the Industry ELTP trades. To better understand the logic and importance of the P/E Ratio, please read the link below:
http://investorshub.advfn.com/boards/rea...

Because of the due diligence that have been discussed thus far, I am confident or at least willing to take my chances that ELTP has turned the corner for the better for good by posting their minimum Fully Diluted Net Income = $0.02 per share. This is the ELTP Earnings Per Share (EPS) for its third fiscal year quarter that’s already calculated for us. I’m confident that ELTP will generate a minimum of .02 per share EPS for 4 consecutive quarters to then give it a .08 per share EPS for the year. This means that ELTP will have a fundamental annual share price value of…

.08 Annual EPS x 12 Conservative P/E Ratio = $0.96 per share

This means that ELTP:OTCBB ”should” fundamentally trade within the $0.96 per share price range based on its Fully Diluted EPS of $0.02 per share that was ”officially” released by the company.

For those not wanting to be conservative, we could still fairly apply the ”actual” P/E Ratio of 37.70 for the Industry in which ELTP trades to derived a fundamental share price below:

.08 Annual EPS x 37.70 Actual Industry P/E Ratio = $3.01 per share

This means that ELTP:OTCBB ”should” fundamentally trade between the $0.96 per share and $3.01 per share price range based on comparing and contrasting a conservative P/E Ratio of 12 with its ”actual” Industry P/E Ratio of 37.70 for which it trades. Again, this is all based on its Fully Diluted EPS of $0.02 per share that was ”officially” released by the company.
Courtesy of Hike within the post below, a powerful Power Point Slide Presentation was created that should greatly help investors to also see the potential here in ELTP:
http://www.cliffordpaper.com/Rob/print_s...
http://investorshub.advfn.com/boards/rea...

Post of the Week

This has been one hell of a week for those wacky ELTP message boarders.  Constant bickering.  Pumping, sucking, spitting, bashing, screaming, milking, and doubting hopefuls with weak hands giving shares away to preserve a narrowing margin after last month's nice run-up.  Here's some DD -- FREE!

Report of Elite being 1 of 10 Pharma Companies as a leading company of chronic pain management

http://finance.yahoo.com/news/Reportlink...



1. Shipped diet drug.

http://www.globenewswire.com/newsroom/ne...



2. Massive pipeline worth an estimated $6 billion market with EPIC.

http://www.globenewswire.com/newsroom/ne...



3. Settled lawsuit.

http://www.globenewswire.com/newsroom/ne...



4. Two additional FDA approved drugs next to Lodrane ready to be distributed.



5. Both oxycodone drugs currently in Phase 3 in a multi-billion dollar market (Moses take the wheel if this gets approved).

http://www.otcequity.com/?p=854



6. Reduced spending, cut labor costs, and actually were profitable last year.

http://www.globenewswire.com/newsroom/ne...



7. MASSIVE volume in comparison to past history's volume. Sign of things heating up (shares being held tightly by insiders for quite some time...hmm something seems fishy...expensively fishy).



A bump in the road may come when their two cold/allergy products get pulled from the shelves in 6 months.

http://www.globenewswire.com/newsroom/ne...

Oh Those Yahoo Message Boards...

They are so enticing!  The Yahoo! finance message board for Elite has been one amazing journey.  From the final week of March up through April I've followed it with dedication.  Daily, by the minute, I have read practically every thread on there.

Now, the stock has been in a smashing forward momentum swing that has taken a dive in recent days (4 out of the last five days were red) and the mood of the boards has darkened just a bit.  Seems like for every mess up, there is someone else there ready to pick up the slack and momentum has for the most part, over this period of time, been upbeat and more importantly, profitable if played properly.  I have a few friends who I told the stock about who actually caught it at a high point, and two of them even bought in at .24!

Hey, I never told them to BUY.  I dunno more than the next average chump change investor, I guess.  But what I do know is that Elite has taken amazing steps toward greatness.

Outside of life inside the Yahoo message boards I found this quote today from my Twitter feed RE: ELTP. 

"Hope to see news soooon,if nothing buy,buy,buy end of week more peeps will be out,I just don't understand why someone would sell at these prices,with all ELTP has going for them,when I see a company that only puts out news when it's legitimate,and not just some fluff PR 3 times a week.I see a buy and hold long here,sure it would nice to make some $$$ here and there,but I can handle seeing the red knowing long term the outlook is very promising."

DD - Some incredible links from the wild Yahoo! ELTP message board

1) Elite FDA Approved Phentermine diet drugs have launched, it will bring millions of dollars to Elite's revenue:
http://finance.yahoo.com/news/Elite-Phar...

2) Elite FDA Approved Diet Drug Phentermine deliver results - CNN Report

"Phentermine shown significant promise in promoting weight loss, according to a new report"
http://thechart.blogs.cnn.com/2011/04/10...

3) ELITE 6 BILLION DOLLAR PIPELINE
Two more FDA-approved drugs (Hydromorphone, and Naltrexone) will be launched soon:
http://www.elitepharma.com/product_pipel...

4) Lodrane drugs are still on the market by simply changing its label:

You can buy Lodrane right now, Lodrane is on shelf for sale at CVS
http://www.cvs.com/CVSApp/health/medicat...

http://www.coloradoallergy.com/pdf/ho155...

5) EPIC paid Elite $3.75M for a strategic alliance agreement, adding many more products to pipeline:
http://finance.yahoo.com/news/Elite-Phar...

6) TPN paid Elite $500K for lawsuit settlement, and Elite can make and commercialize Methadone drugs without any restriction:
http://biz.yahoo.com/e/110317/eltp.ob8-k...

7) Oxycodone pain relief drugs are in phase-3 trial, will be approved soon. Pain relief market is worth
$18 BILLION in 2010 and $24.9 BILLION in 2017:
http://www.businesswire.com/news/home/20...

8) New manangement say company is turning around from no drugs approve, to many drugs approved. New management will lead the company to success.
http://www.veracast.com/webcasts/bio/ceo...

9) Elite with Epic Pharma - Largest contract manufacturer in the United States for a large pharmaceutical company
http://www.epic-pharma.com/

My 1st Elite Blog Chart

Big thanks if you are visiting for the first time.  There has been a few of you and I would like to present today's (our 1st as a blog, we're only a few hours old, in fact) traffic chart.  It slightly resembles the chart which shows the recent rumblings for Elite Pharmaceuticals!  Hopefully this trend can continue, though I can't promise numbers even close to as steady as the recent ELTP chart.  I'm thinking by tomorrow I'll be back in the low pennies.  Hey - I have a job, buddy!

Dedicated to the Longs, Part 4

A strong future...

Dedicated to the Longs, Part 3

Believe!

Dedicated to the Longs, Part 2

More coming... (notice labels include Epic's name in black n white!! Epic has our back.)

Dedicated to the Longs, Part 1

Something to look forward to in the near future...

Welcome to Elite Pharmaceuticals' Pipeline

Product Pipeline

Programs Under Development	Branded Products (a)	Therapeutic Category	NDA / ANDA	Development Stage (b)	Partnered
ELI-154 Oxycodone CR Once a day	NA	Pain	NDA	Phase III pending	No
ELI-216 Abuse Resistance Product for use with oxycodone or other opioids	N/A	Pain	NDA	Phase III pending	No
Undisclosed Twice a day	Undisclosed	Anti-infective	ANDA	Pilot BE study complete	No
Undisclosed Once a day	Undisclosed	Gastrointestinal	ANDA	Pilot BE study complete	Yes
Commercial Products
Commercial  Product	Branded Products (a)	Therapeutic Category	Commercial Status	Partner
Lodrane® Once a Day	N/A	Allergy	Launched	ECR Pharmaceuticals
Lodrane 24D ® Once a day	N/A	Allergy	Launched	ECR Pharmaceuticals
Phentermine HCl 37.5 mg tablets	Adipex-P® 37.5 mg	Bariatric	Launched	Precision Dose, Inc. / TAGI
Hydromorphone Hydrochloride 8 mg tablets	Dilaudid® 8 mg	Pain	FDA Approved, Launch pending	Precision Dose, Inc. / TAGI
Naltrexone Hydrochloride 50 mg	ReVia® and Depade®	Opioid Receptor Antagonist	FDA Approved, Launch pending	Precision Dose, Inc. / TAGI