Tuesday, May 22, 2012

Elite Pharmaceuticals Announces Issuance of U.S. Patent for Abuse Resistant Oral Dosage Formulation

What a good long fight to win a patent of significant proportions.  This is a major battle the ELTP team has won after years of grappling with TPTB.

NORTHVALE, N.J., May 22, 2012 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP.OB - News) 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.

How will this fact impact ELTP's PPS?  Opinions are overwhelmingly positive in the chatboards, but who listens to those, right?  There is a poster going by the name Dr. Lowenstein you may see popping up on boards discussing information on ELTP.  It appears that he been given the magical gift of distraction.  His famous quote tagline is "LOL," and makes us all knowledgeable that ELTP has competition. And yeah there's a ton of other stories about life on the chat boards.  The speculation is interesting and makes our days, weeks, years go by.  Remember these people don't do what they do for free, it costs money to hold a beast like ELTP down for so long.  Facts are facts, investors.  And without question the person doing the most consistent/active DD on the boards is pagiantmetsknicksfan. Here is one of pagiantmetknicksfan's popular posts: 

(Editor's "Objective" Disclaimer -- Sorry Dr. Low, you don't have any worthy DD to add here.  The only real testimony to your DD is your ability to find weaker products from competitors to downplay this patent.)

The big news is Elite is getting the patent for their abuse resistant opioid technology. This patent can be used to develop abuse resistant versions of pretty much every opioid based drug.

Here is the patent App#, review for yourselves - (App# 12/478,952)

The opioid market ~ 20 billion dollars a year. Elite's closest competitor is Embeda which uses a core of Naltrexone but that product was pulled from the market for mfg issues.

Patent supports Eli 216, Elite's PH3 $800m, once a day abuse resistant oxy pill. You won't find one on the market.

While this is huge, there are so many pending items. Here is the list. Also, below is the list of IDs used to manipulate and confuse on this msg board. My opinion, verify everything for yourselves.

Elite has been moving forward, rapidly growing its pipeline, partners and revenue sources. Most of the revenue producing products are just recently approved/launched. Many more are close.

Cash flow positive? - ~500k from the NJEDT from their program to assist companies. Elite was ~500k in the red the previous Q on just R&D, Phntermine and newly launched Lodrane D. The CFO noted that R&D revenues were continuing as they were. Simply add in the 500k, the launch of generic methadone and hydromorphone.


Operating profit - Based on the items above, as well as the items noted below. Should be close based on current projections in Q1,and met in Q2.


Approval/Launch of generic Naltrexone - Inspections in August. Supp. application for change of facility ~November/December

Approval and Launch -4th ANDA - Also inspected in August. Due any time

New R&D for Hong Kong Pharma. Elite is contract developing an NDA - Product already exists overseas.

Upcoming launch of 1st of 8 Epic drugs - Profit split and milestones. Submitted to FDA quite a while ago

New Hi-tech (HITK)- Partnership on generic of $100m branded product - development and manufacturing deal. Been working on this for over a year. Milestone, R&D and profit split

Actavis/Mikah products for contract mfg - (Isradipine, Phendimetrazine) and working R&D MIK001. Elite is making Mikah's leading products per their website. Tech transfer began quite a while ago. Again, waiting on the FDA. Note that Mikah has increased the number of products on their website, with many approved ANDAs. We will see if Elite will be making these too.

Lodrane 24, 24D - expected return- 3rd, 4th quarter - 1 year ago, Elite hit operating profit on these two products alone. Then the FDA pulled 500 cold meds. Being worked as an NDA with Elite providing support.

Socius funding - Elite has access to 5m in funding if they need it for PH3 of Eli 216 or other projects

And Eli 154 - Once a day oxycontin - Elite has a partner willing to fund half, need second half

Another pending ANDA - submitted more recently

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