Elite Pharmaceuticals Inc (ELTP)

[Couch]

FOR THOSE WANTING A DEEPER UNDERSTANDING OF WHY ELITE IS A SAFE BET NOW

First one will want to understand some of the societal and political pressures placed on the FDA and pharmaceutical companies to develop abuse deterrent formulation (ADF) opioids as soon as possible.

A) ~~~Chicago sues J&J, Purdue, Endo, Actavis, Teva over opioid marketing
http://www.fiercepharma.com/story/chicago-sues-jj-purdue-endo-actavis-teva-over-opioid-marketing/2014-06-03
Quote:
In the wake of a lawsuit brought by two California counties against five manufacturers of prescription painkillers, the city of Chicago has filed a suit of its own. Chicago is suing the same five companies--Actavis ($ACT), Endo ($ENDP), Johnson & Johnson's ($JNJ) Janssen Pharmaceuticals, Purdue Pharma, and Teva ($TEVA)--alleging, much like California does, that they overstated the benefits of opioid painkillers while deceiving the public about the risks. Chicago filed its suit yesterday, according to Bloomberg.


Quote:
In May, the California counties of Orange and Santa Clara accused the companies of violating that state's false advertising laws, as well as engaging in unfair business practices and creating a public nuisance by reaping profits while turning so many of its citizens into drug addicts. That suit also seeks monetary damages.


B) ~~~Under fire, FDA chief Hamburg defends approval of pain pill Zohydro
http://www.fiercepharma.com/story/under-fire-fda-chief-hamburg-defends-approval-pain-pill-zohydro/2014-03-14
Quote:
Following Thursday's hearing, Senator Joe Manchin (D-WV) introduced a bill to force the FDA to withdraw Zohydro from the market. The bill also would prohibit future approvals of painkillers that don't have tamper-resistant features. A similar law has been introduced in the House.


C) ~~~Congress has given the FDA until June 2015 to finalize its labeling guidance for the manufacturing of abuse-deterrent opioids and included language in the year-end spending package that withholds $20 million in salaries and expenses from the FDA commissioner’s office pending finalization of the guidance and warns the funding will be shifted if the document isn’t out by the due date.

http://insidehealthpolicy.com/sites/insidehealthpolicy.com/files/newsletter-pdfs/fda_current.pdf

Second, one will want to know how serious the FDA is in terms of approving ADF's when the appropriate technology comes along.

A) The FDA dedicated a 2 day conference (October 30, 31st, 2014) to the very topic of developing and regulation of Abuse Deterrent Opioid Medications.

http://www.fda.gov/downloads/Drugs/NewsEvents/UCM420846.pdf

*****As a side note, the following was stated openly to all members who attended.
Quote:
Development and Regulation of Abuse-Deterrent Formulations of Opioid Medications
Dr. Hertz presented FDA’s experience with a review of abuse-deterrent products and how that experience was presented in the draft guidance for industry posted for comment in January 2013 (Abuse-Deterrent Opioids—Evaluation and Labeling). The guidance is currently being edited in light of the docket comments received. Dr. Hertz provided the working definition of an abuse- deterrent product as one with properties intended to reduce abuse but not necessarily prevent abuse. She explained that the field of abuse deterrence is young and the technologies and clinical, epidemiological, and statistical methods for evaluation are new and evolving. The FDA has been taking a product-by-product approach with the goal to incentivize incremental improvement, ultimately leading to all or most opioid products having abuse-deterrent properties.



B) It should also be noted that at the conference both the Branded & Generic ADT Industry Working Groups agreed to the following:
Quote:
Recommendations from the Generic Industry Working Group for Regulation of Abuse- De te rre nt Opioid Formulations
Jason Gross, PharmD, Independent Pharmaceutical Consultant, Aluna Research, presented “Recommendations from the Generic Industry Working Group for Regulation of Abuse- Deterrent Opioid Formulations.” He noted areas of agreement with the Branded Industry Working Group on labeling to distinguish between non-abuse-deterrent and abuse-deterrent products and on the importance of manufacturer(s) working to reformulate or withdraw non- abuse deterrent products when true abuse-deterrent alternatives become available (with time for transition). In addition, the Generic Working Industry Group proposed that FDA: develop abuse- deterrent requirements within each product-specific bioequivalence guidance; provide guidance that clarifies when generics submit different types of applications for approval; consider an expedited review process and reduction of application fees for generic manufacturers; and give special abuse-deterrent formulation designation in the Orange Book. Dr. Gross also reported that the Generic Industry Working Group recommended that FDA influence the process within federal agencies to require all states and CII prescribers (e.g. New Mexico and Vermont) to participate in Prescription Drug Monitoring Programs, and mandate that all health care providers that prescribe opioids have appropriate medical education.



C) The closing remarks at the Conference by Dr. Throckmorton are very telling!
Quote:
The importance of continuing to support progress by reducing uncertainty and by making it clear that there is a pathway to appropriate licensure and appropriate labeling and to do this as efficiently as possible. FDA is working on draft guidance for both generic and innovator products.


SO WHAT DOES THIS MEAN FOR ELITE???

This means as Nasrat has pointed out the FDA will take Elite's ART as is currently and consider if Elite needs to give them additional data. This goes along with the FDA stating it will take abuse deterrent products on a case by case basis. Further, the FDA has conveyed that when Elite has given the all the data they need Elite WILL BE GIVEN EXPEDITED REVIEW!

SO WHAT DOES THIS MEAN FOR NEW INVESTORS???

*****Any way you slice it Elite is a low risk penny stock with the capability of being the illusive 10 bagger from today's current PPS by the end of 2015. And a note of comfort. Even if you buy shares today and Elite never does anything further with its abuse resistant technology (ART), Elite would still be a double bagger from here on its generic products alone. Thus the risk is extremely low and the return is at minimum a 10 bagger if Elite markets that whole line of ART products the COB Jerry Treppel mentioned back in 2012. Good luck and if you have questions ask the board. It is extremely knowledgable about this company and stock. My personal favorite #5: Elite's Intellectual Property Rights!

1) Low debt load, 2) Strong management team, 3) Expanding market share, 4) Growing revenues, 5) Game changing intellectual property rights, 6) Access to financial funding sources, 7) Management with skin in the game, 8) Highly undervalued stock, 9) Expanding Infrastructure, 10) Meeting short, mid and long term objectives.

1) Low Debt Load ~~ $18 million in assets - $23 million in liabilities.

http://yahoo.brand.edgar-online.com/displayfilinginfo.aspx?FilingID=9782153-927-228722&type=sect&dcn=0001144204-14-008935

2) Strong management team ~~ nobody can say otherwise at this point. Adding Nasrat, Doug Plassche and Barbara Ellison to Elite's management team makes Elite much much stronger than it was a single year ago. It has moved from the bush leagues to the majors IMO. Not to mention all three were hired with the focus of getting Elite's ART to market. Then you add in Ashok Nigalye who is Elite's CSO and Epic's CEO and you get a top notch addition to Elite's management team. His work at Actavis alone stands out. From August 1993 to February 2008, Dr. Nigalaye served as Vice President of Scientific Affairs and Operations of Actavis Totowa LLC, a manufacturer of generic pharmaceuticals, where he was responsible for directing and organizing company activities relating to pharmaceutical drug manufacturing, regulatory affairs and research and development.

http://www.elitepharma.com/investor_relations.asp?goto=361
http://www.elitepharma.com/investor_relations.asp?goto=363
http://www.elitepharma.com/investor_relations.asp?goto=381

3) Expanding Market Share ~~ As Nasrat has discussed publicly Elite has gained access to new API sources for several of their generic products and their Phentermine prices are the lowest on the market. As Carter Ward has explained during several CC's most of Elite's generic products are less than 2 years on the market and they continue to gain market share quarter after quarter. Additionally, the 12 Andas purchased from Mikah will only continue to give Elite access to a broader and stronger commercial base in the generic pharmaceutical market. This can be proven by the numbers increase tied to their revenues.

http://seekingalpha.com/article/2029611-elite-pharmaceuticals-ceo-discusses-f3q2014-results-earnings-call-transcript?uprof=45

4) Growing Revenues ~~ and will only continue with Elites 12 additional Andas
SIX quarters averaging quarterly revenue gains of 93%. FURTHER, Elite has had its going concern removed from its SEC filings and cured much of its bond debt issue!!

Compare Q2'13 vs Q2'12 Revenue increased +131%
Compare Q3'13 vs Q3'12 Revenue increased +30%
Compare Q4'13 vs Q4'12 Revenue increased +134%
Compare Q1'14 vs Q1'13 Revenue increased +27%
Compare Q2'14 vs Q2'13 Revenue increased +83%
Compare Q3'14 vs Q3'13 Revenue increased +154%

http://finance.yahoo.com/q/sec;_ylt=A0LEV1p7HUtTGnUA.ARXNyoA;_ylu=X3oDMTEzcXRzaTdxBHNlYwNzcgRwb3MDNQRjb2xvA2JmMQR2dGlkA1ZJUDM2NV8x?s=ELTP+SEC+Filings

5) Game Changing Intellectual Property (IP): (And why I am personally here!)

http://seekingalpha.com/instablog/4199131-couch/1941422-elite-pharmaceuticals-eltp-intellectual-property-ip-and-the-right-to-devise-a-better-pain-killer

Elite Pharmaceuticals Expands Abuse Deterrent Technology Patent Portfolio Internationally

http://www.elitepharma.com/investor_relations.asp?goto=379
Quote:

“We are excited to have received this patent in Canada as we continue to broaden our patent protection not only in the United States but also internationally,” stated Nasrat Hakim, President and CEO of Elite. “We will continue to work toward the further expansion of our patent estate in the U.S., Canada and Europe. This patent supports Elite’s initiatives as we develop and file our new abuse deterrent products.”


6) Access to Financial Funding sources to support their signature product line: ART
Acquired $10 million from LPC and would be able to generate another $39.5 million from selling Preferred I shares to a big pharma partner and/or financing partner if the Proxy Vote passes. And TODAY we find out Elite garners another $40 million in funds from LPC at no upper limits to pay for shares!!

http://www.streetinsider.com/Press+Releases/Elite+Pharmaceuticals,+Inc.+Secures+Funding+Commitment+of+Up+to+$40+Million+From+Lincoln+Park+Capital+Fund,+LLC/9376047.html

http://www.elitepharma.com/investor_relations.asp?goto=356

http://secfilings.nasdaq.com/filingFrameset.asp?FileName=0001144204%2D14%2D006951%2Etxt&FilePath=%5C2014%5C02%5C07%5C&CoName=ELITE+PHARMACEUTICALS+INC+%2FNV%2F&FormType=8%2DK&RcvdDate=2%2F7%2F2014&pdf=


7) Management with a lot of their own Skin in the Game!
Both Nasrat Hakim and Jerry Treppel own a large number of common shares and have loaned the company $1 million dollars unsecured. Nasrat owns around 154 million shares after the Preferred I shares and around 14 million besides the Preferred shares. I think JT owns somewhere around 8-10 million shares.

http://www.elitepharma.com/investor_relations.asp?goto=351
http://www.elitepharma.com/investor_relations.asp?goto=368

8) Highly undervalued stock particularly with their IP Rights.
One can see this by Elite adding in their poison pill policy/stockholder rights plan and having a prominent consulting firm give a valuation estimation with a conservative, most likely and best case valuation. That’s $0.40, $2.10 and $2.75. So even with Elite's worst case conservative scenario, I would argue Elite is still highly undervalued. Elite launches just one ART product even with the increase in AS and Elite would still be looking at around a $3 PPS if not more on the expectation of future ART products.

http://secfilings.nasdaq.com/filingFrameset.asp?FileName=0001144204%2D13%2D062436%2Etxt&FilePath=%5C2013%5C11%5C15%5C&CoName=ELITE+PHARMACEUTICALS+INC+%2FNV%2F&FormType=8%2DA12G&RcvdDate=11%2F15%2F2013&pdf=

9) Expanded Infrastructure:
A few years back Elite expanded its GMP and DEA registered facility for research, development, and manufacturing from 15 thousand to 30 thousand square feet and added machinery for packaging as well. It further bought equipment recently so Elite could manufacture Isradipine itself as opposed to having Epic perform this work. Thus, Elite gets a cut of the manufacturing revenues. Additionally, Elite has hired several new key employees and introduced new products as mentioned. From 0 products on the market in 2011 to 8 currently to 16 employees to now 33. However, the real piece of good news here is that Elite has been using its expanded equipment line for the number of batches manufactured and stability tests run in regard to its ART products and is on schedule to submit its first NDA as soon as the FDA gets back to Elite regarding the data it has in hand currently.
http://www.elitepharma.com/investor_relations.asp?goto=354

10) Meeting its short, mid and long term objectives:
One would have to go back to 2009 when Elite delisted from the Amex and JT secured a strategic alliance with Epic for $3.75 million dollars and thus staving off bankruptcy to understand how far Elite has come in such a short time. At that time, Elite used this money to buy several Andas such as hydromorphone, Naltrexone and Phentermine that Elite currently markets. Additionally, as mentioned, Elite obtained key US and Canadian patents related to its abuse resistant technology, doubled the size of its manufacturing space and obtained funding from LPC to move forward with its pivotal BE ART studies after a 7 year hiatus. Further, Elite hired Nasrat Hakim as its CEO and re-initiated attending the Rodman & Renshaw financial conference in NYC after a 6 year hiatus. To me, this signaled to institutional investors that Elite is once again a viable stock and company and to place Elite on their radars. In essence, Elite has something worthwhile to show potential new investors. That it is moving towards becoming cash flow positive off both operations and soon R&D costs but most importantly it plans to launch its first ART product in 2015.

http://www.elitepharma.com/investor_relations.asp?goto=365

11) Elite has purchased additional machinery and hired 3 additional key management position to support its ongoing push to launch its ART opioids Most notably the hiring of Dr. Kenneth Smith, J.D., M.B.A. for their chief legal counsel. Dr. Smith held positions of Chief Intellectual Property Counsel for Alpharma, Inc. and before that Head of North American Intellectual Property for Sanofi Aventis.

In essence, Elite wouldn't spend precious financial resources on these additions unless it expected that money to go a long ways in the not too distant future!

******FINALLY ~~~ New Investors will want to understand that NOBODY has been able to point out one single thing wrong with Elite's Abuse Deterrent Technology (ADT)....That's nobody!!! What this means is that every single abuse deterrent study or trial Elite has ran has been successful!!!

http://www.elitepharma.com/investor_relations.asp

Quote:
ELITE PHARMACEUTICALS REPORTS SUCCESSFUL PIVOTAL BIOEQUIVALENCE STUDY FOR ABUSE-DETERRENT OXYCODONE PRODUCT ELI-201


Northvale, New Jersey, Wednesday, December 03, 2014: Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB: ELTP) announced today successful results from a pivotal bioequivalence (BE) study for ELI-201, Elite’s twice daily abuse-deterrent oxycodone product which utilizes Elite’s proprietary pharmacological abuse-deterrent technology.

The study, initiated in July of 2014, demonstrated Elite’s product is bioequivalent to the branded drug based on pharmacokinetic measures including peak concentration (Cmax) and area under the curve (AUC) as measured for opioid blood plasma levels. The study was a single dose, open label, randomized, cross-over study in healthy volunteers with 34 subjects conducted under fasted conditions Final findings of bioequivalence are dependent upon FDA review.

ELI-201 is another product in Elite’s line of abuse deterrent opioids to pass pivotal bioequivalence studies. The first Elite product to pass pivotal bioequivalence was ELI-200. A third product in this line, ELI-202 is currently undergoing a pivotal BE study, after having successfully completed a pilot study.

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ELITE PHARMACEUTICALS RELEASES POSITIVE TOP LINE HUMAN ABUSE LIABILITY DATA FOR ELI-200, AN OPIOID ABUSE DETERRENT PRODUCT


HAL study compared subjective effects of drug liking, drug high and good drug effects between ELI-200 and the comparator formulation in non-dependent recreational drug users

Northvale, New Jersey, Tuesday, September 09, 2014: Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB: ELTP) today reported top line results from a Human Abuse Liability (HAL) study for the ELI-200 product. ELI-200 is an undisclosed abuse deterrent opioid product for pain.

The study results demonstrated statistically significant (p <.0001) lower measures of drug liking, drug high and good drug effects for Elite’s manipulated (crushed) ELI-200 when compared to the manipulated (crushed) drug listed comparator product and found 91.9% of the subjects experienced increased drug liking with the comparator product compared to ELI-200 in non-dependent recreational drug users when administered intranasally. The study also found 80.6% of the subjects experienced a decrease in drug liking with the intranasal crushed ELI-200 in comparison to the administration of oral intact ELI-200.

The data will be presented at the 16th Annual Rodman and Renshaw Global Investment Conference in New York City on September 9, 2014.

“We could not be more pleased with the top line result from the Human Abuse Liability Study for ELI-200 which confirms the effectiveness of our abuse deterrent technology,” said Nasrat Hakim, President and CEO of Elite Pharmaceuticals. “This successful technology will be the platform for an entire line of opioid products utilizing our proprietary technology. We remain on track to file our first new drug application for ELI-200 by December 2014.”

HAL Study Details
The HAL study was a single-center, randomized, double-blind, double-dummy, active- and placebo-controlled, single-dose, five-way crossover to evaluate the relative bioavailability, abuse potential and safety of crushed intranasal ELI-200 capsules compared to the crushed intranasal comparator product, oral intact ELI-200, and placebo in 37 healthy male and female non-dependent recreational opioid users with intranasal experience. The primary objective was to assess the abuse potential of ground ELI-200 relative to the crushed comparator product when administered intranasally to non-dependent, recreational opioid users with intranasal experience.

The secondary objectives were:
• To assess the abuse potential of crushed intranasal ELI-200 relative to placebo (intranasal and oral) in non-dependent, recreational opioid users with intranasal experience.
• To assess the abuse potential of oral intact ELI-200 relative to crushed intranasal ELI-200, crushed intranasal comparator, and placebo (oral and intranasal) in non-dependent, recreational opioid users with intranasal experience.
• To assess the relative bioavailability of the opioid in plasma from crushed intranasal and oral intact ELI 200 compared with one another and crushed comparator when administered intranasally in non-dependent, recreational opioid users with intranasal experience.
• To assess the safety of crushed intranasal and oral intact ELI-200 compared with crushed intranasal comparator and placebo (intranasal and oral) in non-dependent, recreational opioid users with intranasal experience.

Quote:
Elite Pharmaceuticals Reports Successful Pivotal Bioequivalence Study for Abuse Deterrent Product ELI-200

Northvale, New Jersey, Wednesday, March 05, 2014: Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB: ELTP) announced today successful results from a pivotal bioequivalence study initiated in January 2014 for Elite’s undisclosed abuse deterrent opioid product, ELI-200. The study results demonstrated Elite’s product is bioequivalent to the branded drug based on pharmacokinetic measures including peak concentration (Cmax) and area under the curve (AUC) for opioid blood plasma levels. The study was a single dose, open label, partially randomized, three-way cross over study in healthy volunteers with 42 subjects under fasted conditions and 38 subjects under fed conditions.

The formulation utilized Elite’s proprietary pharmacological abuse deterrent technology with the opioid antagonist naltrexone. Levels of sequestration of naltrexone were also evaluated and dosing of Elite’s intact formulation resulted in almost no exposure levels to naltrexone (LOQ of 4 pg/mL) and its metabolite 6-?-naltrexol (LOQ of 10 pg/mL) as intended. Elite will proceed with the development program for this product including completion of a human abuse liability study. Elite expects to file an NDA for this product by year end.

Quote:
Elite Pharmaceuticals Reports Results of Pilot Bioequivalence Study for ELI-201


...Provides Update on Pivotal Study for Second Opioid Abuse Deterrent Product and Manufacturing Transfer of Generic Products

Northvale, New Jersey, Tuesday, February 18, 2014:
Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB: ELTP) announced today successful results from a pilot bioequivalence study initiated in December 2013 for ELI-201, a twice-daily opioid abuse deterrent oxycodone product with abuse deterrent technology. Three different twice daily formulations developed by Elite were tested in the study. The study results demonstrate that all formulations in the study were bioequivalent to the reference drug based on pharmacokinetic measures including peak plasma concentration (Cmax) and area under the curve (AUC) for oxycodone blood plasma levels. The study was a single dose, open label, randomized, four period, four treatment, cross over study in 16 healthy volunteers under fasted conditions.

The formulations tested utilize Elite's proprietary pharmacological abuse deterrent technology with the opioid antagonist naltrexone. Levels of sequestration of naltrexone were evaluated based upon a naltrexone assay with a level of detection (LOD) of 4 pc/mL. The study results demonstrated that Elite's formulations were superior to an approved and marketed comparator product using a similar pharmacological approach. The comparison was based upon publicly available data from a similar fasted study in healthy volunteers and using a similar naltrexone assay with an LOD of 4 pc/mL. The primary metabolite of naltrexone, 6-Beta-natrexol, was also analyzed in the Elite study although no data from the comparator product was available for direct comparison.

Quote:
ELI -216 Demonstrates Successful Euphoria Blocking Effect During Initial Stage of Phase II Study

Northvale, New Jersey, Thursday, February 15, 2007:
Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (AMEX: ELI - News), has completed the first stage of its Phase II study for ELI-216 and is preparing to initiate the final stage. 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”.

Quote:
Elite Announces Successful Results On Abuse Resistant Technology For Narcotic Analgesics

Northvale, New Jersey, Thursday, December 08, 2005: Elite Pharmaceuticals, Inc. (AMEX: ELI) announced positive results from their completed pilot Phase I study under its Investigational New Drug Application (IND), designed to test Elite’s proprietary abuse resistant technology ("ART™") for use with opioids.

The product tested, OxyNal™, uses a pharmacological agonist-antagonist combination approach of sustained release agonist oxycodone hydrochloride, intended for use in patients with moderate to severe chronic pain, and an antagonist naltrexone hydrochloride formulated to deter abusers of the drug.

“We are very pleased with the positive results we obtained from this study which not only meets a significant milestone in the development of this program in pain management but also validates Elite’s pharmacological approach for our ART™,” stated Bernard Berk, chairman and chief executive officer of Elite Pharmaceuticals. “It gives us a great deal of added confidence in our next steps when we meet with the FDA to present the overall NDA developmental program. Encouraged with these promising results, we are expediting the developmental time lines. This achievement is yet another step forward for Elite to establish itself as a leader and innovator in pain management. Our goal is to address this large unmet medical need and to provide better, safer, and more abuse-resistant pain products that positively affect people who are suffering from chronic pain.”

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.