Elite Pharmaceuticals Inc (ELTP)

[NASDAQ2020]

--ELI-201 OXY/NAL bioequivalence trial initiated
--no more going concern, bond debt current
--strongest balance sheet in Elite's history
--first working capital surplus in 5 years

--The Company’s primary focus has become the accelerated development of their complete line of Abuse Resistant opiods
--Elite's goal is to become the leader in the ART/ADT opiod market "no one will stop us" "we are going to market" CEO
--"We have set in motion several initiatives that will have significant impact on Elite's future" CEO
--aggressive schedule with clinical trials, quadrupling of R&D costs, working on *5-6 ART opiods* concurrently in 2014,
one or two ART/ADT opiods will be filed with FDA in 2014 if fast track status granted
--the longer we go without partnering the high the value of the company
--$40 MILLION in funds secured from LPC(Lincoln Park Capital) to develop ADT/ART products with or without a partner
--$5 MILLION more recieved from sale of Elite's 9.99% ownership in Novel Laboratories 06/10/2014
--Multiple potential partners are approaching ELTP and are waiting on trial results. CEO wants to license ART "after studies and trials completed" making it worth much more due to the steep accretion curve in the pharma field ie. the value goes up exponentially as studies are completed
--completed 3 SUCCESSFUL pivotal bioequivalence studies on both ELI-201(twice day oxy ADT) and ELI-200(undisclosed twice a day)
ADT opiod) Abuse studies for ELI-200 underway
--Generic Business Cash Flow Positive minus R&D costs for last two quarters, approaching 2+ million in revenues per quarter

--Poison Pill 8-A12G filed and a staggerd Board of Directors in place protects shareholders from a hostle take over, independent analyst determined the value of Elite is undervalued and its true value is between $2.10 and $2.75 as of late 2013
--Nasrat Hakim, Elite's President and Chief Executive Officer has provided an unsecured line of credit not to exceed $1,000,000. Proceeds will be used to support Elite's acceleration of ART product development activities.
--Board member Jerry Trepple loand $600,000 unsecured took repayment of his loan in preferred I shares
--Billion dollar pipeline-33+ DRUGS including a complete line of 17 NDA and ANDA abuse resistant (ART) opiods plus multiple generics
--Six quarters in a row of increasing revenues:

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%

--20 FDA approved drugs: 8 launched and gaining market share: hydromorphone, phentermine 37.5 mg, lodrane D, methadone, phendimetazine, phentermine 15mg, phentermine 30mg, naltrexone 50mg.
--Elite has signed a Manufacturing and License Agreement with Epic Pharma who will manufacture 11 of the 12 approved generics ANDAs recently obtained from MIKAH. This will allow Elite to maximize their profit potential for their generic business while devoting their resources to the development of their abuse resistant products. Isradipine CBE-30 filed by Elite and will be manufactured by Elite and only has 1 competitor in a 6 million dollar market. EPIC will file CBE-30 for the second MIKAH ANDA Dantrolene in June 2014, it has one competitor in a 12 million dollar market

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--Partnered with CAMARGO for assistance with 505(b)(2)opportunities for multiple 12 hr ART generic and NDA opiods where Bio-equivalency studies alone are enough
trial #1 mega pilot 4 way cross over on 64 subjects SUCCESSFUL on 12 hr Oxy/Nal ELI-201 completed in 2013
trial #2 and 3 pivotal BE studies SUCCESSFUL for both ELI-201 (12hr oxy) and ELI-200 (12hr undisclosed) ADT
trial #4 and #5 Started 05-19 for ELI-202:the first dosing of a pivotal bioequivalence study in healthy volunteers for ELI-202, an undisclosed opioid abuse deterrent product, utilizing Elite's proprietary pharmacological abuse deterrent technology. Two bioequivalence studies will be run together for ELI-202.
2014 Lifetree 3 tier abuse deterrent studies to obtain * FDA ADT LABELING *
a) snorting trial
b) oral abuse
c) IV abuse
Additional Human Abuse Liability Study started June 2014 to test abuse potential of crushed ELI-200 taken intranasally
ELI-200 believed to be morphine/naltrexone(a better Embeda) is also on schedule for a Dec 2014 FDA filing
trial #5 June/July 2014 ONCE/DAY 24 hr ELI-216 ** $$ will eventually be the ONLY 24 hr oxy in the USA $$ **
this one product may need a Phase III trial, FDA to decide after BE's
--ELI-154 CR (once a day Oxy) in scale up for Large European Market

--CEO owns 23% of co. and has challenged team to get the First 12 hr ART Oxycodone filed with the FDA in 2014
The 12 hr product is for a
*******2.7 Billion dollar market*******, CEO commented that a conservative 20% of that market would get us ****$4.00-$5.00 PPS**** with just their first ART opiod
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--Nasarat Hakim former VP of Activas appointed president and CEO of Elite 08-05-13 has 30 years of pharmaceutical and medical industry experience in Quality Assurance, Analytical Research and Development, Technical Services and Regulatory Compliance. He brings with him proven management experience, in-depth knowledge of manufacturing systems, development knowledge in immediate and extended release formulations and extensive regulatory experience of GMP and FDA regulations. He is making ART priority one. He bought 11 million shares on the open market and takes ELTP stock as compensation. The CEO noted, we are trading on our financials(revenues) and if we had no revenue we would be trading on ART and R&D and we would be valued ***10X*** higher

--Barbara Ellison has been given the position of VP Quality Control Operations & Regulatory Affairs: Barbara will oversee the regulatory and quality functions for Elite and will play a key role for the Company as it expands the product development and commercialization of the Company's opioid abuse deterrent products. Her role was created to support the abuse deterrent product filings, the first of which is planned for THIS year. She also be an important contributor as Elite files additional products and launches our first abuse deterrent product. Her national and international expertise in quality management and regulatory affairs will richly support Elite's compliance and quality goals.

--FDA likes the pharmalogical approach to abuse resistance FDA being very positive
--the ART is rock solid, innovative, superior and he has not seen a better ART CEO
--1st patent for 2 bead ART 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 2 bead ART 8/425.933 formerly 12/640,344 (04/23/2013) combined with first patent, gives Elite 20 years of propietary protection: formulation to make an existing drug abuse resistant
--3rd ART Hammerlock patent 8,703,186 April 2014
--**Canadian Patent Number 2,521,655 titled "Abuse-Resistant Oral Dosage Forms and Method of Use Thereof”. Issuance 03/2014 expands the scope and reach of Elite’s patent estate internationally. Elite has additional patents pending in the U.S., Canada and Europe.
--Additional European and Canadian Patents Pending
--Elites ART is modular, it can be used on ALL opiods just add a different opiod bead to the naltrexone bead
--NE 30 polymer for sequestering naltrexone was found to be far superior to other polymers
--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.
--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 Woodcock & Baker 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 and later the US Congress
--2-bead abuse resistant opiods could gradually replace some of the inferior abuse deterrent opiods now on the market

--CEO and officers being paid with stock
--multiple partners Watson/Actavis, Mikah, Epic, TAGI, The Pharm Network, ECR, Precision Dose, Celgene Corp, TPN/Ascend, Novartis, SmithGlaxoKlein and the undisclosed Hong Kong Pharma
--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 $500,000 invested in faclity in 2014, new encapsulator, tablet press and high shear grandulator
--NEW packaging line operational
--39 employees over double of two years ago
--CEO wants to get a $50 million/ yr ANDA per shareholder meeting 2014
--phentermine 15 & 30mg launched (April 11, 2013) is competing with Qsymia(phentermine and topiramate)
--Acend Labs has new contracts for methadone
--Hong Kong Pharma NDA development over a year to go
--MIK-001 505b2 NDA maybe an improved Embeda on schedule in development on the back burner
--HITK's intermediate for a generic of a branded 100 million dollar market= drug Lots produced
--Naltrexone 50mg launched Sept 2013
--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 with
--undisclosed 100% Elite owned ANDA approx 1 year
--Elite's goal is to commercialize a COMPLETE LINE of 17 abuse resistant opiods
--Uplisting to the NASDAQ exchange per the CEO
--ELTP visibility increasing: Once the pilot and pivotal studies completed in March 2014 CEO to go on the road to present the results to viable partners
--Elite will be attending Rodman Renshaw conference again in Sept 2014
http://seekingalpha.com/article/1688112-elite-pharmaceuticals-call-it-a-comeback-story?source=yahoo
http://seekingalpha.com/article/1905051-elite-pharmaceuticals-swing for-the-fences
http://seekingalpha.com/instablog/4199131-couch/1941422-elite-pharmaceuticals-eltp-intellectual-property-ip-and-the-right-to-devise-a-better-pain-killer

--500 series I convertible stocks created (02/07/14) with a value of 50 million dollars. 105 were used to pay off CEO's drug transfer and Trepple's unsecured loans, 395 available IF NEEDED at a to be determined share conversion price, these can also be used for financing and leverage for a favorable deal for shareholers

--Partner Camargo is a full-service drug development partner specializing in the 505(b)(2) process — an approach for developing products that offer differentiated benefits. Camargo is capable of managing every facet of the plan throughout the development continuum, from feasibility assessments, formulation and testing the drug product, to conducting preclinical and clinical studies, to final submission
--Important FDA meeting coming up in August 2014



ELTP


"We have emerged as one of the leaders in the development of abuse deterrent opioids"