Elite Pharmaceuticals Inc (ELTP)

[NASDAQ2020]

***** ELITE PHARMACEUTICAL *****
"We remain on track to launch our first abuse deterrent opiod ELI-200 in 2015.” having an 8 BILLION dollar market with very limited competition
--Commercial launch preparation has begun for ELI-200
--CEO bought has 11,700,000 shares on the open market, last purchase in IRA 10/2014
--3 New Senior Management Appointments: "These additions greatly strengthen our management team in key areas and enhance our internal expertise in product development, regulatory compliance and intellectual property to support the development of our opioid abuse deterrent products" 10/2014
--Human Abuse Liability (HAL) Studies- HAL 1, HAL 2 and HAL 3 POSITIVE for ELI-200 an undisclosed Abuse Deterrent Opiod for pain, required for valuable FDA ADT labeling
--FDA Face to Face pre-IND filing meeting with Camargo and Elite 11/17/2014
--CEO going on the road after FDA meeting seeking a marketing & distribution partner
--Multi-Billion dollar pipeline of over 40 drugs(20 FDA approved) which includes 17 NDA Abuse Deterrent opiods
--going concerns removed by SEC
--strongest balance sheet ever
--first working capital surplus in 5 years
--9 QUARTERS AVERAGING REVENUE GROWTH PER QUARTER OF 73%.
--600% increase in R&D expenses
--$40 MILLION in funds secured from LPC(Lincoln Park Capital) to develop ADT/ART products
--Generic Business Cash Flow Positive minus R&D costs approaching 2 million in revenues per quarter
--Isradipine launched Jan 2015
--Isradipine in studies for Parkinson's desease and Opiod Withdrawl
--Another Generic launch with limited competition due by Mar 31, 2015

--The Company’s primary focus is the accelerated development of a complete line of Abuse Resistant Opiods
--Elites ART is a MODULAR 2 bead system, it can be used on ALL opiods just add a different opiod beads to the naltrexone(antagonist) beads, once first ADT launches the rest will follow in rapid succession
--Successfully completed pivotal bioequivalence studies on both ELI-201(twice day oxy ADT) and ELI-200(undisclosed twice a day)
--Abuse Liability studies for ELI-200 POSITIVE, required for very RARE and VALUABLE Abuse Resistant Labeling
--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, working on *7 ART opiods* concurrently in 2015, FDA agreed to an***expedited*** review for ELI-200
--Nearly Doubled the FDA-DEA-cGMP registered manufacturing space in 2014 for a total of 50 thousand sq/ft for research, development and manufacturing from concept to commercialization
--Over $500,000 invested in faclity expansion in 2014, new encapsulator, tablet press and high shear grandulator, new commercial fluid processor has 5X more capacity enough for 2+ ADT opiods in house
--space and funds for 3-4 in house ADT opiod products
--NEW packaging line operational
--Poison Pill 8-A12G filed and a staggerd Board of Directors in place protects Elite and shareholders from a hostle take over
-- Fall 2013 an independent analyst determined Elite is undervalued and its true value is between $2.10 and $2.75 Elite is currently trading on its generic business NOT as an R&D co. developing multi-billion dollar ADT opiods
--Multiple potential partners approaching ELTP are awaiting 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
--the longer Elite goes without partnering or buyout the higher the value of the company
--ELI-216 ADT will be the only 24 hour oxycodone in the USA
--ELI-154 CR 24hr (once a day Oxy) in scale up for Large European Market
--20 FDA approved 9 launched and gaining market share: hydromorphone, phentermine 37.5 mg, lodrane D, methadone, phendimetazine, phentermine 15mg, phentermine 30mg, naltrexone 50mg and Isradipine 2.5 and 5.0 mg
--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 manufactured in house by Elite and only has 1 competitor. EPIC filed CBE-30 for the second MIKAH ANDA Dantrolene June 2014, having one competitor in a 12 million dollar market

--Partnered with CAMARGO for assistance with 505(b)(2)opportunities for multiple 12 hour NDA ART opiods where Bio-equivalency studies alone maybe enough for filing
trial #1 mega pilot 4 way cross over on 64 subjects SUCCESSFUL on 12 hr Oxy/Nal ELI-201
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 completed POSITIVE
b) oral abuse POSITIVE
c) IV abuse POSITIVE
Human Abuse Liability study completed to test abuse potential of crushed ELI-200 taken intranasally -POSITIVE
ELI-200 believed to be morphine/naltrexone(a better Embeda) is also on schedule for filing and launch in 2015
--pediatric study to run concurrently during approval process

--Nasarat Hakim former VP of Activas appointed president and CEO of Elite 08-05-13(pps $0.068) 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
--CEO owns 23% of co.

--FDA likes the pharmalogical approach to abuse resistance FDA very positive
--the ART is rock solid, innovative, unique, superior and CEO has not seen a better tech
--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
--Patents good thru 2023
--**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
--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 www.cladd.org
--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 NDA branded opiods will be required to have Abuse deterrent/resistant properties:

http://www.raps.org/Regulatory-Focus/News/2015/01/20/21120/Should-FDA-Pull-Non-Abuse-Deterrent-Generic-Opioids-off-the-Market-PhRMA-Bio-Say-Yes/

--May 10, 2013 Endo Health (ENDP) ruling
--Elite's Competition being taken out one by one by the FDA
--2-bead abuse resistant opiods will gradually replace non-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
--40 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 CEO to go on the road to present the results to viable partners
ELTP