Elite Pharmaceuticals Inc (ELTP)

[NASDAQ2020]

ELITE PHARMACEUTICAL positioned to capitalize on opiod crisis
--primary focus is the accelerated development of a complete line of 17 Abuse Deterrent Opiods
Ellie's technology possess characteristics that are best-in-class among abuse deterrent formulations(ADF).

--Elite Pharmaceutical executed an exclusive License Agreement with Humanwell Healthcare(Puracap) formally Epic Pharma, to market and distribute in the United States, Elite's SequestOx™ (ELI-200), an Immediate Release ADF oxycodone for acute pain with sequestered naltrexone beads. Humanwell will have the exclusive right to market SequestOx™ and its various dosage forms.
--$15 million dollars in milestones for SequestOx™
--Positive Phase III study was a multi-center, randomized, multiple-dose, blinded, placebo-controlled, parallel group, study to evaluate the efficacy and safety of abuse deterrent SequestOx™ for the treatment of 165 adults with moderate to severe pain following surgery.
--Phase III p=0.001
--SequestOx™ Filed and Accepted by FDA
--FDA granted Priority Review
--PDUFA date of July 14, 2016
--Commercial launch preparation underway for SequestOx™ 5 mg, 10 mg, 15 mg, 20 mg and 30 mg capsules.

-- Elites first abuse deterrent opiod SequestOx™ will enter an 11+ BILLION dollar US market followed by a $34.9 BILLION dollar global market
--Only ONE competitor Eaglet's IR Oxaydo which only deters abuse via snorting
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 SequestOx™ taken intranasally -POSITIVE
--pediatric study for SequestOx™ to run concurrently during approval process

--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"
--Human Abuse Liability (HAL) Studies- HAL 1, HAL 2 and HAL 3 POSITIVE for SequestOx™ , HAL required for valuable FDA ADT labeling
--Multi-Billion dollar pipeline of over 40 drugs(20 FDA approved) which includes 17 NDA Abuse Deterrent Formulation(ADF) opiods
--going concerns removed by SEC
--strongest balance sheet ever
--working capital surplus
--9 QUARTERS AVERAGING REVENUE GROWTH PER QUARTER OF 73%.
--$40 MILLION in funds secured from LPC(Lincoln Park Capital) to develop ADT/ART products, enough for 3-4 ADT opiods
--Generic Business Cash Flow Positive minus R&D costs 2+ million in revenues per quarter
--Isradipine launched Jan 2015
--Isradipine in studies for Parkinson's desease and Opiod Withdrawl
--Hydroxyzine launch with limited competition April 2015
--Dantrolene next with a 12 million dollar market - Imminent
--Loxipine - Imminent
Mikah Pharmaceutical six exclusive and six non-exclusive generics Four of the six exclusive have been launched they are Hydroxyzine and Phentermine and Isradpine and Phendimetrazine. Dantrolene and Loxipine are waiting on site transfer.

--Elites ART is a MODULAR 2 bead system, it can be applied to ALL opiods
--first ADT launch will be followed by additional ADF opiods in rapid succession
--Abuse Liability studies for SequestOx™ POSITIVE, awarding a valuable Abuse Resistant Labeling
--Elite's goal is to become the leader in the ART/ADT opiod 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 2016
--Nearly Doubled the FDA-DEA-cGMP registered manufacturing space for a total of 50 thousand sq/ft for research, development and manufacturing from concept to commercialization
--Over $1,000,000 invested in faclity expansion, new encapsulator, tablet press and high shear grandulator, NEW COMMERCIAL FLUID PROCESSOR has 5X more capacity enough for 2+ ADF opiods in house
--space and funds for 3 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
--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, no buyout expected prior to first ADF approval
--Nasrat said they have employed a firm to get them Sar-Box compliant. True, this would be important to get to the Nasdaq. Also important for Elite Aquisition

--ELI-216 will be the only 24 hour ADF ER oxycodone in the USA ($1.2 billion market)
--20 FDA approved 10 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 Hydroxyzine
--Elite has signed a Manufacturing and License Agreement with Humanwell Healthcare who will manufacture 11 of the 12 approved generics ANDAs 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/Humanwell filed CBE-30s for additional MIKAH generics

--Elite's 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

the first dosing of a pivotal bioequivalence study in healthy volunteers for ELI-202, an ADF ER Oxycodone using APAP(acetaminophine). Two bioequivalence studies will be run together for ELI-202.

ELTP