***** ELITE PHARMACEUTICALS, INC (ELTP) *****
--Specializes in the development of oral controlled release products, such as delayed, sustained, targeted and pulsatile release tablets, pellets, capsules, granules and powders. The Company’s primary focus is in the therapeutic areas of pain management, allergy, cardiovascular and infection
--Billion dollar plus pipeline
--8 FDA approved drugs: hydromorphone, phentermine 37.5 mg, lodrane D, methadone, phendimetazine, phentermine 15mg, phentermine 30mg, naltrexone 50mg
--4 quarters of increasing revenues
--launched drugs continue to gain market share
--cash flow positive (CFP) this quarter or next, not including R&D cost
--$10 Million in funding secured from Lincoln Capital Fund 04/22/2013
--600 % increase in market cap in 2 years
--ELI-216 is a controlled release 24 hr abuse resistant(ART) oxycodone requiring Phase III clinical trials, which could start any time
--a partner for commercialization of ELI-216 could be announced any day
--ELI-216 is a priority with Elite and further along than most people think, per the CEO
--1st patent for ELI-216 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 ELI-216 8/425.933 formerly 12/640,344 (04/23/2013) combined with first patent, gives Elite a hammerlock on superior 2 bead ART: formulation to make an existing drug abuse resistant
--patent 13/863,764 Child Continuity Data strengthens Elite's "Hammer Lock" on 2-bead ART giving it triple patent propietary protection for 20+ years
--eventually superior 2-bead abuse resistant opiods(which can not be easily defeated) will replace the inferior abuse deterrent(easily defeated) opiods now on the market
--Elites ART is modular, not for just oxycodone it can be used on ALL opiods
--NE 30 polymer for sequestering naltrexone was found to be far superior to other polymers
--BE and PK studies for ART progressing, some were due finished by March 31, 2013
--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 Washburn & Woodcock 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.
--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
--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
--Elite owns 10% of Novel Labs, Gavis and recently Wintac: Novel has approached Elite for monetization
--Novel Labs net worth growing rapidly, 31 FDA approved drugs, including a new generic morning after(Plan B) pill
--estimates for 10% value of Novel range from 10 to 50 million dollars
--sale of Novel Labs will make Elite's financials rock solid by paying off ALL debt, paying for ELI-216 Phase III clinical trials, and allowing for the purchase of more ANDA's
--CEO Bought 500,000 shares July 2010, officers being paid with stock
--CEO Jerry Trepple loaned the co. 1 million dollars unsecured (non-dilutive)
--CTO of Elite is Epics president and works for shares of ELTP
--VP @ Actavis/Mikah is a special consultant to EPIC
--multiple partners have no concerns: Watson/Actavis, Mikah, Epic, TAGI, The Pharm Network, ECR, Precision Dose, Celgene Corp and the undisclosed Hong Kong Pharma
--interest paid in full on loans
--New Jersey(NJEDA) tax credits
--contracting deals with other pharmas
--TWO 15,000 sq/ft FDA-DEA-GMP registered manufacturing labs for research, development and manufacturing from concept to commercialization
--NEW packaging line operational and adding revenue to the bottom line by making and saving the co. money
--26 employees up from 16, 2 years ago
--4 drugs in * SCALE UP *
--phentermine 15/30mg launched (April 11, 2013) is competing with Qsymia(phentermine and topiramate)
--Hong Kong Pharma NDA progressing
--MIK-001 probably an improved Embeda
--HITK's intermediate for a generic of a branded 100 million dollar drug
--first of 8 Epic drugs due out anytime(from the Stategic Epic Alliance)
--Lodrane 24 and 24D returning after being pulled by FDA with 500 other cold/flu products
--505(b)(2)opportunities's for 12 hr ART generics and NDA's where Bio-equivalency studies alone are enough (no phase III)
--Naltrexone FDA approved, launch pending (May-June 2013)
--undisclosed ANDA could come out any day
--CEO's goal is to commercialize a COMPLETE LINE of abuse resistant opiods
--Uplisting to the NASDAQ exchange per the CEO, IR indicating ASAP
ELTP
