*****ELITE PHARMACUTICAL(ELTP)*****
--Elite Pharmaceuticals, Inc. 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.
--8 FDA approved drugs: hydromorphone, phentermine 37.5 mg, lodrane D, methadone, phendimetazine, phentermine 15mg, phentermine 30mg, naltrexone 50mg, all gaining market share
--4 quarters of increasing revenues
--launched drugs continue to gain market share
--cash flow positive(CFP) this quarter or next
--ELI-216 is a controlled release 24 hr abuse resistant(ART) oxycodone requiring Phase III clinical trials, which could start any time.
--partner for commercializing 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(approval due week of April, 21 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 protection for 20+ years of propietary protection
--2 BEAD abuse resistant technology is superior to abuse deterrent tech on the market now and not easily defeated
--Elites ART is modular: ELI-216 is not just one drug it can be used on ALL opiods
--NE 30 polymer to sequester naltrexone was found to be far superior to other polymers
--BE and PK studies for ART progressing, some were due to be finished by March 31, 2013
--Patent pending 13/379,481 microtablets for use with abuse resistant products
--Patent pending 13/379,486 microtablet 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
--Elite owns 10% of Novel Labs, Gavis and recently Wintac: Novel has approached Elite for monetization
--Novel net worth rapidly growing, 31 FDA approved drugs, including a new generic morning after(Plan B) pill
--estimates for 10% value of Novel range from 10 million to 50 million
--sale of Novel Labs will make Elite's financials rock solid by pay 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 in shares
--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 supporting Elite: Watson/Actavis, Mikah, Epic, TAGI, The Pharm Network, ECR, Precision Dose, Celgene Corp and the undisclosed Hong Kong Pharma
--phentermine 15/30mg launched (April 11, 2013) will compete with Qsymia(phentermine and topiramate)
--interest paid in full on loans
--New Jersey(NJEDA) tax credits approaching 1 million dollars/yr
--Impressive billion dollar pipeline
--contracting deals with other pharmas
--TWO 15,000 sq/ft FDA-DEA-GMPc registered manufacturing labs for research, development and manufacturing from concept to commercialization
--NEW Packaging line operational, making and saving the co. money and adding to the bottom line
--26 employees up from 16, 2 years ago
-- 4-5 drugs in * Scale Up *
--Hong Kong NDA progressing
--MIK-001 probably an improved Embeda
--HITK's generic of a 100 million dollar branded intermediate
--first of 8 Epic drugs due out anytime
--Lodrane 24 and 24D returning after being pulled by FDA with 500 other cold/flu products
--505(b)(2)opportunities's for ART generics and NDA's where Bio-equivalency studies alone are enough (no phase III trials)
--STOPP ACT - a bill before Congress now, introduced by US Rep's Rahall, Rogers and Keating. The Gov. will prohibit any old-formula opiod from enterng the market if the FDA has an equivalent ART opiod approved
--FDA Purdue ruling April 16, 2013 :it will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin
--the FDA decision requires generic companies to develop their own abuse-deterrent designs: it effectively eliminates most of Elites competion and makes their ART MORE VALUABLE
--Naltrexone FDA approved, launch pending (May-June 2013)
--undisclosed ANDA's could come out any day
--CEO's goal is to commercialize a COMPLETE LINE of abuse resistant opiods
--Relisting on NASDAQ per the CEO, IR indicating ASAP
