*****ELITE PHARMACUTICAL(ELTP)*****
--8 FDA approved drugs: hydromorphone, phentermine 37.5 mg, lodrane D, methadone, phendimetazine, phentermine 15mg, phentermine 30mg, naltrexone 50mg
--4 quarters of increasing revenues
--Lodrane 24 and 24D returning after being pulled by FDA with 500 other cold/flu products
--Lodrane D OTC gaining market share
--cash flow positive(CFP) probably this quarter
--CEO Jerry Trepple loaned the co. 1 million dollars unsecured (non-dilutive)
--interest paid in full on loans
--ELI-216 Controlled released (CR) Abuse Resistant(ART) opiods are a priority, further along than 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)
--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(abuse resistant tech)
--Patent pending 13/379,486 microtablet 0.25-1.0mm smallest in the industry for use with ALL medicines
--Patent pending 13/379,481 microtablets for use with abuse resistant products
-- 2 BEAD abuse resistant technology is a superior ART, it is Modular meaning it can be easily used for ALL opiods not just oxy
--ELI-216 is a controlled release 24 hr abuse resistant oxy requiring Phase III clinical trials, after which it can be used for ALL opiods. Trials could start any time.
--partner for ELI-216 could be announced any day
--patent 12/075,816 Sequestering polymer acrylic co-polymer composition: ON HOLD while Elite and lawyers Washburn&Woodcock strategize to add more claims
--Novel net worth growing, 31 FDA approved drugs including generic morning after pill
--Elite owns 10% of Novel Labs, Novel has approached Elite for monetization
--estimates for 10% value of Novel range from 10 million to 50 million
--Elites 3.5 million debt will be eliminated with sale of Novel
--current launched drugs continue to gain market share
--phentermine 15/30mg launched (April 11, 2013) will compete with Qsymia(phentermine and topiramate)
--BE and PK studies progressing, some maybe completed or near completion
--New Jersey(NJEDA) tax credits approaching 1 million dollars/yr
--Impressive billion dollar pipeline
--multiple partners supporting Elite: Watson/Actavis, Mikah, Epic, TAGI, The Pharm Network, ECR, Precision Dose, Celgene Corp and the undisclosed Hong Kong Pharma
--contracting deals with other Pharmas
--NEW Packaging line operational, making and saving the co. money, adding to the bottom line
--TWO 15,000 sq/ft FDA-DEA-GMPc registered manufacturing labs for research, development and manufacturing from concept to commercialization
-- 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 100 million dollar branded intermediate
--first of 8 Epic drugs due out anytime
--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
--Naltrexone FDA approved, launch pending (May-June 2013)
--undisclosed ANDA's could come out any day
--CEO's goal is to comercialize a COMPLETE LINE of abuse resistant opiods
--Relisting on NASDAQ 2-4 years
ELTP
