*****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
--current launched drugs continue to gain market share
--cash flow positive(CFP) probably this quarter
--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
--interest paid in full on loans
--ELI-216 Controlled released (CR) Abuse Resistant(ART) opiods are a priority, 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(abuse resistant tech) formulation to make an existing drug abuse resistant via 2-bead technology
--patent 13/863,764 Child Continuity Data strengthens Elite's "Hammer Lock" on 2-bead ART giving it triple patent protection. Gives ELI-216 ART 20+ years of propietary protection
--2 BEAD abuse resistant technology is a superior ART, it is Modular meaning it can be easily used for ALL opiods not just oxycodone
--NE 30 polymer to sequester naltrexone was found to be far superior to other polymers
--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
--ELI-216 is a controlled release 24 hr abuse resistant oxy requiring Phase III clinical trials, trials could start any time.
--partner for ELI-216 could be announced any day
--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 + 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, pay for ELI-216 phase III clinical trials, and allow for purchase of more ANDA's
--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
--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 ruled 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
-- FDA ruled 04/16/2013 to prohibit original non-abuse resistant oxycodone from being made in generic form, unless it has abuse resistant/deterrent properties. Elite is now in a great position because it has the best 2-bead ART which can be applied to ALL generic opiods.
-- FDA eliminated MOST of Elite's competion leaving only a hand full of companies to divide up billions and billions of dollars.
Elites Abuse Resistant Technology will be preferred over the others only Deterrent formulas at best.
--Additionally, with the FDA ruling in favor of Purdue's abuse deterrent oxycontin formulation and requiring generic pharmas to include Abuse Deterrent technology in their Oxycodone Anda's....this is a sure sign of how the FDA is going to mandate abuse deterrent/resistant technology for both branded and generic opioid products.....and additionally with the STOPP ACT in chambers......Elite stands a real chance of catching some eyes should Elite be able to start trials before the FDA's official PR on the matter.
ELTP
