Elite Pharma:
--Specializes in the development of oral ABUSE RESISTANT OPIODS
Recent news out of FDA keeps eliminating all of Elites competition in this sector.
--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
--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(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 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 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 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