ELTP --Billion dollar pipeline(33 DRUGS plus the A
Post# of 21194
Posted On: 09/19/2013 10:24:20 AM
ELTP --Billion dollar pipeline(33 DRUGS plus the ART line of opiods) made up of a complete line of NDA and ANDA abuse resistant (ART) opiods and multiple generics
--20 FDA approved drugs: hydromorphone, phentermine 37.5 mg, lodrane D, methadone, phendimetazine, phentermine 15mg, phentermine 30mg, naltrexone 50mg plus the 12 from MIKAH many which only need CBE30 review for quick transfer
--Nasarat Hakim former VP of Activas appointed president and CEO of Elite 08-05-13 with 30 years of pharmaceutical and medical industry experience in Quality Assurance, Analytical Research and Development, Technical Services and Regulatory Compliance. He brings with him proven management experience, in-depth knowledge of manufacturing systems, development knowledge in immediate and extended release formulations and extensive regulatory experience of GMP and FDA regulations. He is making ART priority one. He only wants ELTP stock as compensation , refusing cash. the CEO noted, we are trading on our financials(revenues) and if we had no revenue we would be trading on ART and R&D and we would be valued 10x higher ($0.90)
--Doug Plassche appointed Vice President of operations to run manufacturing and to lead the operational initiatives of the Company as it expands its product pipeline. Mr. Plassche has a proven track record in all critical areas including quality, compliance , process, operations, planning and personnel development
--4th quarter 2013 1.5 million in revenues best in co. history
--1st quarter 2014 up 41% yr to yr
--cash flow positive (CFP) goal for this fiscal year
--launched drugs continue to gain market share
--$10 Million equity line of funding secured from Lincoln Capital Fund (LPC) 04/22/2013 for product development only, temporary working capital, pilot studies and trials used $320k so far
--600 % increase in market cap in 2 years
--out standing shares 403K
--ELI-154 24 hr ER oxy (w/o ART) still in scale up for the European market
--12 hr oxycodone with ART starting pilot studies calendar 2013 for a 3 Billion dollar market will pave the way for the once a day which will only have to demonstrate (prove) bioequivalence to the twice a day formula
--ELI-216 is a controlled release 24 hr NDA abuse resistant(ART) oxycodone requiring Phase III clinical trials
--a partner for commercialization of ELI-216 will be done once human data gathered(multiple short studies required) then discuss with FDA JT wants to license after studies and trials complete making it worth much more due to the steep accretion curve in the pharma field
--ELI-216 is a priority with Elite and further along than most people think, JT
--FDA likes the pharmalogical approach to abuse resistance JT
--Hakim, the ART is rock solid, innovative, superior and has not seen anything better in ART
--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 20 years of propietary protection on their 2 bead ART: formulation to make an existing drug abuse resistant
--patent 13/863,764 Child Continuity Data strengthens Elite's patent protection of 2-bead ART giving it triple patent propietary protection
--2-bead abuse resistant opiods could replace the inferior abuse deterrent(easily defeated) opiods now on the market
--Elites ART is modular (plug and play system), not for just oxycodone it can be used on ALL opiods just add a different opiod bead to the standard sequestered naltrexone bead
--NE 30 polymer for sequestering naltrexone was found to be far superior to other polymers
--Elite has advanced the development of this technology(twice/day) through commercial scale up 05-2013
--The Company expects their first commercially scaled-up, abuse-resistant opioid(twice daily) product to enter human pilot studies late calendar 2013, Work has also been conducted on another abuse-resistant opioid product(once/day)
--Elite may license these ART products at a later date to a third party who could provide funding for the remaining clinical studies and who could provide sales and distribution for the product.
--BE and PK studies for ART progressing, some will complete in 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.
January 9, 2013, the FDA released its new draft guidance document, titled "Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling". The document discusses what it will take for an opioid formulation to secure an abuse resistant label. The implications for companies that meet these expectations are significant and even more so for those that meet these requirements and have patented abuse resistant technologies.
March 2013, 48 state attorney generals called on the agency to require generic makers to produce tamper-resistant versions of opioid medicines
--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
--CLADD petitions FDA to reject all opiods without ART
--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
--May 10, 2013 Endo Health (ENDP) ruling
--Elite's Competition being taken out one by one by the FDA and later the US Congress
--Elite owns approx 10% of Novel Labs, Gavis and recently Wintac: Novel and Elite have an ongoing dialog for monetization a lot goes into determining the value of a private co.
--Novel Labs adds to Elites value estimates for Novel's value range from 10 to 50 million dollars CEO admits value is worth more than their initial investment
--There are accordingly a total of 30+ products including a generic morning after (PLAN B) pill currently identified as being approved/marketed by Novel and Gavis, with such total representing an increase of 4 products as compared to a comparable point in the prior year
--Novel has provided to the Company, copies of its prior year tax returns and management prepared forecasts showing growing revenues
--CEO and officers being paid with stock
--Former CEO Jerry Trepple loaned the co. 1 million dollars unsecured $600k used considering taking stock as repayment of loan
--multiple partners have no concerns: Watson/Actavis, Mikah, Epic, TAGI, The Pharm Network, ECR, Precision Dose, Celgene Corp, TPN/Ascend, Novartis, SmithGlaxoKlein and the undisclosed Hong Kong Pharma
--contracting deals with other pharmas
--TWO 15,000 sq/ft FDA-DEA-cGMP registered manufacturing labs for research, development and manufacturing from concept to commercialization
--NEW packaging line operational and adding revenue to the bottom line
--30 employees double of two years ago
--Nasarat brings 13 new ANDA drugs many requiring only CBE 30 review for transfer
--4 drugs in * SCALE UP *
--phentermine 15 & 30mg launched (April 11, 2013) is competing with Qsymia(phentermine and topiramate)
--Acend Labs has new contracts for methadone
--Hong Kong Pharma NDA development over a year to go
--MIK-001 505b2 NDA maybe an improved Embeda on schedule in development
--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)
--505(b)(2)opportunities's for 12 hr ART generics and NDA's where Bio-equivalency studies alone are enough
--Naltrexone FDA approved, launch pending (Sept-Aug 2013) production began late June 2013
--Lodrane 24D equivalent waiting on feed back from FDA they will tell them which pseudoephedrine salt to use and which product to use to run trials with
--undisclosed 100% Elite owned ANDA approx 1 year
--Elite's goal is to commercialize a COMPLETE LINE of abuse resistant opiods
--Uplisting to the NASDAQ exchange per the CEO
--ELTP visibility increasing: Rodman Renshaw GLOBAL Investing Conference presentation
--Right Place at the Right Time with the Right Products Jerry Treppel
The NEW ELTP
--20 FDA approved drugs: hydromorphone, phentermine 37.5 mg, lodrane D, methadone, phendimetazine, phentermine 15mg, phentermine 30mg, naltrexone 50mg plus the 12 from MIKAH many which only need CBE30 review for quick transfer
--Nasarat Hakim former VP of Activas appointed president and CEO of Elite 08-05-13 with 30 years of pharmaceutical and medical industry experience in Quality Assurance, Analytical Research and Development, Technical Services and Regulatory Compliance. He brings with him proven management experience, in-depth knowledge of manufacturing systems, development knowledge in immediate and extended release formulations and extensive regulatory experience of GMP and FDA regulations. He is making ART priority one. He only wants ELTP stock as compensation , refusing cash. the CEO noted, we are trading on our financials(revenues) and if we had no revenue we would be trading on ART and R&D and we would be valued 10x higher ($0.90)
--Doug Plassche appointed Vice President of operations to run manufacturing and to lead the operational initiatives of the Company as it expands its product pipeline. Mr. Plassche has a proven track record in all critical areas including quality, compliance , process, operations, planning and personnel development
--4th quarter 2013 1.5 million in revenues best in co. history
--1st quarter 2014 up 41% yr to yr
--cash flow positive (CFP) goal for this fiscal year
--launched drugs continue to gain market share
--$10 Million equity line of funding secured from Lincoln Capital Fund (LPC) 04/22/2013 for product development only, temporary working capital, pilot studies and trials used $320k so far
--600 % increase in market cap in 2 years
--out standing shares 403K
--ELI-154 24 hr ER oxy (w/o ART) still in scale up for the European market
--12 hr oxycodone with ART starting pilot studies calendar 2013 for a 3 Billion dollar market will pave the way for the once a day which will only have to demonstrate (prove) bioequivalence to the twice a day formula
--ELI-216 is a controlled release 24 hr NDA abuse resistant(ART) oxycodone requiring Phase III clinical trials
--a partner for commercialization of ELI-216 will be done once human data gathered(multiple short studies required) then discuss with FDA JT wants to license after studies and trials complete making it worth much more due to the steep accretion curve in the pharma field
--ELI-216 is a priority with Elite and further along than most people think, JT
--FDA likes the pharmalogical approach to abuse resistance JT
--Hakim, the ART is rock solid, innovative, superior and has not seen anything better in ART
--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 20 years of propietary protection on their 2 bead ART: formulation to make an existing drug abuse resistant
--patent 13/863,764 Child Continuity Data strengthens Elite's patent protection of 2-bead ART giving it triple patent propietary protection
--2-bead abuse resistant opiods could replace the inferior abuse deterrent(easily defeated) opiods now on the market
--Elites ART is modular (plug and play system), not for just oxycodone it can be used on ALL opiods just add a different opiod bead to the standard sequestered naltrexone bead
--NE 30 polymer for sequestering naltrexone was found to be far superior to other polymers
--Elite has advanced the development of this technology(twice/day) through commercial scale up 05-2013
--The Company expects their first commercially scaled-up, abuse-resistant opioid(twice daily) product to enter human pilot studies late calendar 2013, Work has also been conducted on another abuse-resistant opioid product(once/day)
--Elite may license these ART products at a later date to a third party who could provide funding for the remaining clinical studies and who could provide sales and distribution for the product.
--BE and PK studies for ART progressing, some will complete in 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.
January 9, 2013, the FDA released its new draft guidance document, titled "Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling". The document discusses what it will take for an opioid formulation to secure an abuse resistant label. The implications for companies that meet these expectations are significant and even more so for those that meet these requirements and have patented abuse resistant technologies.
March 2013, 48 state attorney generals called on the agency to require generic makers to produce tamper-resistant versions of opioid medicines
--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
--CLADD petitions FDA to reject all opiods without ART
--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
--May 10, 2013 Endo Health (ENDP) ruling
--Elite's Competition being taken out one by one by the FDA and later the US Congress
--Elite owns approx 10% of Novel Labs, Gavis and recently Wintac: Novel and Elite have an ongoing dialog for monetization a lot goes into determining the value of a private co.
--Novel Labs adds to Elites value estimates for Novel's value range from 10 to 50 million dollars CEO admits value is worth more than their initial investment
--There are accordingly a total of 30+ products including a generic morning after (PLAN B) pill currently identified as being approved/marketed by Novel and Gavis, with such total representing an increase of 4 products as compared to a comparable point in the prior year
--Novel has provided to the Company, copies of its prior year tax returns and management prepared forecasts showing growing revenues
--CEO and officers being paid with stock
--Former CEO Jerry Trepple loaned the co. 1 million dollars unsecured $600k used considering taking stock as repayment of loan
--multiple partners have no concerns: Watson/Actavis, Mikah, Epic, TAGI, The Pharm Network, ECR, Precision Dose, Celgene Corp, TPN/Ascend, Novartis, SmithGlaxoKlein and the undisclosed Hong Kong Pharma
--contracting deals with other pharmas
--TWO 15,000 sq/ft FDA-DEA-cGMP registered manufacturing labs for research, development and manufacturing from concept to commercialization
--NEW packaging line operational and adding revenue to the bottom line
--30 employees double of two years ago
--Nasarat brings 13 new ANDA drugs many requiring only CBE 30 review for transfer
--4 drugs in * SCALE UP *
--phentermine 15 & 30mg launched (April 11, 2013) is competing with Qsymia(phentermine and topiramate)
--Acend Labs has new contracts for methadone
--Hong Kong Pharma NDA development over a year to go
--MIK-001 505b2 NDA maybe an improved Embeda on schedule in development
--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)
--505(b)(2)opportunities's for 12 hr ART generics and NDA's where Bio-equivalency studies alone are enough
--Naltrexone FDA approved, launch pending (Sept-Aug 2013) production began late June 2013
--Lodrane 24D equivalent waiting on feed back from FDA they will tell them which pseudoephedrine salt to use and which product to use to run trials with
--undisclosed 100% Elite owned ANDA approx 1 year
--Elite's goal is to commercialize a COMPLETE LINE of abuse resistant opiods
--Uplisting to the NASDAQ exchange per the CEO
--ELTP visibility increasing: Rodman Renshaw GLOBAL Investing Conference presentation
--Right Place at the Right Time with the Right Products Jerry Treppel
The NEW ELTP
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