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Elite Pharmaceuticals (ELTP)

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Elite Pharmaceuticals is a specialty pharmaceutical company specializing in niche generics and committed to the development of abuse-deterrent opioids to help curb diversion, misuse and abuse.  Elite has a pipeline of opioid abuse-deterrent products under development utilizing the company’s proprietary pharmacological abuse-deterrent technology.

 
Elite’s website can be found by going to http://www.elitepharma.com


How ART Works:

Elite’s proprietary abuse-deterrent technology, ART™, is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol dependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist, naltrexone, is designed to release. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers. Elite’s pharmacological approach to abuse-deterrence can be applied to a wide range of opioids used today in pain management.
 


 

Recent Press Releases:

Oct 21, 2015
Elite Pharmaceuticals Announces Positive Top-Line Results From a Pivotal Phase 3 Study for Abuse-Deterrent Opioid ELI-200
http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=79416&BzID=2258&t=1948&g=939&Nav=0&LangID=1&s=0

Aug 10, 2015
Elite Pharmaceuticals Reports Record Revenues for First Quarter of Fiscal Year 2016
http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=78453&GoTopage=1&Category=2163&BzID=2258&t=1948&G=939

Aug 3, 2015
Elite Pharmaceuticals Completes Enrollment and Dosing for ELI-200 Phase III Efficacy Trial
http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=78262&GoTopage=1&Category=2163&BzID=2258&t=1948&G=939

Jun 16, 2015
Elite Pharmaceuticals Granted New Patent for Abuse Deterrent Technology
http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=77581&GoTopage=1&Category=2163&BzID=2258&t=1948&G=939

Jun 9, 2015
Elite Pharmaceuticals and Epic Pharma Enter Into a Sales and Distribution Licensing Agreement for Abuse-Deterrent ELI-200
http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=77479&BzID=2258&t=1948&g=939&Nav=0&LangID=1&s=0


More information can be found by going to Elite’s investor section:  http://ir.elitepharma.com/press_releases
Highlights From Last Quarter:
 
Second quarter ending September, 2015
Consolidated revenues for the second quarter of fiscal 2015 was $2.7M, all of which came from Elite's generic operation. An increases of 30% over last quarter's generic revenues. Generic revenue continues to grow with new highs being set  8 out of the 10 last quarters. The cost of revenue for this quarter totals $1.4M, for a gross profit of $1.3M. Overall expenses for the quarter total $5.3M with $4.2M going towards the development of Elite’s proprietary abuse-deterrent opioid product,ELI-200.
 
Business Update
The first product to utilize Elite's abuse deterrent technology, ELI-200, has successfully completed Phase III studies. The Company believes that it will be able to file a New Drug Application (NDA) with the FDA during this calendar year. When this application is accepted by the FDA it will be granted expedited review by the FDA,the company estimates that approval could be achieved in calender Q2\2016. Shareholders will be notified when the FDA accepts the ELI-200 NDA which is estimated to be in the first or second week in Jan, 2016.
 
Common shares issued pursuant to the strategic alliance agreement with Epic Investments LLC.
As per the Epic Strategic Alliance, Elite is entitled to 15% of the profits achieved from the commercial sales of Epic's immediate release oxycodone tablets, for a 10 year period commencing on the date of first commercial shipment and Epic is to receive 3 million shares of Common Stock upon approval by the FDA of the ANDA.
 

Financials:
 
 
 

Products:
 
http://www.elitepharma.com/products/

Leadership:

President & Chief Executive Officer - Nasrat Hakim

Nasrat Hakim joined Elite in August 2013 as Director, President and Chief Executive Officer. Mr. Hakim has more than 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. Prior to his leading Elite, from 2004 to 2013, Mr. Hakim was employed by Actavis, Watson and Alpharma in various senior management positions. Most recently, Mr. Hakim served as International Vice President of Quality Assurance at Actavis, overseeing 25 sites with more than 3,000 employees under his leadership. Mr. Hakim also served as Corporate Vice President of Technical Services, Quality and Regulatory Compliance for Actavis U.S., Global Vice President, Quality and Regulatory Compliance for Alpharma, as well as Executive Director of Quality Unit at TheraTech, overseeing manufacturing and research and development. In 2009, Mr. Hakim founded Mikah Pharma, LLC, a virtual, fully functional pharmaceutical company.

Mr. Hakim’s career started in Medical Laboratory Technology from the Academy of Health and Sciences in the U.S. Army based in San Antonio, TX, followed by Graduate Certification in Regulatory Affairs (RAC) from California State University at Sacramento, Sacramento, CA; Bachelor in Chemistry/Bio-Chemistry and Masters of Science in Chemistry from California State University at Sacramento, Sacramento, CA; and a Masters in Law with Graduate Certification in U.S. Taxation from St. Thomas University, School of Law, Miami, FL.

Board of Directors Chairman - Jerry Treppel

Mr. Treppel is currently a Managing Director of ArcLight Advisors, an investment bank specializing in the health care sector. From October 2008 through March 2013, Mr. Treppel was Managing Director of Ledgemont Capital Group LLC, a boutique merchant bank that provided access to capital and corporate advisory services to public and private companies. Additionally, he served as the managing member of Wheaten Capital Management LLC, a capital management company focusing on investments in the health care sector from 2003 to 2008. Over the past 20 years, Mr. Treppel was an equity research analyst focusing on the specialty pharmaceuticals and generic drug sectors at several investment banking firms including Banc of America Securities, Warburg Dillon Read LLC (now UBS), and Kidder Peabody and Co. He previously served as a healthcare services analyst at various firms, including Merrill Lynch & Co. Mr. Treppel holds a BA in Biology from Rutgers College, an MHA in Health Administration from Washington University, and an MBA in Finance from New York University. Mr. Treppel has been a Chartered Financial Analyst *CFA) since 1988.


Investor Relations:

Vice President of Investor Relations and Corporate - Dianne Will

Dianne Will joined Elite in 2003 as an Investor Relations Specialist and was named Elite’s Vice President of Investor Relations and Corporate Affairs in 2013. In 1996, Ms. Will founded Willstar Consultants, an investor relations consulting firm and has been providing investor relations services to a range of public companies for more than 19 years with a primary focus in the pharmaceutical and tech sectors. Her firm provides corporate services including management and execution of investor relations programs, investor communication, peer research, compliance services, support for
management team changes, proxy fights, crisis management and IPOs.

Investor Relations and Corporate Inquiries

Dianne Will
Vice President of Investor Relations and Corporate Affairs
Telephone: 518-398-6222
Email: [email protected]

Corporate Headquarters

165 Ludlow Avenue
Northvale, New Jersey 07647
Phone: 201-750-2646
Fax: 201-750-2755
 


Miscellaneous Links:

SEC Filings: http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001053369&owner=include

FDA website: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails

Clinical Trials.Gov: https://www.clinicaltrials.gov/




 


  Using the industry average PE\Ratio of 15, an over exaggerated  share count of 100% of the 995M authorized shares, and a very conservative
  profit margin of 30%, Elite stands to garner an increase in share price with the launch of each abuse resistant opioid product.

               



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ELTP News: Current Report Filing (8-k) 12/22/2016 05:25:52 PM
ELTP News: Confidential Treatment Order (ct Order) 12/22/2016 05:17:13 PM
ELTP News: Amended Annual Report (10-k/a) 11/17/2016 04:05:38 PM
ELTP News: Amended Quarterly Report (10-q/a) 11/17/2016 04:03:30 PM
ELTP News: Prospectus Filed Pursuant to Rule 424(b)(3) (424b3) 11/09/2016 05:10:17 PM
PostSubject
#239843  Sticky Note Maz, this has nothing to do with SequestOx WeeZuhl 01/20/17 08:56:19 PM
#239443  Sticky Note Yes IMO first SequestOx FDA Commercial approval in lasers 01/17/17 11:02:44 PM
#236265  Sticky Note Elite Pharma: The company of firsts: namtae 12/14/16 12:32:00 PM
#234937  Sticky Note THIS IS WHAT YOU NEED TO KNOW BEFORE Couch 11/30/16 03:04:07 PM
#189564  Sticky Note $ELTP SequestOx and ADF Patents lasers 03/18/16 04:29:26 AM
#185967  Sticky Note The only topic here is ELTP. IH Admin [Dan] 02/23/16 09:32:46 PM
#240336   bought more myself today..but just threw luvwetscent 01/24/17 08:14:08 PM
#240335   LMAO; must be why NOBODY filled my buy Couch 01/24/17 07:15:58 PM
#240334   I'll remember that statement when the company is mrwrn2010 01/24/17 05:29:36 PM
#240331   Since you can't short the stock, there was BostonTrader 01/24/17 05:15:30 PM
#240326   Roc, surely hope so!We are back to that 14-16 snupoled 01/24/17 03:56:04 PM
#240323   Big bids and a small fry offer only namtae 01/24/17 03:38:50 PM
#240322   IMO, was to stop any hope of a PH4RM4C3UT1C4LS 01/24/17 03:35:30 PM
#240321   Something is definitely in the works. There PH4RM4C3UT1C4LS 01/24/17 03:33:59 PM
#240319   ETRF suddenly offering 600k @.159? FAKE? Trend-Setter 01/24/17 03:33:31 PM
#240318   PH4: AGREE; MAYBE NEW PR TOMORROW - rocioyogi 01/24/17 03:30:17 PM
#240317   That's the massive lot I was speaking about. PH4RM4C3UT1C4LS 01/24/17 03:26:20 PM
#240316   2x 300K bid@ .15 Trend-Setter 01/24/17 03:24:01 PM
#240315   my scttrd acct showing 600,000 on the BID rocioyogi 01/24/17 03:21:51 PM
#240314   yap calling all shorts 3,6,9s NAM been calling tommy1969 01/24/17 03:21:25 PM
#240313   Your absolutely right. But you know what man. jbdiver 01/24/17 03:16:57 PM
#240312   Signals. Hilarious. 90% Goodtimes93 01/24/17 03:04:16 PM
#240311   To each his own doncamel 01/24/17 03:02:08 PM
#240307   Buy the dips, GL NASDAQ2020 01/24/17 02:49:51 PM
#240306   Maybe keeping a close eye on Elites share namtae 01/24/17 02:44:19 PM
#240305   Cool. News to me. I don't obsess over mrwrn2010 01/24/17 02:23:32 PM
#240304   Got to get that Roth IRA loaded NASDAQ2020 01/24/17 02:23:11 PM
#240303   Elite is holding 15 pennies bid.. Exciting times!! namtae 01/24/17 02:20:33 PM
#240300   I'll get right on it commissioner doncamel 01/24/17 01:51:12 PM
#240299   I just saw a trade on Elite for namtae 01/24/17 01:50:18 PM
#240298   Haha, this kind of behavior is only executable doncamel 01/24/17 01:47:35 PM
#240296   Right, I know the textbook stuff..... I'm doncamel 01/24/17 01:40:20 PM
#240294   Been hearing that for years. mrwrn2010 01/24/17 01:24:03 PM
#240293   Insiders holding for THE BUYOUT. NASDAQ2020 01/24/17 01:18:22 PM
#240283   And when MMs break up an order that doncamel 01/24/17 01:04:20 PM
#240279   There usually single, double or triple digit. CMDawg 01/24/17 12:57:20 PM
#240278   Can anyone tell what the message between market doncamel 01/24/17 12:54:36 PM
#240277   They don't want to sell at low price Goodtimes93 01/24/17 12:48:41 PM
#240276   If they don't sell at .15 then they doncamel 01/24/17 12:46:41 PM
#240275   Of course, many can and do predict the namtae 01/24/17 12:41:18 PM
#240274   If they knew it would be .15 cents Scared_Trader 01/24/17 12:08:26 PM
#240273   Seven Pathways to Dollarland NASDAQ2020 01/24/17 11:58:57 AM
#240272   Gee I put a bid in at .145 Couch 01/24/17 11:57:58 AM
#240269  Restored Almost all sellers and very little movement. Goodtimes93 01/24/17 11:26:52 AM
#240268   They're holding, to sell it for around $3-$5..... doncamel 01/24/17 11:21:03 AM
#240267   Chutes and Ladders littlerhody 01/24/17 11:16:06 AM
#240266   If so, looks like INSIDERS made another HUGE MISCALCULATION!! namtae 01/24/17 10:56:57 AM
#240265   Insiders are NOT selling they are waiting on NASDAQ2020 01/24/17 10:53:04 AM
#240264   What are the chances Nasrat sells the company NASDAQ2020 01/24/17 10:51:38 AM
#240263   Indeed. May be the highest I've seen on PH4RM4C3UT1C4LS 01/24/17 10:26:58 AM
#240262   Hmmmmmm....Interesting Trend-Setter 01/24/17 10:25:36 AM
#240261   Massive 1/2 mil bid on the block. Someone PH4RM4C3UT1C4LS 01/24/17 10:19:51 AM
#240260   but but but he is a rookie ceo dr_lowenstein 01/24/17 10:15:16 AM
#240259   Looks like the weak hands that all got namtae 01/24/17 09:37:12 AM
#240258   Sounds about right, snupoled 01/24/17 09:14:59 AM
#240257   All the WEAK hands should have left yesterday. aELmTPa 01/24/17 09:04:42 AM
PostSubject