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:
Jun 9, 2015 Elite Pharmaceuticals and Epic Pharma Enter Into a Sales and Distribution Licensing Agreement for Abuse-Deterrent ELI-200
Apr 21, 2015 Elite Pharmaceuticals Announces Launch Of Generic Hydroxyzine Tablets
Feb 17, 2015 Elite Pharmaceuticals Provides Guidance On Phase III Study For ELI-200 http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=75450&GoTopage=1&Category=2163&BzID=2258&t=1948&G=939
Jan, 15 2015 Elite Pharmaceuticals Announces First Shipment Of Generic Isradipine Capsules http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=74835&GoTopage=1&Category=2163&BzID=2258&t=1948&G=939 More information can be found by going to Elite’s investor section: http://ir.elitepharma.com/press_releases
Highlights From Last Quarter: Third Quarter ending December 31, 2014 ♦ Consolidated revenues for the third quarter of Fiscal 2015 continued their upward trend, rising to $1.4 million, an increase of approximately 8.5% over consolidated revenues for the second quarter of Fiscal 2015. The third quarter revenues for this year were $0.3 million below revenues reported for the third quarter of the prior fiscal year due to a one-time $0.6 million milestone that occurred in the prior year third quarter. Development of our proprietary abuse-deterrent opioid technology continues to be Elite's top priority. During the quarter, Elite invested an additional $2.3 million in clinical trials and other product development activities. Highlights for the third quarter
♦ As of December 31, our working capital was $8.9 million, including cash of $8.3 million.
♦ Isradipine was recently launched, and we expect to introduce Hydroxyzine and Dantrolene in the near-term.
♦ We're a penny stock company with eyes on NASDAQ; we need to be Sarbanes Oxley compliant. So we are evaluating the gaps that we have by hiring consultants and external consultants in order to evaluate the checks and balances we have in order for us to get there.
♦ We are creating infrastructure in our facilities with expanding the facilities and adding new equipment and upgrading the current equipment in order to support our (Eli-200) product launch.
2014 was our best year, 2015 will be the year we file our first ART product, and Q1 2016 will be the year we launch our first ART product and hopefully will be the year we will be on NASDAQ. Nine-Month Period Ending December 31, 2014 ♦ Revenues for the nine months ending December 31, 2014 were $3.8 million, an increase of 6% over revenues for the comparable period of the prior year, even with the one-time milestone being included in the prior year revenues. The increase in revenues is due to the continued growth and expansion of Elite's generic product lines. ♦ During the first nine months of the fiscal year, Elite has invested a total of $9.9 million in product development, including successful completion of the human abuse liability study for ELI-200.
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
Vice President of Investor Relations and Corporate Affairs
165 Ludlow Avenue
Northvale, New Jersey 07647
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/
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