Elite Pharmaceuticals, Inc. (ELTP)
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company developing a pipeline of proprietary pharmacological abuse-deterrent opioid products and niche generic products. Elite specializes in oral sustained and controlled release drug products with high barriers to entry. Elite owns generic which have been licensed to TAGI Pharma, Epic Pharma, Dr. Reddy’s Laboratories and Glenmark Pharmaceuticals Inc., USA. About Elite's Abuse Deterrent Technology Elite's abuse deterrent products utilize the Company's proprietary pharmacological abuse deterrent technology. Elite's abuse deterrent technology is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist. Naltrexone is an opioid receptor 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, 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 currently has eight commercial products currently being sold, six products filed with the FDA, additional approved products pending manufacturing site transfer and the NDA filing for SequestOx™.
Elite’s pipeline products include abuse-deterrent opioids utilizing the Company’s patented proprietary technology and a once-daily opioid. These products include sustained release oral formulations of opioids for the treatment of chronic pain. These formulations are intended to address two major limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential opioid abuse.
Located in Northvale, New Jersey, Elite operates a 55,000 square foot campus under Current Good Manufacturing Practice (“cGMP”) and is a United States Drug Enforcement Agency (“DEA”) registered facility for research, development, manufacturing and packaging of pharmaceutical products.
\ Elite continues to expands the intellectual property for the Company's opioid abuse deterrent technology. Elite now has four US patents, one European patent, and two Canadian patents issued in this area with additional patents pending in the U.S., Canada and Europe. More information including Elite’s proprietary Abuse Resistant Technology can be found at http://www.elitepharma.com
Products & Pipeline Elite’s principle product is SequestOx
™, an immediate-release oxycodone with sequestered naltrexone abuse-deterrent opioid product for the management of moderate to severe acute pain. Additional products include bariatric, cardiovascular, antihistamine, skeletal muscle relaxants, antipsychotic, tricyclic antidepressant, along with a number of approved products pending manufacturing site transfer. Elite owns generic and OTC products which have been licensed to TAGI Pharma, Epic Pharma, Dr. Reddy's Laboratories and Valeant Pharmaceuticals International. Additional information regarding Elite’s wholly owned products, partnerships, and contract manufacturing can be found at http://www.elitepharma.com/products
\The list of pipeline products can be found at http://www.elitepharma.com/pipeline-generics
Nasrat Hakim, Chairman, President & Chief Executive Officer
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.