ELITE PHARMACEUTICALS INITIATES PIVOTAL BIOEQUIVALENCE STUDY FOR SECOND OPIOID ABUSE DETERRENT PRODUCT
Northvale, New Jersey, Tuesday, January 14, 2014: Elite Pharmaceuticals, Inc. ("Elite" or the “Company") ("Elite”) (OTCBB: ELTP) announced today the first dosing of a pivotal bioequivalence study in healthy volunteers for an undisclosed opioid abuse deterrent product utilizing Elite’s proprietary pharmacological abuse deterrent technology.
The study is a single-dose, open-label, partially randomized, three-way crossover study in which 52 healthy adult subjects will receive treatment in a partially randomized sequence. The primary objective of this study is to compare the bioavailability of the Company’s abuse deterrent product to that from the reference listed drug under fasted and fed conditions. The secondary objectives are: (i) determine whether or not subjects receiving the Company’s formulation are exposed to naltrexone; (ii) evaluate the safety and tolerability of the Company’s product. “Abuse of prescription narcotics is a serious problem in our society and we believe that our pharmacological approach provides a higher barrier to abuse than a physical approach,” said Nasrat Hakim, President and CEO of Elite. “We are pleased to announce initiation of this pivotal study for this undisclosed proprietary opioid abuse deterrent product. The dosing of our pilot study for our extended release oxycodone product has also been completed and we await final results from that study.” The bioequivalence studies for these opioid abuse deterrent products are being conducted under the direction of Camargo Pharmaceutical Services.
ELITE PHARMACEUTICALS INITIATES PILOT BIOEQUIVALENCE STUDY FOR ELI-201
Northvale, New Jersey, Thursday, December 05, 2013: Elite Pharmaceuticals, Inc. ("Elite" or the “Company") ("Elite”) (OTCBB: ELTP) announced today the first dosing of a pilot bioequivalence study in healthy volunteers for ELI-201, the Company’s twice daily abuse deterrent oxycodone/naltrexone product.
Elite has met the goal of starting the bio study for ELI-201 in December. A pivotal bioequivalence study for a second abuse deterrent product is scheduled to begin dosing in January 2014, and the pivotal bioequivalence study for ELI-201 is scheduled to begin dosing in March 2014. The bioequivalence studies for these opioid abuse deterrent products are being conducted under the direction of Camargo Pharmaceutical Services. “The start of the ELI-201 pilot study marks a major milestone for the development of products utilizing our proprietary abuse deterrent technology,” said Nasrat Hakim, Elite’s President and CEO. “I am extremely pleased with the progress Elite has made with the development of this technology. We have set several initiatives in motion and all of our research and development projects are on or ahead of schedule. We appreciate the guidance and expertise that has been provided by Camargo and look forward to this next phase for the Company.”
About Section 505(b)(2)
The Company plans to file an NDA for this product based on the provisions of section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act. Section 505(b)(2) allows the FDA to approve a drug on the basis of data in the scientific literature or data previously cited by the FDA as the basis for the approval of related drugs. This procedure makes it easier and potentially faster for drug developers to obtain approval of new formulations of drugs based, in part, on proprietary data of the developer of the original drug.
About Camargo Pharmaceutical Services
Camargo is a full-service drug development partner specializing in the 505(b)(2) process — an approach for developing products that offer differentiated benefits. Camargo is capable of managing every facet of the plan throughout the development continuum, from feasibility assessments, formulation and testing the drug product, to conducting preclinical and clinical studies, to final submission.
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 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.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. develops oral sustained and controlled release products. Elite's strategy includes assisting partner companies in the life cycle management of products to improve off-patent drug products and developing generic versions of controlled release drug products with high barriers to entry. Elite has seven commercial products currently being sold, twelve additional approved products pending manufacturing site transfer and two additional products under review pending approval by the FDA. Elite’s lead pipeline products include abuse resistant opioids utilizing the Company’s patented proprietary technology, and a once-daily opioid. They are sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.) and has partnered with Epic Pharma for the manufacturing and distribution of eleven approved products pending manufacturing site, with Hi-Tech Pharmacal to develop an intermediate for a generic product, and a Hong Kong based company to develop a branded product for the United States market and its territories. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
State-of-the Art Facility:
Elite can develop and manufacture oral solid dosage forms such as tablets and capsules. Elite's facility in Northvale, NJ includes administrative offices,
R&D labs, analytical labs and manufacturing suites. The GMP manufacturing facility is DEA registered for research, development, and manufacturing.
Elite is capable of taking a project from concept to commercialization.
Elite Pharmaceuticals develops products that have high barriers to entry with regard to factors such as:
- Products with formulation complexities
- Products with regulatory challenges
- Products requiring specialized release profiles
- Products with raw material problems
Elite typically develops these products through proof of concept and then partners or
licenses them out to fund the further development and for marketing. Under licensing terms,
Elite typically receives milestone payments during development and royalty payments upon commercialization.
Elite is a full service research and development company and can pursue an ANDA/NDA project
from its inception through development and approval to launch stage.
ELTP is financially on the right path. They weathered the loss of lodrane by continuing to add products. Treppel has done a great job of reducing the operating loss significantly. Each year getting closer to a profit.
Product pipeline: http://www.elitepharma.com/product_pipeline.asp Elite Leadership: Nasrat Hakim - 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. From 2004 - 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.
Recent Press Releases: http://www.elitepharma.com/investor_relations.asp
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
Doug Plassche - Executive Vice President of Operations Jerry Treppel - Chairman of Board of Directors
Doug Plassche, a Certified Six Sigma Black Belt, joined Elite in August 2013 and brings with him more than 23 years of pharmaceutical industry experience. From 2009 to 2013, Mr. Plassche was employed by Actavis as Managing Director of the New Jersey Solid Oral Dose Operations, overseeing 450 employees and the production of more than 100 products. From 2007 to 2009, Mr. Plassche was Senior Director of Manufacturing for PAR Pharmaceuticals overseeing 200 employees and the production of more than 70 products. From 1990 – 2007, he was employed by Schering-Plough progressing steadily through multiple disciplines, locations and technical operations sectors with increasing levels or responsibility.
Barbara Ellison - Vice President, Quality Operations & Regulatory Affairs
Barbara Ellison has extensive experience in quality assurance, regulatory compliance, validation, performance optimization and quality control. Ms. Ellison will have overall responsibility for Elite’s quality and regulatory functions including the Company’s Quality Assurance and Compliance group and the Analytics and Quality Control group. Ms. Ellison will serve as a member of Elite’s senior leadership team, reporting directly to Nasrat Hakim, Elite’s President and Chief Executive Officer. Prior to joining Elite, Ellison served as Director of Global Quality for the Cell Systems Division of Life Technologies, overseeing the quality and regulatory compliance at ten manufacturing sites worldwide and overseeing 135 people. Before then, Ms. Ellison was Vice President of Quality for West Pharmaceutical Services and Site Head of Quality Operations for Alpharma (now Actavis). She also served in senior level positions with Novartis as Head of Compliance, Warner Lambert as Director of Quality Operations and Regulatory Compliance/Quality Assessment. Ms. Ellison holds a B.S. in Chemistry and Mathematics from Central Connecticut State University, New Britain, CT.
Board Of Directors:
Jerry Treppel has served as the managing member of Wheaten Capital Management LLC, a capital management company focusing on investments in the health care sector, since 2003. In October 2008, Mr. Treppel was also appointed managing director of Ledgemont Capital Group LLC, a boutique merchant bank that provides access to capital and corporate advisory services to public and private companies. 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.
Barry Dash, Ph.D. - Director
Dr.Barry Dash has served as a Director since April 2005, a Member of the Audit Committee since April 2005, a Member of the Nominating Committee since April 2005 and a Member of the Compensation Committee since June 2007. Dr. Dash has been since 1995 President and Managing Member of Dash Associates, L.L.C., an independent consultant to the pharmaceutical and health industries. From 1983 to 1996 he was employed by American Home Products Corporation (now known as Wyeth) its Whitehall-Robins Healthcare Division, initially as Vice President of Scientific Affairs, then Senior Vice President of Scientific Affairs and then Senior Vice President of Advanced Technologies during which time he personally supervised six separate departments: Medical and Clinical Affairs, Regulatory Affairs, Technical Affairs, Research and Development, Analytical R&D and Quality Management/Q.C. Dr. Dash had been employed by the Whitehall Robins Healthcare Division from 1960 to 1976, during which time he served as Director of Product Development Research, Assistant Vice President of Product Development and Vice President of Scientific Affairs. Dr. Dash had been employed by J.B. Williams Company (Nabisco Brands, Inc.) from 1978 to 1982. From 1976 to 1978 he was Vice President, Director of Laboratories of the Consumer Products Division of American Can Company. He currently serves on the board of GeoPharma, Inc. (NASDQ: GORX) Dr. Dash holds a Ph.D. from the University of Florida and M.S. and B.S. degrees from Columbia University where he was Assistant Professor at the College of Pharmaceutical Sciences from 1956 to 1960. He is a member of the American Pharmaceutical Association, the American Association for the Advancement of Science and the Society of Cosmetic Chemist, American Association of Pharmaceutical Scientists, Drug Information Association, American Foundation for Pharmaceutical Education, and Diplomate American Board of Forensic Examiners. He is the author of scientific publications and patents in the pharmaceutical field.
Chris Dick - Chief Operating Officer & President / Director
Chris Dick joined Elite in November of 2002 as Vice President of Corporate Development. He directs licensing and business development activities for Elite. He joined Elite from Elan Drug Delivery, Inc. where he served as Director of Business Development. While in this position he was responsible for licensing and business development of Elan's portfolio of drug delivery technologies. Prior to Elan, Mr. Dick was Manager of Business Development and Marketing for EnTec, a drug delivery business unit within FMC Corporation's Pharmaceutical Division. Mr. Dick held various other business and technical positions at FMC including Manager of Marketing for the FMC's pharmaceutical functional coatings product line. Mr. Dick received an M.B.A. from Stern School of Business, New York University and a B.S. and M.S. in Chemical Engineering from Cornell University
Ashok G. Nigalaye, Ph.D. - Chief Scientific Officer / Director
Dr. Ashok G. Nigalaye has served as a Director since June 24, 2009. Dr.. Nigalaye was elected as a member of Elite's Board in June 2009 as one of three directors designated by Epic pursuant to the terms of the Epic Strategic Alliance Agreement. Since July 2008, Dr. Nigalaye has been the President and Chief Executive Officer of Epic Pharma LLC, a manufacturer of generic pharmaceuticals and Elite's strategic partner pursuant to the Epic Strategic Alliance Agreement. From August 1993 to February 2008, Dr. Nigalaye served as Vice President of Scientific Affairs and Operations of Actavis Totowa LLC, a manufacturer of generic pharmaceuticals, where he was responsible for directing and organizing company activities relating to pharmaceutical drug manufacturing, regulatory affairs and research and development. Dr. Nigalaye currently serves as a director of GTI Inc., a privately held company. Mr. Nigalaye holds a B.S. in Pharmacy from the University of Bombay, an M.S. in Industrial Pharmacy from Long Island University, and a Ph.D. in Industrial Pharmacy from St. John's University. Dr. Nigalaye is also a licensed pharmacist in the State of New York.
Jeenarine Narine - Director
Jeenarine Narine has served as a Director since June 24, 2009. Mr. Narine was elected as a member of Elite's Board in June 2009 as one of three directors designated by Epic pursuant to the terms of the Epic Strategic Alliance Agreement. Since July 2008, Mr. Narine has been the Executive Vice President of Manufacturing and Operations of Epic Pharma LLC, a manufacturer of generic pharmaceuticals and Elite's strategic partner pursuant to the Epic Strategic Alliance Agreement, in which capacity he oversees all manufacturing operations. Mr. Narine is also the current President of Eniran Manufacturing Inc., a contract manufacturer of dietary and nutritional supplements, and has held such office since 2000. In addition, Mr. Narine has been since 1989 the President of A&J Machine Inc., a company owned by Mr. Narine that is engaged in the sales of new and used pharmaceutical manufacturing equipment. In addition to this professional experience, Mr. Narine graduated from the Guyana Industrial Institute, where he studied Metalology and Welding..
Ram Potti - Director
Ram Potti has served as a Director since June 24,2009. Mr. Potti was elected as a member of Elite's Board in June 2009 as one of three directors designated by Epic pursuant to the terms of the Epic Strategic Alliance Agreement. Since July 2008, Mr. Potti has been the Vice President of Business Development of Epic Pharma LLC, a manufacturer of generic pharmaceuticals and Elite's strategic partner pursuant to the Epic Strategic Alliance Agreement, in which capacity he handles the company's new ventures and products. Mr. Potti is also the founder and current President of RSMB Investments LLC, an investment company that specializes in startup ventures in the healthcare and technology sectors. In addition, from 2002 to 2006, Mr. Potti was the President and Chief Operating Officer of Trigen Laboratories, a company which he founded that manufactures generic pharmaceutical products. Mr. Potti holds a B.S. in Chemistry from the University of Kerala, St. Albert's College.
Jeffrey Whitnell - Director
Jeffrey Whitnell has served as a Director since October 2009. Based on information available to the Board, the Board believes that Mr. Whitnell meets the requirements of an "audit committee financial expert" as defined under applicable rules under the Securities Exchange Act of 1934, as amended. Mr. Whitnell previously served as Chief Financial Officer and Senior Vice President of Finance at Akorn, Inc. between June 2004 to June 2009. Prior to that, Mr. Whitnell was Vice President of Finance and Treasurer for Ovation Pharmaceuticals from 2002 to April 2004 and Vice President of Finance and Treasurer for MediChem Research from 1997 to 2001. Before 1997, he held various finance positions at Akzo Nobel and Motorola. Mr. Whitnell began his career as an auditor at Arthur Andersen & Co. He is a certified public accountant and holds an M.B.A. in Finance from University of Chicago and a B.S. in Accounting from University of Illinois.
Officers: Carter J. Ward, CPA, CSCP - Chief Financial Officer
Carter Ward joined Elite in July of 2009 as Chief Financial Officer. Mr. Ward is a certified public accountant, graduated summa cum laude from Long Island University, Brooklyn, NY. For most of the past ten years, Mr. Ward's experience has been in the generic pharmaceutical industry, most recently filling multiple finance and supply chain leadership roles with Actavis Group and its U.S. subsidiary, Amide Pharmaceuticals. Earlier in his career, he was the Chief Financial Officer for Positive Healthcare/Ceejay Healthcare, a U.S.-Indian joint venture engaged in the manufacture and distribution of generic pharmaceuticals and nutraceuticals in India. Mr. Ward began his career in public accounting with KPMG.
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