Website and NEWS links: http://www.elitepharma.com/
ELTP has a NEW CEO Nasrat Hakim who is working for ONLY STOCK SHARES, as he believes the stock is grossly undervalued... Quote from Aug. 15 2013 conference call.
"But if we look at that and at the market that it could generate, this stock will be in a different place. Unfortunately, we are sitting here listening to our earnings of a million and two and even one when we bring Mikah's drawbacks and we bring in millions of dollars more. If you guys are happy with that, I'll consider myself as failure I did not come here to have an R&D -- sorry a manufacturing company that's producing $20 million, $30 million a year. I was looking for a company that's making billions of dollars per year."
Elite has also purchased from Mikah Pharma, LLC ("Mikah")
| Date : || 08/05/2013 @ |
twelve approved and one pending Abbreviated New Drug
Applications ("ANDAs") to add to Elite's pipeline of products.
4/23/2013 ELITE PHARMACEUTICALS AWARDED SECOND U.S. PATENT FOR ABUSE RESISTANT DRUG FORMULATION
4/22/2013 ELITE PHARMACEUTICALS, INC. SECURES $10 MILLION FUNDING COMMITMENT FROM LINCOLN PARK CAPITAL FUND, LLC
4/11/2013 ELITE PHARMACEUTICALS, INC. ANNOUNCES FIRST SHIPMENT OF GENERIC PHENTERMINE CAPSULES
2/13/2013 Elite Pharmaceuticals, Inc. Announces Fiscal Year 2013 Third Quarter Investor Conference Call on Tuesday, February 19, 2013
2/6/2013 ELITE PHARMACEUTICALS ANNOUNCES FDA APPROVAL OF SUPPLEMENTAL APPLICATION FOR NALTREXONE
Link to 11 Billion dollar NYSE company - ACT- Actavis Labs distributing ELTP's Phendimetrazine
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.
LINK to Launched Products and Product Pipeline: http://www.elitepharma.com/product_pipeline.asp
Link to SEC filings: http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001053369&owner=include
Recent Press Releases: http://www.elitepharma.com/investor_relations.asp
Elite Pharmaceuticals Press Release for: Wednesday, February 06, 2013
| ELITE PHARMACEUTICALS ANNOUNCES FDA APPROVAL OF SUPPLEMENTAL APPLICATION FOR NALTREXONE |
Northvale, New Jersey, Wednesday, February 06, 2013: Elite Pharmaceuticals, Inc. ("Elite") (OTCBB: ELTP) announced today that on January 31, 2013, the U.S. Food and Drug Administration approved the Company's supplemental application for the manufacturing and packaging of naltrexone hydrochloride 50 mg tablets. This approval will allow the Company to commence the commercial manufacturing and packaging of this product for its sales and marketing partner, which will distribute the product as part of a multi-product distribution agreement.
Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid addiction. For the twelve months ending December 31, 2012, Revia® and its generic equivalents had total U.S. sales of approximately $16 million according to IMS Health Data.
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 five commercial products with 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 Actavis and Ascend Laboratories (previously a subsidiary of ThePharmaNetwork and now a subsidiary of Alkem Laboratories Ltd.) and has partnered with Mikah Pharma to develop a new product, 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.
For Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
Elite Pharmaceuticals Announces First Shipment of Generic Phendimetrazine Tablet Product
Elite Pharmaceuticals, Inc. (OTCBB:ELTP) announced today the initial shipment of Phendimetrazine tartrate 35 mg tablets, the generic equivalent of Bontril PDM® 35 mg tablets under the previously announced manufacturing and supply agreement with Mikah. Actavis, Inc., recently acquired by Watson Pharmaceuticals Inc., will distribute the product as part of a distribution agreement between Mikah and Actavis.
Bontril PDM and its generic equivalents had total U.S. sales of approximately $3.5 million for the twelve months ending September 2012 based on IMS Health Data. Elite will be compensated at an agreed upon price for the manufacturing and packaging of the product.
"The manufacture of PDM by Elite for Mikah and its subsequent distribution by Actavis/Watson represents another example of the Company's strategy for enhancing our generic pipeline and cash flow," commented Jerry Treppel, Chairman and CEO.
ELITE PHARMACEUTICALS ANNOUNCES ISSUANCE OF U.S. PATENT FOR ABUSE RESISTANT ORAL DOSAGE FORMULATION
Northvale, New Jersey, Tuesday, May 22, 2012:
Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB: ELTP) announced the issuance of U.S Patent No. 8,182,836 entitled "Abuse-Resistant Oral Dosage Forms and Method of Use Thereof" by the United States Patent and Trademark Office (USPTO). The issuance of this patent will further protect Elite's proprietary formulation for abuse resistant products utilizing the pharmacological approach. The Company has additional patents pending for its technology.
"The issuance of this patent is an important milestone for the company. It validates our pharmacological approach to the development of abuse-resistant drug products and provides additional value for these products," said Jerry Treppel, Elite's Chairman and CEO.
Elite Pharmaceuticals Press Release for: Thursday, March 22, 2012
ELITE PHARMACEUTICALS SIGNS AN AGREEMENT WITH A PRIVATE HONG KONG-BASED COMPANY TO DEVELOP A PRESCRIPTION PHARMACEUTICAL PRODUCT IN THE US
Northvale, New Jersey, Thursday, March 22, 2012: Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB: ELTP) today announced that it has entered into an agreement to develop for a private Hong Kong-based company (the "Customer") a branded prescription pharmaceutical product.
Under the terms of the agreement, the Customer will provide the formulation for the product and Elite will undertake a developmental program for the product. The Customer shall be responsible for the filing of the New Drug Application ("NDA") for the finished product and the NDA will be filed under the Customer's name. Upon approval of the NDA, Elite will retain certain rights to manufacture the product. The Customer will be responsible for the marketing and sales of the final product. The Customer will pay Elite milestone payments for the development work.
Elite Pharmaceuticals Press Release for: Tuesday, March 13, 2012
ELITE PHARMACEUTICALS ANNOUNCES FIRST SHIPMENT OF GENERIC HYDROMORPHONE PRODUCT
Northvale, New Jersey, Tuesday, March 13, 2012: Elite Pharmaceuticals, Inc. ("Elite") (OTCBB: ELTP) announced today the initial shipment of hydromorphone hydrochloride 8 mg tablets, the generic equivalent of Dilaudid® 8 mg tablets under the License, Manufacturing and Supply Agreement with its sales and marketing partner, triggering a milestone payment. Elite's sales and marketing partner will distribute the product as part of a multi-product distribution agreement.
Hydromorphone hydrochloride is a member of the opioid analgesic and antitussive class. It is a pure opioid agonist used primarily for pain relief or as a cough suppressant. For the twelve months ending September 2011, Dilaudid® 8 mg tablets and its generic equivalents had total U.S. sales of approximately $30 million according to IMS Health Data.
Link to FDA website:
Since our incorporation, we have secured eight United States patents of which two have been assigned for a fee to Celgene Corporation for pulsed delivery of methylphenidate. Elite's patents are:
| PATENTS |
| U.S. patent 5,871,776 |
| U.S. patent 5,902,632 |
| U.S. patent 5,837,284 (assigned to Celgene Corporation) |
| U.S. patent 6,620,439 |
| U.S. patent 6,635,284 (assigned to Celgene Corporation) |
| U.S. patent 6,926,909 |
| U.S. patent 6,984,402 |
| U.S. patent 8,182,836 |
We also have pending applications for four additional U.S. patents and four foreign patents. The pending patent applications are for an opioid agonist and antagonist products that Elite is developing
to be used with controlled-release Oxycodone and other opioids to minimize the abuse potential for the opioids.
Nasrat Hakim Jerry Treppel - Chairman of Board of Directors
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.
Executive Vice President of OperationsDoug 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.
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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Willstar Consultants, Inc.
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Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date. As of November 4, 2013, the issuer had outstanding 507,937,469 shares of common stock, $0.001 par value (exclusive of 100,000 shares held in treasury).