Elite Pharmaceuticals

Elite Pharmaceuticals

Type	Public limited company
Industry	Medical/Drugs
Trades as	OTCBB:ELTP
Website	http://www.elitepharma.com/

Elite Pharmaceuticals is a specialty pharmaceutical company principally engaged in the development and manufacture of oral, controlled-release products, using proprietary technology and generic pharmaceuticals. Our strategy includes improving off-patent drug products for life cycle management and developing generic versions of controlled-release drug products with high barriers to entry. Our technology is applicable to the development of delayed-, sustained- or targeted-release pellets, capsules, tablets, granules and powders.^[1]

Contents 1 Business Description 2 History 3 Products and Services 4 Culture 4.1 Company 4.2 Investor's Community 4.3 Investor Contacts 5 Executives 5.1 Chairman of Board of Directors 5.2 Chief Financial Officer, Secretary & Treasurer 5.3 Chief Operating Officer and Director 5.4 Chief Scientific Officer 5.5 Director 5.6 Director 5.7 Director 6 Additional Information 7 Forward Looking 7.1 Official 7.2 Fundamentals 7.3 Technical 8 References

Business Description

Elite Pharmaceuticals, Inc. (OTCBB:ELTP.QB) 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 three approved ANDA's partnered with TAGI Pharma, with an additional ANDA currently under review by the FDA. Elite's lead pipeline products, ELI-216, a once-daily abuse resistant oxycodone, and ELI-154, a once-daily oxycodone, are novel 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 has partnered with Mikah Pharma to develop a new product and with Hi-Tech Pharmacal to develop an intermediate for a generic product. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.^[2]

History

(2003-2011) Elite Pharmaceuticals ^[3]

June 2003 - Elite Pharmaceuticals Comments on Resignation of Former CEO, Announces New Management Team

August 2003 - Elite Pharmaceuticals Authorizes Negotiation of Merger with Nostrum Pharmaceuticals

May 2004 - Elite Announces Appointment of its Chief Executive Officer as Chairman

January 2005 - Elite Pharmaceuticals Announces Election of New Director to its Board and Date of Annual Stockholders Meeting

February 2007 - Elite Pharmaceuticals Appoints Chief Scientific Officer

June 2006 - Robert J. Levenson elected to the Board of Directors

January 2008 - Elite Pharmaceuticals Appoints Stuart Apfel, M.D. as Chief Medical Officer

April 2008 - Elite Pharmaceuticals Appoints Chief Scientific Officer

July 2009 - Elite Pharmaceuticals announces new Chief Financial Officer

Match 2009 - Elite and Epic Pharma, LLC and Epic Investments, LLC, a subsidiary of Epic Pharma LLC (collectively, “Epic”) entered into the Epic Strategic Alliance Agreement (amended on April 30, 2009, June 1, 2009 and July 28, 2009). Epic is a pharmaceutical company that operates a business synergistic to that of Elite in the research and development, manufacturing and sales and marketing of oral immediate release and controlled-release drug products.

Under the Epic Strategic Alliance Agreement (i) at least eight additional generic drug products will be developed by Epic at the Facility with the intent of filing abbreviated new drug applications for obtaining FDA approval of such generic drugs, (ii) Elite will be entitled to 15% of the profits generated from the sales of such additional generic drug products upon approval by the FDA, and (iii) Epic and Elite will share certain resources, technology and know-how in the development of drug products, which Elite believes will benefit the continued development of its current drug products.

September 2009 - Elite Pharmaceuticals Appoints Chief Executive Officer and Chief Scientific Officer

April 2011 - Elite Pharmaceuticals announces third closing of strategic alliance agreement with Epic Pharma

June 2011 - Elite Pharmaceuticals announces manufacturing and supply agreement with Mikah Pharma, LLC

January 2012 - Elite Pharmaceuticals sits on launch pad preparing for its 2012 mission to da moon.

Products and Services

Phentermine HCl^[4]

Phentermine HCl 37.5 mg tablets to TAGI. This triggered a milestone payment under the Precision Dose Agreement. Phentermine 37.5mg tablets is now a commercial product being distributed by our partner, TAGI and it is currently the Company’s only commercial product. Phentermine 37.5mg was commercially launched during April 2011 and is currently being manufactured on a contract basis at Epic until the production process of such product is transferred to the Northvale Facility. Phentermine 37.5mg is marketed pursuant to the Precision Dose License.

Hydromorphone HCl^[4]

Transfer of the manufacturing process of Hydromorphone 8mg to the Northvale Facility is a prerequisite of the Company’s commercial launch of the product and is currently in process. However, please note that the completion of such transfer has been significantly delayed as a result of the US-FDA’s reclassification of the Company’s CBE-30 supplement filing to a prior approval supplement filing. As a result of the delays caused by this reclassification, the Company has recorded an impairment of the Hydromorphone 8mg ANDA in an amount equal to the entire purchase price of the acquisition.

Naltrexone HCl^[4]

Transfer of the manufacturing process of Naltrexone 50mg to the Northvale Facility is a prerequisite of the Company’s commercial launch of the product and is currently in process. However, please note that the completion of such transfer could be significantly delayed as it included factors similar to those cited by the US-FDA as the reason for its reclassification of the Company’s filings for the transfer of Hydromorphone 8mg. As a result of these probable delays in the transfer of the manufacturing process of Naltrexone 50mg, the Company has recorded an impairment of the Naltrexone 50mg ANDA in an amount equal to the entire purchase price of the acquisition.

Isradipine and Phendimetrazine^[4]

On June 1, 2011, Elite Pharmaceuticals Inc. (“Elite”) executed a Manufacturing and Supply Agreement (the “Isradipine/ Phendimetrazine Agreement”) with Mikah Pharma, LLC (“Mikah”) to undertake and perform certain services relating to two generic products: Isradipine Capsules USP, 2.5 mg and 5 mg (“Isradipine”) and Phendimetrazine Tartrate Tablets USP, 35 mg (“Phendimetrazine”), including (a) developing and preparing the documentation required for the transfer of the manufacturing process to Elite’s facility and the appropriate regulatory filing for the ANDA, and (b) manufacturing finished dosage forms appropriate for commercial sale, marketing and distribution in the United States of America, its territories, possessions, and commonwealths in accordance with the requirements of the Isradipine/ Phendimetrazine Agreement; Elite shall perform, at its sole cost and expense, all Technology Transfer, validation and qualification services (including: equipment, methods and facility qualification), validation and stability services required by Applicable Laws to commence manufacturing Isradipine and Phendimetrazine for commercial sale by Mikah or its designees in accordance with the terms of the Isradipine/ Phendimetrazine Agreement.

During the term of the Isradipine/ Phendimetrazine Agreement and subject to the provisions herein, Mikah shall purchase from Elite and Elite agrees to manufacture and supply solely and exclusively to Mikah, such Isradipine and Phendimetrazine as Mikah may order from time to time pursuant to the Isradipine/ Phendimetrazine Agreement. Mikah will compensate Elite at an agreed upon transfer price for the manufacturing and packaging of Isradipine and Phendimetrazine. For the Isradipine product, Elite will also receive a 10% royalty on net profits of the finished Product. The payment is to be calculated and paid quarterly. Elite will also receive a onetime milestone payment for each Product for the work associated with the Technology transfer. The milestone payment shall be made upon the successful manufacturing and testing of the exhibit batch. The Isradipine/ Phendimetrazine Agreement has a term of five (5) years and shall automatically renew for additional periods of one (1) year unless Mikah provides written notice of termination to Elite at least six (6) months prior to the expiration of the Term or any Renewal Term. Transfer of the manufacturing site to the Northvale Facility, a prerequisite of commercial launch of Isradipine and Phendimetrazine is currently in progress.

Methadone^[4]

On June 29, 2011, Elite Pharmaceuticals, Inc. announced that it entered into a commercial manufacturing and supply agreement with ThePharmaNetwork, LLC and its wholly owned subsidiary, Ascend Laboratories LLC (together “TPN”). Under the terms of the agreement, Elite will perform manufacturing and packaging for TPN’s Methadone Hydrochloride, 10mg tablets. The US-FDA has approved the manufacturing of Methadone 10mg at the Northvale Facility and commercial launch of this product is expected during this fiscal year.

Discontinued Products - Lodrane 24® and Lodrane 24D®^[4]

On March 3, 2011, the U.S. Food and Drug Administration (“US-FDA”) announced its intention to remove approximately 500 cough/cold and allergy related products from the U.S. market. The once daily allergy products manufactured by Elite, Lodrane 24® and Lodrane 24D® (the “Lodrane® Products”), were included in the FDA list of 500 products. After this announcement by the US-FDA, the Company’s customer for the Lodrane® Products cancelled all outstanding orders and manufacturing of the Lodrane® Products has ceased. The shipments made during the quarter ended June 30, 2011 consisted solely of quantities that were in production at the time ECR cancelled all outstanding orders.

ECR (the owner and marketer of the Lodrane® Products) has initiated a formal approval process with the FDA in 2010 regarding the Lodrane® Products and issued a press release on March 3, 2011 stating that they will continue to actively pursue approval for the Lodrane® Products. In addition, on April 29, 2011, ECR filed a Petition for Review with the United States Court of Appeals for the District of Columbia, petitioning such court to review and set aside the final order of the US-FDA with relation to the Lodrane® Products.

The Lodrane® Products were co-developed with our partner, ECR Pharmaceuticals (“ECR”) and the Company was receiving revenues from the manufacture of the Lodrane® Products and laboratory stability study services, as well as royalties on in-market sales.

Under Development - ELI-154 and ELI-216^[4]

For ELI-154, Elite has developed a once-daily oxycodone formulation using its proprietary technology. An investigational new drug application, or IND, has been filed and Elite has completed two pharmacokinetic studies in healthy subjects that compared blood levels of oxycodone from dosing ELI-154 and the twice-a-day product that is on the market currently, OxyContin® marketed in the U.S. by Purdue Pharma LP. These studies confirmed that ELI-154, when compared to twice-daily delivery, demonstrated an equivalent onset, more constant blood levels of the drug over the 24 hour period and equivalent blood levels to the twice-a-day product at the end of 24 hours. Elite has successfully manufactured multiple batches on commercial scale equipment and we have discussions ongoing in Europe for this product. We are looking for a partner who can complete the clinical studies required for Europe and who can sell and distribute the product in key European territories.

ELI-216 utilizes our patent-pending abuse-deterrent technology that is based on a pharmacological approach. ELI-216 is a combination of a narcotic agonist, oxycodone hydrochloride, in a sustained-release formulation intended for use in patients with moderate to severe chronic pain, and an antagonist, naltrexone hydrochloride, formulated to deter abuse of the drug. Both of these compounds, oxycodone hydrochloride and naltrexone hydrochloride, have been on the market for a number of years and sold separately in various dose strengths. Elite has filed an IND for the product and has tested the product in a series of pharmacokinetic studies. In single-dose studies for ELI-216, it was demonstrated that no quantifiable blood levels of naltrexone hydrochloride were released at a limit of quantification (“ LOQ” ) of 7.5 pg/ml. As described below, when crushed, naltrexone hydrochloride was released at levels that would be expected to eliminate the euphoria from the crushed oxycodone hydrochloride. This data is consistent with the premise of Elite’s abuse resistant technology, or ART, that essentially no naltrexone is released and absorbed when administered as intended. Products utilizing the pharmacological approach to deter abuse such as Suboxone®, a product marketed in the United States by Reckitt Benckiser Pharmaceuticals, Inc., and Embeda®, a product marketed in the United States by King Pharmaceuticals, have been approved by the FDA and are being marketed in the United States.

Culture

Company

Research & Development ^[5]

Elite 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.

Technology ^[6]

Elite offers research, development, and manufacture of a customized oral controlled release drug delivery systems in capsule or tablet dosage forms. Controlled release technology is crucial for the formulation and development of twice-a-day and once-a-day oral dosage forms as well as for delayed, sustained, targeted and pulsatile release. Elite uses its proprietary formulation and processing expertise to produce the diverse controlled-release dosage forms such as tables, capsules, granules, pellets, and powders for NDA and ANDA submissions.

Benefits of Elite's controlled release products include reduced side effects and increased compliance resulting from decreased frequency of administration. Additionally, Elite works with environmentally friendly aqueous processes and the formulations have demonstrated a high degree of reproducibility and stability with high manufacturing yields. Elite can develop customized release patterns that are pH dependent or independent. These formulations are patent-able and cost effective.

Investor's Community

Official Page: http://www.elitepharma.com/investor_relations.asp

Community Board: http://investorshub.advfn.com/boards/board.aspx?board_id=15170

Investor Contacts

Dianne Will

Willstar Consultants, Inc.

3978 Route 199

Pine Plains, NY 12567

Phone: (518) 398-6222

Fax: (518) 398-6369

EMail: dianne @ elitepharma.com

Transfer Agent

Jersey Transfer & Trust Company

201 Bloomfield Avenue

Verona, New Jersey 07044

Phone: 973-239-2712

Fax: 973-833-0431

EMail: jerseytransfertr @ msn.com

Accountants

Demetrius & Company, LLC

Wayne Plaza II

155 Route 46

Wayne, NJ 07470

Telephone: (973) 812-0100

Facsimile: (973) 812-0750

Executives

Chairman of Board of Directors

Jerry Treppel

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. - Chairman of Board of Directors

Chief Financial Officer, Secretary & Treasurer

Mark Gittelman

Mark I. Gittelman, CPA, our Chief Financial Officer, Secretary and Treasurer, is the President of Gittelman & Co., P.C., an accounting firm. Prior to forming Gittelman & Co., P.C. in 1984, he worked as a certified public accountant with the international accounting firm of KPMG Peat Marwick, LLP. Mr. Gittelman holds a B.S. in accounting from New York University and a Masters of Science in Taxation from Farleigh Dickinson University. He is a Certified Public Accountant licensed in New Jersey and New York, and is a member of the American Institute of Certified Public Accountants ("AICPA") and the New Jersey State and New York States Societies of CPAs.

Chief Operating Officer and Director

Chris Dick

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

Chief Scientific Officer

Ashok Nigalye, Ph.D.

Ashok Nigalye joined Elite in September, 2009 as Chief Scientific Officer. 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. Dr. 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 a licensed pharmacist in the State of New York.

Director

Barry Dash, Ph.D.

Dr. Barry Dash has been President and Managing Member of Dash Associates, L.L.C., since 1995, an independent consultant to the pharmaceutical and health and beauty aid industries. From 1983 to 1996 he was employed by American Home Products Corporation, 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. He had previously 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 to1982, during which time he helped introduce more than 14 national and test market brands. From 1976 to1978 he was Vice President, Director of Laboratories of the Consumer Products Division of American Can Company. He is a director of GeoPharma, Inc. Dr. Dash holds a Ph.D. from the University of Florida and M.S. and B.S. degrees from Columbia University at which 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.

Director

Robert Levenson

Robert Levenson is currently Managing Member of the Lenox Capital Group, L.L.C. since 2000. Mr. Levenson was previously an Executive Vice President of First Data Corporation from 1993 to 2000 and a member of its Board of Directors from 1992 to 2003. He was Senior Executive Vice President, Chief Operating Officer, and Member of the Office of the President and Director of Medco Containment Services, Inc., a provider of managed care prescription benefits, from October 1990 to December 1992. From 1985 until October 1990, he was a Group President and Director of Automatic Data Processing, Inc. (ADP-NYSE). Mr. Levenson was a Director of Emisphere Technologies, Inc., a biopharmaceutical company, from 1998 to 2005, as well as having been a Director of several other companies, public and private. Mr. Levenson is currently nominated to be a director of Ceridian Corporation (NYSE: CEN). Mr. Levenson is a trustee of the Washington Institute, the Jewish Community Federation, and the Jewish Community Foundation of Metrowest New Jersey.

Director

Melvin Van Woert, M.D.

Dr. Melvin Van Woert, a neurologist, has been, since 1974, a member of the staff of Mount Sinai Medical Center where he has been a Professor of the Department of Neurology and Pharmacology at Mount Sinai School of Medicine since 1978. Dr. Van Woert had been a consultant for Neuropharmacological Drug Products to the Food and Drug Administration from 1974 to 1980; Associate Editor for Journal of the Neurological Sciences; Member of the Editorial Board of Journal of Clinical Neurphamacology; and Medical Director of National Organization for Rare Disorders for which he received in 1993 the Humanitarian Award. His other awards include the U.S. Public Health Service Award for Exceptional Achievement in Orphan Products Development and the National Myoclonus Foundation Award. He has authored and co-authored more than 150 articles appearing in pharmacological, medical and other professional journals or publications.

Additional Information

Headquarters

165 Ludlow Avenue

Northvale, New Jersey 07647

Phone: 201-750-2646

Fax: 201-750-2755

Logos

Advertising and Commercials

Unknown

Forward Looking

Official

Elite is focusing its efforts on the following areas: (i) development of Elite’s pain management products, (ii) set up and launch of approved generic products; (iii) the development of the other products in our pipeline including the eight products pursuant to the Epic Strategic Alliance Agreement; (iv) commercial exploitation of our products either by license and the collection of royalties, or through the manufacture of our formulations, and (v) development of new products and the expansion of our licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations.

Elite is focusing on the development of various types of drug products, including branded drug products which require new drug applications (“NDAs”) under Section 505(b)(1) or 505(b)(2) of the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Drug Price Competition Act”) as well as generic drug products which require abbreviated new drug applications (“ANDAs”).

Elite believes that its business strategy enables it to reduce risk by having a diverse product portfolio that includes both branded and generic products in various therapeutic categories and to build collaborations and establish licensing agreements with companies with greater resources thereby allowing us to share costs of development and improve cash-flow.^[4]

Fundamentals

• http://www.otcmarkets.com/stock/ELTP/financials

Technical

• http://www.barchart.com/opinions/stocks/ELTP
• http://www.americanbulls.com/StockPage.asp?CompanyTicker=ELTP&MarketTicker=OTC&TYP=S
• http://www.otcmarkets.com/stock/ELTP/chart
• http://www.buyins.net/tools/symbol_stats.php?sym=ELTP
• http://stockcharts.com/h-sc/ui?s=ELTP

Forward Looking Statement (Unless specified otherwise)

Certain statements on this website are forward-looking statements, including those that discuss strategies, goals, outlook or other non-historical matters; or project revenues, income, returns or other financial measures. Any action you take as a result of information, analysis, or advertisement provided on this site is ultimately your responsibility. Consult your investment adviser before making any decisions. Many of the “reference links” provided on this site are subject to change by the original content owners/providers. Information updated to this page is provided as-is on a volunteer basis, none of the authors can be assured the content they originally provided has not been modified and make no claims to future changes.

References

1. ↑ Corporation Information - http://www.elitepharma.com/corp_info.asp
2. ↑ Disclosures and News Service - http://www.globenewswire.com/newsroom/news.html?d=223706
3. ↑ Investor Relations Recent and Archived Releases - http://www.elitepharma.com/investor_relations.asp
4. ↑ ^{4.0 4.1 4.2 4.3 4.4 4.5 4.6 4.7} ELTP filing on otcmarkets - http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=8102251
5. ↑ Research & Development - http://www.elitepharma.com/research_development.asp
6. ↑ Elite Technology - http://www.elitepharma.com/technology.asp