ELPT Elite Pharmaceuticals Inc. ELTP Company Infor

ELPT Elite Pharmaceuticals Inc. ELTP Company Information for the board info above

Elite Pharmaceuticals is a specialty pharmaceutical company principally engaged in the development and manufacture of oral, controlled release products, using proprietary technology.  The Company’s 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. Elite’s technology is applicable to develop delayed, sustained or targeted release pellets, capsules, tablets, granules and powders.

The Registrant’s facility in Northvale, New Jersey is a Good Manufacturing Practice (“GMP”) and DEA registered facility for research, development and manufacturing.

Manufacturing: Capabilities and Facility

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.

The facility is equipped with fully validated equipment including a fluid bed dryer, blender, granular, coater, instrumented tablet press, capsule filler, and tablet coater.  The facility is also supported by in-house analytical capabilities including HPLC, GC, IR, UV, automated dissolution systems and scanning electron microscope. The fluid bed capacity for granulation, drying and/or coating batches range from 1 kg to 200 kg.

In-house capabilities include:

Product Development of Oral Solid Dosage Forms

Clinical Batch Manufacturing

Analytical Support

GMP Manufacturing

Research & Development
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.

Elite Technology:  Proprietary Controlled Release Dosage Form
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 tablets, 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 patentable and cost effective.

Product Pipeline and Commercial Products

Product Pipeline

(a)    The name of our competitor’s branded product.  N/A

(b)   Preclinical testing refers to studies done before initiation of any human studies. Pilot Phase I studies for the NDA products are generally preliminary studies done in healthy human subjects to assess the tolerance/safety and pharmacokinetics (PK) of the product. Additional larger studies in humans will be required prior to submission of this product to the FDA for review. Pilot bioequivalence (BE) studies are initial studies done in humans for generic products and are used to assess the likelihood of achieving bioequivalence for generic products. Larger pivotal bioequivalence studies will be required prior to submission of the product for FDA for review.

Patents

We have secured five United States patents and have pending applications for five United States patents and seven foreign patents.  Two of the United States issued patents have been assigned for a fee to Celgene Corporation for the pulsed released delivery of methylphenidate.

Elite's Board of Directors and Management

Jerry Treppel Chairman of 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.
Chairman of Board of Directors

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. .

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.

Partners & Licensing

Elite develops products through proof of concept using its proprietary know-how and then partners these products through co-development and licensing agreements. Elite has a valuable  of products many of which have been evaluated in human trials. The pipeline summary lists Elite’s key products that are licensed or available for license.

Investor Relations
Recent Releases :

6/29/2012 Elite Pharmaceuticals, Inc. Reports Financial Results for the Fiscal Year Ended March 31, 2012
Conference Call Scheduled for Tuesday, July 3rd at 10:00 AM EDT

6/27/2012 Elite Pharmaceuticals, Inc. Announces Fourth Quarter and Fiscal Year Ending March 31st, 2012 Investor Conference Call on Tuesday, July 3, 2012

6/13/2012 ELITE PHARMACEUTICALS ANNOUNCES BRIDGE LOAN FACILITY

5/22/2012 ELITE PHARMACEUTICALS ANNOUNCES ISSUANCE OF U.S. PATENT FOR ABUSE RESISTANT ORAL DOSAGE FORMULATION

3/22/2012 ELITE PHARMACEUTICALS SIGNS AN AGREEMENT WITH A PRIVATE HONG KONG-BASED COMPANY TO DEVELOP A PRESCRIPTION PHARMACEUTICAL PRODUCT IN THE US

3/13/2012 ELITE PHARMACEUTICALS ANNOUNCES FIRST SHIPMENT OF GENERIC HYDROMORPHONE PRODUCT

2/13/2012 Elite Pharmaceuticals, Inc. to Discuss Third Quarter 2012 Results of Operations on Wednesday, February 15, 2012

1/26/2012 ELITE PHARMACEUTICALS ANNOUNCES FDA APPROVAL OF SUPPLEMENTAL APPLICATION FOR HYDROMORPHONE

1/3/2012 ELITE PHARMACEUTICALS SECURES $5 MILLION FUNDING COMMITMENT

Transfer Agent
American Stock Transfer & Trust Company, LLC.
6201 15th Avenue
Brooklyn, NY 11219

Phone:  800-937-5449
Fax:      718-236-2641
E Mail:  info@amstock.com

http://www.elitepharma.com

The pending patent applications relate to four different control release pharmaceutical products on which we are working.  Included among these patent applications are applications for the U.S. patents relating to formulations for delayed and sustained release of drugs.  In addition, an application for a U.S. patent for a narcotic antagonist product that we are developing to be used with Oxycodone and other narcotics to minimize the abuse potential for the narcotics was filed.