Current Report Filing (8-k)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(D)

OF THE SECURITIES EXCHANGE ACT OF 1934

October 20, 2014

Date of Report (Date of earliest event reported)

ELITE PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-15697	22-3542636
(State or other jurisdiction	(Commission	(IRS Employer
of incorporation)	File Number)	Identification No.)

165 Ludlow Avenue, Northvale, New Jersey 07647

(Address of principal executive offices)

(201) 750-2646

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 1.01		Entry Into A Material Definitive Agreement.
Item 8.01		Other Events

On October 20, 2014, the Company hired Dr. G. Kenneth Smith as its Vice President of Legal. The position of Vice President of Legal duties includes providing senior management with effective advice on legal strategies and negotiating critical business contracts. The Vice President of Legal reports to and receives direction from the CEO and shall perform such functions and duties as are required by the Company’s CEO.

Dr. Smith has a Ph.D. in Biochemistry from the University of Houston (1997) and a J.D. from the University of Houston (1994). Prior to joining, Elite, Dr. Smith served as Chief Intellectual Property Counsel for Alpharma Inc and Head of North American Intellectual Property for Sanofi Aventis. In both positions, Dr. Smith had global responsibility for all intellectual property issues related to multiple business units involved in various technologies including branded products, animal health products, active pharmaceutical ingredients (API), generic drugs, and vaccines. He has managed and participated in international intellectual property litigation, including European and Japanese oppositions as well as patent litigation in Canada and France. Dr. Smith has also been involved in trademark issues, and many licensing and acquisition negotiations. Dr. Smith also has an MBA with a concentration in entrepreneurship from Lehigh University (2007), an MS in Biochemistry from the University of Illinois (1989) and a B.S. in Chemistry and Psychology from the College of William and Mary (1978).

The company also announced the appointments of Dr. Jason LePree as Vice President of Scientific Affairs and Dr. Sophy Abraham as Head of Regulatory Affairs.

Dr. LePree joins Elite with a wealth of experience in formulations and analytical research and development having most recently served as the Principal Scientist, Formulations Research and Development for Capsugel. Dr. LePree also held previous positions in research and development with Abon Pharmaceuticals, Penwest Pharmaceuticals, Novartis, and Hoffman-LaRoche. Dr. LePree has a B.S. in Pharmacy from Rutgers University and a Ph.D. in Pharmacy from the University of Wisconsin. He is also an Adjunct Professor of Pharmacy at Long Island University.

Dr. Abraham brings to Elite extensive regulatory and analytical experience having worked for over 20 years at Teva Pharmaceuticals. Her most recent position at Teva was Senior Regulatory Associate. Dr. Abraham has B.S. in Zoology, Botany, and Chemistry from the University of Kerala, India and a Ph.D. in Zoology from the University of Baroda, India.

A copy of the press release is being finished with this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.


*Exhibit No.*		*Description*

99.1		Press release dated October 24, 2014, announcing new management appointments of Dr. Kenneth Smith, J.D., M.B.A., as Vice President of Legal, Dr. Jason LePree as Vice President of Scientific Affairs and Dr. Sophy Abraham as Head of Regulatory Affairs.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: October 24, 2014


		ELITE PHARMACEUTICALS, INC.


	By:	s/Nasrat Hakim
		Nasrat Hakim, President and CEO

Exhibit 99.1

ELITE PHARMACEUTICALS ANNOUNCES NEW MANAGEMENT APPOINTMENTS

NORTHVALE, N.J. – October 24, 2014 – Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB: ELTP), a specialty pharmaceutical company developing a pipeline of abuse-deterrent opioids and niche generic products, today announced key management appointments of Dr. Kenneth Smith, J.D., M.B.A., as Vice President of Legal, Dr. Jason LePree as Vice President of Scientific Affairs and Dr. Sophy Abraham as Head of Regulatory Affairs.

Dr. Smith previously held the positions of Chief Intellectual Property Counsel for Alpharma, Inc. and before that Head of North American Intellectual Property for Sanofi Aventis. In both positions, Dr. Smith had global responsibility for all intellectual property issues related to multiple business units involved with various technologies including branded products, animal health products, active pharmaceutical ingredients, generic drugs, and vaccines. Dr. Smith also brings extensive background and knowledge in the area of abuse deterrent intellectual property. Dr. Smith has a Ph.D. in Biochemistry from University of Houston, an M.B.A from Lehigh University, and a J.D. from the University of Houston.

"We are pleased to welcome Ken, Jason and Sophy to the Elite team and I’m thrilled with the caliber of expertise that these individuals bring to Elite,” said Nasrat Hakim, Elite’s President and Chief Executive Officer. “These additions greatly strengthen our management team in key areas and enhance our internal expertise in product development, regulatory compliance and intellectual property to support the development of our opioid abuse deterrent products.”

About Elite Pharmaceuticals, Inc.

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 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-deterrent 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 transfer, 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.

This news release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Including those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this press release, readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, its ability to obtain FDA approval of the transfers of the ANDAs or the timing of such approval process, delays, uncertainties, inability to obtain necessary ingredients and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements. These risks and other factors, including, without limitation, the Company’s ability to obtain sufficient funding under the LPC Agreement or from other sources, the timing or results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory authorities, intellectual property protections and defenses, and the Company’s ability to operate as a going concern, are discussed in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q and 8-K. Elite undertakes no obligation to update any forward-looking statements.

Contact:

Elite Pharmaceuticals, Inc.

Dianne Will, Investor Relations, 518-398-6222

Dianne@elitepharma.com