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)
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(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 |
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Entry Into A Material Definitive Agreement. |
Item 8.01 |
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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.
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Exhibit No. |
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Description |
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99.1 |
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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
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ELITE PHARMACEUTICALS, INC. |
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By: |
s/Nasrat Hakim |
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Nasrat Hakim, President and CEO |
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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.
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.
"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
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