ELTP Elite Pharmaceuticals Inc (QB)

 

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

 

January 11, 2016

Date of Report (Date of earliest event reported)

 

ELITE PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Nevada		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 5.02.

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

On January 11, 2016, Jerry Treppel resigned as the Chairman and as a member of the Board of Directors of Elite Pharmaceuticals, Inc. ("Elite"), effective January 11, 2016, to pursue other opportunities. On January 12, 2016, the Board of Directors (the “Board”) appointed Nasrat Hakim to serve as Chairman of the Board of Directors.

 

For more information on Mr. Treppel’s resignation and Nasrat Hakim’s appointment, please see a copy of the press release furnished with this Current Report on Form 8-K as Exhibit 99.1.

 

On January 21, 2016, the Board amended the August 1, 2013 employment agreement between Elite and Mr. Hakim (the “Employment Agreement”). Pursuant to the amendment, effective January 1, 2016 and during the term of the Agreement, Mr. Hakim’s base annual salary will be $500,000, plus an annual bonus equal to 100% of his base salary. The base salary is payable in shares of Elite Common Stock with the annual bonus payable in accordance with Elite’s regular payroll practices.

 

Item 8.01

Other Events

 

The United State Food and Drug Administration (“FDA”) granted Elite a waiver of the application fee required for the filing of a New Drug Application (“NDA”) for Elite’s product ELI-200, an immediate release Oxycodone Hydrochloride 5 mg, 10 mg, 15 mg, 20 mg and 30 mg capsules with sequestered Naltrexone Hydrochloride for the treatment of moderate to severe pain. On January 14, 2016, Elite submitted a 505(b)(2) NDA for ELI-200. FDA notification regarding acceptance of the submission for review is expected to take 6 to 12 weeks.

 

Under section 736(d)(1)(E) of the Federal Food, Drug and Cosmetic Act the FDA may grant a waiver of the $2,335,200 NDA application fee for the first human drug application that a small business submits for review.

 

A copy of the press release regarding the waiver is furnished with this Current Report on Form 8-K as Exhibit 99.2.

 

Item 9.01

Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.		Description
10.1		January 21, 2016 amendment No. 1 to Nasrat Hakim Employment Agreement.
99.1		Press release dated January 13, 2016, announcing the resignation of Jerry Treppel as Chairman and member of the Board of Directors.
99.2		Press release dated January 13, 2016, announcing the FDA approval of the waiver of NDA filing fee.

 

 

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:  January 29, 2016
	ELITE PHARMACEUTICALS, INC.
By:	/s/ Nasrat Hakim
	Nasrat Hakim, President and CEO

 

 

 

Exhibit 10.1

 

AMENDMENT 1 TO EMPLOYMENT AGREEMENT

 

WHEREAS Elite Pharmaceuticals Inc., a Nevada corporation (“Company”) and Mr. Nasrat Hakim (“Executive”), are parties to an employment agreement dated August 1, 2013 (the “Hakim Employment Agreement”); and

 

WHEREAS the Board of Directors of Elite (the “Board”) and Mr. Hakim have agreed to certain amendments to the Hakim Employment Agreement, with such amendments being duly approved by the Board at a meeting of Board on January 12, 2016;

 

NOW THEREFORE in consideration of the above provision and the mutual agreements contained herein, the Company and Executive agree as follows:

 

Section 2.1 of the Hakim Employment Agreement is hereby removed in its entirety and replaced with the following:

 

2.1

Salary: Effective January 1, 2016 and during the Term (as defined in section 3), Company shall pay to Executive a base salary at the annual rate of Five Hundred Thousand Dollars ($500,000), (the “Annual Salary”). The Salary shall be paid in shares of the Company’s Common Stock (“Shares”) pursuant to the Company’s current policy for paying Company executives in Shares (ie, with regards to the method of computing the number of Shares to be issued and the timing of such issuances, provided the timing is not later than March 15th following the end of the calendar year for which payment is being made). Notwithstanding the foregoing, the payment of such Shares shall be made in a manner that does not violate Section 409A of the Internal Revenue Code of 1986, as amended (“Section 409A”), as discussed in section 3.2.8.

 

Section 2.2.1 of the Hakim Employment Agreement is hereby removed in its entirety and replaced with the following:

 

2.2.1 Annual Bonus: Effective as of January 1, 2016, Executive shall be paid an annual bonus equal to 100% of Annual Salary (the “Annual Bonus”). The Annual Bonus shall be paid in accordance with the Company’s regular payroll practices. The Annual Bonus shall be paid subsequent to the end of the calendar year to which such Annual Bonus is attributed, but not later than March 15^th following the end of such calendar year.

 

All other terms and conditions of the Hakim Employment Agreement are to remain without amendment or modification.

 

IN WITNESS WHEREOF, this Amendment 1 to the Hakim Employment Agreement has been executed and delivered by the Parties hereto on January 21, 2016.

 

By:	/s/ Nasrat Hakim		By:	/s/ Carter J. Ward
Name: Nasrat Hakim			Name: Carter J. Ward
			Treasurer and Chief Financial Officer
			Elite Pharmaceuticals Inc.

 

  

Exhibit 99.1

 

 

Nasrat Hakim Named Chairman of Board of Directors for Elite Pharmaceuticals

 

Jerry Treppel Resigns

 

NORTHVALE, N.J. – January 13, 2016 – Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB: ELTP) announced that Jerry Treppel has resigned as the Company’s Chairman and as a member of the Board of Directors, effective January 11, 2016, to pursue other opportunities.

 

The Board of Directors has appointed Nasrat Hakim, Elite’s President and CEO to serve as Chairman of the Board of Directors.

 

“I want to thank Jerry for his years of dedicated service and contributions to the company, and I wish him all the best in his future endeavors,” said Mr. Hakim.

 

Mr. Treppel stated, “I am proud of the accomplishments of the company during my time on the Board. It has been my pleasure to work with Elite’s team and I am confident that the company is well-positioned for the future as it continues to execute on its strategy.”

 

About Elite Pharmaceuticals, Inc.

Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company which is developing a pipeline of proprietary pharmacological abuse-deterrent opioid products as well as niche generic products. Elite specializes in oral sustained and controlled release drug products which have high barriers to entry. Elite owns generic and OTC products which have been licensed to TAGI Pharma, Epic Pharma and Valeant Pharmaceuticals International. Elite currently has eight commercial products being sold, additional approved products pending manufacturing site transfer and a product under review pending approval by the FDA. Elite’s lead pipeline products include abuse-deterrent opioids which utilize the Company’s patented proprietary technology and a once-daily opioid. These products include sustained release oral formulations of opioids for the treatment of chronic pain. These formulations are intended to address two major limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential opioid abuse. Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.), and a Hong Kong based company for development of 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

 

 

 

Exhibit 99.2

 

 

 

FDA Approves Waiver of NDA Filing Fee for Elite Pharmaceuticals

 

Elite to Submit New Drug Application for ELI-200

 

NORTHVALE, N.J. –January 13, 2016 – The United State Food and Drug Administration (“FDA”) granted Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB: ELTP) a waiver of the application fee required for the filing of a New Drug Application (NDA). Under section 736(d)(1)(E) of the Federal Food, Drug and Cosmetic Act the FDA may grant a waiver of the $2,335,200 NDA application fee for the first human drug application that a small business submits for review.

 

Elite will immediately submit a 505(b)(2) New Drug Application for its lead opioid abuse-deterrent candidate ELI-200, immediate-release Oxycodone Hydrochloride 5mg, 10mg, 15 mg, 20 mg and 30mg capsules with sequestered Naltrexone Hydrochloride, for the treatment of moderate to severe pain with the United States Food and Drug Administration. FDA notification regarding acceptance of the submission for review is expected to take 6 to 12 weeks.

 

"Having the FDA waive the application fee is a huge benefit to Elite. We will file the ELI-200 submission immediately. I look forward to hearing from the FDA concerning a notification of the acceptance for review in the coming weeks,” said Nasrat Hakim, President and Chief Executive Officer of Elite.

 

About Elite’s Abuse Deterrent Technology

Elite’s proprietary abuse deterrent technology, ART™, is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol dependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases as intended providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist is designed to release and so block the effects of active opioid agonist. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to the same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers. Elite’s pharmacological approach to abuse-deterrence can be applied to a wide range of opioids used today in pain management.

 

About Elite Pharmaceuticals, Inc.

Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company which is developing a pipeline of proprietary pharmacological abuse-deterrent opioid products as well as niche generic products. Elite specializes in oral sustained and controlled release drug products which have high barriers to entry. Elite owns generic and OTC products which have been licensed to TAGI Pharma, Epic Pharma and Valeant Pharmaceuticals International. Elite currently has eight commercial products being sold, additional approved products pending manufacturing site transfer and a product under review pending approval by the FDA. Elite’s lead pipeline products include abuse-deterrent opioids which utilize the Company’s patented proprietary technology and a once-daily opioid. These products include sustained release oral formulations of opioids for the treatment of chronic pain. These formulations are intended to address two major limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential opioid abuse. Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.), and a Hong Kong based company for development of 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