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

    April 30, 2009    
Date of Report (Date of earliest event reported)
 
    ELITE PHARMACEUTICALS, INC.    
(Exact name of Company 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    
(Company’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 Company 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.

           On March 18, 2009, Elite Pharmaceuticals, Inc., a Delaware corporation (the “ Registrant ”), entered into the Strategic Alliance Agreement, dated as of March 18, 2009 (the “ Alliance Agreement ”), with Epic Pharma, LLC (the “ Parent ”) and Epic Investments, LLC (including its successors and assigns, the “ Purchaser ” and, collectively with the Parent and the Registrant, the “ Parties ”). The Registrant’s entry into the Alliance Agreement was previously disclosed by the Registrant in its Current Report on Form 8-K, filed with the U.S. Securities and Exchange Commission March 23, 2009, and in a press release issued by the Registrant on the same date.

           On April 30, 2009, the Parties entered into an Amendment, dated as of April 30, 2009 (the “ Amendment ”), to the Alliance Agreement for the purpose of amending and waiving certain provisions of the Alliance Agreement on the terms and conditions contained in the Amendment. A copy of the Amendment is attached to this report as Exhibit 10.1, and the summary of the material terms of the Amendment set forth below is qualified in its entirety by reference to such exhibit.

           In the Amendment, the Parties agreed to extend (the “ Extension ”) the date by which the conditions precedent to the initial closing of the transactions contemplated by the Alliance Agreement (such initial closing, the “ Initial Closing ” and the date of such Initial Closing, the “ Initial Closing Date ”) must be satisfied or waived, as the case may be, from April 30, 2009 to June 1, 2009. Pursuant to the Amendment, the Registrant received a cash deposit (the “ Deposit ”) of $250,000, which amount is creditable against the $1,000,000 payment to be made by the Purchaser on the Initial Closing Date. The Registrant may use the Deposit in accordance with the terms of the Alliance Agreement, however, in the event the Parent terminates the Alliance Agreement pursuant to the terms thereof as the result of a condition precedent set forth in Section 2.11(b) or 2.12(a) of the Alliance Agreement not being satisfied by the Registrant (other than those which have been waived by the Parent and the Purchaser on or before the Initial Closing Date), the Registrant must promptly refund the Deposit to the Parent. The Amendment also amended the Alliance Agreement to specifically provide for an Initial Closing Date of May 27, 2009, or such other date as the Parties may mutually agree upon in writing.

           The Amendment also extends the date by which the Registrant is required to hold the special meeting of its stockholders for the purpose of obtaining stockholder approval of an amendment to the Registrant’s certificate of incorporation that (i) increases the number of authorized shares of the Registrant’s common stock, par value $0.01 per share (the “ Common Stock ”) from 210,000,000 shares to 360,000,000 shares and (ii) reduces the par value of the authorized shares of Common Stock from $0.01 to $0.001 per share, and the filing of such amendment to the Registrant’s certificate of incorporation with the Secretary of State of Delaware, from June 30, 2009, as originally provided under the Alliance Agreement, to July 31, 2009.

           In the Amendment, the Registrant provides the Parent and Purchaser with additional representations relating to the conversion of certain shares of the Registrant’s Series B 8% Convertible Preferred Stock, par value $0.01 per share (the “ Series B Preferred Stock ”), Series C 8% Convertible Preferred Stock, par value $0.01 per share (the “ Series C Preferred Stock ”), and Series D 8% Convertible Preferred Stock, par value $0.01 per share (the “ Series D Preferred



Stock ” and, together with the Series B Preferred Stock and Series C Preferred Stock, the “ Outstanding Preferred Stock ”) into shares of Common Stock in accordance with the respective terms of the Outstanding Preferred Stock. In reliance upon such representations, the Parent and the Purchaser each waived the conditions precedent to the Initial Closing provided for in the Alliance Agreement which required (i) the conversion of all remaining shares of the Series B Preferred Stock and Series C Preferred Stock into shares of Common Stock and (ii) the conversion of such number of additional shares of Series D Preferred Stock, as the Purchaser determines in its sole discretion, into Common Stock. Further, the Parent and the Purchaser each acknowledged under the Amendment that the Registrant complied with its obligation under the Alliance Agreement to use its best efforts to obtain the agreement of the holders of the Outstanding Preferred Stock to convert all of their shares of Outstanding Preferred Stock into Common Stock. The Amendment also amended certain provisions of the Alliance Agreement and the Certificate of Designation of Preferences, Rights and Limitations of Series E Convertible Voting Preferred Stock to be filed by the Registrant with the Secretary of State of Delaware prior to the Initial Closing in accordance with the waiver by the Parent and Purchaser of the conditions precedent regarding the conversion of Outstanding Preferred Stock described above.

           The Parent and the Purchaser each also waived under the Amendment the condition precedent to the Initial Closing that the Registrant must delist its Common Stock from the NYSE Amex (the “ Exchange ”). In place of such condition precedent, the Amendment added a new provision to the Alliance Agreement requiring the Registrant to delist its Common Stock from the Exchange within 30 days following the Initial Closing Date and to cause the Common Stock to be traded on such trading market as required under any agreement, instrument or security to which the Registrant may be a party or may be bound. As disclosed in Item 3.01 of this report, the Registrant has initiated process to delist its Common Stock from the Exchange and commence quotation on the OTC Bulletin Board.

Item 3.01.     Notice of Delistings or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.

           On April 30, 2009, the Registrant sent written notice to the Exchange of its intention to effect a voluntary delisting of its Common Stock from the Exchange in order to commence quotation of the Common Stock on the OTC Bulletin Board. The Registrant also issued a press release on April 30, 2009 indicating that it has initiated process to delist its Common Stock from the Exchange and commence quotation on the OTC Bulletin Board. A copy of the press release is attached to this report as Exhibit 99.1.

Item 9.01.     Financial Statements and Exhibits

          a)      Not applicable.
          b)      Not applicable.
          c)      Not applicable.
          d)     Exhibits

  Exhibit 10.1   Amendment, dated as of April 30, 2009, by and between the Registrant, on the one hand, and Epic Pharma, LLC and Epic Investments, LLC, on the other hand, relating to the Strategic



      Alliance Agreement, dated as of March 18, 2009.
       
  Exhibit 99.1   Press Release dated April 30, 2009



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: May 6, 2009

  ELITE PHARMACEUTICALS, INC.
 
 
  By:       /s/ Chris Dick  
      Chris Dick  
      Chief Operating Officer, President  
      and Acting Chief Executive  
      Officer  



Exhibit 10.1

Execution Version

AMENDMENT, dated as of April 30, 2009 (this “ Amendment ”), by and between Elite Pharmaceuticals, Inc., a Delaware corporation (the “ Company ”), on the one hand, and Epic Pharma, LLC, a Delaware limited liability company (the “ Parent ”), and Epic Investments, LLC, a Delaware limited liability company (including its successors and assigns, the “ Purchaser ”), on the other hand, relating to a certain STRATEGIC ALLIANCE AGREEMENT, dated as of March 18, 2009 (the “ Alliance Agreement ”; capitalized terms used herein and not otherwise defined have the meaning assigned to such terms in the Alliance Agreement).

 

           WHEREAS, the parties hereto have agreed to amend and waive certain provisions of the Alliance Agreement on the terms and subject to the conditions contained herein.

           NOW, THEREFORE, IN CONSIDERATION of the mutual covenants contained herein, and for other good and valuable consideration the receipt and adequacy of which are hereby acknowledged, the parties hereto agree as follows:

           1.      Amendments . The Alliance Agreement is hereby amended as follows:

           (a)    Article I is amended by:

     (1)     amending the definition of Initial Closing Date to read as follows: “ Initial Closing Date ” means May 27, 2009 or such other date as the Parties may mutually agree upon in writing;

      (2)     amending the definition of Ten Percent Stockholders to read as follows: “ Ten Percent Stockholders ” means the holders of ten percent (10%) or more of the issued and outstanding shares of Common Stock on the Initial Closing Date, after giving effect to (a) the issuance of the Initial Closing Shares pursuant to this Agreement and (b) the conversion of the Outstanding Preferred Stock into Common Stock in accordance with the Conversion Notices.

      (3)     adding a definition for the term “Deposit” which shall read as follows: “ Deposit ” shall have the meaning assigned to such term in Section 2.1A. ”

           (b)    The following Section 2.1A is hereby inserted immediately following Section 2.1 and before Section 2.2:

2.1A      Good Faith Deposit . On or before April 30, 2009, Parent shall deliver the sum of Two Hundred Fifty Thousand Dollars ($250,000) to the Company as a good faith deposit (the “ Deposit ”) to be applied against the amount payable under Section 2.1 above. Upon receipt thereof, the Company shall be free to use such funds in accordance with Section 4.7 herein, provided, however, in the event Parent shall terminate this Agreement pursuant to clause (x) of Section 6.1 below



as the result of the conditions precedent set forth in Section 2.11(b) or 2.12(a) not being satisfied, the Company shall promptly refund such funds to Parent.

           (c)    Section 2.2(a)(viii) is amended by deleting the words “the Secretary of State of Delaware” and inserting in their stead the words “said officer as being true, correct and complete copies thereof”

           (d)    Section 2.2(b) is amended by (1) adding the following to clause (ii) therein: “less the Deposit”, and (2) deleting clauses (B) and (C) from clause (iii) therein.

           (e)    Section 3.1(u) of the Alliance Agreement is hereby deleted in its entirety and replaced with the following text:

Listing and Maintenance Requirements . The Company’s Common Stock is registered pursuant to Section 12(b) or 12(g) of the Exchange Act, and the Company has taken no action designed to, or which to its knowledge is likely to have the effect of, terminating the registration of such class of Common Stock under the Exchange Act nor has the Company received any notification that the Commission is contemplating terminating such registration.

           (f)     The following Section 3.1(pp) is hereby added to the Alliance Agreement:

(pp)     Additional Initial Closing Date Representations . As of the Initial Closing Date, the Company makes the following representations and warranties:

(1)     Set forth on Schedule 3.1(pp)(1) of the Company Disclosure Schedule is a true, correct and complete list of the holders of Outstanding Preferred Stock who have elected to convert all or a portion of their shares to Common Stock in accordance with Section 2.9 hereof, setting forth the name of each such holder, the number, class and series of shares of Outstanding Preferred Stock so converted and the number of shares of Common Stock into which such shares have been converted (each such holder, a “Converting Holder”). The Company has delivered to Parent true, correct and complete copies of all Conversion Notices delivered by each Converting Holder. Any and all representations, warranties and other disclosure made or furnished by or on behalf of the Company to the Converting Holders and to each nonconverting holder of Outstanding Preferred Stock Purchaser regarding the Company, its business and the transactions contemplated hereby, was, when made, true and correct in all material respects and did not contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in light of the circumstances under which they were made, not misleading.

(2)     Set forth on Schedule 3.1(pp)(2) of the Company Disclosure Schedule is a true, correct and complete list of the holders of Outstanding Preferred Stock who have consented to the transactions contemplated by this Agreement, including the issuance of the Series E Preferred Stock hereunder, setting forth the name of each such holder and the number, class and series of shares of Outstanding Preferred Stock held by such holder (each such holder, a “Consenting Holder”). The

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Company has delivered to Parent true, correct and complete copies of all consents delivered by each Consenting Holder. Any and all representations, warranties and other disclosure made or furnished by or on behalf of the Company to the Consenting Holders and to each nonconsenting holder of Outstanding Preferred Stock Purchaser regarding the Company, its business and the transactions contemplated hereby, was, when made, true and correct in all material respects and did not contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in light of the circumstances under which they were made, not misleading.

(3)     Any and all actions and steps taken by the Company in connection with the conversion of the shares of Outstanding Preferred Stock by the Converting Holders and the granting of consent by the Consenting Holders complied in all material respects with any and all applicable laws, rules and regulations.

(4)     Set forth on Schedule 3.1(pp)(4) of the Company Disclosure Schedule is a true, correct and complete list of all Ten Percent Stockholders and the number of shares of Common Stock held by each such holder.

(5)     Set forth on Schedule 3.1(pp)(5) of the Company Disclosure Schedule is a pro forma capitalization table setting forth, in all material respects, after giving effect to the conversion of shares of Outstanding Preferred Stock by the Converting Holders, the number of shares of outstanding Common Stock, the number of shares of Outstanding Preferred Stock, the number of shares of Common Stock to be issued as dividends to the holders of the Outstanding Preferred Stock (assuming a price per share of $0.05) for each of the next five years, the number of shares of Common Stock to be issued to the holders of the Series D Preferred Stock upon the redemption thereof (assuming a price per share of $0.05) and the corresponding adjustments to the conversion price of the Series E Preferred Stock pursuant to the Certificate of Designation.”

           (g)    Section 4.10(a) is amended by deleting the date “June 30, 2009” which appears therein and inserting “July 31, 2009” in its stead.

           (h)    Section 4.14(a)(iii) of the Alliance Agreement is hereby deleted in its entirety and replaced with the following text:

declare, set aside, make or pay any dividend or other distribution (whether payable in cash, stock, property or a combination thereof) with respect to any of its capital stock, other than dividends payable on outstanding shares of Existing Preferred Stock and Series D Preferred Stock in accordance with the terms thereof as in effect on the date hereof;

           (i)     The following Section 4.18 is added to the Alliance Agreement:

4.18      Delisting . Within thirty (30) Business Days following the Initial Closing Date, the Company shall effect the delisting of the Common Stock from the American Stock Exchange (now known as NYSE Alternext U.S) and shall cause

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the Common stock to be traded on such Trading Market as shall be required under any agreement, instrument or security to which the Company may be a party or may be bound.

           (j)     Section 6.1 is amended by deleting the date “April 30, 2009” which appears therein and inserting “June 1, 2009” in its stead.

           (k)    The resolution set forth in Article First of the form of Certificate of Amendment of Certificate of Incorporation attached as Exhibit A to the Alliance Agreement is hereby deleted in its entirety and replaced with the following text:

R ESOLVED , that the Board of Directors deems it in the best interest of the Corporation to amend the Certificate of Incorporation of the Corporation, as amended (the “ Certificate of Incorporation ”), by deleting Article Fourth of the Certificate of Incorporation in its entirety and replacing it with the following:

FOURTH: The total number of shares of all classes of stock which the Corporation shall have authority to issue is Three Hundred Sixty Million (360,000,000) shares, consisting of Four Million Four Hundred Eighty-Three Thousand Four Hundred Forty-Two (4,483,442) shares of Preferred Stock, par value $0.01 per share, and Three Hundred Fifty-Five Million Five Hundred Sixteen Thousand Five Hundred Fifty-Eight (355,516,558) shares of Common Stock, par value of $0.001 per share.

Subject to the provisions of Section 151 of the General Corporation Law, the Board of Directors or any authorized committee thereof of the Corporation is authorized to issue the shares of Preferred Stock in one or more series and determine the number of shares constituting each such series, the voting powers of shares of each such series and the designations, preferences and relative, participating, optional or other special rights, and qualifications, limitations or restrictions as set forth in a resolution or resolutions of the Board of Directors.

           (l)     Section 3(a) of the form of Certificate of Designation attached as Exhibit B to the Alliance Agreement is hereby deleted in its entirety and replaced with the following text:

So long as any Series E Preferred Stock shall remain outstanding, the Corporation shall not declare, pay or set aside any dividends on shares of any other class or series of capital stock of the Corporation (other than dividends payable pursuant to the Series B Certificate, the Series C Certificate and the Series D Certificate) unless the Holder shall first receive, or simultaneously receive, a dividend on each outstanding share of Series E Preferred Stock in an amount equal to the dividend the Holder would have been entitled to receive upon conversion, in full, of one share of Series E Preferred Stock immediately prior to the record date for determination of holders entitled to receive such dividend.

           (m)   Section 4(b)(iii) of the form of Certificate of Designation attached as Exhibit B to the Alliance Agreement is hereby deleted in its entirety and replaced with the following text:

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declare, set aside, make or pay any dividend or other distribution (whether payable in cash, stock, property or a combination thereof) with respect to any of its capital stock, other than dividends payable on outstanding shares of Existing Preferred Stock in accordance with the terms thereof as in effect on the date hereof;

           2.      Waiver . The Parent and the Purchaser each hereby waive the condition precedents set forth in Section 2.12(a)(i), (ii) and (iii) of the Alliance Agreement and acknowledge that the Company complied with its obligations under Section 2.9(a) of the Alliance Agreement. In addition, the Parent and the Purchaser each hereby acknowledge receipt of the Supplemental Company Schedules, which such Supplemental Schedules shall have been delivered to the Parent and the Purchaser by the Company on or before the date of this Amendment in satisfaction of the delivery requirement contained in Section 2.2(a)(ix) .

           3.      Effect of Amendments . Except as expressly amended herein, the terms of the Alliance Agreement are incorporated herein by reference as if fully set out and shall remain in full force and effect in accordance with their terms.

           4.      Severability . If any provision or portion of this Amendment shall be determined to be invalid or unenforceable for any reason, in whole or in part, the remaining provisions of this Amendment shall be unaffected thereby and shall remain in full force and effect to the fullest extent permitted by law.

           5.      Counterparts; Delivery by Facsimile . This Amendment may be executed in any number of counterparts with the same effect as if all parties hereto had signed the same document. All counterparts shall be construed together and shall constitute one Amendment. This Amendment and any amendments hereto, to the extent signed and delivered by means of a facsimile machine or email, shall be treated in all manner and respects as an original agreement or instrument and shall be considered to have the same binding legal effect as if it were the original signed version thereof delivered in person. No party hereto or to any such agreement or instrument shall raise the use of a facsimile machine or email to deliver a signature or the fact that any signature or agreement or instrument was transmitted or communicated through the use of a facsimile machine or email as a defense to the formation of a contract and each such party forever waives any such defense.

           6.      Governing Law; Consent to Jurisdiction . All questions concerning the construction, validity, enforcement and interpretation of this Amendment shall be governed by and construed and enforced in accordance with the internal laws of the State of Jersey, without regard to the principles of conflicts of law thereof. Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Amendment and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any other manner permitted by law. THE PARTIES HEREBY WAIVE ALL RIGHTS TO A TRIAL BY JURY . If either party shall commence an action or proceeding to enforce any provisions of this Amendment, then the prevailing party in such action or proceeding shall be

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reimbursed by the other party for its reasonable attorneys’ fees and other costs and expenses incurred with the investigation, preparation and prosecution of such action or proceeding.

           8.      Headings . The headings contained in this Amendment are for reference purposes only and shall not be deemed to be part of the Amendment or to affect the meaning or interpretation of this Amendment.

 

( Remainder of Page Intentionally Left Blank; Signature Page Follows )

 

 

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           IN WITNESS WHEREOF, this Amendment is executed by the parties hereto as of the day and year first above written.

  ELITE PHARMACEUTICALS, INC.
         
  By:   /s/ Chris Dick  
      Name: Chris Dick  
      Title:  Chief Operating Officer and Acting Chief  
                 Executive Officer  
         
         
  EPIC PHARMA, LLC
         
  By:   /s/ Ashok G. Nigalaye  
      Name:  Ashok G. Nigalaye, Ph.D.  
      Title:  President and Chief Executive Officer  
         
  EPIC INVESTMENTS, LLC
         
  By:   EPIC PHARMA, LLC, its Managing Member  
         
  By:   /s/ Ashok G. Nigalaye  
      Name:  Ashok G. Nigalaye, Ph.D.  
      Title:  President and Chief Executive Officer  



Exhibit 99.1

 


ELITE INITIATES PROCESS TO DELIST ITS COMMON STOCK FROM NYSE AMEX AND
COMMENCE QUOTATION ON OTC BULLETIN BOARD

NORTHVALE, N.J. – April 30, 2009 – On April 30, 2009, Elite Pharmaceuticals, Inc. (“Elite”) (NYSE AMEX Equities: ELI) sent written notice to NYSE Amex (the “Exchange”) of its intention to effect a voluntarily delisting of its common stock, par value $0.01 per share (the “Common Stock”), from the Exchange in order to commence quotation of the Common Stock on the OTC Bulletin Board.

Elite’s decision to effect a voluntarily delisting of the Common Stock from the Exchange is the result of the transactions contemplated by the Strategic Alliance Agreement, dated March 18, 2009 (the “Alliance Agreement”), by and among Elite, on the one hand, and Epic Pharma, LLC, a Delaware limited liability company (the “Parent”), and Epic Investments, LLC, a Delaware limited liability company and wholly-owned subsidiary of the Parent (the “Purchaser”), on the other hand. Elite believes the delisting of the Common Stock from the Exchange is an important step in its continuing efforts to reduce costs. As a result, the obligations of the Parent and the Purchaser under the Alliance Agreement have been conditioned upon, among other things, the effectuation by Elite of the delisting of the Common Stock from the Exchange and the quoting of the Common Stock on the OTC Bulletin Board.

Independent of Elite’s decision to effect a voluntary delisting of the Common Stock from the Exchange, on March 17, 2009, the Exchange issued a letter (the “Exchange Notification”) notifying Elite that the Exchange staff determined, based on its review of publicly available information, that Elite was not in compliance with certain continued listing standards under Part 10 of the NYSE Alternext US LLC Company Guide (the “Company Guide”) and, as a result, has become subject to the procedures and requirements of Section 1009 of the Company Guide. In particular, the Exchange found Elite not to be in compliance with Section 1003(a)(iv) of the Company Guide based on losses which are so substantial in relation to its overall operations or its existing financial resources, or its financial condition has become so impaired, that it appears questionable to the Exchange whether Elite will be able to continue operations and/or meet its future obligations.

The Exchange afforded Elite the opportunity to submit a plan (a “Plan”) of compliance to the Exchange by April 17, 2009 that demonstrates Elite’s ability to regain compliance with Section 1003(a)(iv) of the Company Guide by September 17, 2009. However, pursuant to the terms of the Alliance Agreement and to reduce compliance costs, Elite has determined not submit a Plan to the Exchange. Instead, Elite will effect a voluntarily delisting of the Common Stock from the Exchange and will cause the Common Stock to be quoted on the OTC Bulletin Board.

About Elite Pharmaceuticals, Inc.

Elite 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. Two of Elite’s products, Lodrane 24® and Lodrane 24D®, are marketed by a partner, ECR Pharmaceuticals, for allergy treatment. Elite’s lead pipeline products are novel sustained release oral formulations of oxycodone 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. Both products, ELI-216, a once-daily abuse resistant oxycodone, and ELI-154, a once-daily oxycodone, are in late-stage development. Elite, with partners, also has an ANDA filed with the FDA for a generic equivalent of a pain product and has a generic gastrointestinal drug product in clinical development. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.

This news release contains forward-looking statements, including those related to the preliminary nature of the clinical program results and the potential for further product development, that involve known and unknown risks, delays, uncertainties and other factors not under the control of Elite, which may cause actual results, performance or achievements of the companies to be materially different from the results, performance or other expectations implied by these forward-looking statements. In particular, because substantial future testing will be required prior to approval, the results described above may not be supported by additional data or by the results of subsequent trials. These risks and other factors, including the timing or results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory authorities, and intellectual property protections and defenses, are discussed in Elite's filings with the Securities and Exchange Commission such as the 10K, 10Q and 8K reports. Elite undertakes no obligation to update any forward-looking statements.

Contact:
For Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
Dianne@elitepharma.com
www.elitepharma.com