-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, PcIr7upJusfvFQKEVxHPxD93Q/8BI9i3MLA9jxCCOLvG+AhmIBSQmyykK+0M4kE1 TaXy36goD3qGJugge8dcuA== 0000950137-06-003251.txt : 20060320 0000950137-06-003251.hdr.sgml : 20060320 20060320080042 ACCESSION NUMBER: 0000950137-06-003251 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20060317 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Unregistered Sales of Equity Securities ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060320 DATE AS OF CHANGE: 20060320 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SPECTRUM PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000831547 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 930979187 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-28782 FILM NUMBER: 06697439 BUSINESS ADDRESS: STREET 1: 157 TECHNOLOGY DR CITY: IRVINE STATE: CA ZIP: 92618 BUSINESS PHONE: 9497886700 MAIL ADDRESS: STREET 1: 157 TECHNOLOGY DR CITY: IRVINE STATE: CA ZIP: 92618 FORMER COMPANY: FORMER CONFORMED NAME: NEOTHERAPEUTICS INC DATE OF NAME CHANGE: 19960819 FORMER COMPANY: FORMER CONFORMED NAME: AMERICUS FUNDING CORP DATE OF NAME CHANGE: 19920703 8-K 1 a18660e8vk.htm FORM 8-K e8vk
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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 AND EXCHANGE ACT OF 1934
March 17, 2006
Date of Report (Date of earliest event reported)
 
SPECTRUM PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
         
Delaware
(State or other Jurisdiction
of Incorporation)
  000-28782
(Commission File Number)
  93-0979187
(IRS Employer
Identification Number)
         
157 Technology Drive
Irvine, California

(Address of principal executive offices)
      92618
(Zip Code)
(949) 788-6700
(Registrant’s telephone number, including area code)
N/A
(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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


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Item 1.01 Entry Into Material Definitive Agreement
Item 3.02 Unregistered Sales of Equity Securities.
Item 9.01 Financial Statements and Exhibits.
SIGNATURES
EXHIBIT INDEX
Exhibit 99.1


Table of Contents

Item 1.01 Entry Into Material Definitive Agreement
     On March 17, 2006, Spectrum Pharmaceuticals, Inc. (the “Company”) entered into an asset purchase agreement (the “Purchase Agreement”), by and among the Company, Targent Inc. (“Targent”) and certain stockholders of Targent (the “Stockholders”), pursuant to which the Company will acquire all of the oncology drug product assets of Targent. Other than in respect of the Purchase Agreement, there are no material relationships between the Company, on the one hand, and Targent and the Stockholders, on the other hand. In exchange for the acquired assets of Targent, the Company has agreed to issue to Targent, or its stockholders, an aggregate amount of 600,000 shares of the Company’s common stock at closing, as defined in the Purchase Agreement (the “Closing”). In addition, Targent is eligible to receive payments, in the form of the Company’s common stock and/or cash, upon achievement of certain regulatory and sales milestones, if any. At the option of the Company, any amounts due in cash under the Purchase Agreement may be paid by issuing shares of the Company’s common stock having a value, determined as provided in the Purchase Agreement, equal to the cash payment amount.
     The Company has made customary representations and warranties and covenants in the Purchase Agreement. In addition, pursuant to the terms of the Purchase Agreement, each party has agreed to indemnify the other for an agreed upon period following the acquisition for damages arising from, among other things, such party’s breach of its representations, warranties or covenants under the Purchase Agreement, subject to the limitations contained in the Purchase Agreement. The Closing is subject to a number of conditions, including the unanimous approval of Targent’s stockholders and other customary conditions.
     Concurrently with the issuance of the shares at Closing, the Company will enter into a registration rights agreement with Targent, which requires the Company to file a registration statement covering the resale of one-third of all shares issued to Targent pursuant to the Purchase Agreement.
     The foregoing description of the Purchase Agreement and the transactions contemplated thereby is qualified in its entirety by reference to the press release attached as Exhibit 99.1 hereto, and incorporated herein by reference.
     In connection with the Purchase Agreement, the Company also entered into a voting agreement (the “Voting Agreement”), dated March 17, 2006, by and among the Company and certain stockholders of Targent (the “Voting Agreement Stockholders”), which provides that the Voting Agreement Stockholders will vote all of the shares of Targent’s voting stock that they own in favor of the Purchase Agreement and the transactions contemplated therein.
     The foregoing description of the Voting Agreement and the transactions contemplated thereby is qualified in its entirety by reference to the press release attached as Exhibit 99.1 hereto, and incorporated herein by reference.
Item 3.02 Unregistered Sales of Equity Securities.
     Pursuant to the terms of the Purchase Agreement, the Company will issue, upon Closing, an aggregate amount of 600,000 shares of the Company’s common stock. Upon the completion of certain milestones contained in the Purchase Agreement, the Company will issue up to an aggregate amount of 650,000 additional shares of the Company’s common stock, and may issue additional shares of common stock in lieu of cash payments. Such shares will be issued without registration in reliance upon the exemption provided by Section 4(2) of the Securities Act of 1933, as amended, based in part upon the following: the issuance does not involve any public offering; we made no solicitation in connection with this transaction, other than communication with Targent and its stockholders; we obtained representations from Targent and its stockholders regarding its and their investment intent, experience and sophistication; Targent has received or had access to adequate information about Spectrum in order to make an informed investment decision; Targent and its stockholders have represented that they are each an “accredited investor” within the meaning of Rule 501 of Regulation D under the Act; Spectrum reasonably believes that Targent and its stockholders are sophisticated within the meaning of Section 4(2) of the Act; and the common stock will be

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issued with restricted securities legends. No underwriting discounts or commissions will be paid in conjunction with the issuance.
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits
     
Exhibits:   Description of Document
99.1
  Press Release dated March 20, 2006.

-3-


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SIGNATURES
     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.
Date: March 17, 2006
         
  SPECTRUM PHARMACEUTICALS, INC.
 
 
  By:   /s/ Shyam Kumaria    
    Name:   Shyam Kumaria   
    Title:   V.P. Finance   

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Table of Contents

         
EXHIBIT INDEX
     
Exhibits:   Description of Document
99.1
  Press Release dated March 20, 2006.

-5-

EX-99.1 2 a18660exv99w1.htm EXHIBIT 99.1 exv99w1
 

Exhibit 99.1
(Spectrum Logo)
Contact:
     Dr. Rajesh C. Shrotriya
     Chairman, President and CEO
     (949) 743-9295
Spectrum Pharmaceuticals to Acquire NDA for an
Oncology Drug and other Assets
    Key product in acquisition is Levofolinic acid (LFA) for which a New Drug Application (NDA) is on file with the FDA
 
    Spectrum to acquire North American rights to LFA, which is marketed by Wyeth, Sanofi-Aventis and others in certain parts of the world, including Europe and Japan
 
    Approval and Launch in the US expected late next year
 
    LFA has received two FDA orphan drug designations
 
    LFA is used extensively with 5-FU-containing chemotherapy regimens outside the US
 
    Conference call on Wednesday, March 22, 2006 at 4:30 p.m. ET (1:30 p.m. PT) to discuss LFA and the acquisition
 
    Live Webcast will also be available at www.spectrumpharm.com.
     IRVINE, Calif., March 20, 2006 — Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) today announced that it has entered into a definitive agreement to acquire all of the oncology drug assets of Targent, Inc. The key product to be acquired is levofolinic acid (LFA), the pure active isomer of calcium leucovorin, a component of “standard of care” 5-fluorouracil (5-FU) containing regimens for the treatment of colorectal and other malignancies. Calcium leucovorin is also used after the administration of high-dose methotrexate in treating certain malignancies.
     A New Drug Application (NDA) for LFA has been filed with by the Food and Drug Administration (FDA) for the osteosarcoma indication. In addition, LFA has been granted orphan drug status for colorectal cancer in combination with 5-FU and for osteogenic sarcoma in use with metheotrexate rescue. LFA is currently marketed by Wyeth, Sanofi-Aventis and others in certain parts of the world, including Europe and Japan, while Spectrum will obtain the rights in the U.S., Canada and Mexico. It is estimated that the current annual market of LFA outside North America is approximately $200 million.
     “We are very excited to add LFA to Spectrum’s broad portfolio of late stage anti-cancer drugs currently under development,” stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President. “While LFA was recommended for approval by

 


 

the Oncology Advisory Committee at a vote of 8-0, the Chemistry Manufacturing and Control portion of the submission generated additional questions from the FDA. We believe that it is possible to file a response to these questions in approximately one year and to have this important drug available to patients in late 2007.
     “Scientific consensus in the U.S. and abroad acknowledges that LFA is the only active isomer of leucovorin,” said Dr, Luigi Lenaz, Chief Scientific Officer for Spectrum. “The currently available drug on the market (calcium leucovorin) is a racemic mixture containing only 50% of active drug LFA. “Consistent with the FDA’s position to develop pure isomers of drugs, LFA represents an improvement over the currently marketed product and an opportunity for Spectrum to launch its first proprietary drug.”
     “We are very pleased to be able to work closely with the team at Spectrum, who has expertise and an established track record in the development of oncology drugs,” stated Dr. Patrick Maguire, Chief Executive Officer of Targent. “Spectrum’s pipeline of several oncology drugs will provide greater visibility for our drugs within the medical community.”
     Under the terms of the agreement, Spectrum has agreed to issue to Targent an aggregate amount of 600,000 shares of the company’s common stock at closing. Only 1/3rd (200,000) of these shares will be registered for resale. The remaining 2/3rd (400,000) shares will not be registered and therefore will be subject to restrictions on resale under rule 144 of the Securities Act of 1933. In addition, on achieving certain regulatory and sales milestones, Targent is eligible to receive cash payments as well as up to an aggregate amount of 650,000 shares of the company’s common stock. Only 1/3rd of these shares will be registered for resale. The remaining 2/3rd shares will not be registered and therefore will be subject to restrictions on resale under rule 144. At Spectrum’s option, any amounts due in cash may be paid by issuing shares of the company’s common stock 1/3rd of which will also be registered. Additional financial details have not been disclosed.
     Certain rights to additional potential drug candidates in the oncology therapeutic area will also be acquired under the terms of the deal.
Spectrum to host a conference call on Wednesday, March 22, 2006 at 4:30 p.m. ET
     Spectrum will host a conference call on Wednesday, March 22, 2006 at 4:30 p.m. ET (1:30 p.m. PT) to discuss LFA and the acquisition.
     Dr. Rajesh C. Shrotriya, Chairman, President and Chief Executive Officer will host the call and Dr. Luigi Lenaz, Chief Scientific Officer, will also be available to answer questions during the Q&A period.
     The conference call will be available to interested parties through a live audio Internet broadcast at www.spectrumpharm.com. Following the live webcast, an archived version of the call will be available at the same URL.
About Spectrum Pharmaceuticals
     Spectrum Pharmaceuticals is a specialty pharmaceutical company engaged in the business of acquiring, developing and commercializing prescription drug products for

 


 

the treatment of cancer and other unmet medical needs. By leveraging its operational flexibility and regulatory proficiency, and using the extensive research and development capabilities of its strategic alliance partners, Spectrum has built a diversified portfolio of proprietary and generic drug products in various stages of development and regulatory approval. For more information, please visit our website at www.spectrumpharm.com.
Forward-looking statements
     This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, the Company’s operational flexibility and regulatory proficiency, the extensive research and development capabilities of the Company’s strategic alliance partners, that LFA will be approved and launched in the US late next year, that the parties will close the transaction and Spectrum will acquire all of the oncology drug assets of Targent, the current annual market of LFA outside North America, that Spectrum will file a response to the CMC questions in approximately one year and have LFA available to patients in late 2007, that LFA is an improvement over the currently marketed product and an opportunity for Spectrum to launch its first proprietary drug, that Spectrum’s pipeline of several oncology drugs will provide greater visibility for Targent’s drugs within the medical community and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, that certain issues may arise such that either party is unable to satisfy its closing obligations, the possibility that price and other competitive pressures may make the marketing and sale of our generic drugs not commercially feasible, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited experience in establishing strategic alliances, our limited marketing experience, our limited experience with the generic drug industry, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company’s reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
###

 

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