-----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, IVFV2VQX+TJic6GCt0EWO5OtFMGxl0lZOTvQtWYfI5ot+dsh8y5p4XufGhWtUX2C 3hgNZKcf8E5q7NJbUYWH9g== 0000950137-06-012550.txt : 20061116 0000950137-06-012550.hdr.sgml : 20061116 20061116164220 ACCESSION NUMBER: 0000950137-06-012550 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20061110 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20061116 DATE AS OF CHANGE: 20061116 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: 061223579 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 a25253e8vk.htm FORM 8-K e8vk
 

 
 
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
November 10, 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))
 
 

 


 

Item 1.01 Entry into a Material Definitive Agreement
     On November 10, 2006, Spectrum Pharmaceuticals, Inc. (the “Company”) entered into a settlement agreement (“Agreement”) of patent litigation with Glaxo Group Limited (“GSK”) relating to sumatriptan injection, the generic version of GSK’s Imitrex® Injection. Pursuant to the terms of the Agreement, the parties agreed to dismiss the litigation with prejudice and mutually agreed to release each other from all liability associated with the litigation. In addition, GSK granted the Company an exclusive license to market, sell and distribute generic versions of certain sumatriptan injection products in the United States during GSK’s sumatriptan pediatric exclusivity period, which begins on August 6, 2008, but with the launch occurring not later than November 6, 2008. Also pursuant to the terms of the Agreement, the Company’s distribution partner for sumatriptan injection, Par Pharmaceutical Companies, Inc. (“Par”), on behalf of the Company, entered into a supply and distribution agreement (“Supply Agreement”) with GSK, whereby GSK agreed to supply certain sumatriptan injection products to Par for distribution in the United States. The Agreement is subject to government review and therefore, it could become null and void.
     The Company does not have any material relationship with GSK other than the agreements discussed above.
     The foregoing description of the Agreement and the Supply and Distribution Agreement is qualified in its entirety by reference to the press release attached as Exhibit 99.1 hereto, and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
     
Exhibits:   Description of Document
99.1
  Press Release dated November 13, 2006.
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: November 16, 2006
         
  SPECTRUM PHARMACEUTICALS, INC.
 
 
  By:   /s/ Shyam Kumaria    
  Name:   Shyam Kumaria   
  Title:   Vice President, Finance   
 

-2-


 

EXHIBIT INDEX
     
Exhibits:   Description of Document
99.1
  Press Release dated November 13, 2006.

-3-

EX-99.1 2 a25253exv99w1.htm EXHIBIT 99.1 exv99w1
 

EXHIBIT 99.1
(SPECTRUM PHARMACEUTICALS LOGO)
         
Media
  Raj Shrotryia   Russell Skibsted
Susan Neath
  President & CEO   SVP & Chief Business Officer
Porter Novelli Life Sciences
  Spectrum Pharmaceuticals   Spectrum Pharmaceuticals
(619) 849-6007
  (949) 743-9295   (949) 743-9234
Spectrum Pharmaceuticals Announces Agreement with GlaxoSmithKline to Settle Imitrex® Injection Patent Litigation
Spectrum filed ANDA with paragraph IV certification for sumatriptan injection in October 2004
and received tentative approval from the FDA in October 2006
IRVINE, Calif., November 13, 2006— Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) today announced that it has settled a patent litigation with GlaxoSmithKline (NYSE: GSK) relating to sumatriptan injection, the generic version of GlaxoSmithKline’s Imitrex Injection.
The confidential terms of the settlement, which remain subject to government review, provide that Spectrum may exclusively distribute authorized generic versions of certain sumatriptan injection products in the United States with an expected launch during GSK’s sumatriptan pediatric exclusivity period which begins on August 6, 2008, but with the launch occurring not later than November 6, 2008. Spectrum will launch sumatriptan injection through its partner for the sale and distribution of the drug, Par Pharmaceuticals Companies, Inc. (NYSE: PRX).
GlaxoSmithKline’s Imitrex Injection (sumatriptan succinate injection) for the acute treatment of migraine attacks and the acute treatment of cluster headache episodes has annual U.S. sales of approximately $220 million, according to IMS Health.
“This settlement with GlaxoSmithKline for sumatriptan injection represents another milestone achieved by Spectrum this year, as we now have clarity regarding our exclusive launch of the important products covered under this agreement,” stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. “Spectrum will receive the majority of the profits from the sale of sumatriptan injection, and we expect to use those profits to fund the further development of our proprietary drug pipeline.”

 


 

In February 2006, Spectrum entered into an agreement with Par Pharmaceutical to develop and market generic drugs for the company, including sumatriptan injection. In 2004, Spectrum filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration seeking marketing clearance for sumatriptan injection, which was approved by the FDA in October 2006.
Settlement Agreements
In accordance with the settlement agreement, pending litigation between Spectrum and GSK in the United States District Court for the District of Delaware is expected to be dismissed pending review by the Federal Trade Commission. GSK will grant Spectrum an exclusive license to market, sell and distribute certain generic versions of sumatriptan injection in the United States during GSK’s sumatriptan pediatric exclusivity period, which begins on August 6, 2008, but with the launch occurring not later than November 6, 2008.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals opportunistically acquires and advances a diversified portfolio of drug candidates that meet critical health challenges for which there are few other treatment options. Spectrum’s expertise lies in identifying undervalued drug candidates with demonstrated safety and efficacy, and adding value through further clinical development and selection of the most viable and low-risk methods of commercialization. The company’s pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease. 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, Spectrum’s ability to identify, acquire and develop its portfolio of drug candidates, the Company’s promising pipeline, the timing of the launch of sumatriptan injection, using those profits from sales of generic sumatriptan injection to fund the further development of our proprietary drug pipeline, that the pending litigation will be dismissed pending review by the Federal Trade Commission 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, the possibility that past results may not be indicative of future results, 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 significant revenues, our limited human and financial resources, 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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-----END PRIVACY-ENHANCED MESSAGE-----