-----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, FZtdHK7GLceDrlXA84Y84ecsEKOuPbs6YXJmiWFJf3gytaf12ehr8D/RvJvOaAOP cqDzVQpVxDmalt040BskpQ== 0001193125-06-258891.txt : 20061222 0001193125-06-258891.hdr.sgml : 20061222 20061222120447 ACCESSION NUMBER: 0001193125-06-258891 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20061221 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20061222 DATE AS OF CHANGE: 20061222 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: 061295716 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 d8k.htm FORM 8-K Form 8-K

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

December 21, 2006 Date of Report (Date of earliest event reported)

 


SPECTRUM PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   000-28782   93-0979187

(State or other Jurisdiction

of Incorporation)

  (Commission File Number)  

(IRS Employer

Identification Number)

 

157 Technology Drive

Irvine, California

  92618

(Address of principal executive

offices)

  (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:

 

¨ 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 8.01 Other Events.

On December 21, 2006, we issued a press release, announcing that the pending patent litigation between us and GlaxoSmithKline® (“GSK”) relating to sumatriptan injection, the generic version of GSK’s Imitrex® Injection, has, at our request, been dismissed by the United States District Court for the District of Delaware, pursuant to a settlement agreement between the parties. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit   

Description of Documents

99.1+    Press Release dated December 21, 2006

+ Filed herewith.

 

-2-


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: December 22, 2006

 

SPECTRUM PHARMACEUTICALS, INC.
By:   /s/ Rajesh C. Shrotriya, M.D.
Name:   Rajesh C. Shrotriya, M.D.
Title:   Chairman, CEO & President

 

-3-


EXHIBIT INDEX

 

Exhibit   

Description of Documents

99.1+    Press Release dated December 21, 2006

+ Filed herewith.

 

-4-

EX-99.1 2 dex991.htm PRESS RELEASE Press Release

EXHIBIT 99.1

LOGO

 

Media

Susan Neath

Porter Novelli Life Sciences

(619) 849-6007

  

Raj Shrotriya

President & CEO

Spectrum Pharmaceuticals

(949) 743-9295

  

Russell Skibsted

SVP & Chief Business Officer

Spectrum Pharmaceuticals

(949) 743-9234

Spectrum Pharmaceuticals Announces That Sumatriptan Injection Litigation With GlaxoSmithKline® Has Been Dismissed Pursuant to the Settlement Agreement

 

    Litigation dismissed after the 30-day review period passed with no comment from the Federal Trade Commission (FTC)

 

    Spectrum expects Sumatriptan Injection to launch in 2H 2008

 

    Spectrum received $5 million as a milestone payment from PAR earlier this month

 

    Spectrum to receive majority of profit from sales

IRVINE, CA – December 21, 2006—Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) announced today that patent litigation relating to sumatriptan injection, the generic version of GlaxoSmithKline’s® Imitrex® Injection, has been dismissed by the United States District Court for the District of Delaware pursuant to the previously-announced settlement agreement between Spectrum and GSK.

In November, Spectrum and GSK reached an agreement to settle patent litigation relating to sumatriptan injection. The terms of the confidential agreement 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 Pharmaceutical Companies, Inc.

“As we expected, at our request the court has dismissed this patent litigation with GSK which will allow us to move forward under the previously announced settlement agreement for sumatriptan injection,” stated Rajesh Shrotriya, M.D., Chairman, President and CEO of Spectrum. “This will enable our partner PAR Pharmaceutical to continue with the launch of sumatriptan injection ahead of GSK’s patent expiration and allow us to begin receiving profits upon sales as early as 2008.”

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 tentatively approved by the FDA in October 2006.

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 and receiving profits 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-----