-----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, LCTzo0x4KPIziDHl6mT//H6dxKlB/Lx6+jGGW1yDQa/p/EscWUGgKBbAp4uuDb1r QTdaatQG/rLoqjaS8S2XQQ== 0001362310-09-002829.txt : 20090226 0001362310-09-002829.hdr.sgml : 20090226 20090226161205 ACCESSION NUMBER: 0001362310-09-002829 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20090220 ITEM INFORMATION: Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090226 DATE AS OF CHANGE: 20090226 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: 09637931 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 c81758e8vk.htm FORM 8-K Filed by Bowne Pure Compliance
 
 

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

Date of Report (Date of earliest event reported): February 20, 2009

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 No.)
     
157 Technology Drive, Irvine, California
  92618
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (949) 788-6700
 
Not Applicable
(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))

 
 

 

1


 

Item 2.03   Creation of a Direct Financial Obligation or an Obligation Under an Off-Balance Sheet Arrangement of a Registrant.
On February 20, 2009, Spectrum Pharmaceuticals, Inc. (“Spectrum”) received a written notice from Cell Therapeutics, Inc. (“CTI”) stating that CTI had elected to exercise its option to require Spectrum to purchase CTI’s 50% membership interest in RIT Oncology, LLC (“RIT”), a 50/50-owned joint venture (the “Joint Venture”) formed by Spectrum and CTI in December 2008 to commercialize and develop Zevalin® (ibritumomab tiuxetan) in the United States. Spectrum owns the remaining 50% membership interest in the Joint Venture. Spectrum’s obligation to consummate the purchase of CTI’s membership interest is subject to specified closing conditions, including CTI obtaining all necessary material third party consents and approvals and the delivery to Spectrum of a legal opinion of outside counsel to CTI.
Pursuant to the terms of the Joint Venture’s operating agreement, Spectrum is required to purchase, subject to the specified closing conditions, all of CTI’s membership interest in the Joint Venture for $18.0 million (subject to adjustment for any amounts owed between CTI and RIT at the time of sale) within 30 days of the delivery of CTI’s notice of exercise of its sale option. The operating agreement further permits Spectrum to either pay the entire purchase price in a lump sum at the closing of the sale, or to pay the purchase price in three installments (the first at the closing, and the second two 45 and 90 days after the closing). The post-closing installment payments would be subject to a full-recourse, non-interest-bearing promissory note issued by Spectrum to CTI at the closing. Prior to the closing CTI is required to pay a transfer consent fee of $750,000 to Biogen IDEC Inc. (“Biogen”) pursuant to certain agreements between Biogen and CTI that were entered into in connection with the formation of the Joint Venture.
Additional information regarding the Joint Venture can be found in Spectrum’s Current Report on Form 8-K filed with the Securities and Exchange Commission (the “SEC”) on December 19, 2008. A copy of the press release Spectrum issued on February 23, 2009 to announce CTI’s exercise of the sale option and certain other matters is attached as Exhibit 99.1 hereto.
This Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements may contain words such as “will,” “expect,” “believe,” or the negative thereof or comparable terminology, and may include (without limitation) information regarding Spectrum’s expectations, goals or intentions regarding the future, including but not limited to statements regarding CTI’s exercise of its sale option and the consummation of the transactions contemplated thereby. Forward-looking statements involve certain risks and uncertainties, and actual results may differ materially from those discussed in any such statement. In particular, Spectrum can provide no assurances that the conditions to the closing of its acquisition of CTI’s interest in the Joint Venture will be satisfied. Additional factors that could cause actual results to differ are described in further detail in Spectrum’s reports filed with the SEC, including without limitation its Annual Report on Form 10-K for the year ended December 31, 2007 and its subsequent Quarterly Reports on Form 10-Q. All forward looking statements in this Current Report on Form 8-K speak only as of the date hereof. Spectrum does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained herein except as required by law.

 

2


 

Item 9.01   Financial Statements and Exhibits.
  (d)   Exhibits.
             
 
    99.1     Press Release dated February 23, 2009.

 

3


 

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.
         
February 26, 2009   SPECTRUM PHARMACEUTICALS, INC.
 
 
  By:   /s/ Shyam Kumaria    
    Name:   Shyam Kumaria   
    Title:   V.P. Finance   
 

 

4


 

Exhibit List
     
99.1
  Press Release dated February 23, 2009.

 

5

EX-99.1 2 c81758exv99w1.htm EXHIBIT 99.1 Filed by Bowne Pure Compliance
Exhibit 99.1
(SPECTRUM PHARMACEUTICALS, INC. LOGO)
     
COMPANY CONTACTS
   
Russell Skibsted
  Paul Arndt
SVP & Chief Business Officer
  Manager, Investor Relations
949-788-6700x234
  949-788-6700x216
SPECTRUM PHARMACEUTICALS POISED TO ACQUIRE 100% INTEREST IN RIT ONCOLOGY LLC™
JOINT VENTURE UPON CTI’S FULFILLMENT OF CLOSING CONDITIONS
    Cell Therapeutics Exercises Its Option To Sell Its Interest In ZEVALIN® JV; Spectrum Has Up to 30 Days to Close
 
    FDA Sets July 2, 2009 as New PDUFA Action Date For ZEVALIN in First Line Consolidation Therapy After Additional Data Was Received on February 5, 2009
 
    FUSILEV Sales to Date Are Expected To Substantially Fund the Acquisition Cost of Up To $18 Million
 
    Plans for ZEVALIN on Track; Strong Synergies with FUSILEV Anticipated
 
    Spectrum Will Host a Conference Call on Thursday, February 26th at 1:30pmET/10:30amPT
IRVINE, California — February 23, 2009 — Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI) today announced that Cell Therapeutics exercised its option to sell its 50% ownership interest in RIT Oncology LLC™ to Spectrum for up to $18 million, in three installments (closing, 45 days from closing, 90 days from closing). Per the agreement, Spectrum will have up to 30 days in which to close, assuming CTI fulfills all closing conditions. After the close of the transaction, Spectrum Pharmaceuticals will have 100% ownership in RIT Oncology LLC, and will be responsible for all manufacturing, sales, marketing, and commercialization activities for ZEVALIN® (ibritumomab tiuxetan).
ZEVALIN is currently approved for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma (NHL), including patients who have rituximab-refractory follicular NHL.
“We are very excited at the prospect of a 100% ownership in RIT Oncology,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Following the anticipated approval of ZEVALIN as first line consolidation therapy for patients with B-cell follicular non-Hodgkin’s lymphoma, we expect the combination of compelling new clinical data, together with anticipated regulatory and reimbursement changes and a robust sales and marketing effort, to substantially improve patient access to ZEVALIN. Securing full rights to ZEVALIN following the close of this transaction should also increase the return on our investment, and facilitate synergies with our FUSILEV franchise. Additionally, we expect FUSILEV sales to date to substantially fund the ZEVALIN acquisition.”
On November 28, 2008, the FDA accepted for filing and review, and granted priority review status for, the supplemental Biologics License Application for use of ZEVALIN as first line consolidation therapy for patients with B-cell follicular non-Hodgkin’s lymphoma. Priority review is granted by the FDA for a treatment that addresses a significant unmet medical need.
An amendment to the sBLA was received by FDA on February 5, 2009. This submission was considered to be a major amendment, and because the receipt date was within three months of the user fee goal date, FDA extended the goal date by three months to July 2, 2009, to allow for a full review of the amendment.
-more-
157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.spectrumpharm.com NASDAQ: SPPI

 

 


 

Conference Call
Thursday, February 26, 2009 @ 1:30p.m. Eastern/10:30 a.m. Pacific
         
 
  Domestic:   866-700-7173          passcode 68723288
 
  International:   617-213-8838          passcode 68723288
Webcast and replays: www.spectrumpharm.com.
     
Audio replays will be available through March 5, 2009.
  Domestic:
  888-286-8010, passcode 17320931
  International:
  617-801-6888, passcode 17320931
About ZEVALIN®
ZEVALIN® (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the ZEVALIN therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma, including patients with rituximab-refractory follicular NHL. ZEVALIN is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naïve, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.
Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab (Rituxan®) infusions. Yttrium-90 ZEVALIN administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the ZEVALIN therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to ZEVALIN therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). ZEVALIN should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.
For more information on ZEVALIN, patients and healthcare professionals can visit www.ZEVALIN.com.
About Non-Hodgkin’s Lymphoma
Non-Hodgkin’s lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and normally spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms — aggressive NHL, a rapidly spreading acute form of the disease, and indolent NHL, which progresses more slowly. According to the National Cancer Institute’s SEER database there were nearly 400,000 people in the U.S. with NHL in 2004. The American Cancer Society estimates that in the United States 66,120 people are expected to be diagnosed with NHL in 2008. Additionally, approximately 19,160 are expected to die from this disease in 2008.
About First-Line Consolidation Therapy
Consolidation therapy aims to rapidly improve the quality of the response achieved with initial remission induction treatment. Induction therapy is a treatment designed as a first step toward reducing the number of cancer cells.
About RIT (Radioimmunotherapeutics) Oncology, LLC
Spectrum Pharmaceuticals and Cell Therapeutics are the sole members of the LLC, whose sole purpose is to commercialize ZEVALIN in the United States. The LLC is governed by a Board of Managers comprised of an equal number of members from both companies. Both parties are to equally provide for the future capital requirements of the LLC and share equally in the profits and losses of the LLC.
157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.spectrumpharm.com NASDAQ: SPPI

 

 


 

About Spectrum Pharmaceuticals
Spectrum is a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology. Spectrum’s strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in developing drugs and commercialization in our areas of focus; and, leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit Spectrum’s website at http://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 Spectrum’s business and its future, the safety and effectiveness of ZEVALIN, that we anticipate approval of ZEVALIN as first line consolidation therapy for patients with B-cell follicular non-Hodgkin’s lymphoma, that CTI will fulfill all of its obligations to close the transaction, that we expect the combination of compelling new clinical data, together with anticipated regulatory and reimbursement changes and a robust sales and marketing effort, to substantially improve patient access to ZEVALIN, that securing full rights to ZEVALIN following the close of this transaction should also increase the return on our investment, and facilitate synergies with our FUSILEV franchise, that we expect FUSILEV sales to date to substantially fund the ZEVALIN acquisition 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 Spectrum’s existing and new drug candidates, may not prove safe or effective, the possibility that its 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 its existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that its efforts to acquire or in-license and develop additional drug candidates may fail, its lack of revenues, its limited marketing experience, its dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in Spectrum’s reports filed with the Securities and Exchange Commission, including without limitation its Annual Report on Form 10-K for the year ended December 31, 2007 and its subsequent Quarterly Reports on Form 10-Q. All forward looking statements in this press release speak only as of the date hereof. Spectrum does 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
SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc. TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
ZEVALIN® is a registered trademark of RIT Oncology LLC, and RIT and RIT Oncology are trademarks owned by RIT Oncology, LLC.
© 2009 Spectrum Pharmaceuticals, Inc.
157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.spectrumpharm.com NASDAQ: SPPI

 

 

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-----END PRIVACY-ENHANCED MESSAGE-----