-----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, IZ8is80Pg8uqPc7lx4cenYfRRDcnUAAK/VYbMSou+raKPNp37rAMSRSrWOxgVUI9 OT1NQ2cdTzvHy4ab/fjypA== 0001362310-09-004056.txt : 20090319 0001362310-09-004056.hdr.sgml : 20090319 20090319170530 ACCESSION NUMBER: 0001362310-09-004056 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20090315 ITEM INFORMATION: Completion of Acquisition or Disposition of Assets ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090319 DATE AS OF CHANGE: 20090319 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: 09693971 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 c82847e8vk.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 Exchange Act of 1934

Date of Report (Date of earliest event reported): March 15, 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 2.01 Completion of Acquisition or Disposition of Assets

On March 15, 2009, Spectrum Pharmaceuticals, Inc. (“Spectrum”) and Cell Therapeutics, Inc. (“CTI”) entered into a Limited Liability Company Interest Assignment Agreement and completed the previously announced sale of CTI’s 50% membership interest in RIT Oncology, LLC (“RIT”) to Spectrum. Prior to the completion of the sale, RIT was a 50/50-owned joint venture formed by Spectrum and CTI to commercialize and develop Zevalin® (ibritumomab tiuxetan) in the United States. As a result of the sale, Spectrum now owns 100% of RIT and is its sole member.

The initial purchase price of $18 million was discounted by an amount of $1.5 million for an accelerated payment schedule. As partial consideration for its purchase of CTI’s membership interest in RIT, on March 2, 2009 Spectrum made aggregate payments of $6.5 million to CTI or on its behalf. Additionally, on March 16, 2009, Spectrum funded into escrow an aggregate of $10.0 million, of which $6.5 million will automatically be released to CTI on April 3, 2009 and $3.5 million, subject to certain adjustments for among other things payables determined to be owed between CTI and RIT, will be released to CTI on April 15, 2009. As part of the transaction, CTI agreed to forego the right to receive up to $15.0 million in previously disclosed potential product sales milestone payments provided to CTI in connection with the original transaction establishing the joint venture.

As part of the closing, CTI assigned to Spectrum an amended and restated security agreement and a guarantee granted by CTI in favor of Biogen Idec Inc. to secure the performance of the joint venture’s obligations with respect to Zevalin, and Spectrum agreed to reimburse CTI for any post-sale liability incurred based upon claims made by Biogen under those contracts or any other contracts associated with the Zevalin business to which CTI was previously a party.

A copy of the press release issued by Spectrum on March 16, 2009 to announce the completion of the transaction is attached as Exhibit 99.1 hereto.

Item 9.01 Financial Statements and Exhibits.

(a) Financial Statements of Businesses Acquired.

The audited financial statement of the Zevalin® business for the nine month period ended September 30, 2008 was previously reported on Exhibit 99.2 of Spectrum’s current report on Form 8-K/A filed on March 2, 2009. Any additional information required by Item 9.01(a) will, if applicable, be filed by amendment to this Form 8-K as soon as practicable no later than 71 calendar days after the date on which this initial report on Form 8-K is required to be filed.

(b) Pro Forma Financial Information.

The unaudited pro forma combined financial statements and related notes of Spectrum as of September 30, 2008 and for the nine months and twelve months ended September 30, 2008 and December 31,2007, respectively, were previously reported on Exhibit 99.3 of Spectrum’s current report on Form 8-K/A filed on March 2, 2009. Any additional information required by Item 9.01(b) will, if applicable, be filed by amendment to this Form 8-K as soon as practicable no later than 71 calendar days after the date on which this initial report on Form 8-K is required to be filed.

(d) Exhibits.

     
99.1
  Press Release dated March 16, 2009

 

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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.

             
March 19, 2009   SPECTRUM PHARMACEUTICALS, INC.

    By:   /s/ Shyam Kumaria
         
        Name:   Shyam Kumaria
 
      Title:   V.P. Finance

 

3


 

Exhibit List

     
99.1
  Press Release dated March 16, 2009

 

 

4

EX-99.1 2 c82847exv99w1.htm EXHIBIT 99.1 Exhibit 99.1
Exhibit 99.1
(SPECTRUM PHARMACEUTICALS LOGO)
     
COMPANY CONTACTS
   
Russell Skibsted
  Paul Arndt
SVP & Chief Business Officer
  Manager, Investor Relations
949-788-6700x234
  949-788-6700x216 
SPECTRUM PHARMACEUTICALS ACQUIRES 100% OF ZEVALIN®, AN FDA-APPROVED,
PROPRIETARY, BIOLOGICAL DRUG FOR NON-HODGKIN’S LYMPHOMA
    2008 ZEVALIN Sales Were Approximately $11.4 Million
 
    Spectrum Will Book 100% of ZEVALIN Sales Moving Forward
 
    PDUFA Action Date for ZEVALIN in First-Line Use is July 2, 2009
 
    Multiple Synergies Anticipated With FUSILEV™
IRVINE, California, March 16, 2009 — Spectrum Pharmaceuticals (NasdaqGM: SPPI) announced today the closing of the transaction whereby Spectrum Pharmaceuticals acquired 100% control of RIT Oncology, LLC™, to commercialize ZEVALIN® ([90Y]-ibritumomab tiuxetan) in the United States. In connection with the closing, Spectrum Pharmaceuticals will pay its former partner a total of $16.5 million, which is subject to further adjustments based on outstanding liabilities and obligations. Additionally, there will be no further payments or milestones to the former partner. Spectrum Pharmaceuticals now has 100% ownership of RIT Oncology, LLC, and will be responsible for all activities relating to ZEVALIN. Spectrum Pharmaceuticals will now book 100% of ZEVALIN revenues.
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. ZEVALIN is under review by the FDA for use as a first line consolidation therapy for patients with NHL. The FDA recently established July 2, 2009 as a target date for a decision regarding the ZEVALIN sBLA.
“We are excited to have 100% ownership of ZEVALIN,” said Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Recent clinical data have dramatically underscored the clinical benefits of ZEVALIN in NHL. We believe that approval of the supplemental Biologics License Application (sBLA) for first-line consolidation therapy, which is based on the Phase 3 FIT data, anticipated regulatory and reimbursement changes, combined with our marketing efforts, will substantially improve patient access to ZEVALIN.”
“The anticipated FDA approval of the sBLA for ZEVALIN on or before the July 2, 2009 PDUFA action date will allow for the label to address a substantially larger patient population,” added Dr. Shrotriya. “We expect our commercial launch program to be fully in place by the anticipated approval of the additional indication for ZEVALIN in July. This asset, along with FUSILEV™, creates added synergies across multiple cost centers, thereby maximizing the return on our investments.”
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 a first line consolidation therapy for patients with NHL. Priority review is granted by the FDA for a treatment that addresses a significant unmet medical need. This does not represent any evaluation of the adequacy of the data submitted. A Prescription Drug User Fee Act (PDUFA) target date of July 2, 2009 has been established by the FDA for a decision regarding the ZEVALIN sBLA.
If approved, ZEVALIN would be the first therapeutic available to patients as first-line consolidation therapy to treat NHL. Following the anticipated approval, the addressable patient population would increase by approximately 18,000. Together with ZEVALIN’s current approval as treatment for patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients that are rituximab-refractory or rituximab-naive, approval of ZEVALIN as first-line consolidation therapy may allow ZEVALIN to be used in several lines of NHL therapy.
157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.spectrumpharm.com NASDAQ: SPPI

 

 


 

About RIT Oncology, LLC
Spectrum Pharmaceuticals is the sole member of the LLC, whose sole purpose is to commercialize ZEVALIN in the United States.
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 NHL, 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 the Phase 3 First-line Indolent Trial (FIT)
The multinational, randomized Phase 3 First-line Indolent Trial (FIT) evaluated the benefit and safety of a single infusion of ZEVALIN in 414 patients with CD20-positive follicular NHL who had achieved a partial response or a complete response after receiving one of the standard first-line chemotherapy regimens. The FIT trial demonstrated that when used as a first-line consolidation therapy for patients with follicular NHL, ZEVALIN significantly improved the median progression-free survival time from 13 months (control arm) to 37 months (ZEVALIN arm) (p<0.0001). The FIT trial results were presented for the first time in one oral and three poster presentations at the American Society of Hematology (ASH) conference in December 2007.
157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.spectrumpharm.com NASDAQ: SPPI

 

 


 

The primary investigators of the study concluded that ZEVALIN consolidation of first remission in advanced stage follicular NHL is highly effective, resulting in a total complete response (CR + CRu) rate of 87 percent and prolongation of median progression-free survival (PFS) by approximately two years, with a toxicity profile comparable to that seen with ZEVALIN’s use in approved indications. ZEVALIN-treated patients had reversible Grade 3 or 4 hematologic side effects including neutropenia in 67 percent, thrombocytopenia in 61 percent, and anemia in 3 percent of patients. Non-hematologic toxicities were 24 percent Grade 3, 5 percent Grade 4, and Grade 3/4 infection was 8 percent.
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 believe that approval of the sBLA for first-line consolidation therapy, which is based on the Phase 3 FIT data, anticipated regulatory and reimbursement changes, combined with our marketing efforts, will substantially improve patient access to ZEVALIN, that the anticipated FDA approval of the sBLA for Zevalin on or before the July 2, 2009 PDUFA action date will allow for the label to address a substantially larger patient population, that we expect our commercial launch program to be fully in place by the anticipated approval of the additional indication for ZEVALIN in July, that Zevalin, along with FUSILEV™, creates added synergies across multiple cost centers, thereby maximizing the return on our investments, that approval of ZEVALIN as first-line consolidation therapy may allow ZEVALIN to be used in several lines of NHL therapy, ZEVALIN’s potential, that if approved for first line therapy in NHL, 18,000 patients per year would be eligible to receive ZEVALIN in that setting, 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(TM) and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
ZEVALIN® is a registered trademark of RIT Oncology, LLC, which is wholly owned by Spectrum Pharmaceuticals, Inc., and RIT and RIT Oncology are trademarks owned by RIT Oncology, LLC.
All other trademarks and trade names are the property of their respective owners.
© 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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