-----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, RclJMZ7fWDyxIDMPDal9FelebB2BceVQ52Cj3zQuukD/aNLTIzuU3EinPVKQuN1q FkbjRitNBpLeA5dj2IfmxA== 0000950123-10-009937.txt : 20100208 0000950123-10-009937.hdr.sgml : 20100208 20100208163029 ACCESSION NUMBER: 0000950123-10-009937 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20100202 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100208 DATE AS OF CHANGE: 20100208 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: 10581254 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 c95815e8vk.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): February 2, 2010

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.)
     
701 N. Green Valley Parkway, Suite 265
Henderson, Nevada
  89074
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (702) 990-3308
 
157 Technology Drive, Irvine, CA 92618
(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 1.01. Entry into a Material Definitive Agreement.

On February 2, 2010, Spectrum Pharmaceuticals, Inc. (the “Company”) and TopoTarget A/S (“TopoTarget”) entered into a License and Collaboration Agreement (the “Agreement”) pursuant to which the Company and TopoTarget agreed to a collaboration for the development and commercialization of Belinostat for all uses in North America and India (the “Territory”), with an option for China (as is defined in the Agreement). Belinostat is currently in a registrational trial, under a Special Protocol Assessment (the “SPA”), as a monotherapy for relapsed or refractory Peripheral T-Cell Lymphoma (“PTCL”), an indication in which has been granted Orphan Drug and Fast Track designation by the U.S. Food and Drug Administration (the “FDA”).

In consideration for the rights granted under the Agreement, the Company paid TopoTarget an upfront fee of $30 million. In addition, on the successful achievement of certain development, regulatory and sales milestones the Company is obligated to issue one million (1,000,000) shares of Spectrum Common Stock (subject to certain resale conditions) and pay TopoTarget up to $320 million. Also, the Company will pay TopoTarget royalties based on net sales of the Product in the Territory.

The Company and TopoTarget will jointly fund development activities, whereby: a) Clinical trial costs associated with the ongoing PTCL registrational trial will be borne by the Company; b) Clinical trial costs associated with the ongoing randomized Phase 2 trial, as a combination therapy with carboplatin and paclitaxel, for cancer of unknown primary (CUP) will be borne by TopoTarget; and c) For future clinical trials, the Company and TopoTarget will share costs, in the ratio of 70% borne by the Company, and 30% borne by TopoTarget.

The Agreement contains customary representations and warranties and indemnities by each of the Company and TopoTarget. The Agreement also includes certain restrictions on the ability of the Company and TopoTarget to directly or indirectly commercialize certain similar products during a certain period of time.

The Agreement will continue until the expiration of the last royalty payment period in the last country in the Territory with certain provisions surviving, unless terminated as follows. The Company may terminate the Agreement at its election upon one hundred eighty (180) days notice to Topotarget. Generally, the Company may also terminate immediately upon a prohibition on the use of the Product or clinical hold by the FDA. TopoTarget may also terminate immediately in the event of a challenge (without TopoTarget's consent) by the Company of the TopoTarget patents that cover the Product. Either party may terminate the Agreement upon a bankruptcy by the other party; or in the event of an uncured material breach by the other party.

Under the terms of the Agreement, Topotarget will manufacture and supply the Product under terms to be set forth in a separate manufacturing and supply agreement to follow. Subject to certain conditions, the Company will have the right to engage and utilize an alternate manufacturer and supplier for the Product.

 

2


 

The above summary does not purport to be a complete description of the terms of the Agreement and is qualified in its entirety by reference to the Agreement, a copy of which is expected to be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ending December 31, 2009. Portions of the Agreement may be omitted in accordance with a request for confidential treatment that the Company expects to submit to the Securities and Exchange Commission. A copy of the press release announcing the Agreement is attached hereto as Exhibit 99.1 and is hereby incorporated by this reference.

The Agreement described herein may contain representations, warranties and covenants of the Company and the other parties thereto. The representations, warranties and covenants contained therein were, unless otherwise expressly stated therein, made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements, and may be subject to limitations and exceptions agreed by the parties to such agreements, including being qualified by disclosures exchanged by the parties thereto. The representations and warranties may have been made for the purposes of allocating risk among the parties thereto instead of establishing such matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors or others. No one other than the parties to such agreement and any express third party beneficiaries identified therein should rely on such representations, warranties and covenants, or any descriptions thereof, as characterizations of the actual state of facts or conditions regarding any party thereto or their respective assets or businesses.

Item 9.01. Financial Statements and Exhibits.
 
(d) Exhibits.

     
Exhibit Number   Description
     
     
99.1   Press Release dated February 2, 2010.

 

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.

         
 
       
    SPECTRUM PHARMACEUTICALS, INC.
 
     
February 8, 2010 
  By:     /s/ Shyam Kumaria  
 
       
 
      Shyam Kumaria 
 
      Vice President, Finance 

 

 

 

4


 

EXHIBIT INDEX

     
Exhibit Number   Description
     
     
99.1   Press Release dated February 2, 2010.

 

5

EX-99.1 2 c95815exv99w1.htm EXHIBIT 99.1 Exhibit 99.1
Exhibit 99.1
(LOGO)
COMPANY CONTACTS
Paul Arndt
Senior Manager, Investor Relations
949-788-6700x216
SPECTRUM PHARMACEUTICALS LICENSES BELINOSTAT, A NOVEL ANTICANCER DRUG IN A PIVOTAL REGISTRATIONAL TRIAL
   
Belinostat, a HDAC Inhibitor, is Currently in a Multicenter, Registrational Trial Under a Special Protocol Assessment for Peripheral T-Cell Lymphoma (PTCL)
   
NDA Filing Expected Next Year (in 2011)
 
   
Granted Fast Track and Orphan Drug Designation by FDA
   
Multiple Phase 2 Trials Are Being Pursued In Various Oncology Indications Including Carcinoma Of Unknown Primary (CUP) For Which No Drug Has Yet Been Approved
 
   
National Cancer Institute (NCI) is Conducting Multiple Trials With Belinostat
 
   
More Than 700 Patients Have Been Treated With Belinostat
 
   
Spectrum and TopoTarget Will Jointly Fund the Future Clinical Development Activities In a Ratio Of 70:30
 
   
Spectrum to Host Conference Call on Thursday, February 4, 2010 at 1pmET/10amPT
IRVINE, California — February 2, 2010 — Spectrum Pharmaceuticals (NasdaqGM: SPPI), a commercial-stage biotechnology company with a primary focus in oncology, today announced that it has entered into a co-development and commercialization agreement with TopoTarget A/S for Belinostat, a novel histone deacetylase (HDAC) inhibitor. Belinostat is currently in a registrational trial, under a Special Protocol Assessment (SPA), as a monotherapy for relapsed or refractory Peripheral T-Cell Lymphoma (PTCL), an indication in which it has been granted Orphan Drug and Fast Track designation by the U.S. Food and Drug Administration (FDA). Belinostat is also under investigation in a randomized Phase 2 trial, as a combination therapy with carboplatin and paclitaxel, for cancer of unknown primary (CUP). Additionally, the NCI is currently conducting several clinical trials of Belinostat in a variety of hematological and solid tumors, both as monotherapy as well as combination therapy.
“The addition of Belinostat addresses our key strategic goal of in-licensing a late-stage anti-cancer compound,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “With this collaboration, we have now completed our strategic initiatives relating to in-licensing of compounds with near term commercialization opportunities. Belinostat’s current registrational program is comprehensive and focused in that it targets key hematological indications such as PTCL and other solid tumor indications. Belinostat has the potential to be a best-in-class HDAC inhibitor for both hematological and solid tumors. We look forward to advancing Belinostat in PTCL and other solid tumor indications, with the goal of providing cancer patients with more effective treatment options as quickly and efficiently as possible. With that goal in mind, we currently expect to file the NDA in PTCL in 2011. TopoTarget has laid a solid foundation from which we will further develop Belinostat.”
“So far, Belinostat has demonstrated some unique and differentiating attributes. If approved, it would give Spectrum access to potentially large markets while allowing for enhanced coordination with our marketed drugs, ZEVALIN and FUSILEV,” added Amar Singh, Spectrum’s Chief Commercial Officer. “The recent expansion of our commercial infrastructure positions us to prepare for another successful launch in the near future”.

 

157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.sppirx.com NASDAQ: SPPI

 


 

“We believe that this partnership will bring together synergies in our combined capabilities that will result in significant efficiencies in Belinostat’s development,” said Professor Peter Buhl Jensen, MD, Chief Executive Officer of TopoTarget A/S. “Spectrum as a partner is ideally suited to exploit the full benefits of the drug for cancer patients.”
Under terms of the agreement, Spectrum licensed the rights to Belinostat for North America and India, and an option for China, in exchange for an upfront cash payment of $30 million, potential milestone payments of up to $320 million, and one million shares of Spectrum common stock based upon the successful achievement of certain development, regulatory and commercial milestones, as well as double-digit royalties on net sales of Belinostat. Spectrum and TopoTarget will jointly fund development activities, whereby clinical trial costs will be 70% borne by Spectrum, and 30% by TopoTarget for new trials to be initiated.
Conference Call
Thursday, February 4, 2010 @ 1:00p.m. Eastern/10:00 a.m. Pacific
         
Domestic:
    888-204-4520  
International:
    913-312-0953  
Webcast and replays: www.sppirx.com
Audio replays will be available through February 24, 2010
    Domestic:
    International:
 
888-203-1112, passcode 5055446
719-457-0820, passcode 5055446
About Peripheral T-Cell Lymphoma
The American cancer Society estimates that approximately 66,000 new cases of non-Hodgkin’s lymphoma (NHL) were diagnosed in 2009 and of these, approximately 5,600 are classified as Peripheral T-cell lymphoma (PTCL). PTCL is a group of 13 diverse types of T-cell lymphoma. Most cases of PTCL occur during adulthood, are aggressive in nature and are difficult to manage with current chemotherapies. Many patients with PTCL are treated with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or a CHOP-like regimen, but often patients will stop responding to these therapies. Studies show that only 25-40% of patients will be alive five years after treatment for PTCL, creating a real need for more effective therapies.
About Belinostat
Belinostat (PXD 101) is a Class I and II HDAC inhibitor that is being studied in multiple clinical trials as a single agent or in combination with chemotherapeutic agents for the treatment of various hematological and solid cancers. Its anticancer effect is thought to be mediated through multiple mechanisms of action, including the inhibition of cell proliferation, induction of apoptosis (programmed cell death), inhibition of angiogenesis, induction of differentiation, and the resensitization of cells that have overcome drug resistance to anticancer agents such as platinums, taxanes and topoisomerase II inhibitors. Belinostat is the only HDAC inhibitor in clinical development with multiple potential routes of administration, including intravenous administration, continuous intravenous infusion and oral administration.
About the Belinostat Registrational Study
Belinostat is currently in registrational trial, under a Special Protocol Assessment (SPA), as a monotherapy for Peripheral T-Cell Lymphoma (PTCL), an indication which has been granted Orphan Drug and Fast Track designation by the U.S. Food and Drug Administration (FDA). The registrational trial is in an open-label, multicenter, single arm efficacy and safety study in patients with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior systemic therapy. The primary endpoint is objective response rate (ORR).
About TopoTarget
TopoTarget A/S is an international biotech company headquartered in Denmark, dedicated to finding ''Answers for Cancer’’ and developing improved cancer therapies. The company was founded and is run by clinical cancer specialists and combines years of hands-on clinical experience with in-depth understanding of the molecular mechanisms of cancer. For more information, please refer to www.topotarget.com.

 

157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.sppirx.com NASDAQ: SPPI

 


 

About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a focus in oncology. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. In addition to building an efficient in-house clinical research organization with regulatory and data management capabilities, the Company has established a commercial infrastructure for its drug portfolio. Spectrum markets two oncology drugs, FUSILEV® and ZEVALIN® and now has two drugs in late stage development, Apaziquone (EOquin®) and belinostat, along with a diverse pipeline. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.com.
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, Spectrum’s ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, NDA filing for PTCL in 2011, that Belinostat has the potential to be a best-in-class HDAC inhibitor for both hematological and solid tumors, that we look forward to advancing Belinostat in PTCL and other solid tumor indications, that if approved, it would give Spectrum access to potentially large markets while allowing for enhanced coordination with our marketed drugs, Zevalin and Fusilev, 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 Spectrum’s 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 Spectrum’s existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that Spectrum’s efforts to acquire or in-license and develop additional drug candidates may fail, Spectrum’s lack of significant revenues, limited marketing experience, 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. 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, TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.

 

157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.sppirx.com NASDAQ: SPPI

 

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