-----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, MtlMUxVo5Fe+L1lNqIAznsm2sMl5RUPtwCnekCX1idRCb92hG52xDNvYyrCY8kPt n9mleJBn4k0lGumZlGntkw== 0000950137-07-010633.txt : 20070726 0000950137-07-010633.hdr.sgml : 20070726 20070726170047 ACCESSION NUMBER: 0000950137-07-010633 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20070720 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070726 DATE AS OF CHANGE: 20070726 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: 071003819 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 a32211e8vk.htm FORM 8-K Spectrum Pharmaceuticals, Inc.
Table of Contents

 
 
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
Date of Report: July 20, 2007
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))
 
 

 


TABLE OF CONTENTS

Item 1.01 Entry Into Material Definitive Agreement.
Item 8.01 Other Events.
Item 9.01 Financial Statements and Exhibits.
SIGNATURES
EXHIBIT INDEX
EXHIBIT 99.1
EXHIBIT 99.2


Table of Contents

Item 1.01 Entry Into Material Definitive Agreement.
     On July 20, 2007, Spectrum Pharmaceuticals, Inc. (the “Company”) entered into a world-wide license agreement (the “License Agreement”) with Indena S.p.A., a Italian company (“Indena”), for ortataxel, a third-generation taxane classified as a new chemical entity that has demonstrated clinical activity in taxane-refractory tumors, effective as of July 17, 2007. Pursuant to the License Agreement, the Company obtained an exclusive license to certain patents, know-how and regulatory filings related to ortataxel to research, develop, make, have made, use, offer for sale, sell, have sold, distribute, import and export ortataxel for all uses worldwide. The Company has the right to sublicense the license it received under the License Agreement. Under the terms of the License Agreement, Indena is eligible to receive an upfront payment, upon the satisfaction of certain conditions, as well as payments upon achievement of certain regulatory and sales milestones, in addition to royalties on potential net sales, if any. The term of the License Agreement is determined on a product-by-product and country-by-country basis until royalties are no longer owed under the License Agreement.
     A complete copy of the press release is attached hereto as exhibit 99.1, and is incorporated herein by reference.
Item 8.01 Other Events.
     On July 25, 2007, the Company issued a press release announcing that the United States Food and Drug Administration’s (the “FDA”) Oncologic Drugs Advisory Committee recommended that the FDA should wait for the overall survival analysis of satraplatin. A complete copy of the press release is attached hereto as exhibit 99.2, and is incorporated herein by reference.

-2-


Table of Contents

Item 9.01 Financial Statements and Exhibits.
(c) Exhibits
     
Exhibits:   Description of Document
99.1
  Press Release dated July 25, 2007.
99.2
  Press Release dated July 25, 2007.

-3-


Table of Contents

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: July 26, 2007
         
  SPECTRUM PHARMACEUTICALS, INC.
 
 
  By:   /s/ Shyam Kumaria    
    Name:   Shyam Kumaria   
    Title:   V.P. Finance   

-4-


Table of Contents

         
EXHIBIT INDEX
     
Exhibits:   Description of Document
99.1
  Press Release dated July 25, 2007.
99.2
  Press Release dated July 25, 2007.

-5-

EX-99.1 2 a32211exv99w1.htm EXHIBIT 99.1 Exhibit 99.1
 

EXHIBIT 99.1
(SPECTRUM LOGO)   (INDENA LOGO)
COMPANY CONTACTS
     
SPECTRUM PHARMACEUTICALS
  INDENA S.P.A.
Russell Skibsted
  Roberto De Ponti
SVP & Chief Business Officer
  Vice Director, Business Development & Agreements
 
   
Paul Arndt
  Christian Artaria
Manager, Investor Relations
  Marketing Director
949-788-6700
  +39 02 574961
 
   
MEDIA CONTACTS
   
 
   
SPECTRUM PHARMACEUTICALS
  INDENA S.P.A.
Susan Neath
  Laura Faravelli laura_faravelli@cohnwolfe.com
Porter Novelli Life Sciences
  Lorenzo Petracco Lorenzo_petracco@cohnwolfe.com
619-849-6007
  Cohn & Wolfe
 
  +39 02 202391
SPECTRUM PHARMACEUTICALS ACQUIRES FROM INDENA WORLDWIDE RIGHTS TO
ORTATAXEL, A PHASE 2 THIRD GENERATION TAXANE
    More Than 350 Patients Have Been Treated In Phase 1 & 2 Studies
 
    Ortataxel Is Orally Bioavailable
 
    May Have Activity In Taxane-Refractory Tumors
IRVINE, California and Milan, Italy — July 25, 2007 — Spectrum Pharmaceuticals, Inc., (Nasdaq: SPPI) and Indena S.p.A. today announced the signature of a worldwide license agreement for ortataxel, a third-generation taxane classified as a new chemical entity (NCE) that has demonstrated clinical activity in taxane-refractory tumors. Spectrum Pharmaceuticals has acquired worldwide rights from Indena S.p.A., the Italian company which discovered ortataxel, and will make an upfront payment plus regulatory and sales milestones, and royalties on future net sales.
“Ortataxel has demonstrated activity in taxane-refractory tumors in Phase 2 trials, and has shown oral bioavailability. It is a perfect fit for our risk-reduced business model, as we further strengthen our diversified portfolio with late stage drugs and continue to add value to our Company,” said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. “We believe that with further clinical development, ortataxel could be an effective treatment option within the multi-billion dollar taxane market.”
Commenting the news, Dario Bonacorsi, President and CEO of Indena S.p.A., said: “We are proud of this agreement that confirms the success of one of our research lines dedicated to the discovery of NCEs in the anti-cancer area. We trust Spectrum’s expertise and knowledge for the further study of the product and taking it to the market”.
Under the terms of the agreement, Spectrum Pharmaceuticals gains exclusive worldwide development and commercialization rights to ortataxel and will take the lead in developing the drug. Spectrum is to provide an upfront payment to Indena S.p.A., and will also make additional payments based on the achievement of certain regulatory and sales milestones. Spectrum Pharmaceuticals will also pay Indena single digit royalties on worldwide sales of ortataxel.
Spectrum Pharmaceuticals: 157 Technology Dr Irvine, CA 92618, USA Tel: 949-788-6700 Fax: 949-788-6706 www.spectrumpharm.com NASDAQ: SPPI
Indena S.p.A.: Viale Ortles 12, 20139 Milan Italy Tel: +39 02 574961 Fax: +39 02 57496236 www.indena.com

 


 

(SPECTRUM LOGO)   (INDENA LOGO)
About Ortataxel
Ortataxel (14-beta-hydroxydeacetylbaccatin) belongs to a new generation of taxanes with the potential to be active in tumors resistant to Bristol-Myers Squibb’s Taxol® (paclitaxel) and Sanofi-Aventis’ Taxotere® (docetaxel). The bioavailability of ortataxel following oral administration has been confirmed in previous studies. Phase 2 studies in taxane-refractory solid tumors have indicated a substantial level of activity. The safety profile of ortataxel so far has been comparable to that of paclitaxel and docetaxel.
About Indena S.p.A.
Indena is the world’s leading company dedicated to the identification, development and production of active principles derived from plants, for use in the pharmaceutical, health-food and cosmetics industries. Indena, a privately owned Italian company, has around 700 employees, including 10% dedicated to full-time research. Backed up by over 80 years of botanical experience, the phyto-chemical research is carried out in Indena’s own Settala Research Center, near Milan. Indena is currently focusing on the development of anti-cancer drugs, following the successes of paclitaxel. Indena’s decades-long global presence in the botanical extraction industry is a guarantee of its production reliability, market and regulatory worldwide environment knowledge. The company has more than 150 primary patents and has published around 700 scientific studies. For more information, please visit our website www.indena.com.
About Spectrum Pharmaceuticals Spectrum Pharmaceuticals acquires, develops and commercializes a diversified portfolio of oncology drug candidates that meet critical health challenges for which there are few other treatment options. Spectrum’s expertise lies in identifying undervalued drugs with demonstrated safety and efficacy, and adding value through further clinical development and selection of the most efficient 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 statement — 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, develop and commercialize its portfolio of drug candidates, the Company’s promising pipeline, our team’s ability to identify promising drugs and move these drugs through development and toward commercialization, that ortataxel may have activity in taxane-refractory tumors, the oral bioavailability of ortataxel, that ortataxel could be an effective treatment option within the multi-billion dollar taxane market, the safety and efficacy of ortataxel, that ortataxel belongs to a new generation of taxanes with the potential to be active in tumors resistant to Bristol-Myers Squibb’s Taxol® (paclitaxel) and Sanofi-Aventis’ Taxotere® (docetaxel). 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 our efforts to acquire or in- license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, 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. Information provided by Indena S.p.A. has not been independently verified by Spectrum.

 

EX-99.2 3 a32211exv99w2.htm EXHIBIT 99.2 Exhibit 99.2
 

EXHIBIT 99.2
(SPECTRUM LOGO)
     
COMPANY CONTACTS
  MEDIA CONTACT
Russell Skibsted
  Susan Neath
SVP & Chief Business Officer
  Porter Novelli Life Sciences
 
  619-849-6007
Paul Arndt
Manager, Investor Relations
949-788-6700
ONCOLOGIC DRUGS ADVISORY COMMITTEE RECOMMENDS FDA WAIT FOR OVERALL
SURVIVAL ANALYSIS OF SATRAPLATIN FOR TREATMENT OF HORMONE-REFRACTORY
PROSTATE CANCER
IRVINE, California — July 25, 2007 — Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) today announced that the United States Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended that the FDA should wait for the overall survival analysis of satraplatin.
“We have confidence the final data analysis of overall survival will demonstrate the efficacy and safety of satraplatin for the treatment of hormone-refractory prostate cancer,” said Luigi Lenaz, M.D., Chief Scientific Officer of Spectrum Pharmaceuticals.
“We will continue to advance our late stage, value-driving pipeline which includes ongoing Phase 3 trials for EOquin® for the treatment of non-invasive bladder cancer which is rapidly accruing patients,” said Rajesh C. Shrotriya, M.D. Spectrum’s Chairman, President, and Chief Executive Officer. “We are also planning to begin a Phase 3 trial of ozarelix for benign prostate hypertrophy by the end of the year.”
Conference Call
Spectrum Pharmaceuticals will host a conference call today, Wednesday, July 25, 2007 at 10:00 am Eastern/7:00 am Pacific.
         
 
  Domestic:   800-573-4842
 
  International:   617-224-4327
 
  Passcode:   96669284
You can also listen to the live conference call and replay from Spectrum’s website at www.spectrumpharm.com.
Replays will be available for one week starting July 25th at 11am Eastern Time, ending August 1, 2007.
         
 
  Domestic:   888-286-8010
 
  International:   617-801-6888
 
  Passcode:   44595108
About Prostate Cancer
Prostate cancer is the most common cancer among men in the U.S. and Europe. According to the American Cancer Society, approximately 219,000 men in the U.S. are expected to be diagnosed with the disease in 2007 and over 27,000 men are expected to die from the disease. In the Europe, over 200,000 new cases are expected to be diagnosed, and over 60,000 patients are expected to die. Since the incidence of prostate cancer increases with age, the aging of the overall population is expected to further increase the number of prostate cancer patients.
Most patients diagnosed with prostate cancer initially receive surgery or radiation therapy, and some of these patients are cured. For many others, though, the disease recurs. Recurrent disease is treated
157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.spectrumpharm.com NASDAQ: SPPI

 


 

(SPECTRUM LOGO)
with hormone therapy, and most patients initially respond well to this treatment. Eventually, however, the tumor cells become resistant to the hormones — or hormone-refractory — and the tumor again progresses. Increasingly, chemotherapy is being used as an effective first-line treatment for HRPC. However, it is not a cure. Consequently, there is a growing need for effective therapeutic options, such as second-line chemotherapy treatments, for patients once they have progressed.
About Satraplatin
Satraplatin, an investigational drug, is a member of the platinum family of compounds. Platinum-based drugs are a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. All platinum drugs currently on the market require intravenous administration. Satraplatin is an oral compound that clinical trial patients are able to take at home. Satraplatin is not currently approved by the FDA in the United States, by the EMEA in the European Union or any other regulatory authority and no conclusions can or should be drawn regarding its safety and efficacy.
A Phase 3 registrational trial, called SPARC, is evaluating satraplatin plus prednisone versus placebo plus prednisone in 950 patients with hormone-refractory prostate cancer whose prior chemotherapy has failed. Data from the trial on progression-free survival and on safety have been presented at recent medical conferences. In accordance with the recommendation of the independent Data Monitoring Board for the SPARC trial, patients who have not progressed continue to be treated and all patients will be followed for overall survival.
In addition to hormone refractory prostate cancer, satraplatin has been studied in clinical trials involving a range of tumors. Trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer chemotherapy and in a number of cancer types are underway or planned.
In 2002, Spectrum signed a co-development and licensing agreement with GPC Biotech (Frankfurt Stock Exchange: GPC; TecDAX index; NASDAQ: GPCB). GPC Biotech is responsible for all costs associated with the development and regulatory filings of satraplatin. GPC Biotech has a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion has been granted exclusive commercialization rights to satraplatin for Europe and certain other territories. GPC Biotech also has a co-development and license agreement with Yakult Honsha Co. Ltd., for commercialization and development rights in Japan.
Spectrum licensed worldwide rights to satraplatin from Johnson Matthey PLC.
About Spectrum Pharmaceuticals Spectrum Pharmaceuticals acquires, develops and commercializes a diversified portfolio of oncology drug candidates that meet critical health challenges for which there are few other treatment options. Spectrum’s expertise lies in identifying undervalued drugs with demonstrated safety and efficacy, and adding value through further clinical development and selection of the most viable and risk-reduced 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 statement — 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, develop and commercialize its portfolio of drug candidates, the Company’s promising pipeline, our team’s ability to identify promising drugs and move these drugs through development and toward commercialization, the safety and efficacy of satrplatin, that a Phase 3 trial of ozarelix for begin prostate hypertrophy will begin by the end of the year, that trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer chemotherapy and in a number of cancer types are underway or planned 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 our efforts to acquire or in- license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, 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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