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SPECTRUM PHARMACEUTICALS, INC. (Exact Name of Registrant As Specified in Its Charter) 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 000-28782 93-0979187 (State or other Jurisdiction (Commission File Number) (IRS Employer of Incorporation) Identification Number) 157 Technology Drive Irvine, California 92618 (Address of principal (Zip Code) executive offices) (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- EXHIBIT 99.1 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 [email protected] Porter Novelli Life Sciences Lorenzo Petracco [email protected] 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 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
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