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): November 6, 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, CA	92618
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (949) 788-6700

(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))

Item 1.01. Entry into a Material Definitive Agreement.

     Effective as of November 6, 2009, Spectrum Pharmaceuticals, Inc. (the “Company”) and Nippon Kayaku Co., Ltd. (“Nippon Kayaku”) entered into a License Agreement (the “Agreement”) pursuant to which the Company and Nippon Kayaku agreed to enter into a collaboration for the development and commercialization of a formulation that includes Apaziquone that is suitable for use in treating non-muscle invasive bladder cancer via intravesical instillation (the “Product”).

     The Agreement provides that Nippon Kayaku has the exclusive right to develop and commercialize the Product for the intravesical treatment of non-muscle invasive bladder cancer in humans in Asia (as is defined in the Agreement) (the “Territory”), including Japan and China, but excluding Korea. The Company retained commercial rights for Korea, however, Nippon Kayaku has co-exclusive rights to conduct clinical development activities in South Korea solely for the purpose of providing support to filings outside of Korea. In addition, Nippon Kayaku has non-exclusive rights to make the Product in its Territory and outside of Asia for the purpose of selling the Product in the Territory.

     In consideration for the rights granted under the Agreement, Nippon Kayaku has agreed to pay the Company an upfront fee of $15 million that is due in January 2010. In addition, Nippon Kayaku will pay the Company up to $136 million based on the achievement of certain regulatory and sales milestones. Also, Nippon Kayaku has agreed to pay the Company royalties based on a percentage of net sales of the Product in the Territory.

     Nippon Kayaku will conduct apaziquone clinical trials pursuant to a mutually agreed upon development plan. Nippon Kayaku will be responsible for all expenses relating to the development and commercialization of apaziquone in the Territory.

     The Company will be responsible for supplying the Product to Nippon Kayaku for clinical supplies as well as commercial supplies for a set period of time unless Nippon Kayaku elects to manufacture or supply themselves.

     The Agreement will remain in effect, on a country-by-country basis, until the expiration of the obligation of Nippon Kayaku to pay royalties on sales of the Product in such country. Nippon Kayaku may terminate the Agreement at its election upon nine months notice to the Company. Additionally, either party may terminate the Agreement for an uncured material breach by the other party.

     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.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number		Description
	99.1	Press Release dated November 10, 2009.

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.
November 10, 2009	By:	/s/ Shyam Kumaria
		Shyam Kumaria
		Vice President, Finance

EXHIBIT INDEX

Exhibit Number		Description
	99.1	Press Release dated November 10, 2009.

EX-99.1

Exhibit 99.1

COMPANY CONTACTS
Paul Arndt
Senior Manager, Investor Relations
949-788-6700x216

SPECTRUM PHARMACEUTICALS AND NIPPON KAYAKU ENTER COLLABORATION
AGREEMENT FOR APAZIQUONE IN ASIAN TERRITORIES

• Total Potential Value Of Collaboration Exceeds $151 Million

• Spectrum to Receive an Upfront Payment of $15 Million, up to $136 Million in Milestones, and Royalties

• Nippon Kayaku Responsible for 100% of Development and Commercial Expenses

IRVINE, California — November 10, 2009 —Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a commercial stage biotechnology company with a primary focus in oncology, and Nippon Kayaku today announced an exclusive collaboration for the development and commercialization of apaziquone in Asia. Apaziquone is an antineoplastic agent currently being investigated for the treatment of non-muscle invasive bladder cancer by intravesical instillation. Spectrum Pharmaceuticals has previously entered into a strategic collaboration with Allergan, Inc. (NYSE: AGN) for North America, Europe, and other key markets. These two collaborations are representative of the Company’s stated objective of achieving solid strategic partnerships that are aimed at fully exploiting developmental goals for apaziquone on a worldwide basis.

“We are excited to partner apaziquone with a strong Japanese oncology company such as Nippon Kayaku,” said Rajesh C. Shrotriya, Chairman of the Board and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. “Nippon Kayaku is one of the most established and reputable pharmaceutical companies in Japan and has unparalleled experience in Asia in the field of non-muscle invasive bladder cancer and prostate cancer. We believe that Nippon Kayaku is a terrific strategic partner for apaziquone and for Spectrum.”

“Apaziquone is an ideal candidate to complement our portfolio of 24 anti-cancer products,” said Akira Mandai, Head of Pharmaceuticals Group of Nippon Kayaku. “We look forward to working with Spectrum in developing apaziquone for non-muscle invasive bladder cancer.”

Under the terms of the agreement, Nippon Kayaku will pay Spectrum an upfront payment of $15 million and will make additional payments of up to $136 million based on the achievement of certain regulatory and commercialization milestones. Nippon Kayaku received exclusive rights to apaziquone for the treatment of non-muscle invasive bladder cancer in Asia, including Japan and China. Nippon Kayaku will conduct the apaziquone clinical trials pursuant to a development plan. Nippon Kayaku will be responsible for all expenses relating to the development and commercialization of apaziquone in the Nippon Kayaku territory.

Spectrum is currently conducting two Phase 3 clinical trials to investigate apaziquone’s safety and efficacy in non-muscle invasive bladder cancer. Spectrum’s goal is to complete enrollment in both Phase 3 studies by year-end 2009.

About Non-Muscle Invasive Bladder Cancer

Non-muscle invasive bladder cancer is a form of bladder cancer localized in the surface layers of the bladder and is commonly treated with intravesical therapies. Approximately 70% of all patients newly diagnosed with bladder cancer have non-muscle invasive bladder cancer.¹ More than one million patients in the United States, Europe and Japan are estimated to be affected by the disease, which is treated predominantly by urologists.²

About Apaziquone

Apaziquone is a drug currently being investigated for the treatment of non-muscle invasive bladder cancer. Apaziquone, an anti-cancer agent that becomes activated by reductase enzymes found in cancer cells, is formulated for administration directly into the urinary bladder. Phase 2 data has confirmed anti-tumor activity in patients with multiple, recurrent non-muscle invasive bladder cancer, as evidenced by 31 of 46 patients (67%) showing a complete response after receiving six weekly treatments with 4 mg of apaziquone instilled into the urinary bladder in a marker lesion study. In another Phase 2 study, apaziquone instilled into the bladder following surgery was well tolerated and was not absorbed in any detectable amount from the bladder wall into the bloodstream and therefore, is expected to carry a low risk of systemic toxicity, if any.

1	Kirkali Z, et al. Bladder Cancer: Epidemiology, Staging and Grading, and Diagnosis. Urology 66 (Suppl 6A): 4-34, 2005.
2	For U.S. see National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/statfacts/html/urinb.html accessed 10-23-2008; For Europe see Globocan 2002 database, http://www-dep.iarc.fr/ accessed 10-23-2008.

The apaziquone registration plan, which the U.S. Food and Drug Administration (FDA) concurred with under a Special Protocol Assessment, calls for two double blind, placebo-controlled, randomized Phase 3 clinical studies, each with 562 patients with Ta G1 or G2 low risk non-invasive bladder cancer. Patients are randomized in a one-to-one ratio to apaziquone or placebo. Under the protocol, the patients are given a single 4 mg dose following surgical removal of the tumors. The primary endpoint is a statistically significant difference (p<0.05) in the rate of tumor recurrence between the two treatment groups by year two. The FDA has granted Fast Track Designation for the investigation of apaziquone for the treatment of non-muscle invasive bladder cancer. Spectrum also received scientific advice from the European Medicines Agency (EMEA) whereby the EMEA agreed that the two Phase 3 studies as designed should be sufficient for a regulatory decision regarding European registration.

About Nippon Kayaku

Nippon Kayaku is a general chemical company focused on IT, health care and safety systems. The Company’s Pharmaceuticals Group maintains extensive original expertise related to research and development, production, sales, and aftermarket investigations of anti-cancer drugs. The Company’s lineup of cancer-fighting drugs and cancer supportive products has reached 28 products. Nippon Kayaku is also strengthening its licensing activities, and is introducing generic products in order to expand its cancer-related business. For more information, please visit the Company’s website at www.nipponkayaku.co.jp/english/.

About Spectrum Pharmaceuticals

Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a primary focus in oncology. The Company’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 its approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in its areas of focus; and, leveraging the expertise of partners around the world to assist it in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.com.

Forward Looking Statements — This press release may also 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, establishing a commercial organization for Spectrum’s approved drugs, continuing to build Spectrum’s team, leveraging the expertise of partners around the world to assist Spectrum in the execution of its strategy, that apaziquone is expected to carry a low risk of systemic toxicity, if any, the safety and efficacy of apaziquone and that enrollment in the Phase 3 clinical trials will be completed by year-end 2009, 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 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.

Information regarding Nippon Kayaku has been obtained from Nippon Kayaku and not independently verified by Spectrum.

^© 2009 Spectrum Pharmaceuticals, Inc. All Rights Reserved.