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 AND EXCHANGE ACT OF 1934

February 16, 2007 Date of Report (Date of earliest event reported)

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 Number)

157 Technology Drive Irvine, California	92618
(Address of principal executive offices)	(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:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01 Other Events.

On February 16, 2007, we issued a press release, announcing the completion of the submission of the New Drug Application, or NDA, to the U.S. Food and Drug Administration, or FDA, for satraplatin, our lead drug candidate for the treatment of hormone refractory prostate cancer, or HRPC, for those patients who have failed prior chemotherapy. Pursuant to the terms of a License Agreement dated August 28, 2001, as amended (the “License Agreement”) by and between us and Johnson Matthey, PLC, or Johnson Matthey, we are required to pay to Johnson Matthey $500,000 in shares of our common stock (or approximately 81,000 shares) upon the submission of the complete NDA filing and $500,000 in cash upon acceptance of the NDA by the FDA. On February 23, 2007, we agreed to amend the License Agreement to pay Johnson Matthey $500,000 in cash in lieu of the shares of our common stock. Milestone payments are payable within thirty (30) days of the achievement of the milestone. In 2002, we out-licensed worldwide rights to satraplatin to GPC Biotech AG. GPC Biotech is obligated to pay us $4 million upon acceptance of the NDA by the FDA.

Under the License Agreement with Johnson Matthey, we in-licensed the worldwide rights to satraplatin for treating cancer. We have paid Johnson Matthey an upfront fee and one milestone payment and we are required to make additional payments based upon achievement of certain milestones and royalties based on any net sales, if any, if and when a commercial drug is approved and sales are initiated.

Copies of the recent amendment to the License Agreement and the press release are attached hereto as Exhibits 10.1 and 99.1, respectively, and are incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit	Description of Documents
10.1+	Second Amendment to License Agreement by and between the Registrant and Johnson Matthey PLC dated February 23, 2007
99.1+	Press Release dated February 16, 2007

+ Filed herewith.

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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.

Date: March 2, 2007

SPECTRUM PHARMACEUTICALS, INC.
By:	/s/ Rajesh C. Shrotriya, M.D.
Name:	Rajesh C. Shrotriya, M.D.
Title:	Chairman, CEO & President

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EXHIBIT INDEX

Exhibit	Description of Documents
10.1+	Second Amendment to License Agreement by and between the Registrant and Johnson Matthey PLC dated February 23, 2007
99.1+	Press Release dated February 16, 2007

+ Filed herewith.

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EX-10.1

Exhibit 10.1

SECOND AMENDMENT TO LICENCE AGREEMENT

This Second Amendment to License Agreement (“SECOND AMENDMENT”) is entered into and effective this 23 day of February, 2007 (“EFFECTIVE DATE”), by and between Johnson Matthey PLC, a company organised under the laws of England and Wales whose registered office was formerly at 2-4 Cockspur Street, Trafalgar Square, London, SW1Y 5BQ, England, and is now at 40-42 Hatton Garden, London EC1N 8EE, England acting for itself and for its AFFILIATES including particularly Johnson Matthey, Inc (collectively, “LICENSOR”), and Spectrum Pharmaceuticals, Inc., a corporation organized under the laws of the State of Delaware, United States of America, formerly NeoTherapeutics, Inc. (“LICENSEE”), whose principal place of business is at 157 Technology Drive, Irvine, California 92618, United States of America, with reference to the following facts and on the following terms and conditions.

RECITALS

(A) Effective August 28, 2001, LICENSOR and LICENSEE entered into the License Agreement (the “LICENSE”) pursuant to which LICENSOR granted a license for the use of technical information relating to the use of platinum complex JM216 in the treatment of tumor cells as well as for the use of the PATENT RIGHTS (as defined in the LICENSE). All defined terms in this SECOND AMENDMENT (as set forth in capital letters), not defined herein, shall have the same meaning as set forth in the LICENSE.

(B) Effective September 30, 2002, LICENSOR and LICENSEE entered into an amendment (“FIRST AMENDMENT”) to amend and modify certain terms and conditions of the LICENSE; and

(C) LICENSOR has requested LICENSEE to pay LICENSOR a milestone payment in cash in lieu of shares of the LICENSEE’S common stock. Therefore, the parties now wish to amend and modify the LICENSE and FIRST AMENDMENT on the terms and conditions as set forth in this SECOND AMENDMENT.

Now, therefore, for good and valuable consideration, the parties agree to enter into this SECOND AMENDMENT to amend the LICENSE and the FIRST AMENDMENT, as set forth below.

(1) ARTICLE V

Part (i) of Paragraph 3 of Article V of the LICENSE, as amended by the FIRST AMENDMENT, shall be amended to read as follows:

(i) the First MILESTONE: US $500,000

(2) Section (9) of the FIRST AMENDMENT titled “ISSUANCE OF LICENSEE SHARES TO LICENSOR; INVESTMENT REPRESENTATIONS; VOTING TRUST; PIGGYBACK REGISTRATION RIGHTS” shall be deleted in its entirety.

This SECOND AMENDMENT, the FIRST AMENDMENT and the LICENSE shall constitute the complete and integrated agreement of the parties with respect to the subject matter hereof and thereof. Except as provided in this SECOND AMENDMENT, the FIRST AMENDMENT and the LICENSE will remain in full force and effect and unchanged in all other respects.

This SECOND AMENDMENT may be executed in two or more counterparts, including email and/or facsimile exchange of signatures, each of which will be deemed an original, but all of which together will constitute one and the same instrument.

[Signature Page Follows]

The parties have caused this SECOND AMENDMENT to be executed by their respective authorized representatives as of the EFFECTIVE DATE set forth above.

SPECTRUM PHARMACEUTICALS, INC.		JOHNSON MATTHEY PLC
By:	/s/    Rajesh C. Shrotriya, M.D.	By:	/s/    Ian C. Wishart
	Chairman, CEO and President		Corporate Patents and Licensing Director

EX-99.1

Exhibit 99.1

COMPANY CONTACTS Russell Skibsted SVP & Chief Business Officer   Paul Arndt Manager, Investor Relations 949-788-6700 MEDIA CONTACT Susan Neath Porter Novelli Life Sciences 619-849-6000

SPECTRUM PHARMACEUTICALS ANNOUNCES COMPLETION OF NDA FILING FOR SATRAPLATIN FOR HORMONE REFRACTORY PROSTATE CANCER

• Spectrum to Receive $4 Million Milestone Payment Upon Acceptance by FDA

IRVINE, California – February 16, 2007 Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) today announced the completion of the submission of the New Drug Application (NDA) to the US Food & Drug Administration (FDA) for satraplatin, the Company’s lead drug candidate for the treatment of hormone refractory prostate cancer (HRPC) for those patients who have failed prior chemotherapy. This clinical submission, the third and final portion of the rolling NDA, is based on data from the SPARC (Satraplatin and Prednisone Against Refractory Cancer) Phase 3 registrational trial. The trial enrolled 950 patients, and the study data results for progression-free survival (PFS) were highly statistically significant (p<0.00001). Satraplatin was granted fast-track status, which allowed the FDA to accept a rolling NDA. Major components of the NDA, including, chemistry, manufacturing and controls and nonclinincal (safety) information have previously been accepted for review by the FDA. The FDA has up to 60 days to formally accept the completed application. Upon acceptance, the FDA will determine if the application will be granted priority review, which has already been requested and would allow for a six-month review of the NDA.

The FDA’s acceptance of the NDA will trigger a $4 million milestone payment to Spectrum. Spectrum is also entitled to receive milestone payments upon the achievement of additional regulatory milestones in the U.S., Europe, Japan and other countries. Further payments are due on achieving certain sales targets. In addition to milestones, Spectrum is entitled to receive royalties on worldwide sales of satraplatin. The company also has co- promotion rights in the U.S., if its partner markets satraplatin itself in the U.S.

“The completion of the filing of the satraplatin NDA is an important landmark for Spectrum as we are now one step closer to bringing forth a new treatment option for patients with prostate cancer. The completion of this rolling NDA also validates our business model of identifying promising drug candidates and opportunistically advancing those candidates through clinical development,” said Rajesh C. Shrotriya, M.D., Spectrum’s President and Chief Executive Officer. “Beginning with the acceptance of this filing, Spectrum will be entitled to receive a

series of milestone payments that will serve as a source of non-dilutive funding, a key part of our strategy for the advancement of our broad and deep pipeline of drugs. We plan to follow this strategy as we continue to develop our portfolio of 10 drug candidates, two of which are expected to be in phase 3 clinical trials this year: Ozarelix for benign prostate hypertrophy and EOquin(R) for noninvasive bladder cancer.”

About Prostate Cancer

Prostate cancer is the most common cancer among men in the U.S. and Europe. Approximately 234,000 men in the U.S. are expected to be diagnosed with the disease in 2006 and more than 27,000 men are expected to die from the disease. In the European Union, over 200,000 new cases are expected to be diagnosed, and more than 60,000 patients are expected to die each year. 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 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, a fourth-generation, oral investigational drug, is a member of the platinum family of compounds. Over the past three decades, platinum-based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an oral compound and is given as capsules that patients can take at home. In addition to HRPC, satraplatin has been studied in clinical trials involving a range of tumors, and Phase 2 trials have been completed in ovarian cancer and small cell lung cancer. Other trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in various other cancers are underway or planned.

In September 2006, positive topline results were announced from a double-blind, randomized Phase 3 trial, the SPARC trial. The trial evaluated satraplatin plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer. The study data show that the results for PFS were highly statistically significant (p<0.00001) using the protocol-specified log-rank test. PFS is the primary endpoint for submission for accelerated approval in the U.S. and also serves as the primary basis for a Marketing Authorization Application in Europe.

The most common adverse reactions in the SPARC trial consisted of myelosuppression (bone marrow functions, such as lowered platelet count or lowered white blood cell count); gastrointestinal events, such as nausea, constipation and diarrhea; and fatigue. These adverse reactions were mostly mild to moderate in severity. No significant degradation of renal function or worsening of neuropathy was noted.

In 2002, Spectrum licensed the global rights to 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.

Spectrum licensed worldwide rights to satraplatin from Johnson Matthey PLC. Spectrum is required to pay to Johnson Matthey $500,000 in shares of Spectrum common stock (or approximately 81,000 shares) upon submission of the complete NDA filing and $500,000 in cash upon acceptance of the NDA by the FDA.

About Spectrum Pharmaceuticals

Spectrum Pharmaceuticals is opportunistically acquiring and advancing 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 low-risk 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 and develop its portfolio of drug candidates, the Company’s promising pipeline, our team’s ability to identify promising drugs and opportunistically move these drugs through development and toward commercialization, that we will receive milestones and royalties from sales of satraplatin, that we will continue to advance our pipeline of drug candidates through the clinical process, our strategy for the advancement of our broad and deep pipeline of drugs, that we expect to have two drugs in Phase 3 clinical trials this year, that other trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in various other cancers will be initiated 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 price and other competitive pressures may make the marketing and sale

of our generic drugs not commercially feasible, the possibility that our efforts to acquire or in- license and develop additional drug candidates may fail, our lack of revenues, our limited experience in establishing strategic alliances, our limited marketing experience, our limited experience with the generic drug industry, 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.