Spectrum Pharmaceuticals Provides an Update on Ozarelix in BPH

Spectrum Pharmaceuticals, Inc., (NasdaqGM:SPPI) today announced the completion of a 9-month, randomized, double-blind, placebo-controlled, Phase 2b study of the safety and efficacy of ozarelix, the Company’s drug candidate for the treatment of benign prostatic hypertrophy (BPH). The primary endpoint of the study was the change in International Prostate Symptom Score (IPSS), the standard method of assessing BPH symptoms. Secondary endpoints included measurements in Peak Urine Flow (Qmax), Erectile Function, Quality of Life measures as well as safety and tolerability. A total of 76 patients were enrolled in the trial to meet the target 68 evaluable patients. Two patients withdrew consent prior to randomization, resulting in an Intent-to-Treat population (ITT) of 74 patients, of which, 57 completed all study visits. The Company’s monitoring of the conduct of the study revealed major protocol violations at 4 of the 15 sites. Violations included: inaccurate diagnosis, concomitant use of other drugs effective in BPH, and patient participation in multiple trials at the same time. One of these sites was closed early due to irregularities in data collection and was reported to the FDA. Because of these major protocol violations, an analysis excluding these 4 sites was performed. All 44 patients at the other 11 sites met protocol inclusion criteria and were included in a per-protocol population analysis. Because randomization was within site, balance between treatment groups was maintained. The ITT and the per-protocol population analysis are as follows. Study Results In the ITT population, ozarelix demonstrated a numerical improvement in Peak Urine Flow (2.5mL/sec) compared to placebo (1.3mL/sec) at 12 weeks, but did not reach statistical significance (p=0.41). The improvement in IPSS at 12 weeks was 4.4 in placebo group and 2.9 in the ozarelix group, and did not reach statistical significance (p=0.37). In the per-protocol analysis, ozarelix demonstrated a clinically meaningful improvement in IPSS of 6.0 compared to 3.0 for placebo. This improvement in IPSS was observed as early as 8 weeks, approached statistical significance (p=0.09) and the effect was observed out to 36 weeks. Ozarelix demonstrated a numerical improvement in peak urine flow (1.6mL/sec) as early as 4 weeks, compared to no change in placebo (0.0mL/sec), (p=0.14), although this difference was not consistently seen at later time points. In both the ITT and the per-protocol populations, ozarelix was well tolerated, allergic reactions were not seen, and there was no reported adverse effect on erectile function as measured by the International Index of Erectile Function (IIEF-EF). "The data demonstrate sufficient clinical activity to justify the continued development of ozarelix in BPH,” said Claus Roehrborn, MD, Professor and Chairman of the Department of Urology at The University of Texas Southwestern at Dallas, and lead investigator for the study. "For example, a 3-point difference in IPSS is generally accepted as a clinically meaningful improvement in BPH symptoms. Additionally, the 1.6mL/sec improvement in Peak Urine Flow is commensurate with those reported in pivotal alpha-blocker approval studies.” "We have learned much valuable information from this study,” said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals. "The initial ozarelix Phase 2 trial, conducted in Eastern Europe, was a dose finding trial in a treatment naïve patient population that excluded placebo responders. Before rushing into large, expensive pivotal trials, we elected to run a small Phase 2b study in the U.S. to assess regional differences and to help in the design of future studies. We believe that, while the results of this study are not as robust as seen in the previous study, the data indicate clinically meaningful activity in BPH. The information learned will be incorporated into the protocol design of future studies. This was one of the main purposes of performing this trial.” Based on these results, the Company is planning to submit to the FDA a protocol for the next study of ozarelix in BPH. Conference Call Spectrum Pharmaceuticals will host a conference call to discuss these clinical results on: Tuesday, April 22, 2008 @ 2:00p.m. Eastern/11:00 a.m. Pacific Domestic: 800-638-4930 passcode 97325885 International: 617-614-3944 passcode 97325885 Webcast and replays: www.spectrumpharm.com. Audio replays will be available through April 29, 2008. Domestic: 888-286-8010, passcode 68022697 International: 617-801-6888, passcode 68022697 About Ozarelix and Development Alliance with AEterna Zentaris Ozarelix is an injectable fourth generation Luteinizing Hormone Releasing Hormone (LHRH) antagonist. Spectrum has an exclusive license from AEterna Zentaris to develop and market ozarelix in North America and India. In addition, Spectrum will receive 50 percent of any upfront and milestone payments, royalties and/or profits from sales of the product in Japan. Japanese rights for oncology indications have been licensed to Nippon Kayaku, a key player in the Japanese oncology market. About the Phase 2b Study Design This study was initiated in early 2007 with a target enrollment of 68 evaluable patients with symptomatic BPH at 15 sites in North America. Patients were randomized to either ozarelix 15mg or placebo on day 0 and 14 following a two injection, 4 week placebo run-in period. Unlike the European study, placebo responders were not excluded following the run-in period. The primary endpoint for the study was the improvement in lower urinary tract symptoms secondary to BPH as measured by the IPSS for ozarelix 15mg compared to placebo at 12 weeks. Secondary endpoints included measurements in Peak Urine Flow (Qmax), Erectile Function, Quality of Life measures as well as safety and tolerability. The study further assessed the safety and efficacy of this dosing regimen at time points up to 24 weeks and the durability of the IPSS response up to 36 weeks. About Benign Prostatic Hypertrophy Benign prostatic hypertrophy is a non-cancerous enlargement of the prostate frequently occurring in men over the age of 50. According to the National Institutes of Health, BPH affects more than 50% of men over the age of 60 and as many as 90% of men over the age of 70 and it is estimated that there are currently more than 28 million men suffering from BPH in the United States. The IPSS (also known as AUA symptom index) is a standardized scoring system that evaluates the seven principal symptoms of BPH. The enlargement can result in the gradual squeezing of the urethra, resulting in increased frequency or difficulty in urinating. Treatment options for BPH include surgery and medications to help reduce the obstruction and increase the flow of urine. Current treatment options have limited efficacy, leading to inadequate compliance. Medications currently available belong to two classes: alpha blockers (such as FLOMAX®, CARDURA® and HYTRIN®) which relax the neck of the bladder and the prostate, but have no direct effect on the prostate growth itself, and alpha reductase inhibitors (such as PROSCAR® and AVODART®), which can result in some reduction of the prostate size but have a very slow onset of action, and may be associated with impotence and decreased libido. About Spectrum Pharmaceuticals We are a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus on oncology, urology and other critical health challenges. Our strategy is comprised of the following four parts: acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products with a focus on oncology and urology; establishing a commercial organization for the drug products in our pipeline as they are approved; continuing to build a team with significant drug development and commercialization expertise in our areas of focus, and; leveraging the expertise of partners around the world in areas of manufacturing, development and commercialization to assist us in the execution of our strategy. The company recently received FDA approval for LEVOleucovorin and is preparing for its launch in June 2008. 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, our strategy, Spectrum's ability to identify, acquire, develop and commercialize its portfolio of drug candidates, the Company's promising pipeline, the safety and efficacy of ozarelix, that we are planning to submit to the FDA a protocol for the next study, 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. SPECTRUM PHARMACEUTICALS, INC. ™, TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc. All other trademarks and trade names are the property of their respective owners. © 2008 Spectrum Pharmaceuticals, Inc. All Rights Reserved