Spectrum Expands Clinical Trials Into Canada; Directorate of Health Canada Accepts Spectrum Pharmaceuticals Clinical Trial Application for Ozarelix in BPH

* Phase 3 Trials to Begin in 2H07; Preparations Underway

    IRVINE, Calif., May 3 /PRNewswire-FirstCall/ -- Spectrum
 Pharmaceuticals, Inc., ( SPPI) today announced that the Therapeutic
 Product Directorate of Health Canada has issued a No Objection Letter to
 Spectrum's Clinical Trial Application. This action authorizes the
 initiation of investigational clinical trials for ozarelix in Benign
 Prostate Hypertrophy (BPH), as part of a multinational development program
 in this indication. Advancement into pivotal registration trials is
 anticipated in late 2007.
     "We expect to begin Phase 3 testing with ozarelix in patients with BPH
 later this year, and the opportunity to conduct trials with ozarelix at
 select sites in both Canada and the U.S. will enable us to enroll and begin
 dosing patients quickly," stated Rajesh Shrotriya, M.D., Chairman,
 President and CEO of Spectrum Pharmaceuticals. "Adding Canadian trial sites
 will allow additional clinicians to learn more about ozarelix and to
 experience firsthand the potential benefits for the drug in patients
 suffering from BPH."
     In late 2006, Spectrum reported highly statistically significant
 results in favor of ozarelix from a double-blinded, randomized,
 placebo-controlled, multi-center, European dose ranging study of ozarelix
 in men (N=144) with BPH. Results from that trial were used to support an
 Investigational New Drug application (IND) with the FDA. Following the
 acceptance of the IND by the FDA in January 2007, a randomized,
 placebo-controlled Phase 2b trial of ozarelix in patients suffering from
 BPH has just completed enrollment. The data from this trial is expected to
 be available in the second half of 2007, with safety and efficacy data
 expected to be used to support a New Drug Application (NDA) for ozarelix.
     About Ozarelix and Development Alliance with AEterna Zentaris
     Ozarelix is a fourth generation Luteinizing Hormone Releasing Hormone
 (LHRH) antagonist administered as an intramuscular injection. In August
 2004, Spectrum received an exclusive license from AEterna Zentaris to
 develop and market ozarelix for all potential indications in North America
 (including Canada and Mexico) 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 all potential oncology indications have recently
 been licensed to Nippon Kayaku, a key player in the Japanese oncology
 market.
     Spectrum is developing ozarelix for benign prostatic hypertrophy (BPH),
 hormone-dependent prostate cancer and other indications.
     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 reduce the amount of tissue 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(R)1, CARDURA(R)2 and HYTRIN(R)3)
 which relax the muscles in the neck of the bladder and in the prostate, but
 have no direct effect on the prostate growth itself, and alpha reductase
 inhibitors (such as PROSCAR(R)4 and AVODART(R)5), 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
     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 reduced-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, 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 initiation of a phase 3 trial
 in 2007, that the opportunity to conduct trials with ozarelix at select
 sites in both Canada and the U.S. will enable us to enroll and begin dosing
 patients quickly, that adding Canadian trial sites will allow additional
 clinicians to learn more about ozarelix and to experience firsthand the
 potential benefits for the drug in patients suffering from BPH, that the
 data from the Phase 2b trial is expected to be available in the second half
 of 2007, with safety and efficacy data expected to be used to support a New
 Drug Application (NDA) for ozarelix, the safety and efficacy of ozarelix,
 the potential indications for ozarelix 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.
     [1] FLOMAX is a registered trademark of Boehringer Ingelheim
     [2] CARDURA is a registered trademark of Pfizer, Inc.
     [3] HYTRIN is a registered trademark of Abbott Laboratories
     [4] PROSCAR is a registered trademark of MERCK & CO., Inc.
     [5] AVODART is a registered trademark of GlaxoSmithKline
 
     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
 
 

SOURCE Spectrum Pharmaceuticals, Inc.