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Ozarelix Phase 2 Data Presented at 29th Congress of the Societe Internationale d'Urologie
Date:9/5/2007

tion on Day1 and Day 15 in one of five dose groups:

Group 1: placebo, + placebo

Group 2: 5mg ozarelix + 5mg ozarelix;

Group 3: 10mg ozarelix +10mg ozarelix;

Group 4: 15mg ozarelix + 15mg ozarelix; and,

Group 5: 20mg ozarelix + placebo.

Study participants were followed for six months. The primary efficacy endpoint was a change in the International Prostate Symposium Score (IPSS) at 12 weeks compared to baseline. Secondary efficacy endpoints included changes in IPSS Quality of Life (QoL), IPSS improvement by > 30% and > 40%, uroflow values (Qmax), PVR and prostate volume at time points up to 28 weeks. Safety analysis included changes in erectile function (IIEF-5), treatment emergent AEs, lab values (including testosterone, PSA) and vital signs. Mean age was 69.1 (range 52 - 85), IPSS 19.8, Qmax 9.7 mL/sec and prostate size (cm cubed) 41.6 at baseline.

Compared to baseline, ozarelix significantly improved scores for IPSS, IPSS > 30% change and Qmax, at 12 and 28 weeks versus placebo. Testosterone levels declined transiently, but returned to baseline in all groups by 6 weeks. No impact on erectile function was observed; IIEF-5 scores remained unchanged from baseline for all treatment groups at all timepoints.

Ozarelix was well tolerated and maintained statistically significant and clinically meaningful efficacy in the treatment of LUTS secondary to BPH for six months following dosing. Serious Adverse Events were reported in 4 patients but were not considered treatment related. No systemic allergic reactions were seen, and the injections were well tolerated.

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 (inclu
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SOURCE Spectrum Pharmaceuticals, Inc.
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