Ozarelix (SPI-153) - A fourth generation Luteinizing Hormone
Releasing Hormone (LHRH) Antagonist

Initial Indications:
Hormone-dependent prostate cancer
Benign Prostatic Hyperplasia (BPH)

Other Indication:
Endometriosis

Route of Administration:
Intramuscular

Mode of Action:
Luteinizing Hormone Releasing Hormone Antagonist
Suppression of Testosterone

Drug Properties (compared to other LHRH Antagonist):
Immediate and complete suppression of testosterone
No risk of testosterone surge or "flare up"
Improved solubility
Minimal histamine release tendency

Status
Phase II studies in prostate cancer
Phase II studies in Benign Prostatic Hyperplasia

Ozarelix Potential Treatment Areas
Ozarelix is currently being evaluated for its intended initial
indications, hormone-dependent prostate cancer and benign prostatic
hypertrophy. We also plan to evaluate the compound for the treatment of
endometriosis.

Ozarelix may prove to be an important addition in treating
hormone-dependent prostate cancer patients because of its ability to
induce prolonged testosterone suppression in healthy volunteers as
shown in early trials. For benign prostatic hypertrophy, Ozarelix,
which is an antagonist of GnRH, has the potential to reduce
testosterone just enough to reduce both prostate size and symptoms.