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Ferring Pharmaceuticals Announces Immediate Availability of Degarelix for the Treatment of Advanced Prostate Cancer
Date:3/4/2009

These PSA results should be interpreted with caution because of the heterogeneity of the patient population studied. No evidence has shown that the rapidity of PSA decline is related to a clinical benefit.

"Degarelix, the lead product in our urology portfolio, demonstrated both a rapid onset of action and a profound long-term suppression of testosterone," said Wayne Anderson, President and CEO Ferring Pharmaceuticals Inc., USA. "Now, advanced prostate cancer can be treated with a direct-acting GnRH receptor antagonist inducing rapid reduction of testosterone and sustaining those levels over time, meeting the goals of systemic therapy. We are excited to provide this effective new treatment option for men fighting advanced prostate cancer."

Approved by the FDA on December 24, 2008, degarelix represents Ferring Pharmaceuticals' first global launch and the second urology product launch for Ferring Pharmaceuticals, USA. The European Commission granted marketing authorization for degarelix on February 19, 2009. Degarelix is awaiting approval in other key global markets.

Phase III Study Results

The 12-month, randomized, open-label, parallel-group Phase III study evaluated the efficacy and safety of degarelix compared with leuprolide administered monthly over one year of prostate cancer treatment. Patients with histologically confirmed prostate cancer were randomized to either degarelix or leuprolide: a degarelix subcutaneous (under the skin) injection of 240 mg for one month with monthly maintenance doses of 80 mg (n=207) or monthly intramuscular (into the muscle) injections of leuprolide depot 7.5 mg (n=201).

The primary endpoint was testosterone suppression to less than or equal to 50 ng/dL during monthly measurements from Day 28 to Day 364. Degarelix was at least as effective as leuprolide in achieving and maintaining castrate levels of testosterone.


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