FERRING PHARMACEUTICALS

Important safety information:

The most commonly observed adverse reactions during Firmagon® therapy included injection site reactions (e.g. pain, erythema, swelling or induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT). Ninety-nine percent of these observed adverse reactions were Grade 1 or 2 (mild to moderate). Specifically relating to the injection site adverse reactions, most were transient, of mild to moderate intensity, occurred primarily with the starting dose and led to few discontinuations (<1%). Grade 3 (severe) injection site reactions occurred in two percent or less of patients receiving Firmagon.

Firmagon is contraindicated in patients with known hypersensitivity to degarelix or to any of the product components. Firmagon is not indicated in women or pediatric patients. Long-term androgen deprivation therapy prolongs the QT interval. Physicians should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic medications.

Ferring Pharmaceuticals Announces Availability of FIRMAGON^® (degarelix for injection) for the Treatment of Advanced Prostate Cancer

Prostate cancer strikes one in every six men in this country, and is the second leading cause of cancer death among men in the U.S. This year alone, it will claim more than 28,000 lives, but a new treatment offers hope for those with advanced prostate cancer.

FIRMAGON^® (degarelix for injection), a new injectable prostate cancer medication for the treatment of advanced prostate cancer, is now available in the U.S. The treatment rapidly inhibits the production of testosterone, a hormone that stimulates cancer growth. FIRMAGON^® was approved by the U.S. Food and Drug Administration (FDA) on December 24, 2008 and was granted marketing authorization by the European Commission on February 19, 2009. It was launched in the U.S. in March 2009 under the generic name, degarelix.

“When you hear the word cancer right away you can panic, or you can go into denial, or you can accept it and say 'Alright, what can I do?'”

FIRMAGON^® offers men like Mike D’Ambrosio with advanced prostate cancer a unique therapy that is fast and effective in reducing testosterone and PSA. If you have advanced prostate cancer, ask your doctor about FIRMAGON^®.

In a recent study, after just three days of treatment, participants in the FIRMAGON^® group achieved a 90% decrease in median testosterone levels, whereas patients who were treated with 7.5 mg of Lupron Depot^®, or leuprolide, a drug commonly used to treat advanced prostate cancer, saw a 65% increase in median testosterone levels. FIRMAGON^® was as effective as leuprolide in suppressing testosterone levels from Day 28 to the end of the study (Day 364) with 97.2% of the FIRMAGON^® patients maintaining medical castrate levels compared with 96.4% for leuprolide.

FIRMAGON^® reduces the production of testosterone by binding immediately and reversibly to the cells in the pituitary gland, quickly reducing the release of a hormone that causes testosterone production. FIRMAGON^® also significantly lowered levels of prostate specific antigen or PSA – a marker for prostate cancer. The clinical benefit is not yet known on the value of fast PSA reduction.

Lupron Depot^® (leuprolide acetate for depot suspension) is a registered trademark of TAP Pharmaceuticals Inc.
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