Ferring Pharmaceuticals submits new drug application for degarelix, a prostate cancer treatment
Plan to launch GnRH blocker in 2009 subject to regulatory approval.
Saint-Prex, Switzerland – February 28, 2008 –
Ferring Pharmaceuticals announced today that it has submitted applications in Europe and the United States for the marketing authorisation of its prostate cancer treatment, degarelix, a new GnRH receptor blocker intended for patients in whom androgen deprivation is warranted.
The applications follow the successful completion of a pivotal phase 3 study, in which degarelix was studied for the speed of the suppression in levels of testosterone, the maintenance of the reduction during the one year study period as well as prostate-specific antigen (PSA) reduction.
“We believe that the data for degarelix is convincing and demonstrates the benefits that this drug can offer to patients suffering from the most common form of cancer in men,” said Dr. Pascal Danglas, Ferring’s Executive Vice President of Clinical and Product Development. “Subject to approval by regulatory bodies, we plan to start launching globally in 2009.”
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Notes for editors
About Prostate Cancer
Prostate cancer is the most common form of cancer in men, and the second leading cause of cancer death. In the US 218,890 new cases were estimated for 2007, with a mortality of 27,050. In 2005 127,490 new cases were diagnosed in the 5 biggest European countries and 18,310 in Japan.
About Ferring Pharmaceuticals
Ferring is a Swiss-based, research driven, speciality biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of endocrinology, gastroenterology, gynaecology, fertility and urology. In recent years Ferring has expanded beyond its traditional European base and now has offices in over 40 countries. To learn more about Ferring or our products please visit www.ferring.com.