New drug application submission to be made in Q1 2008
Saint Prex, Switzerland, December 3, 2007 - Ferring Pharmaceuticals announced today that it has successfully completed the pivotal phase III study for degarelix, its novel prostate cancer treatment. The study met the primary objective of reducing levels of testosterone, while the safety profile was in line with previously conducted studies.
Degarelix is one of the first drugs in the emerging GnRH blocker class of treatments for prostate cancer. This class can offer important benefits versus existing prostate cancer therapies. Ferring intends to submit a New Drug Application (NDA) to the FDA and EMEA in the first quarter of 2008.
Dr. Pascal Danglas, Ferring's Executive Vice President of Clinical and Product Development, commented: "with the successful completion of this phase III study, degarelix has become one of the most studied molecules in development in the field of prostate cancer. We are confident that the data generated will meet FDA and EMEA requirements and allow a fast and successful review of the file."
"We believe that degarelix offers physicians and patients an important new prostate cancer treatment which can satisfy as yet unmet medical needs," said Ferring's Chief Operating Officer, Michel Pettigrew. "Once approved, we hope to launch globally beginning in the second half of 2009."
Notes for editors
How degarelix works
Currently used hormonal treatments for prostate cancer include GnRH (gonadotrophin releasing hormone) agonists. Unlike degarelix, agonist therapies stimulate the natural hormone's receptor on the pituitary gland. These agents also have a desired clinical effect, but they initially stimulate testosterone production before shutting it down. This initial stimulation of the receptors stimulates hormone-dependent tumour growth rather than inhibits it, and may lead to a worsening of cancer symptoms or 'flare'.
Degarelix is designed to target and block the GnRH receptor. This immediately prevents the production of testosterone and thereby avoids the surge of testosterone and flare of the disease.
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 rate of 27,050. In 2005 127,490 new cases were diagnosed in the 5 biggest European countries and 18,310 in Japan.
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.
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