Committee for Medicinal Products for Human Use (CHMP) Recommends Granting Marketing Authorisation for FIRMAGON(R) (degarelix) for Treatment of Prostate Cancer
- New Gonadotropin-Releasing Hormone (GnRH) Receptor AntagonistDemonstrates Rapid, Long-Term Suppression of Testosterone
Ferring Pharmaceuticals received today notification that the Committeefor Medicinal Products for Human Use (CHMP), part of the European MedicinesAgency (EMEA), has adopted a positive opinion and is recommending to grant amarketing authorization for FIRMAGON(R) (degarelix), a new GnRH receptorantagonist indicated for patients with advanced, hormone-dependent prostatecancer. In Phase III studies degarelix produced a significant reduction inlevels of testosterone (i),(ii) within three days in more than 96% of studypatients.(ii) Testosterone plays a major role in the growth and spread ofprostate cancer cells.
The data show that degarelix provided an extremely fast effect ontestosterone levels, close to the immediate effect achieved with surgery(orchidectomy).(ii),(iii)
The Phase III study compared monthly administration of degarelix withmonthly luteneising hormone releasing-hormone (LHRH) agonist leuprorelin's7.5 mg in a 12-month randomised, open-label, parallel-group study in prostatecancer patients. In comparison to leuprorelin, degarelix suppressed serumtestosterone and Prostate Specific Antigen (PSA) significantly faster. Inaddition, degarelix was able to sustain these low levels during the entire 12month study.(ii)
By day 3 of the study, testosterone levels were suppressed to =0.5ng/mLin 96.1% of patients in the degarelix arms of the study compared to 0% in theleuprorelin arm. By day 14, 100% of patients in the degarelix arms achievedsuppression of testosterone levels at =0.5ng/mL compared to 18.2% in theleuprorelin arm.(ii) After 14 days of treatment, PSA levels had declined inthe degarelix treated patients by a median of 64%, while patients who wereadministered leuprorelin saw an 18% decline. Both treatments were welltolerated and showed similar side effect profiles. The most common sideeffects are hot flushes, injection site pain, injection site erythema,increased weight, nasopharyngitis, fatigue and back pain.
"Degarelix was discovered and developed by Ferring Pharmaceuticals and inits pivotal Phase III study demonstrated both an immediate onset of actionand a profound long-term suppression of testosterone and PSA," commented DrPascal Danglas, Executive Vice President Clinical & Product Development atFerring Pharmaceuticals. "We will be delighted to deliver a new treatmentoption for advanced prostate cancer to the medical community. Ferring has aconsiderable pipeline of urology products in development and we expect tointroduce additional innovations in the urology field in the near future."
"Our goal is always to have a fast and sustained reduction intestosterone levels," said Mr John Anderson, Consultant Urological Surgeon,The Royal Hallamshire Hospital, Sheffield, United Kingdom "Degarelix producesan extremely rapid impact, approaching the immediacy of surgery and it isgood news that the product should become imminently available."
Ferring Pharmaceuticals plans to launch FIRMAGON(R) (degarelix) in Europein the first quarter of 2009 and is also awaiting an imminent FDA decision onapproval for commercialisation in the US. It is expected thatcommercialisation in other key global markets will follow during 2009 and2010 once approval is received from the relevant local regulatory authorities.
Michel Pettigrew, Chief Operating Officer Ferring Pharmaceuticals,stated: "The recommendation from the EMEA to grant marketing authorisationfor FIRMAGON(R) is a significant milestone for Ferring. It is the firstpositive opinion we have received from a regulatory authority for FIRMAGON(R)which, in turn, will be the first product that Ferring will launch on aglobal basis. We are truly excited to be on the brink of introducing this newtherapy to physicians and patients, and we look forward to providing aninnovative tool that will add meaningfully to the treatment options foraddressing prostate cancer."
Degarelix went through an extensive clinical programme of more than 20studies. All studies have found degarelix to be well tolerated and with noevidence of systemic allergic reactions.(ii),(iv),(v)
Notes to Editors
About Prostate Cancer
Prostate cancer is the most common form of cancer in men, and the secondleading cause of cancer death. In the US 218,890 new cases were estimated for2007, with a mortality rate of 27,050. In 2005 127,490 new cases werediagnosed in the 5 biggest European countries and 18,310 in Japan.
Degarelix is a GnRH receptor antagonist indicated for advanced prostatecancer.
Ferring is a Swiss-headquartered, research driven, specialitybiopharmaceutical group active in global markets. The company identifies,develops and markets innovative products in the areas of urology,endocrinology, gastroenterology, gynaecology, and fertility. In recent yearsFerring has expanded beyond its traditional European base and now has officesin over 40 countries. To learn more about Ferring or our products pleasevisit http://www.ferring.com.--------------------------------- (i) Van Poppel H, De La Rosette JJ, Persson B.E, Oleson TK, Degarelix Study Group; Long-term evaluation of degarelix, a gonadotrophin- releasing hormone (GnRH) receptor blocker, investigated in a multicentre randomised study in prostate cancer (CAP) patients. Abstract (23.) Euro Urol Suppl 2007;6(2):28 (ii) Boccon-Gibod L, Klotz L, Schroder FH, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK; Degarelix compared to leuprolide depot 7.5 mg in a 12-month randomised, open-label, parallel-group phase III study in prostate cancer patients. Abstract 537 presented at the 23rd EAU Congress, Milan, Italy, 2008. (iii) Nielsen S, Connolly M, Persson B, Variation between countries in the perceived use of antiandrogens to prevent flare symptoms: results of a comprehensive survey. Abstract 539 presented at the 23rd EAU Congress, Milan, Italy, 2008 (iv) Gittelman M, Pommerville P, Persson B, Olesen T, A 1-year, open label, randomised Phase II dose finding study of degarelix for the treatment of prostate cancer in North America. Journal of Urology, Vol. 180, November 2008. (v) Tammela T, Iversen P, Johansson J, Persson B, Jensen J, Olesen T. Degarelix-a phase II multicentre, randomised dose escalating study testing a novel GnRH receptor blocker in prostate cancer patients (Abstract No. 904) European Urology Supplements 4 (2005) No.3, pp 228. For further information please contact: Katie Fyfe, Tonic Life Communications, Tel: +44-207-798-9920, Katie.firstname.lastname@example.org . Monica Gounaropoulos, Tonic Life, Communications, Tel: +44-207-798-9910, Monica.email@example.com . Helen Gallagher, Ferring Pharmaceuticals, Tel: +41-58-301-0051, Helen.Gallagher@ferring.com .
SOURCE Ferring Pharmaceuticals
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