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 theCommittee for Medicinal Products for Human Use (CHMP), part of theEuropean Medicines Agency (EMEA), has adopted a positive opinion andis recommending to grant a marketing authorization for FIRMAGON(R)(degarelix), a new GnRH receptor antagonist indicated for patientswith advanced, hormone-dependent prostate cancer. In Phase IIIstudies degarelix produced a significant reduction in levels oftestosterone (i),(ii) within three days in more than 96% of studypatients.(ii) Testosterone plays a major role in the growth andspread of prostate cancer cells.
The data show that degarelix provided an extremely fast effect ontestosterone levels, close to the immediate effect achieved withsurgery (orchidectomy).(ii),(iii)
The Phase III study compared monthly administration of degarelixwith monthly luteneising hormone releasing-hormone (LHRH) agonistleuprorelin's 7.5 mg in a 12-month randomised, open-label,parallel-group study in prostate cancer patients. In comparison toleuprorelin, degarelix suppressed serum testosterone and ProstateSpecific Antigen (PSA) significantly faster. In addition, degarelixwas able to sustain these low levels during the entire 12 monthstudy.(ii)
By day 3 of the study, testosterone levels were suppressed to=0.5ng/mL in 96.1% of patients in the degarelix arms of the studycompared to 0% in the leuprorelin arm. By day 14, 100% of patients inthe degarelix arms achieved suppression of testosterone levels at=0.5ng/mL compared to 18.2% in the leuprorelin arm.(ii) After 14 daysof treatment, PSA levels had declined in the degarelix treatedpatients by a median of 64%, while patients who were administeredleuprorelin saw an 18% decline. Both treatments were well toleratedand showed similar side effect profiles. The most common side effectsare hot flushes, injection site pain, injection site erythema,increased weight, nasopharyngitis, fatigue and back pain.
"Degarelix was discovered and developed by FerringPharmaceuticals and in its pivotal Phase III study demonstrated bothan immediate onset of action and a profound long-term suppression oftestosterone and PSA," commented Dr Pascal Danglas, Executive VicePresident Clinical & Product Development at Ferring Pharmaceuticals."We will be delighted to deliver a new treatment option for advancedprostate cancer to the medical community. Ferring has a considerablepipeline of urology products in development and we expect tointroduce additional innovations in the urology field in the nearfuture."
"Our goal is always to have a fast and sustained reduction intestosterone levels," said Mr John Anderson, Consultant UrologicalSurgeon, The Royal Hallamshire Hospital, Sheffield, United Kingdom"Degarelix produces an extremely rapid impact, approaching theimmediacy of surgery and it is good news that the product shouldbecome imminently available."
Ferring Pharmaceuticals plans to launch FIRMAGON(R) (degarelix)in Europe in the first quarter of 2009 and is also awaiting animminent FDA decision on approval for commercialisation in the US. Itis expected that commercialisation in other key global markets willfollow during 2009 and 2010 once approval is received from therelevant local regulatory authorities.
Michel Pettigrew, Chief Operating Officer FerringPharmaceuticals, stated: "The recommendation from the EMEA to grantmarketing authorisation for FIRMAGON(R) is a significant milestonefor Ferring. It is the first positive opinion we have received from aregulatory authority for FIRMAGON(R) which, in turn, will be thefirst product that Ferring will launch on a global basis. We aretruly excited to be on the brink of introducing this new therapy tophysicians and patients, and we look forward to providing aninnovative tool that will add meaningfully to the treatment optionsfor addressing prostate cancer."
Degarelix went through an extensive clinical programme of morethan 20 studies. All studies have found degarelix to be welltolerated and with no evidence of systemic allergicreactions.(ii),(iv),(v)
Notes to Editors
About Prostate Cancer
Prostate cancer is the most common form of cancer in men, and thesecond leading cause of cancer death. In the US 218,890 new caseswere estimated for 2007, with a mortality rate of 27,050. In 2005127,490 new cases were diagnosed in the 5 biggest European countriesand 18,310 in Japan.
Degarelix is a GnRH receptor antagonist indicated for advancedprostate cancer.
Ferring is a Swiss-headquartered, research driven, specialitybiopharmaceutical group active in global markets. The companyidentifies, develops and markets innovative products in the areas ofurology, endocrinology, gastroenterology, gynaecology, and fertility.In recent years Ferring has expanded beyond its traditional Europeanbase and now has offices in over 40 countries. To learn more aboutFerring or our products please visit 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 .
ots Originaltext: Ferring Pharmaceuticals A/SIm Internet recherchierbar: http://www.presseportal.de
Contact:For further information please contact: Katie Fyfe, Tonic Life Communications, Tel: +44-207-798-9920, Katie.firstname.lastname@example.org. MonicaGounaropoulos, Tonic Life, Communications,Tel: +44-207-798-9910, Monica.email@example.com. Helen Gallagher, FerringPharmaceuticals, Tel: +41-58-301-0051, Helen.Gallagher@ferring.com.
Ferring Pharmaceuticals A/S