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Published on 20 March 2009

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Prostate cancer treatment launched

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FIRMAGON® (degarelix),a new treatment option in hormonal therapy for prostate cancer has been launched with details presented at the 24th Annual European Association of Urology(EAU) Congress in Stockholm. FIRMAGON is a new GnRH receptor blockerindicated for the treatment of patients with advanced hormone dependentprostate cancer.

FIRMAGON has a novel mechanism of action that is different fromcommonly used hormonal therapies. Administered as a subcutaneousinjection, FIRMAGON rapidly reduces levels of prostate specificantigen (PSA) by immediately blocking the GnRH receptors in thepituitary gland. Blocking the receptors suppresses the luteinisinghormone, which decreases production of testosterone by the testicles.Prostate cancer is dependant on testosterone for its growth, soreducing testosterone levels can slow the growth of cancer cells.

In clinical studies, FIRMAGON suppressed testosterone and PSA fasterthan leuprolide, an existing treatment for advanced prostate cancer.

“This is an important new step for the treatment of advanced,hormone-dependent prostate cancer, with FIRMAGON® offering a new optionand hope for many patients,” comments John Anderson, ConsultantUrological Surgeon, The Royal Hallamshire Hospital, Sheffield, UnitedKingdom. “Our goal is to achieve fast and sustained reduction intestosterone levels, and FIRMAGON offers a rapid impact which iscomparable to the immediacy achieved by surgery.”

The European launch of FIRMAGON follows the decision of the EuropeanCommission to grant marketing authorisation in the European Union lastmonth. This approval was based on pivotal Phase III studies whereFIRMAGON produced a reduction in levels of testosterone below0.5ng/ml within three days in more than 96% of study patients.Testosterone plays a major role in the growth and spread of prostatecancer cells, and the data showed FIRMAGON® provided a fast reductionof testosterone to very low levels, close to the immediate effectachieved with surgery (orchidectomy). This effect was sustained overthe whole study period.

In clinical trials FIRMAGON was generally well tolerated. Common sideeffects are hot flushes, injection site pain and erythema, increasedweight, nasopharyngitis, fatigue and back pain.

FIRMAGON will be marketed in Europe by Ferring Pharmaceuticals.Today’s launch represents another important milestone in the company’slong-standing commitment to develop new and improved treatment optionsin the field of urology.

Ferring



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