FIRMAGON(R) (Degarelix) is Launched in Europe for the Treatment of Advanced Prostate Cancer

By Prne, Gaea News Network
Tuesday, March 17, 2009

STOCKHOLM, Sweden - Today marks the European launch of FIRMAGON(R) (degarelix), a new
treatment option in hormonal therapy for prostate cancer, with details
presented at the 24th Annual European Association of Urology (EAU) Congress
in Stockholm. FIRMAGON(R) is a new GnRH receptor blocker indicated for the
treatment of patients with advanced hormone-dependent prostate cancer.

FIRMAGON(R) has a novel mechanism of action that is different from
commonly used hormonal therapies. Administered as a subcutaneous injection,
FIRMAGON(R) rapidly reduces levels of prost ate specific antigen (PSA) by
immediately blocking the GnRH receptors in the pituitary gland. Blocking the
receptors suppresses the luteinising hormone, which decreases production of
testosterone by the testicles. Prostate cancer is dependant on testosterone
for its growth, so reducing testosterone levels can slow the growth of cancer
cells.

In clinical studies, FIRMAGON(R) suppressed testosterone and PSA faster
than leuprolide, an existing treatment for advanced prostate cancer.(2)

“This is an important new step for the treatment of advanced,
hormone-dependent prostate cancer, with FIRMAGON(R) offering a new option and
hope for many patients,” comments John Anderson, Consultant Urological
Surgeon, The Royal Hallamshire Hospital, Sheffield, United Kingdom. “Our goal
is to achieve fast and sustained reduction in testosterone levels, and
FIRMAGON(R) offers a rapid impact which is comparable to the immediacy
achieved by surgery.”

The European launch of FIRMAGON(R) follows the decision of the European
Commission to grant marketing authorisation in the European Union last month.
This approval was based on pivotal Phase III studies where FIRMAGON(R)
produced a reduction in levels of testosterone(1,2) below 0.5ng/ml within
three days in more than 96% of study patients.(2) Testosterone plays a major
role in the growth and spread of prostate cancer cells, and the data showed
FIRMAGON(R) provided a fast reduction of testosterone to very low levels,
close to the immediate effect achieved with surgery (orchidectomy).(2,3) This
effect was sustained over the whole study period.

In clinical trials FIRMAGON(R) was generally well tolerated. Common side
effects are hot flushes, injection site pain and erythema, increased weight,
nasopharyngitis, fatigue and back pain.

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

Notes to Editors

About Prostate Cancer

Prostate cancer is the most common form of cancer in men, and the second
leading cause of cancer death. In 2005 127,490 new cases were diagnosed in
the 5 biggest European countries and 18,310 in Japan. In the US 218,890 new
cases were estimated for 2007, with a mortality rate of 27,050. For further
media information and news alerts on prostate cancer please visit Ferring’s
information website www.prostatecancerliving.com

About Ferring

Ferring is a Swiss-headquartered, research driven, speciality
biopharmaceutical 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 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.

References

(1) 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

(2) Klotz L, Boccon-Gibod L, Schröder FH, Shore ND, Andreou C, Persson
BE, Cantor P, Jensen JK, Olesen TK; The efficacy and safety of degarelix: a
12-month, comparative, randomized, open-label, parallel-group phase III study
in patients with prostate cancer. BJU Int. 2008;102(11):1531-1538.

(3) 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

Source: Ferring Pharmaceuticals

Media enquiries: Katie Fyfe, Tonic Life, Communications, Tel: +44-207-798-9920, Katie.fyfe at toniclc.com. Monica Gounaropoulos, Tonic Life Communications, Tel: +44-207-798-9910, Monica.g at toniclc.com. Michael George, Ferring Pharmaceuticals, Tel: +41-58-301-00-53, michael.george at ferring.com

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